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1/ 2016 MLE-M3 Participant Summary MEDICAL LABORATORY E E V V A A L L U U A A T T I I O O N N PARTICIPANT SUMMARY 2 • 0 • 1 • 6 Chemistry 2016 MLE-M3 Total Commitment to Education and Service Provided by ACP, Inc.

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Page 1: M E D I C A L L A B O R A T O R Y E VV AA ALLL UUU A TTT ...5 2016 MLE-M3 Participant Summary/ tCO 2 (mmol/L) Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range

1/ 2016 MLE-M3 Participant Summary

M E D I C A L L A B O R A T O R Y

EEE VVV AAA LLL UUU AAA TTT III OOO NNN

PARTICIPANT SUMMARY

2 • 0 • 1 • 6

Chemistry

2016 MLE-M3

Total Commitment to Education and Service

Provided by ACP, Inc.

Page 2: M E D I C A L L A B O R A T O R Y E VV AA ALLL UUU A TTT ...5 2016 MLE-M3 Participant Summary/ tCO 2 (mmol/L) Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range

2/ 2016 MLE-M3 Participant Summary

Table of Contents Evaluation Criteria ........................................................... 3 Hemoglobin ..................................................................... 7

HDL Cholesterol ............................................................ 77

Acetaminophen ............................................................... 83 Homocysteine ............................................................. 101

Acetone ......................................................................... 103 Insulin ........................................................................... 91

Albumin ............................................................................. 9 Iron ................................................................................ 26

Alcohol, Serum .............................................................. 103 Lactate Dehydrogenase ................................................ 62

Alkaline Phosphatase ...................................................... 52 Lactic Acid .................................................................... 27

Alpha-fetoprotein (AFP) ................................................... 65 LDL Cholesterol, Calculated ......................................... 75

ALT (SGPT) ..................................................................... 49 LDL Cholesterol, Direct ................................................. 76

Ammonia ....................................................................... 104 LH ............................................................................... 101

Amylase (Serum) ............................................................. 61 Lipase ........................................................................... 64

Anti-Microsomal Antibody .............................................. 104 Lithium .......................................................................... 84

Anti-Thyroglobulin Antibody ........................................... 104 Magnesium ................................................................... 27

Apolipoprotein A1 ............................................................ 88 Myoglobin ..................................................................... 96

Apolipoprotein B .............................................................. 88 NT-proBNP ................................................................... 96

AST (SGOT) .................................................................... 55 Parathyroid Hormone .................................................... 92

Beta-2 Microglobulin ........................................................ 98 Phenobarbital ................................................................ 85

Bilirubin, Direct (CH Specimens) ..................................... 12 Phenytoin ...................................................................... 85

Bilirubin, Direct (NB Specimens) ..................................... 89 Phosphorus ................................................................... 29

Bilirubin, Neonatal (Total) ................................................ 88 Potassium (CH Specimens) .......................................... 43

Bilirubin, Total .................................................................. 14 Potassium (IST Specimens) ........................................... 4

Blood Gases .................................................................... 89 Progesterone .............................................................. 101

BNP ................................................................................. 94 Prolactin ...................................................................... 102

C-Peptide ........................................................................ 92 Protein, Total................................................................. 31

CA 125 ............................................................................ 98 PSA (PS Specimens) .................................................... 97

CA 15-3 ........................................................................... 98 PSA (TM Specimens) ................................................... 99

CA 19-9 ........................................................................... 98 PSA, Free ..................................................................... 99

CA 27/29 ......................................................................... 99 Salicylate ...................................................................... 86

Calcium ........................................................................... 17 Sex Hormone Binding Globulin (SHBG) ....................... 93

Calcium, Ionized (IST Specimens) .................................... 8 Sodium (CH Specimens) .............................................. 45

Carbamazepine ............................................................... 83 Sodium (IST Specimens) ................................................ 4

CEA (SC Specimens) .................................................... 100 T3, Free ......................................................................... 67

CEA (TM Specimens) ...................................................... 97 T3 Uptake (% Uptake) ................................................... 66

Chloride (CH Specimens) ................................................ 39 tCO2 (IST Specimens) .................................................... 5

Chloride (IST Specimens) ................................................. 5 Testosterone (SC Samples) ........................................ 102

Cholesterol, Total ............................................................ 72 Testosterone (SHB Samples) ....................................... 93

CK-MB ............................................................................. 94 Testosterone, Bioavailable ............................................ 92

CO2 (CH Specimens) ....................................................... 41 Testosterone, Free ........................................................ 93

Cortisol ............................................................................ 65 Theophylline.................................................................. 86

Creatine Kinase ............................................................... 58 Thyroglobulin ................................................................ 99

Creatinine (CH Specimens) ............................................. 20 Thyroxine, Free ............................................................. 68

Creatinine (IST Specimens) .............................................. 8 Thyroxine, Total T4 ........................................................ 67

D-Dimer ........................................................................... 95 TIBC, Calculated ........................................................... 47

DHEA-S ......................................................................... 100 TIBC, Direct .................................................................. 47

Digoxin ............................................................................ 83 Transferrin .................................................................. 102

Estradiol ........................................................................ 100 Triglycerides.................................................................. 80

Ferritin ........................................................................... 100 Triiodothyronine, Total T3 .............................................. 66

Folate ............................................................................ 101 Troponin I ...................................................................... 97

Fructosamine ................................................................. 124 TSH ............................................................................... 69

FSH ............................................................................... 101 UIBC, Direct .................................................................. 48

Gentamicin ...................................................................... 84 Urea Nitrogen (CH Specimens) .................................... 34

GGT ................................................................................ 60 Urea Nitrogen (IST Specimens) ...................................... 6

Glucose, Whole Blood (WBG Specimens) .................... 123 Uric Acid ....................................................................... 37

Glucose, Serum (CH Specimens) ................................... 23 Urine Chemistry .......................................................... 125

Glucose (IST Specimens).................................................. 6 Urine Drug Screen ...................................................... 104

Glycohemoglobin (AFN Specimens) ............................... 93 Valproic Acid ................................................................. 87

Glycohemoglobin (GH Specimens) ................................. 93 Vancomycin .................................................................. 87

HCG, Serum—Qualitative ............................................... 70 Vitamin B12 .................................................................. 102

HCG, Serum—Quantitative ............................................. 71 Vitamin D (25-Hydroxy) ................................................. 92

Hematocrit ......................................................................... 7

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2016 MLE-M3 Participant Summary/ 3

EVALUATION CRITERIA

For quantitative procedures, a mean and standard deviation (SD) are calculated for each peer group. Acceptable

performance is established on a target value mean the limits listed below.

*Whichever is greater

Acetaminophen 3 SD or 10% * Homocysteine 25% Acetone 80% Consensus Insulin 2 SD Albumin 10% Iron 20% Alcohol 25% Lactate Dehydrogenase 20% Alpha-fetoprotein 3 SD Lactic Acid 0.4 mmol/L or 3 SD * Alkaline Phosphatase 30% LDL Cholesterol 2 SD or 30% * ALT (SGPT) 20% Lipase 30% Ammonia 2 SD or 5% * LH 2 SD Amylase 30% Lithium 0.3 mmol/L or 20% * Anti-Microsomal Antibody 2 SD Magnesium 25% Anti-Thyroglobulin Antibody 2 SD Myoglobin 2 SD or 30% * Apoliprotein A1 30% NT-proBNP 2 SD or 25% * Apoliprotein B 25% Parathyroid Hormone 2 SD AST (SGOT) 20% Phenobarbital 20% B-Type Natriuretic Peptide (BNP) 2 SD or 25% * Phenytoin 25% Beta-2 Microglobulin 3 SD Phosphorus 0.3 mg/dL or 10.7% * Bilirubin, Direct 2 SD Potassium 0.5 mmol/L Bilirubin, Total 0.4 mg/dL or 20% * Progesterone 30% Bilirubin, Neonatal (Total) 0.4 mg/dL or 20% * Prolactin 3.6 ng/mL or 30% * C-Peptide 2 SD Protein, Total (Serum) 10% CA 125 2 SD or 30% * Protein, Total (Urine) 44% CA 15-3 3 SD PSA 0.9 ng/mL or 30% * CA 19-9 3 SD PSA, Free 0.9 ng/mL or 30% * CA 27/29 3 SD pCO2 5 mmHg or 8% * Calcium 1.0 mg/dL pH 0.04 Calcium, Ionized 3 SD pO2 3 SD Carbamazepine 25% Salicylate 3 SD or 10% * CEA 1.2 ng/mL 30% SHBG 3 SD Chloride 5% Sodium 4.0 mmol/L Cholesterol 10% T3 Uptake (% Uptake) 3 SD CK-MB (Quantitative) 3 SD T3, Free 3 SD CO2 20% T4, Free 3 SD Cortisol 25% tCO2 20% Creatine Kinase 30% Testosterone 30% Creatinine (Serum) 0.3 mg/dL or 15% * Testosterone, Bioavailable 3 SD Creatinine (Urine) 17% Testosterone, Free 3 SD D-Dimer 2 SD or 30% * Theophylline 25% DHEA-S 30% Thyroglobulin 2 SD Digoxin 0.2 mg/dL or 20% * Thyroxine, Total T4 1.0 µg/dL or 20% * Estradiol 2 SD TIBC 2 SD or 20% * Ferritin 30% Transferrin 10% Folate 0.9 ng/mL or 30%* Triglyceride 25% Fructosamine (mmol/L) 0.45 or 30% * Triiodothyronine, Total T3 3 SD Fructosamine (µmol/L) 45 or 30% * Troponin I 2 SD or 30% * FSH 25% Troponin T 2 SD or 30% * Gentamicin 25% TSH 3 SD GGT 2 SD or 20% * UIBC 2 SD or 20% * Glucose, Serum 6 mg/dL or 10% * Urea Nitrogen 2.0 mg/dL or 9% * Glucose, Whole Blood 12 mg/dL or 20% * Uric Acid 17% Glycohemoglobin 10% Urine Drug Screen 80% Consensus

HDL Cholesterol 30% Valproic Acid 25% HCG, Serum—Qualitative 80% Consensus Vancomycin 3 SD or 10% * HCG, Serum—Quantitative 3 SD Vitamin B12 30% Hematocrit 6% Vitamin D 2 SD Hemoglobin 7% Troponin I 2 SD or 30% * Homocysteine 25% Troponin T 30%

Page 4: M E D I C A L L A B O R A T O R Y E VV AA ALLL UUU A TTT ...5 2016 MLE-M3 Participant Summary/ tCO 2 (mmol/L) Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range

4/ 2016 MLE-M3 Participant Summary

Sodium (mmol/L)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 98 144.3 0.9 0.6 144 140 - 149 99 125.5 0.6 0.5 125 121 - 130 All i-STAT Instruments 98 144.3 0.9 0.6 144 140 - 149 99 125.5 0.6 0.5 125 121 - 130 i-STAT - moderate 12 143.8 1.1 0.7 144 139 - 148 12 125.1 0.7 0.5 125 121 - 130 i-STAT - waived 86 144.4 0.8 0.6 144 140 - 149 87 125.5 0.6 0.5 126 121 - 130

Specimen IST-13 Specimen IST-14

All Method 85 112.7 0.6 0.6 113 108 - 117 83 167.4 0.7 0.4 167 163 - 172 All i-STAT Instruments 85 112.7 0.6 0.6 113 108 - 117 83 167.4 0.7 0.4 167 163 - 172 i-STAT - moderate 11 112.5 0.8 0.7 113 108 - 117 11 167.1 0.9 0.6 167 163 - 172 i-STAT - waived 74 112.8 0.6 0.5 113 108 - 117 73 167.4 0.7 0.4 167 163 - 172

Specimen IST-15 All Method 84 122.6 0.7 0.6 123 118 - 127 All i-STAT Instruments 84 122.6 0.7 0.6 123 118 - 127 i-STAT - moderate 11 122.8 1.1 0.9 123 118 - 127 i-STAT - waived 74 122.6 0.7 0.5 123 118 - 127

Potassium (mmol/L)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 91 4.10 0.01 0.0 4.1 3.6 - 4.6 98 2.73 0.05 1.7 2.7 2.2 - 3.3 All i-STAT Instruments 91 4.10 0.01 0.0 4.1 3.6 - 4.6 98 2.73 0.05 1.7 2.7 2.2 - 3.3 i-STAT - moderate 12 4.10 0.04 1.0 4.1 3.6 - 4.6 12 2.72 0.04 1.4 2.7 2.2 - 3.3 i-STAT - waived 81 4.10 0.01 0.0 4.1 3.6 - 4.6 86 2.73 0.05 1.7 2.7 2.2 - 3.3

Specimen IST-13 Specimen IST-14 All Method 85 2.05 0.05 2.5 2.0 1.5 - 2.6 81 6.61 0.03 0.5 6.6 6.1 - 7.2 All i-STAT Instruments 85 2.05 0.05 2.5 2.0 1.5 - 2.6 81 6.61 0.03 0.5 6.6 6.1 - 7.2 i-STAT - moderate 11 2.05 0.05 2.6 2.0 1.5 - 2.6 11 6.63 0.08 1.2 6.6 6.1 - 7.2 i-STAT - waived 74 2.05 0.05 2.5 2.1 1.5 - 2.6 66 6.60 0.01 0.0 6.6 6.1 - 7.1

Specimen IST-15 All Method 85 3.22 0.04 1.2 3.2 2.7 - 3.8 All i-STAT Instruments 85 3.22 0.04 1.2 3.2 2.7 - 3.8 i-STAT - moderate 11 3.22 0.04 1.3 3.2 2.7 - 3.8 i-STAT - waived 74 3.22 0.04 1.3 3.2 2.7 - 3.8

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2016 MLE-M3 Participant Summary/ 5

tCO2 (mmol/L)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 92 20.6 0.7 3.6 21 16 - 25 91 22.9 0.8 3.6 23 18 - 28 All i-STAT Instruments 92 20.6 0.7 3.6 21 16 - 25 91 22.9 0.8 3.6 23 18 - 28 i-STAT - moderate 11 21.0 0.8 3.7 21 16 - 26 11 23.2 0.6 2.6 23 18 - 28 i-STAT - waived 81 20.5 0.7 3.5 20 16 - 25 80 22.9 0.9 3.7 23 18 - 28

Specimen IST-13 Specimen IST-14

All Method 82 18.8 0.7 3.9 19 15 - 23 80 21.9 0.8 3.6 22 17 - 27 All i-STAT Instruments 82 18.8 0.7 3.9 19 15 - 23 80 21.9 0.8 3.6 22 17 - 27 i-STAT - moderate 10 18.9 0.6 3.0 19 15 - 23 10 22.1 0.6 2.6 22 17 - 27 i-STAT - waived 72 18.8 0.8 4.0 19 15 - 23 70 21.9 0.8 3.8 22 17 - 27

Specimen IST-15

All Method 80 17.1 0.8 4.6 17 13 - 21 All i-STAT Instruments 80 17.1 0.8 4.6 17 13 - 21 i-STAT - moderate 10 17.1 0.6 3.3 17 13 - 21 i-STAT - waived 70 17.1 0.8 4.8 17 13 - 21

Chloride (mmol/L)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 95 81.7 1.0 1.3 81 77 - 86 98 76.3 0.9 1.2 76 72 - 81 All i-STAT Instruments 95 81.7 1.0 1.3 81 77 - 86 98 76.3 0.9 1.2 76 72 - 81 i-STAT - moderate 12 81.8 1.7 2.1 81 77 - 86 12 76.8 1.0 1.3 77 72 - 81 i-STAT - waived 84 81.7 1.0 1.2 81 77 - 86 85 76.2 0.8 1.1 76 72 - 81

Specimen IST-13 Specimen IST-14

All Method 84 71.8 0.8 1.1 72 68 - 76 83 116.6 0.9 0.8 117 110 - 123 All i-STAT Instruments 84 71.8 0.8 1.1 72 68 - 76 83 116.6 0.9 0.8 117 110 - 123 i-STAT - moderate 11 72.1 1.0 1.4 72 68 - 76 11 116.7 1.1 0.9 117 110 - 123 i-STAT - waived 73 71.7 0.8 1.1 72 68 - 76 72 116.5 0.9 0.8 117 110 - 123

Specimen IST-15

All Method 82 100.8 0.9 0.9 101 95 - 106 All i-STAT Instruments 82 100.8 0.9 0.9 101 95 - 106 i-STAT - moderate 11 100.4 1.6 1.6 101 95 - 106 i-STAT - waived 72 100.8 0.9 0.9 101 95 - 106

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6/ 2016 MLE-M3 Participant Summary

Glucose (mg/dL)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 95 126.8 1.4 1.1 127 114 - 140 97 185.5 1.4 0.7 185 166 - 205 All i-STAT Instruments 95 126.8 1.4 1.1 127 114 - 140 97 185.5 1.4 0.7 185 166 - 205 i-STAT - moderate 12 127.1 1.7 1.3 127 114 - 140 12 185.1 1.2 0.7 185 166 - 204 i-STAT - waived 83 126.7 1.3 1.0 127 114 - 140 85 185.6 1.4 0.7 185 167 - 205

Specimen IST-13 Specimen IST-14

All Method 84 51.6 1.2 2.3 52 45 - 58 82 238.7 2.1 0.9 239 214 - 263 All i-STAT Instruments 84 51.6 1.2 2.3 52 45 - 58 82 238.7 2.1 0.9 239 214 - 263 i-STAT - moderate 11 51.9 1.4 2.8 52 45 - 58 11 238.5 2.0 0.8 238 214 - 263 i-STAT - waived 71 51.4 1.0 1.9 52 45 - 58 71 238.8 2.2 0.9 239 214 - 263

Specimen IST-15

All Method 83 38.6 1.3 3.2 39 32 - 45 All i-STAT Instruments 83 38.6 1.3 3.2 39 32 - 45 i-STAT - moderate 11 39.0 1.8 4.7 39 33 - 45 i-STAT - waived 73 38.6 1.2 3.2 38 32 - 45

Urea Nitrogen (BUN) (mg/dL)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 98 36.7 0.8 2.2 37 33 - 41 95 66.5 1.1 1.6 66 60 - 73 All i-STAT Instruments 98 36.7 0.8 2.2 37 33 - 41 95 66.5 1.1 1.6 66 60 - 73 i-STAT - moderate 12 36.9 1.1 2.9 37 33 - 41 12 66.8 1.3 2.0 67 60 - 73 i-STAT - waived 86 36.7 0.8 2.1 37 33 - 41 84 66.5 1.1 1.6 66 60 - 73

Specimen IST-13 Specimen IST-14 All Method 84 8.1 0.3 3.8 8 6 - 11 84 46.4 1.0 2.1 46 42 - 51 All i-STAT Instruments 84 8.1 0.3 3.8 8 6 - 11 84 46.4 1.0 2.1 46 42 - 51 i-STAT - moderate 11 8.2 0.4 4.9 8 6 - 11 11 47.0 1.1 2.3 47 42 - 52 i-STAT - waived 66 8.0 0.1 0.0 8 6 - 10 73 46.3 0.9 2.0 46 42 - 51

Specimen IST-15

All Method 84 6.2 0.4 6.8 6 4 - 9 All i-STAT Instruments 84 6.2 0.4 6.8 6 4 - 9 i-STAT - moderate 11 6.4 0.5 7.9 6 4 - 9 i-STAT - waived 73 6.2 0.4 6.6 6 4 - 9

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2016 MLE-M3 Participant Summary/ 7

Hemoglobin (g/dL)

Specimen IST-11 Specimen IST-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 20 12.05 0.26 2.2 11.9 11.2 - 12.9 20 6.96 0.23 3.3 6.8 6.4 - 7.5 All i-STAT Instruments 20 12.05 0.26 2.2 11.9 11.2 - 12.9 20 6.96 0.23 3.3 6.8 6.4 - 7.5 i-STAT - waived 17 12.08 0.28 2.3 11.9 11.2 - 13.0 17 6.99 0.24 3.4 6.8 6.4 - 7.5

Specimen IST-13 Specimen IST-14

All Method 11 4.44 0.13 3.0 4.4 4.1 - 4.8 11 10.23 0.18 1.8 10.2 9.5 - 11.0 All i-STAT Instruments 11 4.44 0.13 3.0 4.4 4.1 - 4.8 11 10.23 0.18 1.8 10.2 9.5 - 11.0

Specimen IST-15

All Method 11 6.93 0.16 2.3 6.8 6.4 - 7.5 All i-STAT Instruments 11 6.93 0.16 2.3 6.8 6.4 - 7.5

Hematocrit (percent)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 20 35.5 0.8 2.1 35 33 - 38 20 20.5 0.7 3.4 20 19 - 22 All i-STAT Instruments 20 35.5 0.8 2.1 35 33 - 38 20 20.5 0.7 3.4 20 19 - 22 i-STAT - waived 17 35.5 0.8 2.3 35 33 - 38 17 20.6 0.7 3.5 20 19 - 22

Specimen IST-13 Specimen IST-14

All Method 11 13.1 0.3 2.5 13 12 - 14 11 30.1 0.6 2.0 30 28 - 32 All i-STAT Instruments 11 13.1 0.3 2.5 13 12 - 14 11 30.1 0.6 2.0 30 28 - 32

Specimen IST-15

All Method 11 20.4 0.5 2.6 20 19 - 22 All i-STAT Instruments 11 20.4 0.5 2.6 20 19 - 22

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8/ 2016 MLE-M3 Participant Summary

Creatinine (mg/dL)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 111 1.67 0.06 3.3 1.7 1.3 - 2.0 110 3.86 0.09 2.3 3.9 3.2 - 4.5 All i-STAT Instruments 111 1.67 0.06 3.3 1.7 1.3 - 2.0 110 3.86 0.09 2.3 3.9 3.2 - 4.5 i-STAT - moderate 13 1.66 0.05 3.0 1.7 1.3 - 2.0 13 3.84 0.10 2.5 3.8 3.2 - 4.5 i-STAT - waived 98 1.67 0.06 3.4 1.7 1.3 - 2.0 97 3.86 0.09 2.3 3.9 3.2 - 4.5

Specimen IST-13 Specimen IST-14

All Method 84 0.36 0.06 16.0 0.4 0.0 - 0.7 85 2.66 0.07 2.5 2.7 2.2 - 3.1 All i-STAT Instruments 84 0.36 0.06 16.0 0.4 0.0 - 0.7 85 2.66 0.07 2.5 2.7 2.2 - 3.1 i-STAT - moderate 12 0.36 0.08 22.1 0.4 0.0 - 0.7 12 2.65 0.05 2.0 2.7 2.2 - 3.1 i-STAT - waived 72 0.36 0.05 15.0 0.4 0.0 - 0.7 73 2.66 0.07 2.5 2.7 2.2 - 3.1

Specimen IST-15 All Method 84 6.68 0.20 3.0 6.7 5.6 - 7.7 All i-STAT Instruments 84 6.68 0.20 3.0 6.7 5.6 - 7.7 i-STAT - moderate 12 6.60 0.25 3.8 6.6 5.6 - 7.6 i-STAT - waived 73 6.68 0.21 3.1 6.7 5.6 - 7.7

Ionized Calcium (mmol/L)

Specimen IST-11 Specimen IST-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 87 1.427 0.020 1.4 1.43 1.36 - 1.49 87 2.096 0.024 1.1 2.09 2.02 - 2.17 All i-STAT Instruments 87 1.427 0.020 1.4 1.43 1.36 - 1.49 87 2.096 0.024 1.1 2.09 2.02 - 2.17 i-STAT - waived 78 1.428 0.020 1.4 1.43 1.36 - 1.49 78 2.098 0.023 1.1 2.09 2.02 - 2.17

Specimen IST-13 Specimen IST-14

All Method 79 0.556 0.007 1.2 0.56 0.53 - 0.58 79 0.591 0.007 1.2 0.59 0.56 - 0.62 All i-STAT Instruments 79 0.556 0.007 1.2 0.56 0.53 - 0.58 79 0.591 0.007 1.2 0.59 0.56 - 0.62 i-STAT - waived 71 0.556 0.006 1.2 0.56 0.53 - 0.58 71 0.591 0.007 1.2 0.59 0.56 - 0.62

Specimen IST-15 All Method 77 2.296 0.025 1.1 2.30 2.22 - 2.38 All i-STAT Instruments 77 2.296 0.025 1.1 2.30 2.22 - 2.38 i-STAT - waived 70 2.294 0.024 1.1 2.30 2.22 - 2.37

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2016 MLE-M3 Participant Summary/ 9

Albumin (g/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 285 5.10 0.53 10.4 5.3 4.5 - 5.7 285 2.58 0.27 10.4 2.7 2.3 - 2.9 All Bromocresol Green Reagents 189 5.43 0.24 4.4 5.4 4.8 - 6.0 190 2.73 0.18 6.7 2.8 2.4 - 3.1 All Bromocresol Purple Reagents 91 4.41 0.20 4.5 4.5 3.9 - 4.9 91 2.27 0.08 3.4 2.3 2.0 - 2.5 Abaxis Piccolo Abaxis Piccolo - waived 27 4.20 0.12 3.0 4.2 3.7 - 4.7 27 2.29 0.09 4.1 2.3 2.0 - 2.6 All Chemistry Instruments 35 4.21 0.12 2.8 4.2 3.7 - 4.7 35 2.29 0.08 3.6 2.3 2.0 - 2.6 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 28 5.38 0.09 1.7 5.4 4.8 - 6.0 28 2.76 0.06 2.2 2.8 2.4 - 3.1 Beckman AU Beckman AU systems 34 5.58 0.11 2.1 5.6 5.0 - 6.2 34 2.72 0.06 2.4 2.7 2.4 - 3.0 Horiba ABX Pentra Horiba ABX Pentra 400 20 5.25 0.16 3.1 5.3 4.7 - 5.8 20 2.82 0.09 3.1 2.8 2.5 - 3.1 Roche Integra Roche Integra 20 5.75 0.15 2.6 5.7 5.1 - 6.4 20 2.95 0.08 2.6 2.9 2.6 - 3.3 Siemens Healthcare Siemens Dimension 45 4.54 0.07 1.6 4.5 4.0 - 5.0 47 2.24 0.06 2.6 2.2 2.0 - 2.5 All Chemistry Instruments 46 4.54 0.07 1.6 4.5 4.0 - 5.0 48 2.24 0.06 2.6 2.2 2.0 - 2.5 Vital Diagnostics Vital Diagnostics Envoy 500 14 5.33 0.13 2.4 5.3 4.7 - 5.9 14 2.83 0.08 2.9 2.8 2.5 - 3.2 All Chemistry Instruments 14 5.33 0.13 2.4 5.3 4.7 - 5.9 14 2.83 0.08 2.9 2.8 2.5 - 3.2 VITROS VITROS 250,350,500,700,750,950 37 5.26 0.20 3.9 5.3 4.7 - 5.8 37 2.44 0.09 3.5 2.4 2.1 - 2.7 All Chemistry Instruments 41 5.28 0.20 3.8 5.3 4.7 - 5.9 41 2.45 0.09 3.5 2.5 2.2 - 2.7

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10/ 2016 MLE-M3 Participant Summary

Albumin (g/dL) Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 256 4.15 0.13 3.2 4.2 3.7 - 4.6 261 1.90 0.19 10.2 1.9 1.7 - 2.1 All Bromocresol Green Reagents 187 4.14 0.15 3.5 4.1 3.7 - 4.6 190 1.98 0.16 8.0 2.0 1.7 - 2.2 All Bromocresol Purple Reagents 67 4.19 0.08 2.0 4.2 3.7 - 4.7 68 1.67 0.07 4.2 1.7 1.5 - 1.9 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 4.2 3.8 - 4.7 5 - - - 1.7 1.5 - 2.0 All Chemistry Instruments 12 4.23 0.05 1.2 4.2 3.8 - 4.7 12 1.76 0.05 2.9 1.8 1.5 - 2.0 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 29 4.03 0.11 2.7 4.0 3.6 - 4.5 29 2.04 0.06 3.1 2.0 1.8 - 2.3 Beckman AU Beckman AU systems 34 4.12 0.09 2.1 4.1 3.7 - 4.6 34 1.91 0.06 2.9 1.9 1.7 - 2.2 Horiba ABX Pentra Horiba ABX Pentra 400 20 4.07 0.12 2.9 4.1 3.6 - 4.5 20 2.10 0.07 3.3 2.1 1.8 - 2.4 Roche Integra Roche Integra 20 4.33 0.08 1.8 4.3 3.8 - 4.8 20 2.12 0.06 2.9 2.1 1.9 - 2.4 Siemens Healthcare Siemens Dimension 46 4.19 0.09 2.1 4.2 3.7 - 4.7 47 1.64 0.05 3.0 1.6 1.4 - 1.9 All Chemistry Instruments 47 4.19 0.09 2.1 4.2 3.7 - 4.7 48 1.64 0.05 3.0 1.6 1.4 - 1.9 Vital Diagnostics Vital Diagnostics Envoy 500 14 4.05 0.09 2.1 4.0 3.6 - 4.5 14 2.09 0.05 2.3 2.1 1.8 - 2.4 VITROS VITROS 250,350,500,700,750,950 36 4.17 0.12 2.9 4.2 3.7 - 4.6 37 1.74 0.06 3.4 1.7 1.5 - 2.0 All Chemistry Instruments 40 4.18 0.12 3.0 4.2 3.7 - 4.6 41 1.74 0.06 3.4 1.7 1.5 - 2.0

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2016 MLE-M3 Participant Summary/ 11

Albumin (g/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 261 3.67 0.36 9.8 3.8 3.3 - 4.1 All Bromocresol Green Reagents 188 3.86 0.15 4.0 3.8 3.4 - 4.3 All Bromocresol Purple Reagents 68 3.12 0.08 2.6 3.1 2.8 - 3.5 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 3.0 2.7 - 3.4 All Chemistry Instruments 12 3.08 0.10 3.1 3.1 2.7 - 3.4 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 29 3.81 0.07 1.9 3.8 3.4 - 4.2 Beckman AU Beckman AU systems 34 3.84 0.09 2.2 3.9 3.4 - 4.3 Horiba ABX Pentra Horiba ABX Pentra 400 20 3.79 0.09 2.5 3.8 3.4 - 4.2 Roche Integra Roche Integra 20 4.10 0.09 2.1 4.1 3.6 - 4.6 Siemens Healthcare Siemens Dimension 47 3.12 0.06 2.0 3.1 2.8 - 3.5 All Chemistry Instruments 48 3.12 0.06 2.0 3.1 2.8 - 3.5 Vital Diagnostics Vital Diagnostics Envoy 500 14 3.88 0.11 2.7 3.9 3.4 - 4.3 VITROS VITROS 250,350,500,700,750,950 37 3.74 0.13 3.5 3.7 3.3 - 4.2 All Chemistry Instruments 40 3.75 0.14 3.6 3.8 3.3 - 4.2

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12/ 2016 MLE-M3 Participant Summary

Bilirubin, Direct (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 178 0.82 0.30 36.5 0.8 0.2 - 1.5 179 0.28 0.12 41.8 0.3 0.0 - 0.6 All Alfa Wassermann Reagents 20 1.06 0.11 10.0 1.0 0.8 - 1.3 19 0.40 0.01 0.0 0.4 0.3 - 0.5 All Roche Integra/c111/c301/c501 Reagents 21 0.63 0.10 16.1 0.7 0.4 - 0.9 19 0.20 0.01 0.0 0.2 0.1 - 0.3 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 20 1.06 0.11 10.0 1.0 0.8 - 1.3 19 0.40 0.01 0.0 0.4 0.3 - 0.5 Beckman AU Beckman AU systems 28 0.81 0.13 15.5 0.8 0.5 - 1.1 28 0.27 0.05 19.7 0.3 0.1 - 0.4 Horiba ABX Pentra Horiba ABX Pentra 400 13 1.03 0.14 13.4 1.0 0.7 - 1.4 13 0.30 0.01 0.0 0.3 0.2 - 0.4 Roche Integra Roche Integra 14 0.69 0.05 6.9 0.7 0.5 - 0.8 14 0.20 0.01 0.0 0.2 0.1 - 0.3 Siemens Healthcare Siemens Dimension 33 0.60 0.08 12.5 0.6 0.4 - 0.8 34 0.18 0.04 22.9 0.2 0.0 - 0.3 All Chemistry Instruments 36 0.60 0.08 12.6 0.6 0.4 - 0.8 37 0.18 0.04 21.9 0.2 0.1 - 0.3 Vital Diagnostics Vital Diagnostics Envoy 500 10 0.96 0.33 34.8 1.1 0.2 - 1.7 10 0.34 0.05 15.2 0.3 0.2 - 0.5 VITROS-BuBc and Bc VITROS 250,350,500,700,750,950 22 0.93 0.47 50.1 1.1 0.0 - 1.9 22 0.34 0.19 56.3 0.4 0.0 - 0.8 All Chemistry Instruments 25 0.97 0.45 46.5 1.1 0.0 - 1.9 25 0.35 0.18 52.5 0.4 0.0 - 0.8

Specimen CH-13 Specimen CH-14

All Method 170 0.05 0.06 125.2 0.0 0.0 - 0.2 175 0.12 0.06 51.8 0.1 0.0 - 0.3 All Alfa Wassermann Reagents 18 0.10 0.01 0.0 0.1 0.0 - 0.2 20 0.20 0.01 0.0 0.2 0.1 - 0.3 All Roche Integra/c111/c301/c501 Reagents 21 0.04 0.07 157.8 0.0 0.0 - 0.2 19 0.10 0.01 0.0 0.1 0.0 - 0.2 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 18 0.10 0.01 0.0 0.1 0.0 - 0.2 20 0.20 0.01 0.0 0.2 0.1 - 0.3 Beckman AU Beckman AU systems 28 0.00 0.01 0.0 0.0 0.0 - 0.1 26 0.10 0.01 0.0 0.1 0.0 - 0.2 Horiba ABX Pentra Horiba ABX Pentra 400 14 0.01 0.04 254.2 0.0 0.0 - 0.1 14 0.10 0.01 0.0 0.1 0.0 - 0.2 Roche Integra Roche Integra 14 0.01 0.04 254.2 0.0 0.0 - 0.1 14 0.10 0.01 0.0 0.1 0.0 - 0.2 Siemens Healthcare Siemens Dimension 32 0.06 0.05 87.6 0.1 0.0 - 0.2 32 0.09 0.03 32.7 0.1 0.0 - 0.2 All Chemistry Instruments 34 0.06 0.05 83.1 0.1 0.0 - 0.2 35 0.09 0.03 31.1 0.1 0.0 - 0.2 Vital Diagnostics Vital Diagnostics Envoy 500 10 0.01 0.03 316.2 0.0 0.0 - 0.1 10 0.11 0.03 28.7 0.1 0.0 - 0.2 VITROS-BuBc and Bc VITROS 250,350,500,700,750,950 20 0.10 0.11 110.5 0.1 0.0 - 0.4 22 0.19 0.14 72.7 0.2 0.0 - 0.5 All Chemistry Instruments 21 0.10 0.10 107.5 0.1 0.0 - 0.3 25 0.19 0.13 69.2 0.2 0.0 - 0.5

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2016 MLE-M3 Participant Summary/ 13

Bilirubin, Direct (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 179 0.50 0.18 36.8 0.5 0.1 - 0.9 All Alfa Wassermann Reagents 20 0.70 0.07 9.9 0.7 0.5 - 0.9 All Roche Integra/c111/c301/c501 Reagents 21 0.36 0.05 13.7 0.4 0.2 - 0.5 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 20 0.70 0.07 9.9 0.7 0.5 - 0.9 Beckman AU Beckman AU systems 28 0.50 0.06 12.7 0.5 0.3 - 0.7 Horiba ABX Pentra Horiba ABX Pentra 400 14 0.59 0.07 12.3 0.6 0.4 - 0.8 Roche Integra Roche Integra 13 0.40 0.01 0.0 0.4 0.3 - 0.5 Siemens Healthcare Siemens Dimension 34 0.34 0.05 14.6 0.3 0.2 - 0.5 All Chemistry Instruments 37 0.35 0.06 16.1 0.3 0.2 - 0.5 Vital Diagnostics Vital Diagnostics Envoy 500 10 0.66 0.08 12.8 0.7 0.4 - 0.9 VITROS-BuBc and Bc VITROS 250,350,500,700,750,950 22 0.55 0.29 51.8 0.6 0.0 - 1.2 All Chemistry Instruments 25 0.58 0.28 48.1 0.6 0.0 - 1.2

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14/ 2016 MLE-M3 Participant Summary

Bilirubin, Total (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 284 2.39 0.26 10.8 2.4 1.9 - 2.9 285 0.79 0.12 14.9 0.8 0.3 - 1.2 All Alfa Wassermann Reagents 37 2.65 0.22 8.3 2.7 2.1 - 3.2 37 0.93 0.06 6.6 0.9 0.5 - 1.4 All Horiba Pentra Reagents 21 2.28 0.23 10.1 2.3 1.8 - 2.8 21 0.71 0.06 8.0 0.7 0.3 - 1.2 All Roche T. bili Special Reagents 24 2.08 0.14 6.6 2.1 1.6 - 2.5 24 0.66 0.05 7.5 0.7 0.2 - 1.1 All Vital Diagnostics Reagents 17 2.19 0.19 8.6 2.2 1.7 - 2.7 17 0.72 0.10 13.3 0.7 0.3 - 1.2 Abaxis Piccolo Abaxis Piccolo - waived 26 2.31 0.13 5.7 2.3 1.8 - 2.8 26 0.89 0.06 6.3 0.9 0.4 - 1.3 All Chemistry Instruments 34 2.34 0.15 6.6 2.4 1.8 - 2.9 34 0.89 0.05 6.1 0.9 0.4 - 1.3 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 36 2.66 0.22 8.3 2.7 2.1 - 3.2 36 0.93 0.06 6.5 0.9 0.5 - 1.4 Beckman AU Beckman AU systems 34 2.58 0.15 5.7 2.6 2.0 - 3.1 34 0.84 0.05 5.9 0.8 0.4 - 1.3 Horiba ABX Pentra Horiba ABX Pentra 400 20 2.28 0.23 10.3 2.3 1.8 - 2.8 20 0.72 0.06 8.2 0.7 0.3 - 1.2 Roche Integra-T. bili Gen.3 Roche Integra 10 2.07 0.12 5.6 2.1 1.6 - 2.5 10 0.65 0.05 8.1 0.7 0.2 - 1.1 All Chemistry Instruments 11 2.07 0.11 5.3 2.1 1.6 - 2.5 11 0.65 0.05 8.0 0.7 0.2 - 1.1 Siemens Healthcare Siemens Dimension 46 2.35 0.15 6.5 2.4 1.8 - 2.9 47 0.71 0.05 7.1 0.7 0.3 - 1.2 All Chemistry Instruments 47 2.34 0.15 6.4 2.3 1.8 - 2.9 48 0.71 0.05 7.0 0.7 0.3 - 1.2 Vital Diagnostics Vital Diagnostics Envoy 500 15 2.17 0.18 8.5 2.2 1.7 - 2.7 15 0.71 0.09 12.5 0.7 0.3 - 1.2 All Chemistry Instruments 16 2.18 0.19 8.6 2.2 1.7 - 2.7 16 0.72 0.10 13.7 0.7 0.3 - 1.2 VITROS - TBIL VITROS 250,350,500,700,750,950 34 2.47 0.15 5.9 2.4 1.9 - 3.0 34 0.81 0.12 15.3 0.8 0.4 - 1.3 All Chemistry Instruments 38 2.49 0.15 6.0 2.5 1.9 - 3.0 38 0.81 0.12 14.6 0.8 0.4 - 1.3

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2016 MLE-M3 Participant Summary/ 15

Bilirubin, Total (mg/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 252 0.11 0.08 69.0 0.1 0.0 - 0.6 259 0.35 0.09 25.4 0.3 0.0 - 0.8 All Alfa Wassermann Reagents 36 0.13 0.05 35.8 0.1 0.0 - 0.6 37 0.45 0.05 11.2 0.5 0.0 - 0.9 All Horiba Pentra Reagents 21 0.05 0.06 114.9 0.0 0.0 - 0.5 21 0.31 0.07 20.8 0.3 0.0 - 0.8 All Roche T. bili Special Reagents 24 0.09 0.08 91.1 0.1 0.0 - 0.5 24 0.29 0.03 11.7 0.3 0.0 - 0.7 All Vital Diagnostics Reagents 16 0.11 0.07 64.0 0.1 0.0 - 0.6 14 0.30 0.01 0.0 0.3 0.0 - 0.7 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 0.3 0.0 - 0.7 5 - - - 0.5 0.1 - 1.0 All Chemistry Instruments 12 0.27 0.05 18.5 0.3 0.0 - 0.7 12 0.53 0.05 8.6 0.5 0.1 - 1.0 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 35 0.13 0.05 35.8 0.1 0.0 - 0.6 36 0.45 0.05 11.3 0.5 0.0 - 0.9 Beckman AU Beckman AU systems 33 0.10 0.01 0.0 0.1 0.0 - 0.5 34 0.39 0.03 8.4 0.4 0.0 - 0.8 Horiba ABX Pentra Horiba ABX Pentra 400 20 0.05 0.05 113.4 0.0 0.0 - 0.5 20 0.32 0.07 21.3 0.3 0.0 - 0.8 Roche Integra-T. bili Gen.3 Roche Integra 10 0.06 0.07 116.5 0.1 0.0 - 0.5 10 0.29 0.03 10.9 0.3 0.0 - 0.7 All Chemistry Instruments 11 0.07 0.08 108.1 0.1 0.0 - 0.5 11 0.28 0.04 14.4 0.3 0.0 - 0.7 Siemens Healthcare Siemens Dimension 40 0.07 0.06 82.6 0.1 0.0 - 0.5 46 0.30 0.04 12.2 0.3 0.0 - 0.7 All Chemistry Instruments 41 0.08 0.06 82.5 0.1 0.0 - 0.5 47 0.30 0.04 12.0 0.3 0.0 - 0.7 Vital Diagnostics Vital Diagnostics Envoy 500 15 0.09 0.05 49.0 0.1 0.0 - 0.5 14 0.30 0.01 0.0 0.3 0.0 - 0.7 VITROS - TBIL VITROS 250,350,500,700,750,950 33 0.14 0.07 46.5 0.1 0.0 - 0.6 33 0.33 0.11 33.3 0.3 0.0 - 0.8 All Chemistry Instruments 37 0.14 0.06 45.8 0.1 0.0 - 0.6 37 0.34 0.11 31.6 0.3 0.0 - 0.8

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Bilirubin, Total (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 259 1.43 0.17 11.6 1.4 1.0 - 1.9 All Alfa Wassermann Reagents 36 1.63 0.12 7.2 1.6 1.2 - 2.1 All Horiba Pentra Reagents 21 1.33 0.10 7.2 1.3 0.9 - 1.8 All Roche T. bili Special Reagents 24 1.24 0.08 6.2 1.2 0.8 - 1.7 All Vital Diagnostics Reagents 16 1.29 0.11 8.4 1.3 0.8 - 1.7 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 1.5 1.1 - 2.0 All Chemistry Instruments 12 1.53 0.05 3.0 1.5 1.1 - 2.0 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 35 1.63 0.12 7.2 1.6 1.2 - 2.1 Beckman AU Beckman AU systems 34 1.53 0.08 5.3 1.5 1.1 - 2.0 Horiba ABX Pentra Horiba ABX Pentra 400 20 1.33 0.10 7.4 1.3 0.9 - 1.8 Roche Integra-T. bili Gen.3 Roche Integra 10 1.23 0.05 3.9 1.2 0.8 - 1.7 All Chemistry Instruments 11 1.23 0.05 3.8 1.2 0.8 - 1.7 Siemens Healthcare Siemens Dimension 47 1.36 0.09 6.8 1.4 0.9 - 1.8 All Chemistry Instruments 48 1.36 0.09 6.8 1.4 0.9 - 1.8 Vital Diagnostics Vital Diagnostics Envoy 500 15 1.30 0.10 7.7 1.3 0.9 - 1.7 VITROS - TBIL VITROS 250,350,500,700,750,950 34 1.49 0.11 7.5 1.5 1.0 - 1.9 All Chemistry Instruments 38 1.50 0.12 8.3 1.5 1.0 - 1.9

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2016 MLE-M3 Participant Summary/ 17

Calcium (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 285 12.96 0.43 3.3 12.9 11.9 - 14.0 284 8.00 0.24 3.0 8.0 6.9 - 9.0 All Arsenazo Methods 146 12.81 0.40 3.1 12.8 11.8 - 13.9 145 8.04 0.25 3.1 8.0 7.0 - 9.1 All CPC Methods 132 13.13 0.40 3.0 13.1 12.1 - 14.2 132 7.96 0.23 2.9 8.0 6.9 - 9.0 Abaxis Piccolo Abaxis Piccolo - waived 26 12.40 0.31 2.5 12.4 11.3 - 13.4 26 8.15 0.20 2.4 8.2 7.1 - 9.2 All Chemistry Instruments 32 12.42 0.31 2.5 12.4 11.4 - 13.5 33 8.15 0.19 2.4 8.2 7.1 - 9.2 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 38 12.75 0.34 2.7 12.8 11.7 - 13.8 37 8.23 0.20 2.4 8.2 7.2 - 9.3 Beckman AU Beckman AU systems 35 13.38 0.30 2.2 13.4 12.3 - 14.4 35 8.07 0.18 2.2 8.1 7.0 - 9.1 Horiba ABX Pentra Horiba ABX Pentra 400 18 13.33 0.35 2.6 13.5 12.3 - 14.4 18 8.02 0.20 2.5 8.0 7.0 - 9.1 Roche Integra Roche Integra 20 13.14 0.25 1.9 13.0 12.1 - 14.2 20 8.03 0.17 2.1 8.0 7.0 - 9.1 Siemens Healthcare Siemens Dimension 46 12.80 0.31 2.4 12.8 11.8 - 13.8 46 7.78 0.19 2.5 7.8 6.7 - 8.8 All Chemistry Instruments 48 12.80 0.30 2.4 12.8 11.8 - 13.9 48 7.78 0.19 2.5 7.8 6.7 - 8.8 Vital Diagnostics Vital Diagnostics Envoy 500 15 12.97 0.22 1.7 12.9 11.9 - 14.0 15 7.71 0.17 2.2 7.7 6.7 - 8.8 All Chemistry Instruments 16 12.98 0.22 1.7 12.9 11.9 - 14.0 16 7.74 0.21 2.7 7.8 6.7 - 8.8 VITROS VITROS 250,350,500,700,750,950 37 12.94 0.27 2.1 12.9 11.9 - 14.0 37 7.96 0.16 2.0 8.0 6.9 - 9.0 All Chemistry Instruments 41 12.92 0.27 2.1 12.9 11.9 - 14.0 41 7.95 0.16 2.0 7.9 6.9 - 9.0

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Calcium (mg/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 260 5.45 0.30 5.4 5.4 4.4 - 6.5 261 6.66 0.22 3.4 6.7 5.6 - 7.7 All Arsenazo Methods 123 5.52 0.35 6.4 5.6 4.5 - 6.6 122 6.69 0.26 3.9 6.7 5.6 - 7.7 All CPC Methods 129 5.41 0.21 3.9 5.4 4.4 - 6.5 130 6.65 0.16 2.5 6.7 5.6 - 7.7 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 5.6 4.7 - 6.8 5 - - - 7.1 5.8 - 7.9 All Chemistry Instruments 11 5.72 0.37 6.4 5.6 4.7 - 6.8 11 6.83 0.36 5.2 6.9 5.8 - 7.9 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 38 5.86 0.16 2.7 5.8 4.8 - 6.9 36 6.93 0.14 2.0 6.9 5.9 - 8.0 Beckman AU Beckman AU systems 35 5.65 0.11 2.0 5.7 4.6 - 6.7 35 6.69 0.13 1.9 6.7 5.6 - 7.7 Horiba ABX Pentra Horiba ABX Pentra 400 18 5.33 0.17 3.2 5.4 4.3 - 6.4 18 6.53 0.18 2.8 6.6 5.5 - 7.6 Roche Integra Roche Integra 20 5.34 0.12 2.3 5.3 4.3 - 6.4 20 6.68 0.12 1.7 6.7 5.6 - 7.7 Siemens Healthcare Siemens Dimension 44 5.25 0.17 3.3 5.3 4.2 - 6.3 46 6.59 0.21 3.1 6.6 5.5 - 7.6 All Chemistry Instruments 46 5.25 0.17 3.2 5.3 4.2 - 6.3 48 6.59 0.21 3.2 6.6 5.5 - 7.6 Vital Diagnostics Vital Diagnostics Envoy 500 15 5.54 0.15 2.6 5.5 4.5 - 6.6 15 6.41 0.14 2.2 6.4 5.4 - 7.5 VITROS VITROS 250,350,500,700,750,950 37 5.13 0.14 2.6 5.1 4.1 - 6.2 37 6.62 0.13 2.0 6.6 5.6 - 7.7 All Chemistry Instruments 41 5.13 0.13 2.5 5.1 4.1 - 6.2 41 6.62 0.12 1.9 6.6 5.6 - 7.7

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2016 MLE-M3 Participant Summary/ 19

Calcium (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range All Method 258 9.97 0.28 2.8 10.0 8.9 - 11.0 All Arsenazo Methods 121 10.05 0.25 2.5 10.0 9.0 - 11.1 All CPC Methods 130 9.91 0.29 2.9 9.9 8.9 - 11.0 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 10.1 9.0 - 11.1 All Chemistry Instruments 11 10.05 0.25 2.5 10.1 9.0 - 11.1 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 37 10.15 0.26 2.5 10.1 9.1 - 11.2 Beckman AU Beckman AU systems 35 10.07 0.19 1.9 10.1 9.0 - 11.1 Horiba ABX Pentra Horiba ABX Pentra 400 18 10.09 0.28 2.8 10.2 9.0 - 11.1 Roche Integra Roche Integra 20 9.98 0.18 1.8 9.9 8.9 - 11.0 Siemens Healthcare Siemens Dimension 45 9.65 0.21 2.1 9.7 8.6 - 10.7 All Chemistry Instruments 47 9.65 0.21 2.1 9.7 8.6 - 10.7 Vital Diagnostics Vital Diagnostics Envoy 500 15 9.85 0.23 2.3 9.8 8.8 - 10.9 VITROS VITROS 250,350,500,700,750,950 37 10.02 0.20 2.0 10.0 9.0 - 11.1 All Chemistry Instruments 40 10.01 0.20 2.0 10.0 9.0 - 11.1

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Creatinine (mg/dL) Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 286 4.50 0.64 14.2 4.7 3.8 - 5.2 286 1.35 0.10 7.1 1.3 1.0 - 1.7 All Alfa Wassermann Reagents 37 4.59 0.17 3.7 4.6 3.8 - 5.3 38 1.43 0.07 5.2 1.4 1.1 - 1.8 All Roche Integra/c111/c301/c501 Reagents 30 4.48 0.38 8.4 4.3 3.8 - 5.2 29 1.33 0.08 6.3 1.3 1.0 - 1.7 Abaxis Piccolo Abaxis Piccolo - waived 27 4.91 0.21 4.2 4.9 4.1 - 5.7 27 1.40 0.12 8.5 1.4 1.1 - 1.8 All Chemistry Instruments 34 4.92 0.20 4.1 4.9 4.1 - 5.7 34 1.40 0.11 7.7 1.4 1.1 - 1.7 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 36 4.57 0.15 3.3 4.6 3.8 - 5.3 37 1.43 0.07 4.9 1.4 1.1 - 1.8 Beckman AU Beckman AU systems 35 4.73 0.10 2.0 4.7 4.0 - 5.5 35 1.30 0.03 2.6 1.3 1.0 - 1.6 Horiba ABX Pentra Horiba ABX Pentra 400 20 4.60 0.24 5.2 4.7 3.9 - 5.3 20 1.30 0.08 5.9 1.3 0.9 - 1.6 Roche Integra Roche Integra 21 4.35 0.33 7.6 4.2 3.6 - 5.0 21 1.29 0.11 8.5 1.3 0.9 - 1.6 Siemens Healthcare Siemens Dimension 45 4.99 0.14 2.8 5.0 4.2 - 5.8 45 1.40 0.05 3.9 1.4 1.0 - 1.7 All Chemistry Instruments 47 4.99 0.14 2.7 5.0 4.2 - 5.8 47 1.40 0.05 3.9 1.4 1.0 - 1.7 Vital Diagnostics Vital Diagnostics Envoy 500 15 4.50 0.18 4.0 4.5 3.8 - 5.2 15 1.39 0.10 7.4 1.4 1.0 - 1.7 All Chemistry Instruments 16 4.54 0.23 5.1 4.5 3.8 - 5.3 16 1.40 0.10 7.4 1.4 1.1 - 1.7 VITROS - CREA VITROS 250,350,500,700,750,950 26 3.14 0.10 3.3 3.1 2.6 - 3.7 26 1.26 0.05 3.9 1.3 0.9 - 1.6 All Chemistry Instruments 30 3.14 0.10 3.2 3.1 2.6 - 3.7 30 1.26 0.05 4.0 1.3 0.9 - 1.6 VITROS - CRSC (DT) VITROS 250,350,500,700,750,950 10 3.13 0.13 4.3 3.1 2.6 - 3.6 10 1.23 0.07 5.5 1.2 0.9 - 1.6

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Creatinine (mg/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 262 0.48 0.09 19.2 0.5 0.1 - 0.8 261 0.44 0.08 18.8 0.4 0.1 - 0.8 All Alfa Wassermann Reagents 38 0.61 0.05 8.6 0.6 0.3 - 1.0 38 0.53 0.05 10.0 0.5 0.2 - 0.9 All Roche Integra/c111/c301/c501 Reagents 30 0.47 0.05 9.9 0.5 0.1 - 0.8 30 0.42 0.05 11.9 0.4 0.1 - 0.8 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 0.6 0.2 - 0.9 5 - - - 0.5 0.2 - 0.9 All Chemistry Instruments 11 0.53 0.15 28.2 0.5 0.2 - 0.9 11 0.51 0.13 25.5 0.5 0.2 - 0.9 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 37 0.61 0.05 8.4 0.6 0.3 - 1.0 37 0.54 0.05 10.1 0.5 0.2 - 0.9 Beckman AU Beckman AU systems 34 0.46 0.05 10.7 0.5 0.1 - 0.8 34 0.39 0.04 11.3 0.4 0.0 - 0.7 Horiba ABX Pentra Horiba ABX Pentra 400 20 0.44 0.09 21.5 0.4 0.1 - 0.8 20 0.40 0.08 19.9 0.4 0.1 - 0.7 Roche Integra Roche Integra 21 0.47 0.05 9.8 0.5 0.1 - 0.8 21 0.41 0.04 8.7 0.4 0.1 - 0.8 Siemens Healthcare Siemens Dimension 45 0.44 0.05 12.3 0.4 0.1 - 0.8 44 0.38 0.05 13.0 0.4 0.0 - 0.7 All Chemistry Instruments 47 0.44 0.05 12.2 0.4 0.1 - 0.8 46 0.38 0.05 13.1 0.4 0.0 - 0.7 Vital Diagnostics Vital Diagnostics Envoy 500 15 0.43 0.05 11.3 0.4 0.1 - 0.8 15 0.49 0.05 9.3 0.5 0.1 - 0.8 VITROS - CREA VITROS 250,350,500,700,750,950 26 0.42 0.05 11.2 0.4 0.1 - 0.8 26 0.46 0.05 10.7 0.5 0.1 - 0.8 All Chemistry Instruments 30 0.41 0.04 10.5 0.4 0.1 - 0.8 30 0.47 0.05 10.3 0.5 0.1 - 0.8 VITROS - CRSC (DT) VITROS 250,350,500,700,750,950 10 0.40 0.05 11.8 0.4 0.1 - 0.7 10 0.43 0.05 11.2 0.4 0.1 - 0.8

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Creatinine (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 260 2.59 0.21 8.1 2.7 2.2 - 3.0 All Alfa Wassermann Reagents 37 2.70 0.11 4.1 2.7 2.2 - 3.2 All Roche Integra/c111/c301/c501 Reagents 30 2.57 0.16 6.3 2.5 2.1 - 3.0 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 2.8 2.3 - 3.2 All Chemistry Instruments 11 2.71 0.14 5.1 2.7 2.3 - 3.2 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 36 2.69 0.11 4.0 2.7 2.2 - 3.1 Beckman AU Beckman AU systems 35 2.65 0.07 2.8 2.7 2.2 - 3.1 Horiba ABX Pentra Horiba ABX Pentra 400 19 2.59 0.15 5.7 2.6 2.2 - 3.0 Roche Integra Roche Integra 21 2.51 0.15 5.8 2.5 2.1 - 2.9 Siemens Healthcare Siemens Dimension 46 2.72 0.09 3.4 2.7 2.3 - 3.2 All Chemistry Instruments 48 2.72 0.09 3.4 2.7 2.3 - 3.2 Vital Diagnostics Vital Diagnostics Envoy 500 14 2.64 0.10 3.8 2.6 2.2 - 3.1 VITROS - CREA VITROS 250,350,500,700,750,950 26 2.22 0.06 2.6 2.2 1.8 - 2.6 All Chemistry Instruments 30 2.22 0.06 2.7 2.2 1.8 - 2.6 VITROS - CRSC (DT) VITROS 250,350,500,700,750,950 10 2.22 0.09 4.1 2.2 1.8 - 2.6

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Glucose (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 296 246.3 8.8 3.6 246 221 - 271 301 88.8 4.4 4.9 88 79 - 98 All Alfa Wassermann Reagents 39 253.4 4.8 1.9 253 228 - 279 39 94.6 2.5 2.7 95 85 - 105 All Horiba Pentra Reagents 21 250.8 11.9 4.7 253 225 - 276 21 90.0 4.0 4.5 90 81 - 100 All Roche Integra/c111/c301/c501 Reagents 30 242.4 5.9 2.4 240 218 - 267 30 88.3 1.6 1.8 88 79 - 98 All Vital Diagnostics Reagents 16 260.8 8.4 3.2 262 234 - 287 16 93.8 4.1 4.4 94 84 - 104 Abaxis Piccolo Abaxis Piccolo - waived 27 235.3 1.9 0.8 235 211 - 259 27 86.1 1.3 1.5 86 77 - 95 All Chemistry Instruments 34 235.3 1.9 0.8 235 211 - 259 34 86.1 1.4 1.7 86 77 - 95 Alere Cholestech LDX All Chemistry Instruments 10 262.9 14.4 5.5 262 236 - 290 10 86.8 4.2 4.9 86 78 - 96 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 38 253.3 4.9 1.9 253 227 - 279 38 94.6 2.5 2.7 95 85 - 105 Beckman AU Beckman AU systems 34 244.3 5.1 2.1 244 219 - 269 34 88.0 2.0 2.3 88 79 - 97 Horiba ABX Pentra Horiba ABX Pentra 400 20 252.4 9.7 3.8 255 227 - 278 20 90.5 3.7 4.1 91 81 - 100 Roche Integra Roche Integra 21 240.4 4.6 1.9 239 216 - 265 21 88.0 1.3 1.5 88 79 - 97 Siemens Healthcare Siemens Dimension 45 247.1 4.6 1.9 247 222 - 272 46 90.0 2.0 2.2 90 80 - 99 All Chemistry Instruments 47 247.0 4.6 1.9 247 222 - 272 48 90.0 2.0 2.3 90 81 - 99 Vital Diagnostics Vital Diagnostics Envoy 500 15 262.3 6.2 2.4 262 236 - 289 15 94.3 3.7 3.9 94 84 - 104 All Chemistry Instruments 16 260.8 8.4 3.2 262 234 - 287 16 93.8 4.1 4.4 94 84 - 104 VITROS VITROS 250,350,500,700,750,950 38 244.7 4.8 2.0 244 220 - 270 38 83.5 2.3 2.7 83 75 - 92 All Chemistry Instruments 42 244.7 4.7 1.9 244 220 - 270 42 83.6 2.2 2.7 83 75 - 92

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Glucose (mg/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 268 52.5 2.9 5.5 52 46 - 59 269 49.5 3.4 6.8 50 43 - 56 All Alfa Wassermann Reagents 41 56.1 1.3 2.3 56 50 - 63 40 53.4 1.3 2.5 53 47 - 60 All Horiba Pentra Reagents 21 51.8 3.4 6.6 52 45 - 58 21 49.9 3.5 7.0 50 43 - 56 All Roche Integra/c111/c301/c501 Reagents 30 51.3 1.0 1.9 51 45 - 58 30 49.3 1.1 2.3 49 43 - 56 All Vital Diagnostics Reagents 15 55.3 1.9 3.4 55 49 - 62 15 52.8 1.7 3.3 52 46 - 59 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 52 46 - 59 5 - - - 49 43 - 56 All Chemistry Instruments 11 52.2 1.3 2.5 52 46 - 59 11 49.3 1.0 2.0 49 43 - 56 Alere Cholestech LDX All Chemistry Instruments 2 - - - 55 49 - 61 2 - - - 50 44 - 56 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 40 56.1 1.3 2.4 56 50 - 63 39 53.4 1.3 2.5 53 47 - 60 Beckman AU Beckman AU systems 33 51.2 1.3 2.5 51 45 - 58 33 48.9 1.2 2.5 49 42 - 55 Horiba ABX Pentra Horiba ABX Pentra 400 20 52.3 2.8 5.4 52 46 - 59 20 50.4 2.9 5.8 51 44 - 57 Roche Integra Roche Integra 21 51.2 1.0 2.0 51 45 - 58 21 49.1 1.1 2.2 49 43 - 56 Siemens Healthcare Siemens Dimension 45 53.3 1.3 2.4 53 47 - 60 46 50.3 1.4 2.7 50 44 - 57 All Chemistry Instruments 47 53.3 1.3 2.4 53 47 - 60 47 50.3 1.4 2.7 50 44 - 57 Vital Diagnostics Vital Diagnostics Envoy 500 15 55.3 1.9 3.4 55 49 - 62 15 52.8 1.7 3.3 52 46 - 59 VITROS VITROS 250,350,500,700,750,950 38 49.4 2.0 4.1 49 43 - 56 38 44.0 1.8 4.1 44 38 - 51 All Chemistry Instruments 42 49.5 2.0 4.0 49 43 - 56 42 44.1 1.7 4.0 44 38 - 51

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Glucose (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range All Method 267 148.4 6.6 4.5 148 133 - 164 All Alfa Wassermann Reagents 40 155.1 4.0 2.5 155 139 - 171 All Horiba Pentra Reagents 21 150.0 7.1 4.7 151 135 - 165 All Roche Integra/c111/c301/c501 Reagents 30 147.3 3.0 2.1 147 132 - 162 All Vital Diagnostics Reagents 15 158.1 5.1 3.2 158 142 - 174 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 143 128 - 157 All Chemistry Instruments 11 142.3 1.6 1.1 142 128 - 157 Alere Cholestech LDX All Chemistry Instruments 2 - - - 139 124 - 153 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 39 155.0 4.0 2.6 155 139 - 171 Beckman AU Beckman AU systems 33 146.9 2.8 1.9 148 132 - 162 Horiba ABX Pentra Horiba ABX Pentra 400 20 150.8 6.2 4.1 151 135 - 166 Roche Integra Roche Integra 21 146.3 2.8 1.9 146 131 - 161 Siemens Healthcare Siemens Dimension 46 149.7 3.0 2.0 150 134 - 165 All Chemistry Instruments 48 149.7 3.0 2.0 150 134 - 165 Vital Diagnostics Vital Diagnostics Envoy 500 15 158.1 5.1 3.2 158 142 - 174 VITROS VITROS 250,350,500,700,750,950 38 140.3 3.2 2.3 140 126 - 155 All Chemistry Instruments 42 140.7 3.7 2.6 140 126 - 155

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Iron (µg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 105 249.8 26.0 10.4 250 199 - 300 104 81.9 6.9 8.4 82 65 - 99 All Roche Integra/c111/c301/c501 Reagents 13 257.2 8.2 3.2 257 205 - 309 13 83.3 4.3 5.2 84 66 - 100 Beckman AU Beckman AU systems 22 254.9 6.7 2.6 254 203 - 306 21 85.5 2.5 3.0 85 68 - 103 Siemens Healthcare Siemens Dimension 22 245.7 3.1 1.3 246 196 - 295 22 79.1 1.9 2.5 79 63 - 95 All Chemistry Instruments 23 245.6 3.1 1.3 245 196 - 295 23 79.1 1.9 2.4 79 63 - 95 VITROS VITROS 250,350,500,700,750,950 10 294.4 8.4 2.9 295 235 - 354 10 95.3 7.3 7.6 94 76 - 115 All Chemistry Instruments 13 290.8 10.0 3.4 292 232 - 350 13 94.5 6.6 7.0 91 75 - 114

Specimen CH-13 Specimen CH-14 All Method 102 304.1 11.9 3.9 301 243 - 365 102 38.0 3.4 8.8 38 30 - 46 All Roche Integra/c111/c301/c501 Reagents 13 300.8 6.2 2.1 303 240 - 362 12 38.9 2.0 5.2 39 31 - 47 Beckman AU Beckman AU systems 22 320.0 7.5 2.4 321 256 - 384 21 40.2 2.3 5.8 39 32 - 49 Siemens Healthcare Siemens Dimension 21 297.5 3.7 1.3 297 238 - 358 20 37.6 1.2 3.3 38 30 - 46 All Chemistry Instruments 22 297.4 3.7 1.2 297 237 - 357 21 37.6 1.2 3.2 38 30 - 46 VITROS VITROS 250,350,500,700,750,950 10 305.4 15.8 5.2 300 244 - 367 10 37.3 5.5 14.8 36 29 - 45 All Chemistry Instruments 13 305.9 13.9 4.5 303 244 - 368 13 37.5 5.0 13.3 36 30 - 46

Specimen CH-15

All Method 104 147.3 15.8 10.7 148 117 - 177 All Roche Integra/c111/c301/c501 Reagents 13 151.1 6.8 4.5 150 120 - 182 Beckman AU Beckman AU systems 22 151.4 4.6 3.1 152 121 - 182 Siemens Healthcare Siemens Dimension 22 141.0 1.8 1.3 141 112 - 170 All Chemistry Instruments 23 140.9 1.8 1.3 141 112 - 170 VITROS VITROS 250,350,500,700,750,950 10 182.5 9.2 5.0 182 146 - 219 All Chemistry Instruments 13 180.5 9.0 5.0 178 144 - 217

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Lactic Acid (mmol/L)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 5.88 0.50 8.5 6.1 4.3 - 7.4 6 1.50 0.20 13.3 1.5 0.9 - 2.1

Specimen CH-13 Specimen CH-14

All Method 6 0.23 0.18 75.1 0.3 0.0 - 0.8 6 0.43 0.10 23.8 0.5 0.1 - 0.8

Specimen CH-15

All Method 6 3.18 0.15 4.6 3.2 2.7 - 3.7

Magnesium (mg/dL) Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 135 4.28 0.23 5.5 4.3 3.2 - 5.4 133 1.84 0.09 5.1 1.8 1.3 - 2.3 All Horiba Pentra Reagents 18 4.17 0.29 6.9 4.2 3.1 - 5.3 18 1.84 0.17 9.3 1.8 1.3 - 2.4 All Roche Integra/c111/c301/c501 Reagents 22 4.17 0.14 3.3 4.1 3.1 - 5.3 22 1.83 0.07 3.8 1.8 1.3 - 2.3 Beckman AU Beckman AU systems 22 4.33 0.15 3.4 4.3 3.2 - 5.5 22 1.85 0.05 2.7 1.9 1.3 - 2.4 Horiba ABX Pentra Horiba ABX Pentra 400 17 4.19 0.29 6.9 4.2 3.1 - 5.3 17 1.85 0.17 9.4 1.8 1.3 - 2.4 Roche Integra Roche Integra 15 4.11 0.11 2.6 4.1 3.0 - 5.2 15 1.81 0.06 3.5 1.8 1.3 - 2.3 Siemens Healthcare Siemens Dimension 24 4.47 0.11 2.4 4.5 3.3 - 5.6 25 1.82 0.07 3.6 1.8 1.3 - 2.3 VITROS VITROS 250,350,500,700,750,950 18 4.47 0.10 2.3 4.5 3.3 - 5.6 18 1.93 0.05 2.4 1.9 1.4 - 2.5 All Chemistry Instruments 21 4.43 0.13 3.0 4.4 3.3 - 5.6 21 1.91 0.07 3.7 1.9 1.4 - 2.4

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Magnesium (mg/dL) Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 135 1.22 0.14 11.2 1.2 0.9 - 1.6 136 1.21 0.11 8.7 1.2 0.9 - 1.6 All Horiba Pentra Reagents 18 1.31 0.14 11.0 1.3 0.9 - 1.7 18 1.23 0.17 13.6 1.2 0.9 - 1.6 All Roche Integra/c111/c301/c501 Reagents 22 1.28 0.06 4.8 1.3 0.9 - 1.6 22 1.21 0.06 4.6 1.2 0.9 - 1.6 Beckman AU Beckman AU systems 21 1.27 0.05 3.8 1.3 0.9 - 1.6 21 1.21 0.05 3.9 1.2 0.9 - 1.6 Horiba ABX Pentra Horiba ABX Pentra 400 17 1.31 0.15 11.3 1.3 0.9 - 1.7 17 1.24 0.17 14.0 1.2 0.9 - 1.6 Roche Integra Roche Integra 15 1.27 0.07 5.5 1.3 0.9 - 1.6 15 1.20 0.05 4.5 1.2 0.9 - 1.5 Siemens Healthcare Siemens Dimension 24 1.26 0.07 5.2 1.3 0.9 - 1.6 25 1.19 0.06 4.8 1.2 0.8 - 1.5 VITROS VITROS 250,350,500,700,750,950 18 1.04 0.07 6.7 1.0 0.7 - 1.3 18 1.25 0.05 4.1 1.3 0.9 - 1.6 All Chemistry Instruments 21 1.03 0.07 7.1 1.0 0.7 - 1.3 21 1.24 0.06 4.8 1.2 0.9 - 1.6

Specimen CH-15

All Method 135 2.78 0.13 4.8 2.8 2.0 - 3.5 All Horiba Pentra Reagents 18 2.78 0.21 7.7 2.8 2.0 - 3.5 All Roche Integra/c111/c301/c501 Reagents 22 2.75 0.10 3.5 2.8 2.0 - 3.5 Beckman AU Beckman AU systems 21 2.80 0.06 2.3 2.8 2.1 - 3.5 Horiba ABX Pentra Horiba ABX Pentra 400 17 2.79 0.22 7.7 2.8 2.0 - 3.5 Roche Integra Roche Integra 15 2.72 0.09 3.2 2.7 2.0 - 3.4 Siemens Healthcare Siemens Dimension 25 2.83 0.07 2.6 2.8 2.1 - 3.6 VITROS VITROS 250,350,500,700,750,950 18 2.91 0.08 2.6 2.9 2.1 - 3.7 All Chemistry Instruments 21 2.90 0.08 2.7 2.9 2.1 - 3.7

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Phosphorus (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 110 5.08 0.21 4.1 5.1 4.5 - 5.7 113 2.26 0.15 6.5 2.3 1.9 - 2.6 All Alfa Wassermann Reagents 10 4.73 0.39 8.2 4.9 4.2 - 5.3 11 2.28 0.14 6.1 2.3 1.9 - 2.6 All Roche Integra/c111/c301/c501 Reagents 17 4.99 0.14 2.8 5.0 4.4 - 5.6 17 2.21 0.04 1.9 2.2 1.9 - 2.6 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 10 4.73 0.39 8.2 4.9 4.2 - 5.3 11 2.28 0.14 6.1 2.3 1.9 - 2.6 Beckman AU Beckman AU systems 21 4.89 0.13 2.7 4.9 4.3 - 5.5 21 2.09 0.12 5.6 2.1 1.7 - 2.4 Horiba ABX Pentra Horiba ABX Pentra 400 11 5.25 0.14 2.7 5.3 4.6 - 5.9 11 2.29 0.05 2.4 2.3 1.9 - 2.6 Roche Integra Roche Integra 12 4.94 0.11 2.2 5.0 4.4 - 5.5 12 2.20 0.04 1.9 2.2 1.9 - 2.5 Siemens Healthcare Siemens Dimension 16 5.21 0.12 2.3 5.2 4.6 - 5.8 17 2.36 0.09 4.0 2.4 2.0 - 2.7 VITROS VITROS 250,350,500,700,750,950 13 5.28 0.15 2.8 5.3 4.7 - 5.9 13 2.46 0.09 3.5 2.5 2.1 - 2.8 All Chemistry Instruments 16 5.27 0.15 2.9 5.3 4.7 - 5.9 16 2.44 0.10 4.2 2.5 2.1 - 2.8

Specimen CH-13 Specimen CH-14 All Method 111 7.85 0.31 4.0 7.8 7.0 - 8.7 111 1.53 0.12 8.0 1.5 1.2 - 1.9 All Alfa Wassermann Reagents 11 8.30 0.52 6.2 8.3 7.4 - 9.2 11 1.59 0.11 7.1 1.6 1.2 - 1.9 All Roche Integra/c111/c301/c501 Reagents 17 7.99 0.20 2.6 7.9 7.1 - 8.9 17 1.46 0.06 4.1 1.5 1.1 - 1.8 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 11 8.30 0.52 6.2 8.3 7.4 - 9.2 11 1.59 0.11 7.1 1.6 1.2 - 1.9 Beckman AU Beckman AU systems 21 7.69 0.21 2.8 7.6 6.8 - 8.6 21 1.36 0.14 10.0 1.4 1.0 - 1.7 Horiba ABX Pentra Horiba ABX Pentra 400 11 7.82 0.30 3.8 7.8 6.9 - 8.7 11 1.54 0.09 6.0 1.5 1.2 - 1.9 Roche Integra Roche Integra 12 8.00 0.23 2.8 8.0 7.1 - 8.9 12 1.45 0.05 3.6 1.5 1.1 - 1.8 Siemens Healthcare Siemens Dimension 16 8.04 0.19 2.4 8.1 7.1 - 8.9 17 1.59 0.07 4.4 1.6 1.2 - 1.9 VITROS VITROS 250,350,500,700,750,950 13 7.65 0.14 1.8 7.7 6.8 - 8.5 13 1.70 0.08 4.8 1.7 1.4 - 2.0 All Chemistry Instruments 16 7.63 0.17 2.2 7.7 6.8 - 8.5 16 1.69 0.09 5.2 1.7 1.3 - 2.0

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Phosphorus (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 114 3.32 0.18 5.4 3.3 2.9 - 3.7 All Alfa Wassermann Reagents 11 3.28 0.24 7.3 3.2 2.9 - 3.7 All Roche Integra/c111/c301/c501 Reagents 17 3.25 0.08 2.5 3.2 2.9 - 3.7 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 11 3.28 0.24 7.3 3.2 2.9 - 3.7 Beckman AU Beckman AU systems 21 3.13 0.12 3.8 3.2 2.7 - 3.5 Horiba ABX Pentra Horiba ABX Pentra 400 11 3.40 0.10 2.9 3.4 3.0 - 3.8 Roche Integra Roche Integra 12 3.23 0.06 1.9 3.2 2.8 - 3.6 Siemens Healthcare Siemens Dimension 17 3.45 0.09 2.7 3.5 3.0 - 3.9 VITROS VITROS 250,350,500,700,750,950 13 3.52 0.09 2.6 3.5 3.1 - 3.9 All Chemistry Instruments 16 3.49 0.10 2.9 3.5 3.1 - 3.9

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Protein, Total (g/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 280 9.52 0.48 5.0 9.6 8.5 - 10.5 279 4.28 0.13 3.0 4.3 3.8 - 4.8 All Alfa Wassermann Reagents 35 9.73 0.16 1.7 9.8 8.7 - 10.8 36 4.34 0.08 1.8 4.3 3.9 - 4.8 All Horiba Pentra Reagents 21 9.43 0.27 2.9 9.5 8.4 - 10.4 21 4.20 0.11 2.6 4.2 3.7 - 4.7 All Roche Integra/c111/c301/c501 Reagents 30 9.41 0.25 2.6 9.4 8.4 - 10.4 30 4.25 0.12 2.9 4.2 3.8 - 4.7 All Vital Diagnostics Reagents 15 9.63 0.18 1.9 9.6 8.6 - 10.6 15 4.27 0.10 2.5 4.3 3.8 - 4.7 Abaxis Piccolo Abaxis Piccolo - waived 27 9.91 0.20 2.0 9.9 8.9 - 11.0 27 4.34 0.08 1.8 4.3 3.9 - 4.8 All Chemistry Instruments 35 9.88 0.19 1.9 9.9 8.8 - 10.9 35 4.34 0.08 1.8 4.3 3.9 - 4.8 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 34 9.73 0.16 1.7 9.8 8.7 - 10.7 35 4.34 0.08 1.8 4.3 3.9 - 4.8 Beckman AU Beckman AU systems 34 9.50 0.21 2.2 9.5 8.5 - 10.5 34 4.16 0.10 2.4 4.2 3.7 - 4.6 Horiba ABX Pentra Horiba ABX Pentra 400 20 9.43 0.28 3.0 9.5 8.4 - 10.4 20 4.20 0.11 2.7 4.2 3.7 - 4.7 Roche Integra Roche Integra 21 9.31 0.18 1.9 9.3 8.3 - 10.3 21 4.20 0.10 2.5 4.2 3.7 - 4.7 Siemens Healthcare Siemens Dimension 44 9.99 0.17 1.7 10.0 8.9 - 11.0 44 4.42 0.07 1.5 4.4 3.9 - 4.9 All Chemistry Instruments 45 10.00 0.17 1.7 10.0 8.9 - 11.0 45 4.42 0.07 1.5 4.4 3.9 - 4.9 Vital Diagnostics Vital Diagnostics Envoy 500 14 9.62 0.18 1.9 9.6 8.6 - 10.6 14 4.26 0.10 2.4 4.3 3.8 - 4.7 All Chemistry Instruments 15 9.63 0.18 1.9 9.6 8.6 - 10.6 15 4.27 0.10 2.5 4.3 3.8 - 4.7 VITROS VITROS 250,350,500,700,750,950 37 8.64 0.22 2.5 8.6 7.7 - 9.5 37 4.20 0.11 2.5 4.2 3.7 - 4.7 All Chemistry Instruments 41 8.65 0.21 2.5 8.6 7.7 - 9.6 41 4.21 0.10 2.5 4.2 3.7 - 4.7

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Protein, Total (g/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 255 5.93 0.21 3.5 5.9 5.3 - 6.6 257 2.91 0.11 3.9 2.9 2.6 - 3.3 All Alfa Wassermann Reagents 37 6.03 0.11 1.9 6.0 5.4 - 6.7 37 2.92 0.08 2.8 2.9 2.6 - 3.3 All Horiba Pentra Reagents 20 5.79 0.15 2.6 5.8 5.2 - 6.4 21 2.83 0.10 3.6 2.8 2.5 - 3.2 All Roche Integra/c111/c301/c501 Reagents 30 5.92 0.15 2.6 5.9 5.3 - 6.6 30 2.88 0.10 3.5 2.9 2.5 - 3.2 All Vital Diagnostics Reagents 15 5.84 0.28 4.8 5.8 5.2 - 6.5 14 2.89 0.10 3.4 2.9 2.6 - 3.2 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 5.9 5.3 - 6.6 5 - - - 3.0 2.6 - 3.3 All Chemistry Instruments 12 5.94 0.07 1.1 5.9 5.3 - 6.6 12 2.99 0.10 3.3 3.0 2.6 - 3.3 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 36 6.03 0.11 1.9 6.1 5.4 - 6.7 36 2.92 0.08 2.8 2.9 2.6 - 3.3 Beckman AU Beckman AU systems 34 5.88 0.12 2.0 5.9 5.2 - 6.5 34 2.85 0.11 3.7 2.8 2.5 - 3.2 Horiba ABX Pentra Horiba ABX Pentra 400 19 5.78 0.15 2.7 5.8 5.2 - 6.4 20 2.84 0.10 3.7 2.8 2.5 - 3.2 Roche Integra Roche Integra 21 5.88 0.13 2.1 5.9 5.2 - 6.5 21 2.83 0.08 2.8 2.8 2.5 - 3.2 Siemens Healthcare Siemens Dimension 44 6.19 0.11 1.8 6.2 5.5 - 6.9 45 3.02 0.07 2.2 3.0 2.7 - 3.4 All Chemistry Instruments 45 6.19 0.11 1.8 6.2 5.5 - 6.9 46 3.02 0.07 2.3 3.0 2.7 - 3.4 Vital Diagnostics Vital Diagnostics Envoy 500 14 5.90 0.17 2.8 5.9 5.3 - 6.5 14 2.89 0.10 3.4 2.9 2.6 - 3.2 VITROS VITROS 250,350,500,700,750,950 37 5.66 0.12 2.1 5.7 5.0 - 6.3 37 2.93 0.10 3.3 2.9 2.6 - 3.3 All Chemistry Instruments 41 5.68 0.12 2.1 5.7 5.1 - 6.3 41 2.93 0.09 3.2 2.9 2.6 - 3.3

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Protein, Total (g/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range All Method 257 6.29 0.22 3.5 6.3 5.6 - 7.0 All Alfa Wassermann Reagents 37 6.42 0.15 2.3 6.4 5.7 - 7.1 All Horiba Pentra Reagents 20 6.20 0.11 1.8 6.2 5.5 - 6.9 All Roche Integra/c111/c301/c501 Reagents 30 6.27 0.15 2.3 6.3 5.6 - 6.9 All Vital Diagnostics Reagents 14 6.35 0.19 2.9 6.4 5.7 - 7.0 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 6.3 5.7 - 7.0 All Chemistry Instruments 12 6.34 0.09 1.4 6.4 5.7 - 7.0 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 36 6.42 0.15 2.4 6.4 5.7 - 7.1 Beckman AU Beckman AU systems 34 6.19 0.12 2.0 6.2 5.5 - 6.9 Horiba ABX Pentra Horiba ABX Pentra 400 19 6.19 0.11 1.8 6.2 5.5 - 6.9 Roche Integra Roche Integra 21 6.21 0.12 1.9 6.2 5.5 - 6.9 Siemens Healthcare Siemens Dimension 44 6.52 0.10 1.5 6.5 5.8 - 7.2 All Chemistry Instruments 45 6.52 0.10 1.5 6.5 5.8 - 7.2 Vital Diagnostics Vital Diagnostics Envoy 500 14 6.35 0.19 2.9 6.4 5.7 - 7.0 VITROS VITROS 250,350,500,700,750,950 36 6.02 0.13 2.2 6.0 5.4 - 6.7 All Chemistry Instruments 40 6.04 0.15 2.5 6.1 5.4 - 6.7

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Urea Nitrogen (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 284 41.3 2.1 5.2 41 37 - 46 284 12.8 0.9 7.0 13 10 - 15 All Alfa Wassermann Reagents 38 41.1 1.3 3.2 41 37 - 45 39 12.9 0.7 5.4 13 10 - 15 All Horiba Pentra Reagents 21 42.2 1.2 2.8 42 38 - 46 20 12.6 0.5 4.1 13 10 - 15 All Roche Integra/c111/c301/c501 Reagents 29 41.7 1.2 2.9 42 37 - 46 29 12.8 0.5 4.0 13 10 - 15 All Vital Diagnostics Reagents 16 41.6 1.3 3.1 42 37 - 46 16 13.6 0.7 5.3 14 11 - 16 Abaxis Piccolo Abaxis Piccolo - waived 27 38.6 0.8 2.0 39 35 - 43 27 12.6 0.6 5.1 13 10 - 15 All Chemistry Instruments 34 38.6 0.7 1.9 39 35 - 43 34 12.6 0.7 5.2 13 10 - 15 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 30 41.0 1.0 2.5 41 37 - 45 32 12.9 0.7 5.5 13 10 - 15 Beckman AU Beckman AU systems 35 42.9 1.5 3.5 43 39 - 47 35 13.3 0.7 5.4 13 11 - 16 Horiba ABX Pentra Horiba ABX Pentra 400 20 42.3 1.2 2.8 42 38 - 47 19 12.6 0.5 4.0 13 10 - 15 Roche Integra Roche Integra 20 41.3 1.2 2.8 41 37 - 46 20 12.7 0.6 4.6 13 10 - 15 Siemens Healthcare Siemens Dimension 44 43.2 1.1 2.6 43 39 - 48 46 13.3 0.6 4.4 13 11 - 16 All Chemistry Instruments 46 43.1 1.1 2.6 43 39 - 48 48 13.3 0.6 4.4 13 11 - 16 Vital Diagnostics Vital Diagnostics Envoy 500 14 41.8 1.2 2.8 42 38 - 46 14 13.7 0.6 4.5 14 11 - 16 All Chemistry Instruments 15 41.6 1.4 3.3 42 37 - 46 15 13.6 0.7 5.4 14 11 - 16 VITROS VITROS 250,350,500,700,750,950 38 39.1 0.9 2.4 39 35 - 43 38 11.6 0.5 4.4 12 9 - 14 All Chemistry Instruments 42 39.0 1.0 2.5 39 35 - 43 42 11.5 0.5 4.4 12 9 - 14

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2016 MLE-M3 Participant Summary/ 35

Urea Nitrogen (mg/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 258 5.8 0.9 15.0 6 3 - 8 259 5.6 0.8 13.9 6 3 - 8 All Alfa Wassermann Reagents 39 5.9 0.5 8.0 6 3 - 8 38 5.8 0.5 8.2 6 3 - 8 All Horiba Pentra Reagents 20 5.9 0.6 10.0 6 3 - 8 21 5.5 0.7 12.4 5 3 - 8 All Roche Integra/c111/c301/c501 Reagents 29 5.7 0.5 8.3 6 3 - 8 29 5.7 0.5 8.6 6 3 - 8 All Vital Diagnostics Reagents 15 6.5 0.6 9.8 7 4 - 9 15 6.5 0.5 8.0 6 4 - 9 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 7 5 - 9 5 - - - 7 4 - 9 All Chemistry Instruments 10 7.0 0.1 0.0 7 5 - 9 11 6.2 1.8 29.7 7 4 - 9 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 32 5.9 0.5 8.4 6 3 - 8 31 5.8 0.5 8.2 6 3 - 8 Beckman AU Beckman AU systems 32 6.0 0.1 0.0 6 4 - 8 31 6.0 0.1 0.0 6 4 - 8 Horiba ABX Pentra Horiba ABX Pentra 400 19 5.8 0.6 10.3 6 3 - 8 20 5.5 0.7 12.5 6 3 - 8 Roche Integra Roche Integra 20 5.6 0.5 9.2 6 3 - 8 20 5.5 0.5 9.3 6 3 - 8 Siemens Healthcare Siemens Dimension 45 6.1 0.6 9.6 6 4 - 9 46 5.6 0.7 13.3 6 3 - 8 All Chemistry Instruments 47 6.1 0.6 9.4 6 4 - 9 48 5.6 0.8 13.5 6 3 - 8 Vital Diagnostics Vital Diagnostics Envoy 500 14 6.5 0.7 10.0 7 4 - 9 14 6.5 0.5 8.0 7 4 - 9 VITROS VITROS 250,350,500,700,750,950 38 4.6 0.5 11.1 5 2 - 7 38 4.6 0.5 10.6 5 2 - 7 All Chemistry Instruments 42 4.5 0.5 11.2 5 2 - 7 42 4.6 0.5 10.6 5 2 - 7

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Urea Nitrogen (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range All Method 260 23.5 1.5 6.2 24 21 - 26 All Alfa Wassermann Reagents 38 23.6 0.9 3.7 24 21 - 26 All Horiba Pentra Reagents 21 23.4 0.6 2.5 23 21 - 26 All Roche Integra/c111/c301/c501 Reagents 29 23.5 0.8 3.3 24 21 - 26 All Vital Diagnostics Reagents 14 25.0 0.9 3.5 25 22 - 28 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 22 19 - 24 All Chemistry Instruments 11 21.7 0.5 2.1 22 19 - 24 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 31 23.6 0.9 3.7 24 21 - 26 Beckman AU Beckman AU systems 35 24.3 0.9 3.7 24 22 - 27 Horiba ABX Pentra Horiba ABX Pentra 400 20 23.4 0.6 2.6 23 21 - 26 Roche Integra Roche Integra 20 23.4 0.7 3.2 24 21 - 26 Siemens Healthcare Siemens Dimension 45 24.4 0.7 2.8 24 22 - 27 All Chemistry Instruments 47 24.4 0.7 2.8 24 22 - 27 Vital Diagnostics Vital Diagnostics Envoy 500 14 25.0 0.9 3.5 25 22 - 28 VITROS VITROS 250,350,500,700,750,950 38 21.3 0.6 2.9 21 19 - 24 All Chemistry Instruments 42 21.3 0.7 3.2 21 19 - 24

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2016 MLE-M3 Participant Summary/ 37

Uric Acid (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 180 10.96 0.43 3.9 11.0 9.0 - 12.9 176 3.62 0.23 6.4 3.6 3.0 - 4.3 All Alfa Wassermann Reagents 21 10.95 0.43 3.9 11.0 9.0 - 12.9 20 4.14 0.15 3.5 4.2 3.4 - 4.9 All Roche Integra/c111/c301/c501 Reagents 21 10.88 0.26 2.4 10.8 9.0 - 12.8 21 3.57 0.07 2.0 3.6 2.9 - 4.2 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 21 10.95 0.43 3.9 11.0 9.0 - 12.9 20 4.14 0.15 3.5 4.2 3.4 - 4.9 Beckman AU Beckman AU systems 32 11.22 0.32 2.8 11.3 9.3 - 13.2 32 3.66 0.15 4.0 3.7 3.0 - 4.3 Horiba ABX Pentra Horiba ABX Pentra 400 16 10.68 0.20 1.9 10.7 8.8 - 12.5 16 3.49 0.12 3.5 3.5 2.8 - 4.1 Roche Integra Roche Integra 14 10.82 0.21 1.9 10.8 8.9 - 12.7 14 3.56 0.06 1.8 3.6 2.9 - 4.2 Siemens Healthcare Siemens Dimension 29 10.57 0.35 3.3 10.6 8.7 - 12.4 30 3.45 0.09 2.5 3.4 2.8 - 4.1 All Chemistry Instruments 30 10.58 0.35 3.3 10.6 8.7 - 12.4 31 3.45 0.09 2.5 3.4 2.8 - 4.1 Vital Diagnostics Vital Diagnostics Envoy 500 11 11.45 0.09 0.8 11.4 9.4 - 13.4 11 3.67 0.05 1.3 3.7 3.0 - 4.3 VITROS VITROS 250,350,500,700,750,950 25 11.20 0.27 2.4 11.2 9.2 - 13.2 25 3.59 0.11 2.9 3.6 2.9 - 4.2 All Chemistry Instruments 29 11.19 0.26 2.3 11.2 9.2 - 13.1 29 3.59 0.10 2.8 3.6 2.9 - 4.2

Specimen CH-13 Specimen CH-14

All Method 177 1.68 0.37 22.2 1.6 1.3 - 2.0 173 1.74 0.29 16.6 1.7 1.4 - 2.1 All Alfa Wassermann Reagents 21 2.71 0.21 7.6 2.7 2.2 - 3.2 21 2.69 0.19 7.0 2.6 2.2 - 3.2 All Roche Integra/c111/c301/c501 Reagents 21 1.51 0.04 2.4 1.5 1.2 - 1.8 21 1.66 0.05 3.1 1.7 1.3 - 2.0 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 21 2.71 0.21 7.6 2.7 2.2 - 3.2 21 2.69 0.19 7.0 2.6 2.2 - 3.2 Beckman AU Beckman AU systems 31 1.63 0.07 4.3 1.6 1.3 - 2.0 32 1.74 0.09 5.2 1.7 1.4 - 2.1 Horiba ABX Pentra Horiba ABX Pentra 400 16 1.51 0.11 7.2 1.5 1.2 - 1.8 16 1.63 0.09 5.3 1.6 1.3 - 2.0 Roche Integra Roche Integra 14 1.51 0.04 2.4 1.5 1.2 - 1.8 14 1.65 0.05 3.1 1.7 1.3 - 2.0 Siemens Healthcare Siemens Dimension 30 1.52 0.14 8.9 1.5 1.2 - 1.8 29 1.62 0.07 4.5 1.6 1.3 - 1.9 All Chemistry Instruments 31 1.53 0.13 8.8 1.5 1.2 - 1.8 30 1.62 0.07 4.4 1.6 1.3 - 1.9 Vital Diagnostics Vital Diagnostics Envoy 500 11 1.66 0.12 7.2 1.6 1.3 - 2.0 11 1.77 0.09 5.1 1.8 1.4 - 2.1 VITROS VITROS 250,350,500,700,750,950 24 1.55 0.08 5.0 1.5 1.2 - 1.9 25 1.63 0.09 5.8 1.6 1.3 - 2.0 All Chemistry Instruments 28 1.57 0.08 5.2 1.6 1.3 - 1.9 29 1.63 0.09 5.7 1.6 1.3 - 2.0

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Uric Acid (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range All Method 177 6.40 0.23 3.6 6.4 5.3 - 7.5 All Alfa Wassermann Reagents 21 6.51 0.22 3.4 6.5 5.4 - 7.7 All Roche Integra/c111/c301/c501 Reagents 21 6.39 0.17 2.6 6.4 5.3 - 7.5 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 21 6.51 0.22 3.4 6.5 5.4 - 7.7 Beckman AU Beckman AU systems 32 6.48 0.19 2.9 6.5 5.3 - 7.6 Horiba ABX Pentra Horiba ABX Pentra 400 16 6.21 0.14 2.3 6.2 5.1 - 7.3 Roche Integra Roche Integra 14 6.36 0.16 2.6 6.4 5.2 - 7.5 Siemens Healthcare Siemens Dimension 30 6.16 0.11 1.8 6.1 5.1 - 7.3 All Chemistry Instruments 31 6.17 0.12 2.0 6.1 5.1 - 7.3 Vital Diagnostics Vital Diagnostics Envoy 500 11 6.70 0.15 2.2 6.7 5.5 - 7.9 VITROS VITROS 250,350,500,700,750,950 25 6.43 0.14 2.2 6.4 5.3 - 7.6 All Chemistry Instruments 29 6.44 0.14 2.1 6.5 5.3 - 7.6

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2016 MLE-M3 Participant Summary/ 39

Chloride (mmol/L)

Specimen CH-11 Specimen CH-12 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 279 122.0 6.4 5.2 122 115 - 129 278 92.1 1.8 2.0 92 87 - 97 Abaxis Piccolo Abaxis Piccolo - waived 26 115.5 2.0 1.7 116 109 - 122 26 93.0 1.6 1.7 93 88 - 98 All Chemistry Instruments 32 115.3 2.0 1.7 116 109 - 122 33 93.1 1.5 1.6 93 88 - 98 ISE Diluted Beckman AU systems 30 114.7 1.0 0.9 115 108 - 121 30 91.3 0.7 0.8 91 86 - 96 Roche Integra 21 120.2 2.3 1.9 120 114 - 127 21 92.1 1.9 2.0 92 87 - 97 Siemens Dimension QuickLyte - Xpand/EXL 32 123.2 1.6 1.3 123 116 - 130 33 91.5 0.9 1.0 91 86 - 97 Vital Diagnostics Envoy 500 15 124.1 2.0 1.6 123 117 - 131 15 92.7 1.4 1.5 93 88 - 98 All Chemistry Instruments 136 120.0 4.0 3.4 121 114 - 127 136 91.2 1.8 1.9 91 86 - 96 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 36 133.8 2.1 1.6 134 127 - 141 38 93.8 2.1 2.2 94 89 - 99 Horiba ABX Pentra 400 16 130.2 5.0 3.9 130 123 - 137 17 92.7 2.5 2.7 93 88 - 98 All Chemistry Instruments 64 130.8 6.3 4.8 132 124 - 138 65 93.2 2.1 2.2 93 88 - 98 VITROS VITROS 250,350,500,700,750,950 36 121.0 2.1 1.7 121 114 - 128 37 92.0 1.7 1.9 92 87 - 97 All Chemistry Instruments 41 121.1 2.0 1.6 121 115 - 128 42 92.0 1.6 1.8 92 87 - 97

Specimen CH-13 Specimen CH-14

All Method 257 89.1 2.5 2.8 89 84 - 94 255 84.7 2.0 2.4 85 80 - 89 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 95 89 - 99 5 - - - 88 82 - 91 All Chemistry Instruments 11 94.1 2.2 2.3 95 89 - 99 11 86.6 1.9 2.1 87 82 - 91 ISE Diluted Beckman AU systems 30 90.2 0.8 0.9 90 85 - 95 30 85.0 0.8 0.9 85 80 - 90 Roche Integra 21 87.7 1.2 1.4 88 83 - 93 21 84.8 1.9 2.2 85 80 - 89 Siemens Dimension QuickLyte - Xpand/EXL 32 88.2 1.0 1.2 88 83 - 93 33 83.5 0.8 1.0 83 79 - 88 Vital Diagnostics Envoy 500 15 89.6 2.3 2.6 90 85 - 95 15 85.3 1.9 2.3 85 81 - 90 All Chemistry Instruments 135 88.5 2.3 2.6 89 84 - 93 137 84.0 2.2 2.6 84 79 - 89 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 38 89.3 2.1 2.4 90 84 - 94 37 84.0 1.8 2.1 84 79 - 89 Horiba ABX Pentra 400 17 86.9 1.9 2.2 87 82 - 92 17 84.8 2.2 2.6 85 80 - 90 All Chemistry Instruments 65 88.8 2.4 2.7 89 84 - 94 64 84.4 1.9 2.2 85 80 - 89 VITROS VITROS 250,350,500,700,750,950 37 90.5 1.6 1.8 91 86 - 96 37 85.9 1.6 1.9 86 81 - 91 All Chemistry Instruments 42 90.5 1.5 1.7 91 86 - 96 42 85.9 1.5 1.8 86 81 - 91

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Chloride (mmol/L)

Specimen CH-15 Method/Instrument Labs Mean SD CV Median Range

All Method 256 103.1 2.8 2.7 103 97 - 109 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 102 96 - 107 All Chemistry Instruments 11 101.5 2.7 2.7 102 96 - 107 ISE Diluted Beckman AU systems 31 99.9 1.0 1.0 100 94 - 105 Roche Integra 20 102.4 2.1 2.1 103 97 - 108 Siemens Dimension QuickLyte - Xpand/EXL 33 103.5 1.2 1.1 103 98 - 109 Vital Diagnostics Envoy 500 15 104.5 1.3 1.2 104 99 - 110 All Chemistry Instruments 136 102.1 2.3 2.2 102 96 - 108 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 36 106.7 1.5 1.4 107 101 - 113 Horiba ABX Pentra 400 17 105.9 3.5 3.3 106 100 - 112 All Chemistry Instruments 63 105.9 2.6 2.5 106 100 - 112 VITROS VITROS 250,350,500,700,750,950 37 103.1 2.1 2.1 103 97 - 109 All Chemistry Instruments 42 103.2 2.3 2.2 103 98 - 109

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2016 MLE-M3 Participant Summary/ 41

CO2 (mmol/L)

Specimen CH-11 Specimen CH-12

Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 276 42.0 4.5 10.8 42 33 - 51 275 22.7 2.1 9.3 22 18 - 28 Enzymatic Reagent Abaxis Piccolo - waived 25 35.0 1.5 4.2 35 27 - 42 25 21.6 0.9 4.0 21 17 - 26 Alfa Wassermann ACE Alera/Axcel 22 44.9 3.5 7.9 45 35 - 54 21 24.3 2.1 8.5 24 19 - 30 Beckman AU systems 29 46.1 3.5 7.7 45 36 - 56 29 23.2 1.4 6.1 23 18 - 28 Horiba ABX Pentra 400 14 42.8 2.8 6.6 44 34 - 52 14 22.6 2.3 10.2 23 18 - 28 Roche Integra 16 41.8 1.7 4.0 42 33 - 51 16 21.4 1.3 6.1 22 17 - 26 Siemens Dimension 32 43.3 4.3 9.9 44 34 - 53 33 24.5 2.3 9.2 25 19 - 30 All Chemistry Instruments 169 42.4 4.9 11.5 44 33 - 51 169 23.0 2.2 9.4 23 18 - 28 ISE Diluted Vital Diagnostics Envoy 500 14 40.9 4.1 10.0 40 32 - 50 14 21.4 2.2 10.3 22 17 - 26 All Chemistry Instruments 30 42.3 4.5 10.6 43 33 - 51 30 22.2 2.2 9.9 22 17 - 27 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 14 44.9 3.8 8.5 47 35 - 54 14 24.3 2.0 8.1 24 19 - 30 All Chemistry Instruments 26 43.7 4.1 9.4 45 34 - 53 25 24.0 1.7 7.3 24 19 - 29 VITROS VITROS 250,350,500,700,750,950 34 40.0 1.1 2.7 40 32 - 48 36 21.4 1.0 4.7 22 17 - 26 All Chemistry Instruments 39 40.2 1.3 3.2 40 32 - 49 41 21.6 1.0 4.6 22 17 - 26

Specimen CH-13 Specimen CH-14

All Method 253 14.1 1.8 12.9 14 11 - 17 253 17.2 2.0 11.4 17 13 - 21 Enzymatic Reagent Abaxis Piccolo - waived 4 - - - 13 11 - 18 4 - - - 16 13 - 21 Alfa Wassermann ACE Alera/Axcel 22 14.4 1.9 13.2 15 11 - 18 22 18.0 2.2 12.3 18 14 - 22 Beckman AU systems 28 14.7 1.2 8.4 15 11 - 18 29 17.3 1.3 7.7 17 13 - 21 Horiba ABX Pentra 400 14 14.3 2.4 17.0 14 11 - 18 14 17.1 1.8 10.4 17 13 - 21 Roche Integra 16 13.1 1.2 9.0 13 10 - 16 16 15.9 1.1 7.1 16 12 - 20 Siemens Dimension 32 15.4 2.1 13.5 16 12 - 19 33 19.0 1.6 8.4 19 15 - 23 All Chemistry Instruments 148 14.3 2.0 13.8 15 11 - 18 148 17.4 2.0 11.4 17 13 - 21 ISE Diluted Vital Diagnostics Envoy 500 14 12.4 1.5 12.1 12 9 - 15 14 17.3 2.1 11.9 17 13 - 21 All Chemistry Instruments 30 13.5 1.8 13.3 14 10 - 17 30 16.8 2.2 13.2 17 13 - 21 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 14 14.2 1.8 12.7 14 11 - 18 14 18.0 2.3 12.7 18 14 - 22 All Chemistry Instruments 26 14.6 1.7 11.8 15 11 - 18 26 17.9 2.2 12.1 18 14 - 22 VITROS VITROS 250,350,500,700,750,950 36 13.7 1.3 9.6 14 10 - 17 36 15.9 1.2 7.8 16 12 - 20 All Chemistry Instruments 41 13.7 1.3 9.2 14 10 - 17 41 16.0 1.2 7.7 16 12 - 20

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CO2 (mmol/L) Specimen CH-15 Method/Instrument Labs Mean SD CV Median Range

All Method 252 30.1 3.0 9.8 30 24 - 37 Enzymatic Reagent Abaxis Piccolo - waived 4 - - - 28 24 - 37 Alfa Wassermann ACE Alera/Axcel 22 31.5 3.1 9.7 33 25 - 38 Beckman AU systems 29 31.4 2.2 7.1 32 25 - 38 Horiba ABX Pentra 400 14 29.7 2.4 8.1 29 23 - 36 Roche Integra 16 28.3 1.6 5.7 29 22 - 34 Siemens Dimension 33 32.5 2.5 7.6 33 26 - 40 All Chemistry Instruments 149 30.8 2.8 9.2 31 24 - 37 ISE Diluted Vital Diagnostics Envoy 500 14 29.0 2.5 8.8 29 23 - 35 All Chemistry Instruments 30 29.5 2.8 9.4 30 23 - 36 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 14 32.1 3.8 11.8 32 25 - 39 All Chemistry Instruments 26 31.0 4.0 12.9 32 24 - 38 VITROS VITROS 250,350,500,700,750,950 36 27.6 1.6 5.7 27 22 - 34 All Chemistry Instruments 40 27.8 1.6 5.7 28 22 - 34

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Potassium (mmol/L)

Specimen CH-11 Specimen CH-12 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 286 6.81 0.60 8.8 6.5 6.3 - 7.4 286 3.26 0.13 4.0 3.2 2.7 - 3.8 Abaxis Piccolo Abaxis Piccolo - waived 25 6.48 0.21 3.3 6.5 5.9 - 7.0 26 3.16 0.15 4.8 3.2 2.6 - 3.7 All Chemistry Instruments 32 6.52 0.24 3.7 6.5 6.0 - 7.1 33 3.17 0.16 4.9 3.2 2.6 - 3.7 ISE Diluted Beckman AU systems 32 6.23 0.07 1.2 6.2 5.7 - 6.8 28 3.20 0.01 0.0 3.2 2.7 - 3.7 Roche Integra 21 6.46 0.06 0.9 6.5 5.9 - 7.0 21 3.25 0.05 1.6 3.2 2.7 - 3.8 Siemens Dimension QuickLyte - Xpand/EXL 33 6.46 0.06 1.0 6.5 5.9 - 7.0 30 3.20 0.01 0.0 3.2 2.7 - 3.7 Vital Diagnostics Envoy 500 14 6.15 0.19 3.0 6.2 5.6 - 6.7 14 3.09 0.09 3.1 3.1 2.5 - 3.6 All Chemistry Instruments 133 6.38 0.15 2.4 6.4 5.8 - 6.9 131 3.21 0.06 2.0 3.2 2.7 - 3.8 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 39 7.38 0.18 2.4 7.4 6.8 - 7.9 38 3.32 0.06 1.8 3.3 2.8 - 3.9 Horiba ABX Pentra 400 16 6.99 0.15 2.1 7.0 6.4 - 7.5 17 3.29 0.09 2.6 3.3 2.7 - 3.8 All Chemistry Instruments 69 7.13 0.38 5.3 7.2 6.6 - 7.7 67 3.30 0.08 2.3 3.3 2.8 - 3.9 VITROS VITROS 250,350,500,700,750,950 38 7.88 0.15 1.9 7.9 7.3 - 8.4 38 3.46 0.06 1.7 3.5 2.9 - 4.0 All Chemistry Instruments 43 7.88 0.14 1.8 7.9 7.3 - 8.4 43 3.46 0.06 1.7 3.5 2.9 - 4.0

Specimen CH-13 Specimen CH-14 All Method 251 2.35 0.13 5.4 2.4 1.8 - 2.9 259 2.43 0.10 3.9 2.4 1.9 - 3.0 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 3.3 2.7 - 3.8 5 - - - 2.3 1.8 - 2.8 All Chemistry Instruments 11 3.28 0.17 5.2 3.3 2.7 - 3.8 11 2.30 0.13 5.5 2.3 1.8 - 2.8 ISE Diluted Beckman AU systems 32 2.42 0.07 3.0 2.4 1.9 - 3.0 31 2.46 0.06 2.5 2.5 1.9 - 3.0 Roche Integra 21 2.36 0.11 4.8 2.3 1.8 - 2.9 21 2.42 0.04 1.7 2.4 1.9 - 3.0 Siemens Dimension QuickLyte - Xpand/EXL 32 2.31 0.07 2.9 2.3 1.8 - 2.9 33 2.40 0.01 0.0 2.4 1.9 - 2.9 Vital Diagnostics Envoy 500 14 2.09 0.07 3.2 2.1 1.5 - 2.6 14 2.33 0.09 3.9 2.4 1.8 - 2.9 All Chemistry Instruments 135 2.33 0.13 5.7 2.3 1.8 - 2.9 135 2.42 0.07 3.0 2.4 1.9 - 3.0 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 38 2.37 0.12 5.1 2.4 1.8 - 2.9 38 2.35 0.07 2.9 2.3 1.8 - 2.9 Horiba ABX Pentra 400 17 2.32 0.11 4.9 2.3 1.8 - 2.9 17 2.49 0.08 3.3 2.5 1.9 - 3.0 All Chemistry Instruments 67 2.35 0.12 5.0 2.3 1.8 - 2.9 68 2.41 0.10 4.1 2.4 1.9 - 3.0 VITROS VITROS 250,350,500,700,750,950 38 2.41 0.04 1.8 2.4 1.9 - 3.0 37 2.54 0.06 2.2 2.5 2.0 - 3.1 All Chemistry Instruments 43 2.41 0.04 1.7 2.4 1.9 - 3.0 42 2.54 0.05 2.2 2.5 2.0 - 3.1

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Potassium (mmol/L)

Specimen CH-15 Method/Instrument Labs Mean SD CV Median Range

All Method 264 4.54 0.24 5.2 4.5 4.0 - 5.1 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 4.5 4.0 - 5.1 All Chemistry Instruments 11 4.54 0.12 2.7 4.5 4.0 - 5.1 ISE Diluted Beckman AU systems 32 4.33 0.05 1.2 4.3 3.8 - 4.9 Roche Integra 21 4.44 0.05 1.1 4.4 3.9 - 5.0 Siemens Dimension QuickLyte - Xpand/EXL 33 4.41 0.04 0.9 4.4 3.9 - 5.0 Vital Diagnostics Envoy 500 14 4.24 0.11 2.6 4.3 3.7 - 4.8

All Chemistry Instruments 136 4.39 0.10 2.2 4.4 3.8 - 4.9

ISE Undiluted

Alfa Wassermann ACE Alera/Axcel 38 4.61 0.07 1.5 4.6 4.1 - 5.2

Horiba ABX Pentra 400 17 4.58 0.10 2.3 4.6 4.0 - 5.1

All Chemistry Instruments 68 4.57 0.11 2.5 4.6 4.0 - 5.1 VITROS VITROS 250,350,500,700,750,950 38 4.98 0.09 1.8 5.0 4.4 - 5.5 All Chemistry Instruments 43 4.98 0.09 1.8 5.0 4.4 - 5.5

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Sodium (mmol/L) Technical tip: Incomplete or incorrect method reporting is a common cause of proficiency test failure, especially when it comes to the electrolytes. If your test method is “ISE Direct”, it should be reported as ISE Undiluted on your MLE test result form (TRF). If your test method is “ISE Indirect”, it should be reported as ISE Diluted on your MLE TRF. Be sure to check your package insert for the correct test method, or contact the manufacturer of the instrument or reagent.

Specimen CH-11 Specimen CH-12 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 278 166.0 13.9 8.4 159 161 - 170 281 130.0 3.1 2.4 130 125 - 134 Abaxis Piccolo Abaxis Piccolo - waived 26 162.8 1.8 1.1 162 158 - 167 26 128.9 1.5 1.2 129 124 - 133 All Chemistry Instruments 32 162.8 2.3 1.4 162 158 - 167 33 128.6 1.6 1.2 129 124 - 133 ISE Diluted Beckman AU systems 31 151.2 1.3 0.9 151 147 - 156 30 127.0 0.9 0.7 127 123 - 131 Roche Integra 21 155.4 1.2 0.7 155 151 - 160 21 128.0 0.9 0.7 128 123 - 132 Siemens Dimension QuickLyte - Xpand/EXL 33 155.1 1.7 1.1 155 151 - 160 34 130.1 1.0 0.8 130 126 - 135 Vital Diagnostics Envoy 500 13 154.3 3.6 2.3 155 150 - 159 13 127.5 2.9 2.3 128 123 - 132 All Chemistry Instruments 131 154.0 2.5 1.6 155 149 - 158 133 128.3 1.8 1.4 128 124 - 133 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 38 181.5 2.5 1.4 181 177 - 186 39 130.7 1.3 1.0 131 126 - 135 Horiba ABX Pentra 400 16 177.3 2.5 1.4 177 173 - 182 17 131.1 1.5 1.1 131 127 - 136 All Chemistry Instruments 63 177.9 7.3 4.1 180 173 - 182 68 130.6 1.8 1.3 131 126 - 135 VITROS VITROS 250,350,500,700,750,950 37 187.4 3.3 1.7 187 183 - 192 37 136.3 2.1 1.5 136 132 - 141 All Chemistry Instruments 42 187.4 3.1 1.7 187 183 - 192 42 136.2 2.0 1.4 136 132 - 141

Specimen CH-13 Specimen CH-14 All Method 261 123.2 4.4 3.6 122 119 - 128 261 121.7 2.6 2.2 121 117 - 126 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 127 121 - 130 5 - - - 122 116 - 125 All Chemistry Instruments 11 125.6 2.3 1.9 126 121 - 130 11 120.8 1.4 1.2 121 116 - 125 ISE Diluted Beckman AU systems 30 120.6 1.0 0.8 121 116 - 125 30 120.6 1.3 1.1 121 116 - 125 Roche Integra 20 120.7 1.0 0.8 121 116 - 125 21 120.9 0.9 0.7 121 116 - 125 Siemens Dimension QuickLyte - Xpand/EXL 33 122.8 1.1 0.9 123 118 - 127 33 124.1 0.9 0.7 124 120 - 129 Vital Diagnostics Envoy 500 14 118.6 2.8 2.4 119 114 - 123 13 120.0 2.2 1.9 121 116 - 124 All Chemistry Instruments 132 121.3 1.6 1.4 121 117 - 126 132 121.8 1.9 1.5 121 117 - 126 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 38 120.7 1.2 1.0 121 116 - 125 39 118.9 1.3 1.1 119 114 - 123 Horiba ABX Pentra 400 17 122.9 1.6 1.3 123 118 - 127 17 120.8 1.4 1.2 121 116 - 125 All Chemistry Instruments 68 121.6 1.7 1.4 121 117 - 126 68 119.8 1.8 1.5 120 115 - 124 VITROS VITROS 250,350,500,700,750,950 37 132.2 2.2 1.7 132 128 - 137 37 125.6 1.6 1.3 125 121 - 130 All Chemistry Instruments 42 132.1 2.1 1.6 132 128 - 137 42 125.5 1.6 1.2 125 121 - 130

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Sodium (mmol/L)

Specimen CH-15 Method/Instrument Labs Mean SD CV Median Range

All Method 263 142.7 6.5 4.5 140 138 - 147 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 140 135 - 144 All Chemistry Instruments 11 139.5 1.5 1.1 140 135 - 144 ISE Diluted Beckman AU systems 31 136.2 1.4 1.0 137 132 - 141 Roche Integra 21 137.9 1.0 0.8 138 133 - 142 Siemens Dimension QuickLyte - Xpand/EXL 34 139.5 1.1 0.8 140 135 - 144 Vital Diagnostics Envoy 500 14 136.8 2.2 1.6 137 132 - 141 All Chemistry Instruments 132 137.9 1.7 1.3 138 133 - 142 ISE Undiluted Alfa Wassermann ACE Alera/Axcel 39 146.3 1.5 1.0 146 142 - 151 Horiba ABX Pentra 400 17 146.7 1.8 1.2 147 142 - 151 All Chemistry Instruments 67 145.4 3.2 2.2 146 141 - 150 VITROS VITROS 250,350,500,700,750,950 35 154.1 1.5 0.9 154 150 - 159 All Chemistry Instruments 40 154.2 1.6 1.0 154 150 - 159

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TIBC – Calculated (µg/dL)

Specimen CH-11 Specimen CH-12 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 25 454.3 142.7 31.4 521 169 - 740 25 179.2 58.2 32.5 203 62 - 296 Calculated TIBC (TRF x CF) Beckman AU systems 11 456.7 126.6 27.7 526 203 - 710 11 188.7 53.0 28.1 216 82 - 295 All Chemistry Instruments 25 454.3 142.7 31.4 521 169 - 740 25 179.2 58.2 32.5 203 62 - 296

Specimen CH-13 Specimen CH-14

All Method 25 350.0 25.5 7.3 349 280 - 421 24 119.5 29.4 24.6 129 60 - 179 Calculated TIBC (TRF x CF) Beckman AU systems 11 362.0 14.0 3.9 362 289 - 435 11 121.2 31.5 26.0 137 58 - 185 All Chemistry Instruments 25 350.0 25.5 7.3 349 280 - 421 24 119.5 29.4 24.6 129 60 - 179

Specimen CH-15 All Method 25 286.2 93.3 32.6 326 99 - 473 Calculated TIBC (TRF x CF) Beckman AU systems 11 290.5 82.1 28.2 337 126 - 455 All Chemistry Instruments 25 286.2 93.3 32.6 326 99 - 473

TIBC – Direct (µg/dL)

Specimen CH-11 Specimen CH-12 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 27 391.5 33.6 8.6 408 313 - 470 28 164.8 27.2 16.5 154 110 - 220 Siemens Healthcare Siemens Dimension 16 408.3 8.1 2.0 408 326 - 490 17 147.7 6.5 4.4 147 118 - 178 All Chemistry Instruments 18 408.2 8.5 2.1 408 326 - 490 19 147.5 6.4 4.3 147 118 - 178

Specimen CH-13 Specimen CH-14 All Method 27 345.9 28.9 8.3 336 276 - 416 27 104.3 32.1 30.7 90 40 - 169 Siemens Healthcare Siemens Dimension 16 334.8 8.1 2.4 336 267 - 402 16 83.4 7.1 8.5 83 66 - 101 All Chemistry Instruments 17 334.3 8.2 2.4 335 267 - 402 18 83.4 6.7 8.1 83 66 - 101

Specimen CH-15 All Method 27 251.7 13.4 5.3 252 201 - 303 Siemens Healthcare Siemens Dimension 17 246.1 7.6 3.1 246 196 - 296 All Chemistry Instruments 19 245.7 7.8 3.2 246 196 - 295

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UIBC – Direct (µg/dL)

Specimen CH-11 Specimen CH-12 Method/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 32 267.1 14.4 5.4 270 213 - 321 32 126.6 10.6 8.4 128 101 - 152 All Roche Integra/c111/c301/c501 Reagents 12 264.8 10.5 3.9 264 211 - 318 12 121.3 7.3 6.0 124 97 - 146 Beckman AU Beckman AU systems 17 271.5 14.9 5.5 275 217 - 326 17 131.7 10.2 7.7 133 105 - 159

Specimen CH-13 Specimen CH-14 All Method 32 36.4 14.7 40.5 36 6 - 66 32 92.7 10.0 10.8 93 72 - 113 All Roche Integra/c111/c301/c501 Reagents 12 26.4 7.2 27.3 27 11 - 41 12 89.1 8.5 9.6 91 71 - 107 Beckman AU Beckman AU systems 17 46.6 11.6 24.8 47 23 - 70 17 96.3 10.1 10.5 98 76 - 117

Specimen CH-15

All Method 32 179.6 11.8 6.6 182 143 - 216 All Roche Integra/c111/c301/c501 Reagents 12 175.1 9.9 5.7 177 140 - 211 Beckman AU Beckman AU systems 17 184.9 10.2 5.5 187 147 - 222

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ALT (SGPT) (IU/L)

Specimen CH-11 Specimen CH-12 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 271 238.0 24.2 10.2 241 190 - 286 277 61.4 9.2 14.9 61 49 - 74 All Alfa Wassermann Reagents 36 208.5 7.4 3.5 210 166 - 251 38 49.2 2.6 5.3 50 39 - 60 All Horiba Pentra Reagents 21 271.8 10.5 3.9 274 217 - 327 20 67.6 1.5 2.3 68 54 - 82 All Roche Integra/c111/c301/c501 Reagents 28 244.9 12.6 5.2 247 195 - 294 29 59.9 2.0 3.4 60 47 - 72 All Vital Diagnostics Reagents 16 250.4 17.0 6.8 251 200 - 301 15 62.3 3.8 6.0 61 49 - 75 Abaxis Piccolo Abaxis Piccolo - waived 27 208.1 33.0 15.9 223 166 - 250 26 57.1 3.7 6.5 58 45 - 69 All Chemistry Instruments 33 214.8 22.6 10.5 224 171 - 258 34 57.1 3.5 6.1 57 45 - 69 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 28 209.5 6.5 3.1 210 167 - 252 30 49.5 2.5 5.1 50 39 - 60 Beckman AU Beckman AU systems 35 223.6 14.1 6.3 227 178 - 269 34 54.0 1.5 2.7 54 43 - 65 Horiba ABX Pentra Horiba ABX Pentra 400 20 272.3 10.6 3.9 275 217 - 327 20 67.3 2.1 3.2 68 53 - 81 Roche Integra Roche Integra 19 246.7 7.6 3.1 247 197 - 297 20 60.2 1.4 2.3 60 48 - 73 Siemens Healthcare ALTi Siemens Dimension 35 266.7 8.6 3.2 267 213 - 320 37 65.9 4.2 6.4 66 52 - 80 All Chemistry Instruments 36 266.5 8.5 3.2 267 213 - 320 38 65.9 4.1 6.3 66 52 - 80 Vital Diagnostics Vital Diagnostics Envoy 500 15 251.7 16.6 6.6 254 201 - 303 15 64.0 6.3 9.9 62 51 - 77 All Chemistry Instruments 16 250.4 17.0 6.8 251 200 - 301 15 62.3 3.8 6.0 61 49 - 75 VITROS VITROS 250,350,500,700,750,950 37 236.6 13.4 5.6 239 189 - 284 37 76.1 4.4 5.8 75 60 - 92 All Chemistry Instruments 42 236.4 14.0 5.9 240 189 - 284 42 76.0 4.3 5.7 75 60 - 92

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ALT (SGPT) (IU/L)

Specimen CH-13 Specimen CH-14 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 252 15.6 5.8 37.3 15 12 - 19 253 15.4 8.4 54.4 13 12 - 19 All Alfa Wassermann Reagents 38 9.2 1.8 20.1 9 7 - 12 37 7.7 1.6 20.6 8 6 - 10 All Horiba Pentra Reagents 21 16.0 1.7 10.8 16 12 - 20 20 13.3 1.1 8.1 13 10 - 16 All Roche Integra/c111/c301/c501 Reagents 30 12.0 0.8 6.4 12 9 - 15 30 11.2 0.9 8.3 11 8 - 14 All Vital Diagnostics Reagents 14 13.9 1.0 7.4 14 11 - 17 15 12.5 1.0 7.9 12 10 - 16 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 19 15 - 24 5 - - - 19 14 - 23 All Chemistry Instruments 12 19.2 1.7 8.9 19 15 - 24 12 18.6 2.9 15.6 19 14 - 23 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 30 9.5 1.8 18.5 10 7 - 12 29 7.7 1.6 20.3 8 6 - 10 Beckman AU Beckman AU systems 34 10.5 0.6 5.9 10 8 - 13 35 10.0 0.7 7.3 10 8 - 12 Horiba ABX Pentra Horiba ABX Pentra 400 20 16.2 1.3 8.2 16 12 - 20 19 13.3 1.1 7.9 13 10 - 16 Roche Integra Roche Integra 21 11.8 0.7 5.8 12 9 - 15 21 11.0 0.9 8.1 11 8 - 14 Siemens Healthcare ALTi Siemens Dimension 36 18.4 1.5 8.1 19 14 - 23 35 14.6 1.5 10.5 14 11 - 18 All Chemistry Instruments 37 18.4 1.5 8.1 18 14 - 23 36 14.6 1.5 10.4 14 11 - 18 Vital Diagnostics Vital Diagnostics Envoy 500 14 13.9 1.0 7.4 14 11 - 17 15 12.5 1.0 7.9 12 10 - 16 VITROS VITROS 250,350,500,700,750,950 37 24.3 3.7 15.4 25 19 - 30 37 32.1 5.2 16.2 32 25 - 39 All Chemistry Instruments 42 24.7 3.7 15.1 25 19 - 30 42 32.3 5.0 15.6 32 25 - 39

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ALT (SGPT) (IU/L)

Specimen CH-15 Instrument/Reagent Labs Mean SD CV Median Range

All Method 252 127.0 16.3 12.9 131 101 - 153 All Alfa Wassermann Reagents 36 110.1 4.4 4.0 111 88 - 133 All Horiba Pentra Reagents 20 145.6 6.2 4.2 147 116 - 175 All Roche Integra/c111/c301/c501 Reagents 30 128.4 8.1 6.3 132 102 - 155 All Vital Diagnostics Reagents 16 126.6 20.2 16.0 133 101 - 152 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 117 90 - 136 All Chemistry Instruments 12 113.0 9.7 8.6 117 90 - 136 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 29 110.1 4.1 3.7 111 88 - 133 Beckman AU Beckman AU systems 33 116.7 8.2 7.1 119 93 - 141 Horiba ABX Pentra Horiba ABX Pentra 400 19 146.2 5.6 3.8 147 116 - 176 Roche Integra Roche Integra 21 129.0 7.9 6.1 131 103 - 155 Siemens Healthcare ALTi Siemens Dimension 38 135.3 19.3 14.3 142 108 - 163 All Chemistry Instruments 39 135.4 19.1 14.1 141 108 - 163 Vital Diagnostics Vital Diagnostics Envoy 500 15 129.9 15.8 12.2 135 103 - 156 VITROS VITROS 250,350,500,700,750,950 36 136.8 7.0 5.1 137 109 - 165 All Chemistry Instruments 40 137.0 7.3 5.3 137 109 - 165

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Alkaline Phosphatase (IU/L)

Specimen CH-11 Specimen CH-12 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 283 302.8 66.7 22.0 323 211 - 394 283 95.1 11.8 12.4 96 66 - 124 All Alfa Wassermann Reagents 38 320.7 23.9 7.5 328 224 - 417 38 95.6 7.5 7.9 98 66 - 125 All Horiba Pentra Reagents 20 377.1 17.6 4.7 374 263 - 491 20 113.7 5.7 5.0 113 79 - 148 All Roche Integra/c111/c301/c501 Reagents 28 343.1 8.3 2.4 342 240 - 446 28 99.1 2.1 2.1 99 69 - 129 All Vital Diagnostics Reagents 16 287.3 28.8 10.0 292 201 - 374 17 84.4 10.6 12.5 87 59 - 110 Abaxis Piccolo Abaxis Piccolo - waived 26 213.9 9.1 4.3 216 149 - 279 26 76.1 3.9 5.1 76 53 - 99 All Chemistry Instruments 35 214.1 9.1 4.2 215 149 - 279 35 75.7 3.9 5.2 75 52 - 99 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 30 319.3 22.9 7.2 325 223 - 416 30 95.3 7.4 7.7 96 66 - 124 Beckman AU Beckman AU systems 34 315.6 26.0 8.2 316 220 - 411 34 90.3 7.7 8.6 91 63 - 118 Horiba ABX Pentra Horiba ABX Pentra 400 19 378.4 17.1 4.5 374 264 - 492 19 114.1 5.4 4.8 113 79 - 149 Roche Integra Roche Integra 18 342.3 7.8 2.3 340 239 - 446 18 99.1 1.8 1.8 99 69 - 129 All Chemistry Instruments 19 342.8 7.9 2.3 340 239 - 446 19 99.2 1.8 1.8 99 69 - 129 Siemens Healthcare Siemens Dimension 12 373.8 10.6 2.8 375 261 - 486 12 106.0 4.2 4.0 106 74 - 138 All Chemistry Instruments 13 374.3 10.3 2.8 377 262 - 487 13 106.5 4.4 4.1 106 74 - 139 Siemens Healthcare ALPi Siemens Dimension 34 373.7 12.7 3.4 375 261 - 486 34 105.5 4.6 4.3 105 73 - 138 Vital Diagnostics Vital Diagnostics Envoy 500 15 291.9 22.9 7.8 293 204 - 380 15 87.2 6.4 7.4 87 61 - 114 All Chemistry Instruments 16 287.3 28.8 10.0 292 201 - 374 16 86.4 7.0 8.1 87 60 - 113 VITROS VITROS 250,350,500,700,750,950 37 207.9 14.8 7.1 204 145 - 271 37 93.8 4.7 5.0 93 65 - 122 All Chemistry Instruments 42 206.8 14.8 7.2 204 144 - 269 42 93.3 5.0 5.3 93 65 - 122

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Alkaline Phosphatase (IU/L)

Specimen CH-13 Specimen CH-14 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 258 44.6 5.1 11.4 45 31 - 59 256 28.7 3.5 12.2 28 20 - 38 All Alfa Wassermann Reagents 38 43.7 3.5 8.1 45 30 - 57 38 27.4 2.3 8.4 28 19 - 36 All Horiba Pentra Reagents 20 53.6 4.2 7.9 53 37 - 70 20 33.7 2.9 8.7 34 23 - 44 All Roche Integra/c111/c301/c501 Reagents 28 46.3 1.3 2.9 46 32 - 61 29 28.3 1.0 3.5 28 19 - 37 All Vital Diagnostics Reagents 16 42.5 4.3 10.0 43 29 - 56 16 28.8 6.9 24.1 28 20 - 38 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 38 24 - 47 5 - - - 26 16 - 31 All Chemistry Instruments 12 35.7 4.0 11.3 36 24 - 47 12 23.6 3.5 15.0 24 16 - 31 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 30 43.3 3.4 7.9 44 30 - 57 30 27.1 2.3 8.3 27 18 - 36 Beckman AU Beckman AU systems 34 41.5 4.3 10.4 42 29 - 54 34 25.3 2.5 9.8 25 17 - 33 Horiba ABX Pentra Horiba ABX Pentra 400 19 53.9 4.0 7.3 53 37 - 71 19 34.0 2.7 7.9 34 23 - 45 Roche Integra Roche Integra 18 45.8 1.0 2.3 46 32 - 60 19 28.1 0.9 3.3 28 19 - 37 All Chemistry Instruments 19 45.9 1.0 2.3 46 32 - 60 20 28.2 0.9 3.3 28 19 - 37 Siemens Healthcare Siemens Dimension 12 47.3 3.2 6.8 48 33 - 62 12 28.6 3.3 11.7 30 20 - 38 All Chemistry Instruments 13 47.7 3.4 7.0 48 33 - 62 13 29.0 3.5 12.2 30 20 - 38 Siemens Healthcare ALPi Siemens Dimension 33 47.3 3.3 6.9 47 33 - 62 34 28.6 3.1 10.8 28 20 - 38 Vital Diagnostics Vital Diagnostics Envoy 500 15 41.9 3.7 8.9 42 29 - 55 14 28.5 2.2 7.9 28 19 - 38 VITROS VITROS 250,350,500,700,750,950 37 43.1 2.7 6.3 44 30 - 57 37 31.8 2.2 6.8 31 22 - 42 All Chemistry Instruments 42 43.0 2.6 6.1 44 30 - 56 42 31.6 2.1 6.8 31 22 - 42

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Alkaline Phosphatase (IU/L)

Specimen CH-15 Instrument/Reagent Labs Mean SD CV Median Range

All Method 259 187.5 24.5 13.1 191 131 - 244 All Alfa Wassermann Reagents 38 190.2 12.2 6.4 192 133 - 248 All Horiba Pentra Reagents 20 220.1 10.9 5.0 217 154 - 287 All Roche Integra/c111/c301/c501 Reagents 28 196.8 4.9 2.5 196 137 - 256 All Vital Diagnostics Reagents 15 169.9 12.2 7.2 170 118 - 221 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 136 94 - 177 All Chemistry Instruments 12 135.4 5.3 3.9 136 94 - 177 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 30 188.3 11.6 6.1 190 131 - 245 Beckman AU Beckman AU systems 34 179.0 15.3 8.6 179 125 - 233 Horiba ABX Pentra Horiba ABX Pentra 400 19 221.1 10.2 4.6 217 154 - 288 Roche Integra Roche Integra 18 196.2 3.9 2.0 195 137 - 256 All Chemistry Instruments 19 196.5 3.9 2.0 195 137 - 256 Siemens Healthcare Siemens Dimension 12 213.5 6.4 3.0 214 149 - 278 All Chemistry Instruments 13 213.8 6.2 2.9 214 149 - 279 Siemens Healthcare ALPi Siemens Dimension 34 211.3 5.9 2.8 211 147 - 275 Vital Diagnostics Vital Diagnostics Envoy 500 15 169.9 12.2 7.2 170 118 - 221 VITROS VITROS 250,350,500,700,750,950 37 162.6 9.1 5.6 161 113 - 212 All Chemistry Instruments 42 161.7 9.6 5.9 161 113 - 211

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AST (SGOT) (IU/L)

Specimen CH-11 Specimen CH-12 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 238 267.4 34.8 13.0 267 213 - 321 237 73.1 6.3 8.6 75 58 - 88 All Alfa Wassermann Reagents 36 237.3 5.7 2.4 237 189 - 285 38 65.3 2.8 4.3 66 52 - 79 All Horiba Pentra Reagents 21 269.6 9.3 3.4 269 215 - 324 21 76.6 3.0 3.9 77 61 - 92 All Roche Integra/c111/c301/c501 Reagents 28 264.5 9.2 3.5 265 211 - 318 28 73.5 2.2 3.0 74 58 - 89 All Vital Diagnostics Reagents 16 272.9 12.2 4.5 274 218 - 328 16 78.3 3.5 4.5 79 62 - 94 Abaxis Piccolo Abaxis Piccolo - waived 24 259.0 11.5 4.4 259 207 - 311 25 76.3 2.8 3.7 77 61 - 92 All Chemistry Instruments 33 259.5 10.9 4.2 262 207 - 312 34 76.3 2.8 3.6 77 61 - 92 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 28 238.4 5.3 2.2 238 190 - 287 30 65.5 2.8 4.4 66 52 - 79 Beckman AU Beckman AU systems 34 234.2 6.8 2.9 235 187 - 282 34 65.0 2.0 3.0 65 51 - 78 Horiba ABX Pentra Horiba ABX Pentra 400 20 269.6 9.5 3.5 269 215 - 324 20 76.5 3.0 3.9 77 61 - 92 Roche Integra Roche Integra 19 263.5 8.8 3.4 265 210 - 317 19 73.1 2.2 3.0 73 58 - 88 Siemens Healthcare Siemens Dimension 46 321.2 9.7 3.0 320 256 - 386 46 78.8 2.6 3.4 79 63 - 95 All Chemistry Instruments 47 321.1 9.7 3.0 320 256 - 386 47 78.8 2.6 3.3 79 63 - 95 Vital Diagnostics Vital Diagnostics Envoy 500 15 273.0 12.6 4.6 274 218 - 328 15 78.3 3.6 4.6 79 62 - 94 All Chemistry Instruments 16 272.9 12.2 4.5 274 218 - 328 16 78.3 3.5 4.5 79 62 - 94 VITROS VITROS 250,350,500,700,750,950 37 330.9 11.7 3.5 330 264 - 398 36 80.1 2.4 3.0 80 64 - 97 All Chemistry Instruments 42 330.7 11.1 3.4 330 264 - 397 41 80.2 2.3 2.9 80 64 - 97

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AST (SGOT) (IU/L)

Specimen CH-13 Specimen CH-14 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 214 20.7 3.1 14.9 20 16 - 25 214 15.9 3.0 18.6 16 12 - 20 All Alfa Wassermann Reagents 38 16.3 2.2 13.5 16 13 - 20 38 11.5 1.5 13.2 11 9 - 14 All Horiba Pentra Reagents 21 23.0 1.7 7.4 23 18 - 28 21 17.3 1.9 10.8 17 13 - 21 All Roche Integra/c111/c301/c501 Reagents 28 20.4 1.1 5.4 20 16 - 25 27 15.9 1.0 6.4 16 12 - 20 All Vital Diagnostics Reagents 16 22.3 2.2 9.9 22 17 - 27 16 18.1 1.9 10.4 18 14 - 22 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 25 20 - 32 5 - - - 22 17 - 27 All Chemistry Instruments 12 26.2 1.6 6.3 27 20 - 32 12 22.1 1.1 4.9 22 17 - 27 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 30 16.2 2.1 13.2 16 12 - 20 30 11.7 1.5 13.2 12 9 - 15 Beckman AU Beckman AU systems 33 18.9 0.5 2.9 19 15 - 23 33 14.8 0.7 4.8 15 11 - 18 Horiba ABX Pentra Horiba ABX Pentra 400 20 23.1 1.6 6.9 24 18 - 28 20 17.5 1.6 9.4 17 14 - 21 Roche Integra Roche Integra 19 20.1 1.1 5.6 20 16 - 25 18 15.6 0.9 5.5 15 12 - 19 Siemens Healthcare Siemens Dimension 46 18.7 2.2 11.7 19 14 - 23 47 17.0 1.7 10.1 17 13 - 21 All Chemistry Instruments 47 18.7 2.2 11.6 19 14 - 23 48 17.0 1.7 10.1 17 13 - 21 Vital Diagnostics Vital Diagnostics Envoy 500 15 22.5 2.1 9.3 22 18 - 28 15 18.3 1.8 9.6 18 14 - 22 VITROS VITROS 250,350,500,700,750,950 37 21.8 1.0 4.4 22 17 - 27 36 16.7 0.7 4.3 17 13 - 21 All Chemistry Instruments 41 21.9 0.8 3.8 22 17 - 27 41 16.7 0.7 4.0 17 13 - 21

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AST (SGOT) (IU/L)

Specimen CH-15 Instrument/Reagent Labs Mean SD CV Median Range

All Method 213 152.3 15.1 9.9 155 121 - 183 All Alfa Wassermann Reagents 38 137.5 5.2 3.8 137 110 - 166 All Horiba Pentra Reagents 21 158.3 6.4 4.1 156 126 - 190 All Roche Integra/c111/c301/c501 Reagents 28 153.4 5.2 3.4 154 122 - 185 All Vital Diagnostics Reagents 15 161.1 9.7 6.0 162 128 - 194 Abaxis Piccolo Abaxis Piccolo - waived 5 - - - 151 120 - 182 All Chemistry Instruments 12 151.1 5.6 3.7 152 120 - 182 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 30 137.8 4.9 3.5 137 110 - 166 Beckman AU Beckman AU systems 35 134.6 5.3 3.9 135 107 - 162 Horiba ABX Pentra Horiba ABX Pentra 400 20 158.4 6.6 4.1 158 126 - 191 Roche Integra Roche Integra 19 152.8 5.0 3.3 154 122 - 184 Siemens Healthcare Siemens Dimension 45 170.8 4.6 2.7 170 136 - 205 All Chemistry Instruments 46 170.8 4.5 2.6 170 136 - 205 Vital Diagnostics Vital Diagnostics Envoy 500 15 161.1 9.7 6.0 162 128 - 194 VITROS VITROS 250,350,500,700,750,950 37 174.1 4.9 2.8 175 139 - 209 All Chemistry Instruments 41 173.9 5.0 2.9 175 139 - 209

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Creatine Kinase (IU/L)

Specimen CH-11 Specimen CH-12 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 116 312.3 39.1 12.5 319 218 - 406 117 81.1 6.5 8.1 82 56 - 106 All Alfa Wassermann Reagents 14 307.1 12.9 4.2 306 214 - 400 14 85.7 4.3 5.0 88 59 - 112 All Roche Integra/c111/c301/c501 Reagents 11 336.0 15.2 4.5 335 235 - 437 11 84.4 4.8 5.7 83 59 - 110 Beckman AU Beckman AU systems 23 300.8 10.6 3.5 299 210 - 392 23 74.0 3.0 4.0 74 51 - 97 Siemens Healthcare CKI Siemens Dimension 20 342.0 10.4 3.0 346 239 - 445 20 84.7 2.3 2.8 84 59 - 111 VITROS VITROS 250,350,500,700,750,950 13 233.0 17.3 7.4 231 163 - 303 13 75.2 6.8 9.0 75 52 - 98 All Chemistry Instruments 16 231.9 16.2 7.0 231 162 - 302 16 75.6 6.7 8.8 76 52 - 99

Specimen CH-13 Specimen CH-14

All Method 115 57.9 6.2 10.6 59 40 - 76 115 19.7 3.0 15.1 20 13 - 26 All Alfa Wassermann Reagents 14 62.6 3.2 5.1 63 43 - 82 14 24.6 3.1 12.4 25 17 - 33 All Roche Integra/c111/c301/c501 Reagents 11 57.2 4.3 7.5 56 40 - 75 11 20.2 3.1 15.2 20 14 - 27 Beckman AU Beckman AU systems 23 49.7 3.2 6.5 49 34 - 65 23 17.1 1.7 10.1 17 11 - 23 Siemens Healthcare CKI Siemens Dimension 20 60.2 3.2 5.3 60 42 - 79 21 19.0 2.9 15.1 19 13 - 25 VITROS VITROS 250,350,500,700,750,950 13 59.9 5.6 9.4 60 41 - 78 12 20.0 0.1 0.0 20 14 - 26 All Chemistry Instruments 16 60.3 5.4 9.0 61 42 - 79 14 20.0 0.1 0.0 20 14 - 26

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Creatine Kinase (IU/L)

Specimen CH-15 Instrument/Reagent Labs Mean SD CV Median Range

All Method 116 171.5 14.3 8.3 175 120 - 223 All Alfa Wassermann Reagents 14 171.9 7.6 4.4 172 120 - 224 All Roche Integra/c111/c301/c501 Reagents 11 180.2 6.7 3.7 179 126 - 235 Beckman AU Beckman AU systems 23 158.8 5.0 3.2 158 111 - 207 Siemens Healthcare CKI Siemens Dimension 20 183.9 4.3 2.3 184 128 - 240 VITROS VITROS 250,350,500,700,750,950 13 150.5 11.5 7.6 149 105 - 196 All Chemistry Instruments 16 149.1 12.4 8.3 149 104 - 194

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GGT (IU/L)

Specimen CH-11 Specimen CH-12 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 195.6 31.8 16.3 186 131 - 260 71 56.1 13.0 23.1 51 30 - 83 All Roche Integra/c111/c301/c501 Reagents 12 178.7 2.9 1.6 178 142 - 215 12 47.8 0.9 1.8 48 38 - 58 Beckman AU Beckman AU systems 13 161.2 5.6 3.5 161 128 - 194 13 43.0 1.5 3.4 43 34 - 52 Siemens Healthcare Siemens Dimension 14 235.8 4.5 1.9 236 188 - 283 14 69.1 1.4 2.0 69 55 - 83

Specimen CH-13 Specimen CH-14 All Method 67 17.7 4.5 25.6 16 8 - 27 67 18.0 5.4 29.9 16 7 - 29 All Roche Integra/c111/c301/c501 Reagents 12 14.2 0.8 5.9 14 11 - 18 12 13.3 1.3 9.8 13 10 - 16 Beckman AU Beckman AU systems 13 13.5 0.7 4.9 13 10 - 17 13 12.8 0.6 4.3 13 10 - 16 Siemens Healthcare Siemens Dimension 14 25.4 1.5 5.9 25 20 - 31 14 24.9 1.4 5.6 25 19 - 30

Specimen CH-15

All Method 67 111.9 23.4 20.9 109 65 - 159 All Roche Integra/c111/c301/c501 Reagents 12 98.0 1.3 1.3 98 78 - 118 Beckman AU Beckman AU systems 13 87.8 3.1 3.6 88 70 - 106 Siemens Healthcare Siemens Dimension 14 134.2 2.8 2.0 134 107 - 162

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Amylase (IU/L)

Specimen CH-11 Specimen CH-12 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 89 167.0 39.9 23.9 182 116 - 218 90 46.2 10.4 22.4 50 32 - 61 All Roche Integra/c111/c301/c501 Reagents 10 187.4 5.4 2.9 187 131 - 244 10 51.1 1.2 2.3 51 35 - 67 Beckman AU Beckman AU systems 18 144.8 9.2 6.4 144 101 - 189 18 39.3 3.7 9.4 38 27 - 52 Siemens Healthcare Siemens Dimension 13 206.5 7.2 3.5 203 144 - 269 13 55.3 2.3 4.1 55 38 - 72 All Chemistry Instruments 14 206.3 7.0 3.4 203 144 - 269 14 55.3 2.2 4.0 55 38 - 72 VITROS VITROS 250,350,500,700,750,950 14 98.5 5.7 5.8 99 68 - 129 13 30.0 0.1 0.0 30 21 - 39 All Chemistry Instruments 16 98.6 5.4 5.4 99 68 - 129 15 30.0 0.1 0.0 30 21 - 39

Specimen CH-13 Specimen CH-14

All Method 84 17.1 6.7 39.1 15 11 - 23 85 18.8 6.1 32.3 18 13 - 25 All Roche Integra/c111/c301/c501 Reagents 10 15.0 0.7 4.4 15 10 - 20 10 18.2 0.4 2.3 18 12 - 24 Beckman AU Beckman AU systems 18 10.6 0.8 8.0 11 7 - 14 17 11.8 1.0 8.8 11 8 - 16 Siemens Healthcare Siemens Dimension 13 15.5 1.2 7.7 16 10 - 21 14 16.3 1.2 7.4 17 11 - 22 All Chemistry Instruments 14 15.5 1.2 7.5 16 10 - 21 15 16.3 1.2 7.2 17 11 - 22 VITROS VITROS 250,350,500,700,750,950 14 30.0 0.1 0.0 30 21 - 39 14 30.0 0.1 0.0 30 21 - 39 All Chemistry Instruments 16 30.0 0.1 0.0 30 21 - 39 16 30.0 0.1 0.0 30 21 - 39

Specimen CH-15

All Method 85 91.5 23.4 25.6 100 64 - 119 All Roche Integra/c111/c301/c501 Reagents 10 102.3 3.2 3.1 102 71 - 133 Beckman AU Beckman AU systems 18 78.5 5.5 7.0 78 54 - 103 Siemens Healthcare Siemens Dimension 14 113.6 4.0 3.6 114 79 - 148 All Chemistry Instruments 15 113.4 4.0 3.5 113 79 - 148 VITROS VITROS 250,350,500,700,750,950 14 53.3 4.9 9.2 54 37 - 70 All Chemistry Instruments 16 52.8 4.9 9.2 53 36 - 69

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Lactate Dehydrogenase (IU/L)

Specimen CH-11 Specimen CH-12 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 72 590.0 65.6 11.1 626 471 - 708 72 159.6 17.6 11.1 168 127 - 192 All Alfa Wassermann Reagents 7 450.4 10.9 2.4 447 360 - 541 7 130.0 7.1 5.5 130 104 - 156 All Horiba Pentra Reagents 7 644.6 38.0 5.9 662 515 - 774 7 177.4 9.2 5.2 175 141 - 213 All Roche Integra/c111/c301/c501 Reagents 17 636.7 19.5 3.1 640 509 - 765 17 173.6 10.8 6.2 172 138 - 209 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 7 450.4 10.9 2.4 447 360 - 541 7 130.0 7.1 5.5 130 104 - 156 Beckman AU Beckman AU systems 16 543.8 20.5 3.8 550 435 - 653 16 144.6 7.7 5.3 145 115 - 174 Horiba ABX Pentra Horiba ABX Pentra 400 6 652.7 34.3 5.3 668 522 - 784 6 178.7 9.4 5.3 178 142 - 215 Roche cobas c 501 Roche cobas 6000 / c 501 5 639.8 8.9 1.4 642 511 - 768 5 163.0 7.4 4.5 166 130 - 196 Roche Integra Roche Integra 11 638.5 21.1 3.3 640 510 - 767 11 178.7 8.9 5.0 179 142 - 215 Siemens Healthcare Siemens Dimension 5 632.6 27.9 4.4 637 506 - 760 5 161.6 10.0 6.2 165 129 - 194 Siemens Healthcare LDI Siemens Dimension 6 628.8 14.9 2.4 631 503 - 755 6 166.7 10.9 6.5 167 133 - 201 VITROS VITROS 250,350,500,700,750,950 8 2021.9 94.4 4.7 1992 1617 - 2427 8 562.6 8.8 1.6 562 450 - 676 All Chemistry Instruments 12 1984.3 97.7 4.9 1970 1587 - 2382 12 552.4 24.1 4.4 560 441 - 663

Specimen CH-13 Specimen CH-14

All Method 72 99.0 12.1 12.2 106 79 - 119 71 40.3 5.5 13.6 42 32 - 49 All Alfa Wassermann Reagents 7 78.4 5.5 7.0 75 62 - 95 7 38.0 2.8 7.3 38 30 - 46 All Horiba Pentra Reagents 7 113.3 5.9 5.2 113 90 - 136 6 41.2 7.1 17.3 42 32 - 50 All Roche Integra/c111/c301/c501 Reagents 17 107.9 3.1 2.9 107 86 - 130 17 44.7 4.3 9.6 43 35 - 54 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 7 78.4 5.5 7.0 75 62 - 95 7 38.0 2.8 7.3 38 30 - 46 Beckman AU Beckman AU systems 16 88.4 4.8 5.4 88 70 - 107 16 35.9 4.0 11.1 35 28 - 44 Horiba ABX Pentra Horiba ABX Pentra 400 6 114.5 5.5 4.8 115 91 - 138 5 41.8 7.8 18.6 45 33 - 51 Roche cobas c 501 Roche cobas 6000 / c 501 5 105.6 0.9 0.8 105 84 - 127 5 41.8 1.8 4.3 42 33 - 51 Roche Integra Roche Integra 11 108.9 3.4 3.1 107 87 - 131 11 46.2 4.6 10.0 44 36 - 56 Siemens Healthcare Siemens Dimension 5 106.2 6.3 5.9 107 84 - 128 5 39.2 2.9 7.5 39 31 - 48 Siemens Healthcare LDI Siemens Dimension 6 105.0 5.8 5.5 105 84 - 126 6 44.8 5.6 12.4 43 35 - 54 VITROS VITROS 250,350,500,700,750,950 8 277.9 18.7 6.7 278 222 - 334 8 139.8 30.2 21.6 133 111 - 168 All Chemistry Instruments 12 272.5 18.0 6.6 271 218 - 327 12 138.2 24.7 17.9 132 110 - 166

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Lactate Dehydrogenase (IU/L) Specimen CH-15

All Method 72 322.9 36.1 11.2 341 258 - 388

All Alfa Wassermann Reagents 7 253.9 12.7 5.0 255 203 - 305 All Horiba Pentra Reagents 7 354.6 21.8 6.1 352 283 - 426

All Roche Integra/c111/c301/c501 Reagents 17 350.1 14.4 4.1 355 280 - 421

Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 7 253.9 12.7 5.0 255 203 - 305

Beckman AU Beckman AU systems 16 294.9 16.2 5.5 295 235 - 354

Horiba ABX Pentra

Horiba ABX Pentra 400 6 360.8 15.4 4.3 362 288 - 433 Roche cobas c 501

Roche cobas 6000 / c 501 5 342.6 15.4 4.5 349 274 - 412

Roche Integra Roche Integra 11 353.4 14.1 4.0 359 282 - 425

Siemens Healthcare Siemens Dimension 5 340.4 18.8 5.5 345 272 - 409

Siemens Healthcare LDI

Siemens Dimension 6 336.8 17.6 5.2 341 269 - 405 VITROS

VITROS 250,350,500,700,750,950 8 1108.5 18.7 1.7 1105 886 - 1331

All Chemistry Instruments 12 1090.4 37.3 3.4 1104 872 - 1309

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Lipase (IU/L)

Specimen CH-11 Specimen CH-12 Instrument/Reagent Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 30 61.4 5.2 8.5 67 42 - 80 28 25.0 2.3 9.2 27 17 - 33 All Roche Integra/c111/c301/c501 Reagents 7 59.4 2.9 4.8 60 41 - 78 7 24.7 1.1 4.5 25 17 - 33 Beckman AU Beckman AU systems 10 65.3 3.6 5.5 67 45 - 85 10 25.6 1.8 7.2 26 17 - 34 Siemens Healthcare Siemens Dimension 10 251.6 4.4 1.7 250 176 - 328 11 105.5 2.6 2.5 105 73 - 138 VITROS VITROS 250,350,500,700,750,950 7 772.1 25.6 3.3 763 540 - 1004 7 357.6 10.4 2.9 357 250 - 465 All Chemistry Instruments 9 761.8 30.5 4.0 757 533 - 991 8 353.8 14.5 4.1 357 247 - 460

Specimen CH-13 Specimen CH-14

All Method 26 12.5 8.1 64.8 17 8 - 17 29 15.0 3.2 21.5 18 10 - 20 All Roche Integra/c111/c301/c501 Reagents 7 9.0 0.8 9.1 9 6 - 12 7 14.6 0.5 3.7 15 10 - 19 Beckman AU Beckman AU systems 9 10.2 1.0 9.5 10 7 - 14 10 14.3 1.2 8.1 15 10 - 19 Siemens Healthcare Siemens Dimension 10 41.0 2.5 6.2 41 28 - 54 11 65.5 2.3 3.6 65 45 - 86 VITROS VITROS 250,350,500,700,750,950 7 153.7 7.1 4.6 152 107 - 200 7 191.4 10.3 5.4 189 134 - 249 All Chemistry Instruments 9 149.3 10.6 7.1 149 104 - 195 9 186.6 13.2 7.1 188 130 - 243 Specimen CH-15

All Method 30 40.1 3.9 9.6 44 28 - 53 All Roche Integra/c111/c301/c501 Reagents 7 38.1 1.8 4.6 39 26 - 50 Beckman AU Beckman AU systems 10 41.3 2.7 6.5 42 28 - 54 Siemens Healthcare Siemens Dimension 11 163.5 3.8 2.3 163 114 - 213 VITROS VITROS 250,350,500,700,750,950 7 535.9 15.6 2.9 537 375 - 697 All Chemistry Instruments 9 529.1 19.7 3.7 535 370 - 688

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Alpha-fetoprotein (AFP) (ng/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 357.12 11.18 3.1 361.2 323.5 - 390.7 6 76.88 2.69 3.5 76.2 68.8 - 85.0

Specimen CH-13 Specimen CH-14

All Method 6 2.58 0.35 13.5 2.7 1.5 - 3.7 5 0.82 0.25 30.4 1.0 0.0 - 1.6

Specimen CH-15

All Method 6 180.95 5.91 3.3 180.5 163.2 - 198.7

Cortisol (µg/dL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 15 31.16 2.53 8.1 30.1 23.3 - 39.0 15 10.77 0.97 9.1 10.6 8.0 - 13.5

Specimen CH-13 Specimen CH-14

All Method 14 5.16 0.28 5.4 5.2 3.8 - 6.5 15 4.58 0.46 10.0 4.6 3.4 - 5.8

Specimen CH-15

All Method 15 16.77 5.47 32.6 18.0 12.5 - 21.0

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Triiodothyronine (ng/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 26 2.48 0.77 31.0 3.0 0.1 - 4.8 26 1.38 0.22 16.2 1.5 0.7 - 2.1 All Abbott Instruments 6 1.75 0.05 3.1 1.8 1.5 - 2.0 6 1.27 0.10 8.2 1.3 0.9 - 1.6 All TOSOH Instruments 8 4.81 0.24 4.9 4.9 4.1 - 5.6 8 2.99 0.15 4.9 3.0 2.5 - 3.5 Abbott Architect 6 1.75 0.05 3.1 1.8 1.5 - 2.0 6 1.27 0.10 8.2 1.3 0.9 - 1.6 Beckman ACCESS / 2 / DxI 13 3.12 0.41 13.1 3.1 1.8 - 4.4 13 1.45 0.12 8.3 1.4 1.0 - 1.9 TOSOH ST AIA 6 4.75 0.23 4.9 4.8 4.0 - 5.5 6 2.95 0.14 4.7 3.0 2.5 - 3.4

Specimen CH-13 Specimen CH-14

All Method 25 0.29 0.07 24.1 0.3 0.0 - 0.6 26 1.06 0.20 18.6 1.1 0.4 - 1.7 All Abbott Instruments 6 0.28 0.04 14.4 0.3 0.1 - 0.5 6 1.07 0.05 4.8 1.1 0.9 - 1.3 All TOSOH Instruments 6 0.23 0.08 35.0 0.2 0.0 - 0.5 8 2.29 0.22 9.5 2.3 1.6 - 3.0 Abbott Architect 6 0.28 0.04 14.4 0.3 0.1 - 0.5 6 1.07 0.05 4.8 1.1 0.9 - 1.3 Beckman ACCESS / 2 / DxI 13 0.26 0.10 39.9 0.3 0.0 - 0.6 13 1.12 0.07 6.5 1.1 0.9 - 1.4 TOSOH ST AIA 5 0.24 0.09 37.3 0.2 0.0 - 0.6 6 2.23 0.16 7.3 2.3 1.7 - 2.8

Specimen CH-15

All Method 26 1.77 0.36 20.5 2.0 0.6 - 2.9 All Abbott Instruments 6 1.42 0.08 5.3 1.4 1.1 - 1.7 All TOSOH Instruments 8 3.69 0.26 7.2 3.8 2.8 - 4.5 Abbott Architect 6 1.42 0.08 5.3 1.4 1.1 - 1.7 Beckman ACCESS / 2 / DxI 13 2.00 0.16 7.9 2.0 1.5 - 2.5 TOSOH ST AIA 6 3.62 0.26 7.3 3.7 2.8 - 4.5

T3 Uptake (percent)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 24 42.90 4.67 10.9 42.9 28.8 - 57.0 24 51.25 5.44 10.6 52.1 34.9 - 67.6 Beckman ACCESS / 2 / DxI 11 45.31 2.35 5.2 46.0 38.2 - 52.4 11 55.71 2.05 3.7 56.0 49.5 - 61.9

Specimen CH-13 Specimen CH-14 All Method 24 31.55 9.83 31.2 29.0 2.0 - 61.1 24 54.33 6.44 11.9 55.9 34.9 - 73.7 Beckman ACCESS / 2 / DxI 11 41.42 2.49 6.0 41.0 33.9 - 48.9 11 59.19 3.40 5.7 57.8 48.9 - 69.4

Specimen CH-15

All Method 24 47.22 4.99 10.6 46.7 32.2 - 62.2 Beckman ACCESS / 2 / DxI 11 51.86 2.16 4.2 52.0 45.3 - 58.4

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Free T3 (pg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 39 6.13 0.84 13.6 6.3 3.6 - 8.7 39 4.40 0.71 16.1 4.8 2.2 - 6.6 All TOSOH Instruments 13 11.68 0.69 5.9 11.5 9.6 - 13.8 13 7.45 0.48 6.5 7.4 6.0 - 9.0 Beckman ACCESS / 2 / DxI 15 5.68 0.39 6.9 5.6 4.5 - 6.9 15 4.09 0.26 6.3 4.0 3.3 - 4.9

Specimen CH-13 Specimen CH-14

All Method 39 0.63 0.46 73.4 0.5 0.0 - 2.1 38 3.20 0.59 18.5 3.4 1.4 - 5.0 All TOSOH Instruments 10 0.50 0.01 0.0 0.5 0.4 - 0.6 13 4.83 0.36 7.4 4.9 3.7 - 6.0 Beckman ACCESS / 2 / DxI 15 0.44 0.34 76.3 0.4 0.0 - 1.5 15 2.99 0.32 10.9 2.9 2.0 - 4.0

Specimen CH-15

All Method 39 5.12 0.71 13.8 5.1 3.0 - 7.3 All TOSOH Instruments 13 9.02 0.60 6.7 9.0 7.2 - 10.9 Beckman ACCESS / 2 / DxI 15 4.78 0.21 4.4 4.8 4.1 - 5.5

Thyroxine (µg/dL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 24 16.43 2.03 12.3 15.4 13.1 - 19.8 24 9.60 0.74 7.7 10.0 7.6 - 11.6 All TOSOH Instruments 10 15.38 0.68 4.4 15.2 12.3 - 18.5 10 9.52 0.44 4.7 9.5 7.6 - 11.5 Beckman ACCESS / 2 / DxI 15 14.87 1.20 8.1 15.2 11.8 - 17.9 15 10.16 2.22 21.8 10.5 8.1 - 12.2

Specimen CH-13 Specimen CH-14

All Method 20 0.53 0.27 51.3 0.5 0.0 - 1.6 22 7.58 0.51 6.7 8.0 6.0 - 9.1 All TOSOH Instruments 8 - - - 0.5 0.0 - 1.5 10 7.32 1.48 20.3 7.7 5.8 - 8.8 Beckman ACCESS / 2 / DxI 15 0.09 0.15 168.2 0.0 0.0 - 1.1 15 8.92 1.14 12.8 9.0 7.1 - 10.8

Specimen CH-15

All Method 24 12.21 0.95 7.8 12.3 9.7 - 14.7 All TOSOH Instruments 10 11.69 0.54 4.6 11.7 9.3 - 14.1 Beckman ACCESS / 2 / DxI 15 12.62 1.47 11.6 12.7 10.0 - 15.2

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Free Thyroxine (ng/dL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 169 3.63 0.73 20.0 3.8 1.4 - 5.9 171 3.78 0.66 17.4 3.7 1.8 - 5.8 All Roche Elecsys/Cobas Instruments 12 3.91 0.11 2.8 4.0 3.5 - 4.3 12 3.82 0.13 3.3 3.8 3.4 - 4.2 All TOSOH Instruments 36 4.34 0.26 6.0 4.4 3.5 - 5.2 37 4.56 0.31 6.9 4.6 3.6 - 5.6 Abbott Architect 16 4.39 0.46 10.4 4.3 3.0 - 5.8 16 3.48 0.27 7.9 3.5 2.6 - 4.4 Beckman ACCESS / 2 / DxI 44 2.84 0.12 4.3 2.8 2.4 - 3.3 46 3.09 0.16 5.0 3.1 2.6 - 3.6 bioMerieux Vidas, Mini Vidas 12 2.90 0.19 6.6 2.9 2.3 - 3.5 12 3.41 0.20 5.9 3.4 2.8 - 4.1 Siemens Dimension 28 3.96 0.33 8.4 4.0 2.9 - 5.0 29 4.25 0.38 9.0 4.4 3.1 - 5.4 TOSOH AIA 18 4.29 0.32 7.5 4.3 3.3 - 5.3 18 4.56 0.42 9.3 4.6 3.2 - 5.9 TOSOH ST AIA 18 4.39 0.18 4.1 4.4 3.8 - 5.0 19 4.57 0.16 3.6 4.6 4.0 - 5.1

Specimen CH-13 Specimen CH-14 All Method 165 0.15 0.13 91.6 0.1 0.0 - 0.6 170 3.99 0.74 18.7 3.9 1.7 - 6.3 All Roche Elecsys/Cobas Instruments 12 0.10 0.01 0.0 0.1 0.0 - 0.2 12 3.89 0.14 3.7 3.9 3.4 - 4.4 All TOSOH Instruments 31 0.08 0.04 44.6 0.1 0.0 - 0.2 37 4.81 0.36 7.6 4.8 3.7 - 6.0 Abbott Architect 15 0.40 0.01 0.0 0.4 0.3 - 0.5 16 3.21 0.20 6.3 3.2 2.6 - 3.9 Beckman ACCESS / 2 / DxI 45 0.08 0.09 111.8 0.1 0.0 - 0.4 46 3.30 0.16 4.9 3.3 2.8 - 3.8 bioMerieux Vidas, Mini Vidas 11 0.10 0.01 0.0 0.1 0.0 - 0.2 12 3.76 0.57 15.1 3.9 2.0 - 5.5 Siemens Dimension 28 0.10 0.07 71.9 0.1 0.0 - 0.4 29 4.53 0.53 11.6 4.7 2.9 - 6.2 TOSOH AIA 15 0.08 0.04 51.8 0.1 0.0 - 0.3 18 4.71 0.51 10.8 4.8 3.1 - 6.3 TOSOH ST AIA 16 0.09 0.03 39.0 0.1 0.0 - 0.2 20 4.84 0.34 7.0 4.9 3.8 - 5.9

Specimen CH-15

All Method 171 3.61 0.66 18.2 3.7 1.6 - 5.6

All Roche Elecsys/Cobas Instruments 12 3.82 0.13 3.5 3.8 3.4 - 4.3 All TOSOH Instruments 38 4.31 0.35 8.0 4.4 3.2 - 5.4 Abbott Architect 16 3.85 0.44 11.3 3.9 2.5 - 5.2 Beckman ACCESS / 2 / DxI 44 2.87 0.11 3.9 2.9 2.5 - 3.3 bioMerieux Vidas, Mini Vidas 12 3.08 0.20 6.5 3.1 2.4 - 3.7 Siemens Dimension 29 4.00 0.35 8.8 4.1 2.9 - 5.1 TOSOH AIA 18 4.28 0.38 9.0 4.4 3.1 - 5.5 TOSOH ST AIA 20 4.33 0.31 7.3 4.4 3.3 - 5.3

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Specimen CH-13 Specimen CH-14 All Method 219 0.05 0.06 115.0 0.0 0.0 - 0.3 232 2.21 0.66 29.9 2.1 0.2 - 4.2 All Abbott Instruments 18 0.04 0.05 115.0 0.0 0.0 - 0.2 18 2.32 0.10 4.3 2.3 2.0 - 2.7 All Roche Elecsys/Cobas Instruments 14 0.04 0.05 139.2 0.0 0.0 - 0.2 13 2.65 0.13 4.8 2.6 2.2 - 3.1 All TOSOH Instruments 44 0.07 0.05 77.9 0.1 0.0 - 0.3 52 3.12 0.26 8.4 3.1 2.3 - 3.9 Abbott Architect 18 0.04 0.05 115.0 0.0 0.0 - 0.2 18 2.32 0.10 4.3 2.3 2.0 - 2.7 Beckman ACCESS / 2 / DxI 55 0.02 0.04 179.7 0.0 0.0 - 0.2 54 1.88 0.12 6.5 1.9 1.5 - 2.3 bioMerieux Vidas, Mini Vidas 24 0.08 0.04 52.4 0.1 0.0 - 0.3 26 2.05 0.14 6.9 2.0 1.6 - 2.5 Roche cobas e 411 11 0.03 0.05 171.3 0.0 0.0 - 0.2 11 2.47 0.60 24.4 2.6 0.6 - 4.3 Siemens Dimension 35 0.05 0.06 121.4 0.0 0.0 - 0.3 35 1.41 0.14 10.0 1.4 0.9 - 1.9 TOSOH AIA 20 0.07 0.05 71.1 0.1 0.0 - 0.3 24 3.18 0.45 14.2 3.2 1.8 - 4.6 TOSOH ST AIA 24 0.07 0.06 84.7 0.1 0.0 - 0.3 30 3.14 0.23 7.2 3.1 2.4 - 3.9

Specimen CH-15

All Method 233 7.80 2.11 27.1 7.4 1.4 - 14.2 All Abbott Instruments 18 7.88 0.29 3.7 8.0 7.0 - 8.8 All Roche Elecsys/Cobas Instruments 14 8.66 0.34 4.0 8.6 7.6 - 9.7 All TOSOH Instruments 53 11.07 0.93 8.4 11.0 8.2 - 13.9 Abbott Architect 18 7.88 0.29 3.7 8.0 7.0 - 8.8 Beckman ACCESS / 2 / DxI 55 6.38 0.47 7.3 6.3 4.9 - 7.8 bioMerieux Vidas, Mini Vidas 27 7.27 0.51 7.0 7.3 5.7 - 8.8 Roche cobas e 411 11 8.65 0.39 4.5 8.6 7.4 - 9.9 Siemens Dimension 36 5.33 0.64 12.0 5.2 3.4 - 7.3 TOSOH AIA 24 11.09 1.30 11.7 11.1 7.1 - 15.0 TOSOH ST AIA 30 11.16 0.78 7.0 11.0 8.8 - 13.6

TSH (U/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 233 12.35 3.37 27.3 11.7 2.2 - 22.5 233 4.55 1.26 27.6 4.3 0.7 - 8.4 All Abbott Instruments 18 12.42 0.46 3.7 12.5 11.0 - 13.8 18 4.71 0.18 3.8 4.7 4.1 - 5.3 All Roche Elecsys/Cobas Instruments 14 13.21 0.57 4.3 13.1 11.4 - 15.0 14 5.28 0.17 3.3 5.3 4.7 - 5.8 All TOSOH Instruments 54 17.54 1.59 9.1 17.2 12.7 - 22.4 52 6.48 0.56 8.6 6.5 4.8 - 8.2 Abbott Architect 18 12.42 0.46 3.7 12.5 11.0 - 13.8 18 4.71 0.18 3.8 4.7 4.1 - 5.3 Beckman ACCESS / 2 / DxI 54 9.54 0.68 7.1 9.5 7.5 - 11.6 56 3.78 0.22 5.8 3.8 3.1 - 4.5 bioMerieux Vidas, Mini Vidas 27 11.61 0.74 6.4 11.5 9.4 - 13.9 27 4.27 0.32 7.6 4.3 3.2 - 5.3 Roche cobas e 411 11 13.16 0.61 4.6 12.9 11.3 - 15.0 11 5.28 0.19 3.7 5.3 4.6 - 5.9 Siemens Dimension 35 8.91 1.12 12.5 9.2 5.5 - 12.3 36 3.00 0.30 10.1 3.0 2.0 - 4.0 TOSOH AIA 24 17.47 1.70 9.7 17.2 12.3 - 22.6 24 6.52 0.79 12.1 6.6 4.1 - 8.9 TOSOH ST AIA 30 17.59 1.53 8.7 17.3 12.9 - 22.2 29 6.53 0.50 7.7 6.5 5.0 - 8.1

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Serum hCG Qualitative

Specimen HCG-11 Specimen HCG-12

Method

Positive

Negative

Positive

Negative

ALL METHODS - 145 145 - AimStep Combo Pregnancy - 1 1 - Beckman ACCESS / 2 / DxI - 1 1 - Beckman Coulter ICON 25 hCG - 5 5 - bioMerieux Vidas, Mini Vidas - 1 1 - Cardinal Health SP Brand combo - 8 8 - CONSULT diagnostics hCG Combo - 15 15 - Henry Schein One Step + Combo - 6 6 - LifeSign Status hCG - 1 1 - Medline hCG Combo Test Cassette - 1 1 - NDC Pro Advantage - 1 1 - Polymedco Poly stat hCG - 1 1 - PSS Select hCG Combo - 2 2 - Quidel QuickVue + One-Step - 11 11 - Quidel QuickVue One-Step Combo - 79 79 - Quidel QuickVue Semi-Q hCG - 1 1 - Sekisui OSOM hCG Combo Test - 3 3 - Stanbio QUPID Plus - 3 3 - Sure-Vue hCG-STAT - 2 2 -

Specimen HCG-13 Specimen HCG-14

ALL METHODS - 145 145 - AimStep Combo Pregnancy - 1 1 - Beckman ACCESS / 2 / DxI - 1 1 - Beckman Coulter ICON 25 hCG - 5 5 - bioMerieux Vidas, Mini Vidas - 1 1 - Cardinal Health SP Brand combo - 8 8 - CONSULT diagnostics hCG Combo - 15 15 - Henry Schein One Step + Combo - 6 6 - LifeSign Status hCG - 1 1 - Medline hCG Combo Test Cassette - 1 1 - NDC Pro Advantage - 1 1 - Polymedco Poly stat hCG - 1 1 - PSS Select hCG Combo - 2 2 - Quidel QuickVue + One-Step - 11 11 - Quidel QuickVue One-Step Combo - 79 79 - Quidel QuickVue Semi-Q hCG - 1 1 - Sekisui OSOM hCG Combo Test - 3 3 - Stanbio QUPID Plus - 3 3 - Sure-Vue hCG-STAT - 2 2 -

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Serum hCG Qualitative

Specimen HCG-15

Method

Positive

Negative

ALL METHODS 145 - AimStep Combo Pregnancy 1 - Beckman ACCESS / 2 / DxI 1 -

Beckman Coulter ICON 25 hCG 5 - bioMerieux Vidas, Mini Vidas 1 - Cardinal Health SP Brand combo 8 -

CONSULT diagnostics hCG Combo 15 - Henry Schein One Step + Combo 6 - LifeSign Status hCG 1 -

Medline hCG Combo Test Cassette 1 - NDC Pro Advantage 1 - Polymedco Poly stat hCG 1 -

PSS Select hCG Combo 2 - Quidel QuickVue + One-Step 11 - Quidel QuickVue One-Step Combo 79 -

Quidel QuickVue Semi-Q hCG 1 - Sekisui OSOM hCG Combo Test 3 - Stanbio QUPID Plus 3 -

Sure-Vue hCG-STAT 2 -

Serum hCG Quantitative (mIU/mL)

Specimen HCG-11 Specimen HCG-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 1.6 1.5 91.5 1 0 - 7 29 285.9 23.2 8.1 284 216 - 356

Specimen HCG-13 Specimen HCG-14

All Method 31 1.6 1.5 92.1 1 0 - 6 31 296.5 38.1 12.8 295 182 - 411

Specimen HCG-15

All Method 31 139.9 13.8 9.9 139 98 - 182

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Cholesterol, Total (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 258 233.1 10.6 4.5 231 209 - 257 257 115.8 4.9 4.2 116 104 - 128 All Alfa Wassermann Reagents 33 232.3 7.4 3.2 231 209 - 256 33 118.1 3.6 3.0 118 106 - 130 All Horiba Pentra Reagents 16 238.3 8.1 3.4 239 214 - 263 16 118.9 4.3 3.6 119 106 - 131 All Roche Integra/c111/c301/c501 Reagents 23 231.2 5.7 2.5 229 208 - 255 23 117.1 2.9 2.5 117 105 - 129 All Vital Diagnostics Reagents 15 235.4 7.2 3.1 236 211 - 259 15 117.8 3.2 2.7 119 106 - 130 Alere Cholestech LDX Alere Cholestech LDX - waived 31 250.1 10.6 4.2 248 225 - 276 30 118.7 5.8 4.9 118 106 - 131 All Chemistry Instruments 35 249.2 10.4 4.2 247 224 - 275 34 118.7 5.9 5.0 118 106 - 131 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 32 232.2 7.5 3.2 231 208 - 256 31 117.4 2.2 1.9 117 105 - 130 Beckman AU Beckman AU systems 29 228.3 6.1 2.7 228 205 - 252 29 113.6 2.9 2.6 113 102 - 125 Horiba ABX Pentra Horiba ABX Pentra 400 15 237.6 8.0 3.4 238 213 - 262 15 118.3 3.8 3.2 118 106 - 131 Roche Integra Roche Integra 15 229.5 4.5 2.0 228 206 - 253 15 116.9 2.9 2.5 116 105 - 129 Siemens Healthcare Siemens Dimension 41 230.4 5.5 2.4 230 207 - 254 41 114.8 3.3 2.8 116 103 - 127 All Chemistry Instruments 42 230.4 5.4 2.3 230 207 - 254 43 114.8 3.2 2.8 116 103 - 127 Vital Diagnostics Vital Diagnostics Envoy 500 13 236.0 5.6 2.4 236 212 - 260 13 118.4 2.8 2.3 119 106 - 131 All Chemistry Instruments 14 234.8 7.1 3.0 236 211 - 259 14 118.3 2.7 2.3 119 106 - 131 VITROS VITROS 250,350,500,700,750,950 28 224.3 8.1 3.6 224 201 - 247 28 110.1 4.1 3.7 109 99 - 122 All Chemistry Instruments 32 224.6 7.9 3.5 224 202 - 248 32 109.5 4.3 3.9 109 98 - 121

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Cholesterol, Total (mg/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 213 48.8 2.5 5.1 49 43 - 54 224 87.4 5.1 5.8 87 78 - 97 All Alfa Wassermann Reagents 33 50.5 1.8 3.5 50 45 - 56 33 89.1 1.7 1.9 89 80 - 98 All Horiba Pentra Reagents 16 49.5 2.6 5.2 49 44 - 55 15 89.0 3.0 3.4 89 80 - 98 All Roche Integra/c111/c301/c501 Reagents 23 48.5 1.6 3.2 48 43 - 54 23 88.2 2.4 2.7 88 79 - 97 All Vital Diagnostics Reagents 14 49.4 3.1 6.3 49 44 - 55 14 89.9 5.5 6.1 90 80 - 99 Alere Cholestech LDX Alere Cholestech LDX - waived 8 - - - 100 90 - 110 8 - - - 100 90 - 110 All Chemistry Instruments 9 - - - 100 90 - 110 9 - - - 100 90 - 110 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 32 50.4 1.8 3.5 50 45 - 56 32 89.1 1.7 1.9 89 80 - 99 Beckman AU Beckman AU systems 29 46.0 1.4 3.0 46 41 - 51 29 84.9 2.5 2.9 85 76 - 94 Horiba ABX Pentra Horiba ABX Pentra 400 15 49.4 2.6 5.3 49 44 - 55 14 88.9 3.1 3.5 89 79 - 98 Roche Integra Roche Integra 15 48.1 1.0 2.1 48 43 - 53 15 87.9 2.2 2.5 87 79 - 97 Siemens Healthcare Siemens Dimension 38 49.5 2.8 5.7 50 44 - 55 41 86.4 2.7 3.2 87 77 - 96 All Chemistry Instruments 39 49.3 2.4 4.9 50 44 - 55 43 86.5 2.7 3.1 87 77 - 96 Vital Diagnostics Vital Diagnostics Envoy 500 13 49.5 3.2 6.4 49 44 - 55 13 90.5 5.1 5.6 90 81 - 100 VITROS VITROS 250,350,500,700,750,950 28 48.5 2.5 5.1 49 43 - 54 28 80.9 5.5 6.8 82 72 - 89 All Chemistry Instruments 32 48.7 2.4 4.8 49 43 - 54 32 80.2 6.1 7.6 82 72 - 89

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Cholesterol, Total (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range

All Method 226 159.8 5.3 3.3 159 143 - 176 All Alfa Wassermann Reagents 33 160.5 3.0 1.9 160 144 - 177 All Horiba Pentra Reagents 16 162.4 5.8 3.6 163 146 - 179 All Roche Integra/c111/c301/c501 Reagents 23 160.6 3.9 2.4 159 144 - 177 All Vital Diagnostics Reagents 14 164.8 6.0 3.7 163 148 - 182 Alere Cholestech LDX Alere Cholestech LDX - waived 9 - - - 165 149 - 184 All Chemistry Instruments 10 165.4 9.0 5.4 165 148 - 182 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 32 160.5 3.0 1.9 160 144 - 177 Beckman AU Beckman AU systems 28 155.9 3.7 2.4 157 140 - 172 Horiba ABX Pentra Horiba ABX Pentra 400 15 162.0 5.7 3.5 162 145 - 179 Roche Integra Roche Integra 15 160.1 3.8 2.4 158 144 - 177 Siemens Healthcare Siemens Dimension 40 158.0 3.6 2.3 158 142 - 174 All Chemistry Instruments 42 158.0 3.5 2.2 158 142 - 174 Vital Diagnostics Vital Diagnostics Envoy 500 13 165.3 5.9 3.6 163 148 - 182 VITROS VITROS 250,350,500,700,750,950 28 157.1 5.4 3.4 156 141 - 173 All Chemistry Instruments 32 157.3 5.3 3.4 156 141 - 174

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LDL Cholesterol - Calculated (mg/dL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 170 96.8 16.6 17.2 98 63 - 131 186 46.3 9.9 21.4 47 26 - 67 Calculated-Trig/5 Alere Cholestech LDX - waived 15 112.1 13.0 11.6 112 78 - 146 24 57.7 7.1 12.3 57 40 - 76 Alfa Wassermann ACE Alera/Axcel 22 105.1 9.5 9.1 104 73 - 137 22 50.8 4.0 8.0 50 35 - 67 Beckman AU systems 19 93.1 10.8 11.6 93 65 - 122 19 46.1 5.1 11.0 46 32 - 60 Horiba ABX Pentra 400 12 114.1 12.0 10.5 113 79 - 149 12 56.0 2.9 5.1 57 39 - 73 Siemens Dimension 21 97.8 10.0 10.2 97 68 - 128 23 35.4 5.2 14.8 35 24 - 47 Vital Diagnostics Envoy 500 13 92.1 9.4 10.2 92 64 - 120 13 45.2 5.3 11.8 45 31 - 59 VITROS 250,350,500,700,750,950 22 74.5 11.6 15.6 75 51 - 98 21 40.0 5.1 12.7 39 27 - 52 All Chemistry Instruments 156 97.7 15.7 16.1 99 66 - 130 173 46.3 10.0 21.7 47 26 - 67

Specimen CH-13 Specimen CH-14

All Method 140 15.8 7.7 48.5 18 0 - 32 154 31.7 8.8 27.7 33 14 - 50 Calculated-Trig/5 Alere Cholestech LDX - waived 23 22.6 3.4 14.9 23 15 - 30 23 38.4 5.0 13.0 39 26 - 50 Alfa Wassermann ACE Alera/Axcel 19 18.1 3.6 19.8 18 10 - 26 19 33.6 4.3 12.8 34 23 - 44 Beckman AU systems 12 24.3 2.8 11.7 23 16 - 32 12 41.7 2.0 4.7 42 29 - 55 Horiba ABX Pentra 400 17 7.2 4.4 61.0 7 0 - 16 23 22.7 4.8 21.2 21 13 - 33 Siemens Dimension 13 19.6 2.6 13.1 20 13 - 26 13 37.2 5.3 14.2 36 26 - 49 Vital Diagnostics Envoy 500 18 7.8 2.8 36.2 7 2 - 14 21 25.5 7.6 29.8 28 10 - 41 VITROS 250,350,500,700,750,950 130 15.8 7.6 48.0 18 0 - 32 142 31.7 9.0 28.2 33 13 - 50 All Chemistry Instruments 140 15.8 7.7 48.5 18 0 - 32 154 31.7 8.8 27.7 33 14 - 50

Specimen CH-15 All Method 158 63.9 9.7 15.1 63 44 - 84 Calculated-Trig/5 Alere Cholestech LDX - waived 6 - - - 74 44 - 84 Alfa Wassermann ACE Alera/Axcel 22 71.0 4.9 7.0 71 49 - 93 Beckman AU systems 19 63.3 9.0 14.3 62 44 - 83 Horiba ABX Pentra 400 12 73.8 5.0 6.8 73 51 - 96 Siemens Dimension 22 55.4 6.0 10.8 56 38 - 73 Vital Diagnostics Envoy 500 14 61.6 13.2 21.4 63 35 - 88 VITROS 250,350,500,700,750,950 20 56.3 6.5 11.5 55 39 - 74 All Chemistry Instruments 147 63.9 9.7 15.2 63 44 - 84

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LDL Cholesterol - Direct (mg/dL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 71 91.9 11.5 12.6 93 64 - 120 70 37.8 6.5 17.3 39 24 - 51 Beckman AU Direct HDL / LDL Beckman AU systems 13 76.8 2.9 3.8 77 53 - 100 13 29.8 1.7 5.7 30 20 - 39 Siemens Automated LDL Siemens Dimension 20 96.8 6.4 6.6 97 67 - 126 20 40.8 3.9 9.6 41 28 - 54 All Chemistry Instruments 22 96.5 6.5 6.7 97 67 - 126 22 40.6 4.2 10.3 41 28 - 53

Specimen CH-13 Specimen CH-14

All Method 68 9.1 3.0 33.4 9 3 - 16 70 24.7 5.7 23.1 25 13 - 37 Beckman AU Direct HDL / LDL Beckman AU systems 13 5.8 1.1 18.3 6 3 - 8 13 18.6 1.3 6.8 19 13 - 25 Siemens Automated LDL Siemens Dimension 20 10.2 2.6 25.4 10 5 - 16 20 27.0 3.4 12.6 28 18 - 36 All Chemistry Instruments 22 10.2 2.6 25.8 10 4 - 16 22 26.9 3.7 13.7 28 18 - 35

Specimen CH-15 All Method 70 57.5 8.3 14.5 60 40 - 75

Beckman AU Direct HDL / LDL Beckman AU systems 13 47.2 2.5 5.2 48 33 - 62 Siemens Automated LDL Siemens Dimension 20 61.0 4.8 7.9 62 42 - 80 All Chemistry Instruments 22 60.8 4.9 8.1 62 42 - 80

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Cholesterol, HDL (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 242 94.3 7.5 8.0 95 66 - 123 248 52.0 8.1 15.5 51 36 - 68 All Dex-Sulfate 50,000 MW Methods 48 94.8 7.0 7.4 97 66 - 124 49 45.4 5.8 12.7 46 31 - 60 All Direct Methods 146 92.5 7.4 8.0 92 64 - 121 148 53.7 8.2 15.3 53 37 - 70 Alere Cholestech LDX Alere Cholestech LDX - waived 28 97.1 4.9 5.1 100 67 - 127 30 41.9 6.1 14.6 43 29 - 55 All Chemistry Instruments 32 96.4 5.3 5.5 100 67 - 126 34 41.8 7.0 16.6 44 29 - 55 Alfa Wass. ACE HDL-C / LDL-C Alfa Wassermann ACE Alera/Axcel 21 83.8 8.1 9.7 85 58 - 109 21 46.9 5.5 11.6 47 32 - 61 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 11 86.5 3.0 3.5 87 66 - 123 11 48.2 1.9 3.9 49 36 - 68 Beckman AU Direct HDL / LDL Beckman AU systems 21 96.1 5.1 5.3 95 67 - 125 21 50.8 3.2 6.3 50 35 - 67 Horiba ABX Pentra Horiba ABX Pentra 400 15 87.5 6.2 7.1 85 61 - 114 15 45.6 3.1 6.9 46 31 - 60 Roche HDL Direct All Chemistry Instruments 17 92.3 4.2 4.6 91 64 - 120 17 61.5 2.7 4.5 61 43 - 80 Siemens Automated HDL Siemens Dimension 35 94.4 4.2 4.5 95 66 - 123 36 63.3 3.2 5.1 63 44 - 83 All Chemistry Instruments 37 94.5 4.1 4.4 95 66 - 123 38 63.2 3.2 5.0 63 44 - 83 VITROS dHDL Slide VITROS 250,350,500,700,750,950 21 101.9 4.7 4.6 103 71 - 133 22 52.9 2.3 4.3 52 37 - 69 All Chemistry Instruments 25 101.7 4.7 4.6 103 71 - 133 26 52.8 2.3 4.4 52 36 - 69

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Cholesterol, HDL (mg/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 221 29.0 7.8 26.7 27 20 - 38 222 43.0 7.8 18.0 42 30 - 56 All Dex-Sulfate 50,000 MW Methods 27 25.5 6.3 24.5 24 17 - 34 27 36.4 6.5 17.9 38 25 - 48 All Direct Methods 144 28.4 8.0 28.1 25 19 - 37 145 43.8 8.1 18.6 41 30 - 57 Alere Cholestech LDX Alere Cholestech LDX - waived 9 - - - 24 15 - 30 9 - - - 29 20 - 39 All Chemistry Instruments 10 22.8 4.2 18.6 24 15 - 30 10 29.3 3.4 11.5 30 20 - 39 Alfa Wass. ACE HDL-C / LDL-C Alfa Wassermann ACE Alera/Axcel 21 21.8 2.9 13.2 21 15 - 29 21 37.9 3.4 9.0 37 26 - 50 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 11 22.4 1.4 6.4 22 20 - 38 11 39.0 3.0 7.7 39 30 - 56 Beckman AU Direct HDL / LDL Beckman AU systems 21 23.9 2.2 9.1 23 16 - 32 21 39.6 2.6 6.7 40 27 - 52 Horiba ABX Pentra Horiba ABX Pentra 400 15 20.6 1.6 7.7 21 14 - 27 15 35.7 2.1 5.8 36 25 - 47 Roche HDL Direct All Chemistry Instruments 17 36.5 1.5 4.0 36 25 - 48 17 51.9 2.1 4.1 52 36 - 68 Siemens Automated HDL Siemens Dimension 35 38.9 2.5 6.3 39 27 - 51 36 53.8 3.0 5.6 55 37 - 70 All Chemistry Instruments 37 38.9 2.4 6.2 39 27 - 51 38 53.8 3.0 5.5 55 37 - 70 VITROS dHDL Slide VITROS 250,350,500,700,750,950 22 36.2 1.3 3.7 36 25 - 48 22 43.6 1.9 4.4 44 30 - 57 All Chemistry Instruments 26 36.1 1.3 3.6 36 25 - 47 26 43.6 1.9 4.3 44 30 - 57

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Cholesterol, HDL (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range All Method 221 69.7 7.2 10.3 70 48 - 91 All Dex-Sulfate 50,000 MW Methods 27 65.8 6.8 10.3 65 46 - 86 All Direct Methods 145 69.3 7.5 10.8 69 48 - 91 Alere Cholestech LDX Alere Cholestech LDX - waived 9 - - - 65 45 - 84 All Chemistry Instruments 10 64.6 7.1 11.0 65 45 - 84 Alfa Wass. ACE HDL-C / LDL-C Alfa Wassermann ACE Alera/Axcel 21 62.1 4.9 7.9 61 43 - 81 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 11 62.7 3.3 5.2 61 48 - 91 Beckman AU Direct HDL / LDL Beckman AU systems 21 67.4 4.0 5.9 66 47 - 88 Horiba ABX Pentra Horiba ABX Pentra 400 15 62.3 4.1 6.6 62 43 - 82 Roche HDL Direct All Chemistry Instruments 17 75.2 3.3 4.4 75 52 - 98 Siemens Automated HDL Siemens Dimension 36 76.9 3.8 4.9 77 53 - 100 All Chemistry Instruments 38 76.9 3.7 4.8 77 53 - 100 VITROS dHDL Slide VITROS 250,350,500,700,750,950 22 73.5 3.8 5.1 74 51 - 96 All Chemistry Instruments 26 73.7 3.6 4.9 73 51 - 96

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Triglycerides (mg/dL)

Specimen CH-11 Specimen CH-12 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 252 209.5 11.3 5.4 207 157 - 262 251 90.1 4.9 5.4 90 67 - 113 All Alfa Wassermann Reagents 35 206.3 6.0 2.9 206 154 - 258 35 95.7 2.5 2.7 96 71 - 120 All Horiba Pentra Reagents 16 201.9 6.0 3.0 203 151 - 253 16 89.5 3.1 3.5 90 67 - 112 All Roche Integra/c111/c301/c501 Reagents 23 202.0 8.1 4.0 202 151 - 253 23 92.4 3.1 3.4 93 69 - 116 All Vital Diagnostics Reagents 15 206.8 10.7 5.2 206 155 - 259 15 93.7 6.7 7.1 94 70 - 118 Alere Cholestech LDX Alere Cholestech LDX - waived 27 218.7 6.2 2.8 220 164 - 274 26 91.4 3.5 3.8 92 68 - 115 All Chemistry Instruments 31 218.4 7.8 3.6 218 163 - 273 30 90.2 4.6 5.1 91 67 - 113 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 34 206.3 6.1 3.0 206 154 - 258 34 95.7 2.6 2.7 96 71 - 120 Beckman AU Beckman AU systems 28 208.2 6.2 3.0 209 156 - 261 29 90.3 4.0 4.4 91 67 - 113 Horiba ABX Pentra Horiba ABX Pentra 400 15 202.3 6.0 3.0 203 151 - 253 15 89.6 3.2 3.5 90 67 - 112 Roche Integra Roche Integra 15 197.9 6.2 3.1 196 148 - 248 15 91.2 3.0 3.3 91 68 - 114 Siemens Healthcare Siemens Dimension 41 201.8 3.5 1.7 201 151 - 253 41 84.0 2.4 2.9 84 62 - 105 All Chemistry Instruments 43 202.2 4.3 2.1 201 151 - 253 43 84.1 2.4 2.9 84 63 - 106 Vital Diagnostics Vital Diagnostics Envoy 500 13 208.0 6.4 3.1 206 156 - 260 13 94.6 5.9 6.3 94 70 - 119 All Chemistry Instruments 14 208.9 7.0 3.4 208 156 - 262 14 94.6 5.7 6.0 95 70 - 119 VITROS VITROS 250,350,500,700,750,950 28 226.6 6.8 3.0 226 169 - 284 28 88.4 2.8 3.2 89 66 - 111 All Chemistry Instruments 32 226.3 7.3 3.2 226 169 - 283 32 88.2 2.7 3.1 89 66 - 111

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Triglycerides (mg/dL)

Specimen CH-13 Specimen CH-14 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 216 25.4 5.1 19.9 25 19 - 32 226 60.2 5.2 8.7 60 45 - 76 All Alfa Wassermann Reagents 35 31.7 1.8 5.5 32 23 - 40 35 67.2 2.1 3.1 67 50 - 84 All Horiba Pentra Reagents 16 26.0 2.4 9.1 27 19 - 33 16 61.4 2.5 4.0 60 46 - 77 All Roche Integra/c111/c301/c501 Reagents 23 27.0 1.6 6.1 27 20 - 34 23 63.5 2.5 4.0 64 47 - 80 All Vital Diagnostics Reagents 14 29.7 5.6 18.9 30 22 - 38 14 64.4 7.0 10.9 65 48 - 81 Alere Cholestech LDX Alere Cholestech LDX - waived 6 - - - 45 33 - 57 8 - - - 59 42 - 72 All Chemistry Instruments 7 - - - 45 33 - 57 9 - - - 59 42 - 71 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 34 31.7 1.8 5.6 32 23 - 40 34 67.1 2.1 3.2 67 50 - 84 Beckman AU Beckman AU systems 28 24.8 1.5 6.1 25 18 - 32 29 60.9 2.9 4.8 61 45 - 77 Horiba ABX Pentra Horiba ABX Pentra 400 15 25.9 2.4 9.4 27 19 - 33 15 61.5 2.5 4.0 60 46 - 77 Roche Integra Roche Integra 15 26.5 1.6 5.9 26 19 - 34 15 62.5 2.6 4.1 62 46 - 79 Siemens Healthcare Siemens Dimension 40 18.2 2.0 11.3 18 13 - 23 41 53.7 1.8 3.3 54 40 - 68 All Chemistry Instruments 41 18.2 2.0 11.1 18 13 - 23 43 53.7 1.7 3.2 54 40 - 68 Vital Diagnostics Vital Diagnostics Envoy 500 13 30.5 4.9 16.0 30 22 - 39 13 65.4 6.3 9.7 65 49 - 82 VITROS VITROS 250,350,500,700,750,950 28 24.3 1.5 6.0 25 18 - 31 28 57.5 2.0 3.5 58 43 - 72 All Chemistry Instruments 32 24.3 1.4 5.7 25 18 - 31 32 57.3 2.0 3.4 57 43 - 72

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Triglycerides (mg/dL)

Specimen CH-15 Reagent/Instrument Labs Mean SD CV Median Range All Method 225 135.1 5.8 4.3 135 101 - 169 All Alfa Wassermann Reagents 35 138.2 3.7 2.7 138 103 - 173 All Horiba Pentra Reagents 16 132.3 5.5 4.1 134 99 - 166 All Roche Integra/c111/c301/c501 Reagents 23 135.3 5.1 3.7 136 101 - 170 All Vital Diagnostics Reagents 14 138.5 8.0 5.8 139 103 - 174 Alere Cholestech LDX Alere Cholestech LDX - waived 8 - - - 137 104 - 175 All Chemistry Instruments 9 - - - 136 103 - 173 Alfa Wassermann Alfa Wassermann ACE Alera/Axcel 34 138.2 3.8 2.7 138 103 - 173 Beckman AU Beckman AU systems 29 133.9 5.8 4.4 134 100 - 168 Horiba ABX Pentra Horiba ABX Pentra 400 15 132.1 5.6 4.3 133 99 - 166 Roche Integra Roche Integra 15 133.1 4.5 3.4 132 99 - 167 Siemens Healthcare Siemens Dimension 42 129.5 2.3 1.8 129 97 - 162 All Chemistry Instruments 44 129.6 2.3 1.8 129 97 - 162 Vital Diagnostics Vital Diagnostics Envoy 500 13 139.7 7.0 5.0 139 104 - 175 VITROS VITROS 250,350,500,700,750,950 28 139.1 4.6 3.3 140 104 - 174 All Chemistry Instruments 32 139.1 4.9 3.6 140 104 - 174

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Acetaminophen (µg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 113.15 5.99 5.3 113.9 95.1 - 131.2 5 29.30 5.49 18.7 30.1 12.8 - 45.8

Specimen CH-13 Specimen CH-14

All Method 5 9.88 4.09 41.4 9.8 0.0 - 22.2 5 13.23 5.53 41.8 15.7 0.0 - 29.9

Specimen CH-15

All Method 5 58.83 7.86 13.4 61.3 35.2 - 82.5

Digoxin (ng/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 11 2.85 0.38 13.2 2.8 2.2 - 3.5 12 1.03 0.07 6.3 1.0 0.8 - 1.3

Specimen CH-13 Specimen CH-14 All Method 12 0.67 0.10 14.8 0.7 0.4 - 0.9 12 0.62 0.07 11.6 0.6 0.4 - 0.9

Specimen CH-15 All Method 12 1.77 0.18 10.0 1.9 1.4 - 2.2

Carbamazepine (µg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 5 13.23 0.31 2.3 13.3 9.9 - 16.6 5 4.73 0.31 6.6 4.8 3.5 - 6.0

Specimen CH-13 Specimen CH-14 All Method 5 3.15 0.19 6.1 3.2 2.3 - 4.0 5 2.73 0.13 4.6 2.7 2.0 - 3.5

Specimen CH-15

All Method 5 8.03 0.33 4.1 7.9 6.0 - 10.1

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Gentamicin (µg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 9.25 0.07 0.8 9.3 6.9 - 11.6 5 2.90 0.14 4.9 2.9 2.1 - 3.7

Specimen CH-13 Specimen CH-14

All Method 5 1.15 0.07 6.1 1.2 0.8 - 1.5 5 1.30 0.14 10.9 1.3 0.9 - 1.7

Specimen CH-15

All Method 5 5.20 0.01 0.0 5.2 3.9 - 6.5

Lithium (mmol/L)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 2.40 0.01 0.0 2.4 1.9 - 2.9 5 0.75 0.07 9.4 0.8 0.4 - 1.1

Specimen CH-13 Specimen CH-14

All Method 5 0.40 0.01 0.0 0.4 0.1 - 0.7 5 0.30 0.01 0.0 0.3 0.0 - 0.6

Specimen CH-15

All Method 5 1.35 0.07 5.2 1.4 1.0 - 1.7

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Phenobarbital (µg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 1 - - - 25.1 Not graded 1 - - - 9.2 Not graded

Specimen CH-13 Specimen CH-14

All Method 1 - - - 5.9 Not graded 1 - - - 5.6 Not graded

Specimen CH-15

All Method 1 - - - 13.9 Not graded

Phenytoin (µg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 10 27.18 2.40 8.8 26.9 20.3 - 34.0 10 10.77 0.66 6.1 10.8 8.0 - 13.5

Specimen CH-13 Specimen CH-14

All Method 10 7.07 0.52 7.4 7.1 5.3 - 8.9 10 6.72 0.48 7.1 6.9 5.0 - 8.4

Specimen CH-15 All Method 10 16.90 0.65 3.9 16.9 12.6 - 21.2

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Salicylate (mg/dL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 33.55 2.19 6.5 33.6 26.9 - 40.2 5 10.95 1.34 12.3 11.0 6.9 - 15.0

Specimen CH-13 Specimen CH-14

All Method 5 7.05 1.48 21.1 7.1 2.5 - 11.6 5 5.10 0.71 13.9 5.1 2.9 - 7.3

Specimen CH-15

All Method 5 19.35 1.20 6.2 19.4 15.7 - 23.0

Theophylline (µg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 37.05 0.92 2.5 37.1 27.7 - 46.4 5 14.65 0.35 2.4 14.7 10.9 - 18.4

Specimen CH-13 Specimen CH-14 All Method 5 8.90 0.28 3.2 8.9 6.6 - 11.2 5 8.50 0.14 1.7 8.5 6.3 - 10.7

Specimen CH-15

All Method 5 22.95 0.21 0.9 23.0 17.2 - 28.7

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Valproic Acid (µg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 139.46 4.88 3.5 139.1 104.5 - 174.4 5 65.68 1.66 2.5 65.2 49.2 - 82.1

Specimen CH-13 Specimen CH-14

All Method 5 43.06 3.34 7.8 44.6 32.2 - 53.9 5 46.90 1.86 4.0 47.2 35.1 - 58.7

Specimen CH-15

All Method 5 91.70 1.86 2.0 90.8 68.7 - 114.7

Vancomycin (µg/mL)

Specimen CH-11 Specimen CH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 58.10 5.93 10.2 56.7 40.3 - 75.9 6 17.00 1.95 11.5 17.1 11.1 - 22.9

Specimen CH-13 Specimen CH-14

All Method 6 4.60 0.35 7.5 4.4 3.5 - 5.7 6 5.90 1.68 28.5 6.5 0.8 - 11.0

Specimen CH-15

All Method 6 32.13 3.84 12.0 32.8 20.6 - 43.7

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Apolipoprotein A1 (mg/dL)

Specimen LP-5 Specimen LP-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 1 - - - 49 Not graded 1 - - - 3 Not graded

Apolipoprotein B (mg/dL)

Specimen LP-5 Specimen LP-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 55.3 3.8 6.8 57 41 - 70 5 43.3 6.7 15.4 40 32 - 55

Neonatal Bilirubin, Total (mg/dL)

Specimen NB-11 Specimen NB-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 25 10.36 0.66 6.3 10.6 8.2 - 12.5 25 0.09 0.12 140.4 0.0 0.0 - 0.5 No Reagent Required Bilirubinometer / Unistat 13 10.65 0.32 3.0 10.8 8.5 - 12.8 13 0.00 0.01 0.0 0.0 0.0 - 0.4 All Chemistry Instruments 18 10.58 0.45 4.2 10.8 8.4 - 12.7 18 0.08 0.14 170.9 0.0 0.0 - 0.5

Specimen NB-13 Specimen NB-14

All Method 25 5.77 0.44 7.6 5.8 4.6 - 7.0 24 10.35 0.79 7.6 10.6 8.2 - 12.5 No Reagent Required Bilirubinometer / Unistat 13 5.61 0.41 7.3 5.8 4.4 - 6.8 12 10.73 0.31 2.9 10.8 8.5 - 12.9 All Chemistry Instruments 18 5.75 0.49 8.5 5.8 4.6 - 6.9 18 10.49 0.73 6.9 10.7 8.3 - 12.6

Specimen NB-15 All Method 24 5.78 0.41 7.0 5.8 4.6 - 7.0 No Reagent Required Bilirubinometer / Unistat 13 5.65 0.31 5.5 5.7 4.5 - 6.8 All Chemistry Instruments 18 5.78 0.45 7.9 5.8 4.6 - 7.0

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Bilirubin, Direct (mg/dL)

Specimen NB-11 Specimen NB-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 11 4.20 0.46 11.0 4.1 3.2 - 5.2 11 0.07 0.15 204.8 0.0 0.0 - 0.4

Specimen NB-13 Specimen NB-14

All Method 11 1.37 0.16 11.3 1.3 1.0 - 1.7 11 4.77 1.69 35.5 4.2 1.3 - 8.2

Specimen NB-15

All Method 11 1.37 0.17 12.2 1.3 1.0 - 1.8

Blood Gases – pH

Specimen BG-11 Specimen BG-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 11 7.491 0.007 0.1 7.49 7.45 - 7.54 11 7.180 0.006 0.1 7.18 7.14 - 7.22 i-STAT 11 7.491 0.007 0.1 7.49 7.45 - 7.54 11 7.180 0.006 0.1 7.18 7.14 - 7.22

Specimen BG-13 Specimen BG-14

All Method 11 7.327 0.005 0.1 7.33 7.28 - 7.37 11 7.227 0.005 0.1 7.23 7.18 - 7.27 i-STAT 11 7.327 0.005 0.1 7.33 7.28 - 7.37 11 7.227 0.005 0.1 7.23 7.18 - 7.27

Specimen BG-15

All Method 11 6.957 0.005 0.1 6.96 6.91 - 7.00 i-STAT 11 6.957 0.005 0.1 6.96 6.91 - 7.00

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Blood Gases - pCO2 (mmHg)

Specimen BG-11 Specimen BG-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 11 25.74 1.05 4.1 25.4 20.7 - 30.8 11 58.80 1.43 2.4 59.3 53.8 - 63.8 i-STAT 11 25.74 1.05 4.1 25.4 20.7 - 30.8 11 58.80 1.43 2.4 59.3 53.8 - 63.8

Specimen BG-13 Specimen BG-14 All Method 11 33.76 1.90 5.6 34.0 28.7 - 38.8 11 49.20 1.76 3.6 50.0 44.2 - 54.2 i-STAT 11 33.76 1.90 5.6 34.0 28.7 - 38.8 11 49.20 1.76 3.6 50.0 44.2 - 54.2

Specimen BG-15

All Method 11 67.64 2.11 3.1 67.9 62.2 - 73.1

i-STAT 11 67.64 2.11 3.1 67.9 62.2 - 73.1

Blood Gases - pO2 (mmHg)

Specimen BG-11 Specimen BG-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 11 138.14 3.72 2.7 140.0 126.9 - 149.3 11 80.14 4.38 5.5 80.0 67.0 - 93.3 i-STAT 11 138.14 3.72 2.7 140.0 126.9 - 149.3 11 80.14 4.38 5.5 80.0 67.0 - 93.3

Specimen BG-13 Specimen BG-14

All Method 11 77.86 5.93 7.6 76.0 60.0 - 95.7 11 180.71 6.13 3.4 182.0 162.3 - 199.2 i-STAT 11 77.86 5.93 7.6 76.0 60.0 - 95.7 11 180.71 6.13 3.4 182.0 162.3 - 199.2

Specimen BG-15

All Method 11 58.71 4.57 7.8 56.0 44.9 - 72.5 i-STAT 11 58.71 4.57 7.8 56.0 44.9 - 72.5

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Blood Gases – Ionized Calcium (mmol/L)

One participant reported results for Blood Gases-Ionized Calcium. The vendor mean assay values for specimens BG-11 through BG-15 are: 1.4 mmol/L , 2.1 mmol/L, 0.56 mmol/L, 0.59 mmol/L, 2.3 mmolL, respectively.

Blood Gases - Chloride (mmol/L)

One participant reported results for Blood Gases-Chloride. The vendor mean assay values for specimens BG-11 through BG-15 are: 82 mmol/L, 76 mmol/L, 71 mmol/L, 117 mmolL/, 101 mmol/L, respectively.

Blood Gases - Potassium (mmol/L)

One participant reported results for Blood Gases-Potassium. The vendor mean assay values for specimens BG-11 through BG-15 are: 4.1 mmol/L, 2.7 mmol/L, 2.1 mmol/L, 6.6 mmol/L, 3.3 mmol/L, respectively.

Blood Gases – Sodium (mmol/L)

One participant reported results for Blood Gases-Sodium. The vendor mean assay values for specimens BG-11 through BG-15 are: 144 mmol/L, 126 mmol/L , 113 mmol/L , 167 mmol/L , 123 mmol/L, respectively.

Blood Gases – Lactic Acid (mmol/L)

Specimen BG-11 Specimen BG-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 1.40 0.01 0.0 1.4 1.3 - 1.5 5 4.50 0.14 3.1 4.5 4.0 - 5.0 i-STAT 5 1.40 0.01 0.0 1.4 1.3 - 1.5 5 4.50 0.14 3.1 4.5 4.0 - 5.0

Specimen BG-13 Specimen BG-14

All Method 5 5.90 0.14 2.4 5.9 5.4 - 6.4 5 3.25 0.07 2.2 3.3 3.0 - 3.5 i-STAT 5 5.90 0.14 2.4 5.9 5.4 - 6.4 5 3.25 0.07 2.2 3.3 3.0 - 3.5

Specimen BG-15

All Method 5 4.65 0.07 1.5 4.7 4.4 - 4.9 i-STAT 5 4.65 0.07 1.5 4.7 4.4 - 4.9

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C-Peptide (ng/mL)

Specimen CIP-5 Specimen CIP-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 11 0.426 0.154 36.2 0.40 0.11 - 0.74 11 16.741 2.458 14.7 15.60 11.82 - 21.66

Insulin (U/mL)

Specimen CIP-5 Specimen CIP-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 18 30.82 7.64 24.8 32.5 15.5 - 46.1 18 227.50 69.45 30.5 233.3 88.5 - 366.5

Bioavailable Testosterone (ng/dL)

Specimen SHB-5 Specimen SHB-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 1 - - - 240 Not graded 1 - - - 195 Not graded

Parathyroid hormone (pg/mL)

Specimen CIP-5 Specimen CIP-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 42 4.5 2.0 45.6 4 0 - 9 43 91.9 15.5 16.9 93 60 - 123 All TOSOH Instruments 10 5.1 0.9 17.2 5 3 - 7 10 95.3 7.0 7.3 94 81 - 110 Beckman ACCESS / 2 / DxI 16 3.2 0.5 17.1 3 2 - 5 16 84.9 18.6 21.9 80 47 - 123

Vitamin D (25-Hydroxy) (ng/mL)

Specimen CIP-5 Specimen CIP-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 107 13.85 5.38 38.8 12.9 3.0 - 24.7 108 77.08 20.20 26.2 78.7 36.6 - 117.5 All Roche Instruments 10 7.30 1.63 22.3 7.7 4.0 - 10.6 10 51.35 4.76 9.3 51.7 41.8 - 60.9 All TOSOH Instruments 19 19.30 5.03 26.0 18.9 9.2 - 29.4 18 80.09 11.22 14.0 80.7 57.6 - 102.6 Abbott Architect 13 13.38 0.74 5.6 13.3 11.8 - 14.9 13 73.36 4.36 5.9 73.2 64.6 - 82.1 Beckman ACCESS / 2 / DxI 34 10.53 2.35 22.3 10.7 5.8 - 15.3 34 83.62 8.43 10.1 84.5 66.7 - 100.5 Qualigen FastPack 11 16.04 6.68 41.7 12.9 2.6 - 29.5 11 46.91 13.71 29.2 47.8 19.4 - 74.4 Roche cobas e 411 9 6.99 1.37 19.7 7.6 4.2 - 9.8 9 50.62 4.42 8.7 51.3 41.7 - 59.5 Siemens ADVIA Centaur / CP 5 24.40 2.26 9.3 24.3 19.8 - 29.0 5 118.06 7.58 6.4 120.8 102.8 - 133.3 TOSOH AIA 10 17.53 4.60 26.2 18.1 8.3 - 26.8 10 77.40 11.11 14.4 77.2 55.1 - 99.7 TOSOH ST AIA 9 21.27 4.98 23.4 19.6 11.3 - 31.3 9 77.30 21.18 27.4 81.8 34.9 - 119.7

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Glycohemoglobin (percent)

Specimen GH-5 Specimen GH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 194 10.68 0.51 4.8 10.6 9.6 - 11.8 189 8.31 0.32 3.8 8.3 7.4 - 9.2 All Hemoglobin A1c Methods 191 10.67 0.51 4.8 10.6 9.6 - 11.8 185 8.31 0.29 3.5 8.3 7.4 - 9.2 All TOSOH Methods 20 10.60 0.22 2.1 10.6 9.5 - 11.7 19 8.30 0.15 1.8 8.3 7.4 - 9.2 Beckman AU A1c 14 10.38 0.35 3.4 10.4 9.3 - 11.5 14 7.99 0.29 3.6 8.0 7.1 - 8.8 Siemens DCA Vantage 82 10.86 0.38 3.5 10.9 9.7 - 12.0 81 8.41 0.23 2.7 8.4 7.5 - 9.3 Siemens Dimension HB1C 33 10.12 0.23 2.3 10.1 9.1 - 11.2 33 8.05 0.13 1.6 8.1 7.2 - 8.9 TOSOH G8 19 10.58 0.21 2.0 10.5 9.5 - 11.7 19 8.30 0.15 1.8 8.3 7.4 - 9.2

Free Testosterone (pg/mL)

Specimen SHB-5 Specimen SHB-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 5 143.10 59.54 41.6 143.1 0.0 - 321.8 5 106.45 34.86 32.7 106.5 1.8 - 211.1 Calculation with albumin=4.3 5 143.10 59.54 41.6 143.1 0.0 - 321.8 5 106.45 34.86 32.7 106.5 1.8 - 211.1

Sex Hormone Binding Globulin (SHBG) (nmol/L)

Specimen SHB-5 Specimen SHB-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 10 80.237 15.188 18.9 74.55 34.67 - 125.81 10 59.504 8.837 14.9 57.45 32.99 - 86.02 Siemens Immulite/1000 5 71.060 3.448 4.9 72.60 60.71 - 81.41 5 56.120 7.332 13.1 54.80 34.12 - 78.12

Testosterone (ng/dL)

Specimen SHB-5 Specimen SHB-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 5 793.8 228.7 28.8 663 555 - 1032 5 541.4 132.2 24.4 465 378 - 704

Afinion Glycohemoglobin (percent)

Specimen AFN-5 Specimen AFN-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range Axis-Shield Afinion AS100 71 6.11 0.16 2.7 6.1 5.5 - 6.8 70 8.11 0.15 1.8 8.1 7.2 - 9.0

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BNP (pg/mL)

Specimen CK-11 Specimen CK-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 8 2153.25 258.58 12.0 1940.0 1614.9 - 2691.6 9 455.36 140.50 30.9 437.0 174.3 - 736.4 Alere Triage 41 1940.73 378.72 19.5 1890.0 1183.2 - 2698.2 42 442.33 68.08 15.4 441.0 306.1 - 578.5 i-STAT - moderate 5 1979.80 86.14 4.4 1995.0 1484.8 - 2474.8 5 386.80 29.56 7.6 386.0 290.1 - 483.5

Specimen CK-13 Specimen CK-14

All Method 7 718.24 159.93 22.3 739.5 398.3 - 1038.2 7 1155.81 416.25 36.0 1225.0 323.3 - 1988.4 Alere Triage 24 728.79 98.27 13.5 739.5 532.2 - 925.4 24 1200.92 168.92 14.1 1205.0 863.0 - 1538.8 i-STAT - moderate 5 719.20 55.01 7.6 733.0 539.4 - 899.0 5 1251.60 104.27 8.3 1283.0 938.7 - 1564.5

Specimen CK-15

All Method 6 60.35 23.16 38.4 66.2 14.0 - 106.7 Alere Triage 24 70.10 11.40 16.3 67.2 47.2 - 93.0 i-STAT - moderate 5 51.20 6.53 12.8 54.0 38.1 - 64.3

CK-MB (ng/mL)

Specimen CK-11 Specimen CK-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 13 109.48 10.53 9.6 37.1 77.8 - 141.1 13 17.79 2.05 11.5 6.6 11.6 - 24.0 Alere Triage 29 30.88 7.11 23.0 30.9 9.5 - 52.3 29 6.04 0.99 16.4 5.9 3.0 - 9.1 Dade Stratus CS 6 99.57 1.81 1.8 99.8 94.1 - 105.1 6 16.72 0.29 1.7 16.8 15.8 - 17.6

Specimen CK-13 Specimen CK-14 All Method 14 30.89 3.19 10.3 10.8 21.3 - 40.5 13 56.05 5.82 10.4 19.5 38.5 - 73.6 Alere Triage 29 9.67 1.76 18.2 9.5 4.3 - 15.0 28 17.36 3.21 18.5 17.4 7.7 - 27.0 Dade Stratus CS 6 28.23 0.41 1.5 28.4 26.9 - 29.5 6 51.07 1.20 2.3 51.1 47.4 - 54.7

Specimen CK-15 All Method 13 6.62 0.92 13.9 2.6 3.8 - 9.4 Alere Triage 29 2.22 0.42 19.1 2.2 0.9 - 3.5 Dade Stratus CS 6 6.58 0.19 2.9 6.6 6.0 - 7.2

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D-Dimer (ng/mL) Specimen CK-11 Specimen CK-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 10 2904.3 1165.3 40.1 2280 573 - 5235 10 946.3 357.1 37.7 844 232 - 1661 Alere Triage 25 2244.0 272.5 12.1 2270 1570 - 2918 25 841.5 86.6 10.3 827 589 - 1094 Dade Stratus CS 6 3050.0 126.1 4.1 3068 2135 - 3965 6 934.8 35.3 3.8 944 654 - 1216

Specimen CK-13 Specimen CK-14 All Method 7 1250.3 156.2 12.5 1080 875 - 1626 7 1875.3 117.7 6.3 1585 1312 - 2438 Alere Triage 23 1033.5 131.0 12.7 1060 723 - 1344 22 1487.7 152.7 10.3 1500 1041 - 1935 Dade Stratus CS 6 1306.5 52.2 4.0 1323 914 - 1699 6 1911.2 76.1 4.0 1913 1337 - 2485

Specimen CK-15 All Method 7 583.7 35.2 6.0 583 408 - 759 Alere Triage 23 582.5 77.7 13.3 579 407 - 758 Dade Stratus CS 6 573.5 24.7 4.3 580 401 - 746 D-Dimer (µgFEU/mL) Specimen CK-11 Specimen CK-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 3.5850 2.2415 62.5 3.585 0.000 - 8.069 5 1.2200 0.8768 71.9 1.220 0.000 - 2.974

Specimen CK-13 Specimen CK-14 All Method 1 - - - 2.250 Not graded 1 - - - 3.250 Not graded

Specimen CK-15 All Method 1 - - - 1.380 Not graded

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Myoglobin (ng/mL)

Specimen CK-11 Specimen CK-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 5 404.90 108.71 26.8 305.0 187.4 - 622.4 5 61.42 11.07 18.0 69.6 39.2 - 83.6 Alere Triage 24 300.71 44.44 14.8 285.0 210.4 - 391.0 24 67.60 9.22 13.6 69.9 47.3 - 87.9

Specimen CK-13 Specimen CK-14

All Method 5 108.40 22.04 20.3 113.0 64.3 - 152.5 5 204.50 52.67 25.8 187.0 99.1 - 309.9 Alere Triage 24 114.25 15.46 13.5 113.5 79.9 - 148.6 24 186.96 18.60 9.9 187.5 130.8 - 243.1

Specimen CK-15

All Method 5 15.28 2.51 16.4 16.1 10.2 - 20.3 Alere Triage 24 17.09 3.63 21.3 17.9 9.8 - 24.4

NT-proBNP (pg/mL)

Specimen CK-11 Specimen CK-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 3790.2 1583.3 41.8 3541 623 - 6957 6 350.5 219.1 62.5 257 0 - 789

Specimen CK-13 Specimen CK-14

All Method 3 - - - 424 105 - 968 3 - - - 942 268 - 2112

Specimen CK-15 All Method 3 - - - 18 6 - 34

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Troponin I (ng/mL)

Specimen CK-11 Specimen CK-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 14.017 14.899 106.3 11.50 0.00 - 43.82 47 0.909 0.983 108.2 0.62 0.00 - 2.88 Alere Triage 30 11.921 2.504 21.0 11.80 6.91 - 16.93 30 0.677 0.152 22.5 0.63 0.37 - 0.99 Dade Stratus CS 6 5.392 0.286 5.3 5.41 3.77 - 7.01 6 0.633 0.027 4.2 0.63 0.44 - 0.83 i-STAT - moderate 5 37.946 4.981 13.1 38.27 26.56 - 49.33 5 4.950 0.578 11.7 4.92 3.46 - 6.44 Siemens Dimension 5 4.650 0.152 3.3 4.59 3.25 - 6.05 5 0.602 0.040 6.6 0.60 0.42 - 0.79

Specimen CK-13 Specimen CK-14

All Method 47 2.188 1.973 90.2 1.64 0.00 - 6.14 47 5.359 3.845 71.7 4.71 0.00 - 13.05 Alere Triage 30 1.883 0.460 24.4 1.82 0.96 - 2.81 30 5.301 1.114 21.0 5.16 3.07 - 7.53 Dade Stratus CS 6 1.340 0.097 7.2 1.34 0.93 - 1.75 6 2.695 0.178 6.6 2.69 1.88 - 3.51 i-STAT - moderate 5 10.364 1.293 12.5 9.80 7.25 - 13.48 5 20.516 2.570 12.5 19.23 14.36 - 26.68 Siemens Dimension 5 1.216 0.049 4.0 1.23 0.85 - 1.59 5 2.392 0.068 2.8 2.42 1.67 - 3.11

Specimen CK-15

All Method 47 0.071 0.084 118.0 0.05 0.00 - 0.25 Alere Triage 30 0.050 0.001 0.0 0.05 0.03 - 0.07 Dade Stratus CS 6 0.038 0.008 19.6 0.04 0.02 - 0.06 i-STAT - moderate 5 0.412 0.031 7.6 0.40 0.28 - 0.54 Siemens Dimension 5 0.058 0.011 18.9 0.05 0.03 - 0.08

PSA (ng/mL)

Specimen PS-5 Specimen PS-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 155 6.919 0.823 11.9 6.96 4.84 - 9.00 153 13.545 1.776 13.1 13.69 9.48 - 17.61 All TOSOH Instruments 38 6.063 0.456 7.5 6.07 4.24 - 7.89 38 11.617 0.718 6.2 11.68 8.13 - 15.11 Abbott Architect 15 6.103 0.334 5.5 5.95 4.27 - 7.94 15 12.107 0.502 4.1 12.26 8.47 - 15.74 Beckman ACCESS / 2 / DxI 17 7.553 0.433 5.7 7.59 5.28 - 9.82 17 14.901 0.896 6.0 14.70 10.43 - 19.38 Beckman ACCESS Hybritech PSA 21 7.530 0.405 5.4 7.63 5.27 - 9.79 21 15.080 0.763 5.1 14.93 10.55 - 19.61 bioMerieux Vidas, Mini Vidas 15 7.267 0.391 5.4 7.30 5.08 - 9.45 15 14.274 0.802 5.6 14.47 9.99 - 18.56 Siemens Dimension TPSA 25 6.810 0.325 4.8 6.75 4.76 - 8.86 25 13.537 0.716 5.3 13.60 9.47 - 17.60 TOSOH AIA 16 6.086 0.463 7.6 6.04 4.25 - 7.92 16 11.596 0.663 5.7 11.68 8.11 - 15.08 TOSOH ST AIA 22 6.047 0.461 7.6 6.07 4.23 - 7.87 22 11.632 0.770 6.6 11.67 8.14 - 15.13

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Beta-2 microglobulin

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 0.242 0.043 17.6 0.25 0.11 - 0.37 5 2.398 0.132 5.5 2.37 2.00 - 2.80

CA 125 (U/mL)

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 13 9.5 4.0 41.6 16 1 - 18 13 105.8 27.4 25.9 158 51 - 161 All TOSOH Instruments 10 21.4 1.3 5.9 22 14 - 28 10 266.1 15.9 6.0 269 186 - 346

CA 15-3 (U/mL)

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 11 14.1 7.3 51.5 12 0 - 36 11 37.9 23.7 62.4 32 0 - 109

CA 19-9 (U/mL)

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 10 15.3 10.0 65.4 14 0 - 46 10 218.7 178.6 81.6 223 0 - 755

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CA 27/29 (U/mL)

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 12 33.7 2.3 6.7 34 26 - 41 12 135.2 8.7 6.4 136 109 - 162 All TOSOH Instruments 12 33.7 2.3 6.7 34 26 - 41 12 135.2 8.7 6.4 136 109 - 162 TOSOH ST AIA 11 33.5 2.3 6.7 33 26 - 41 11 134.7 8.9 6.6 135 107 - 162

CEA (ng/mL)

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 13 0.73 0.32 43.4 1.2 0.0 - 2.0 13 33.10 5.76 17.4 47.3 23.1 - 43.1 All TOSOH Instruments 12 1.51 0.08 5.3 1.5 0.3 - 2.8 12 52.71 1.55 2.9 52.6 36.8 - 68.6 TOSOH ST AIA 10 1.50 0.08 5.4 1.5 0.3 - 2.7 10 52.64 1.70 3.2 52.2 36.8 - 68.5

Free PSA (ng/mL)

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 18 0.076 0.020 26.7 0.07 0.00 - 0.98 18 8.637 1.506 17.4 7.78 6.04 - 11.23

PSA (ng/mL)

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 44 0.272 0.072 26.6 0.30 0.00 - 1.18 44 9.539 1.569 16.4 10.13 6.67 - 12.41 All TOSOH Instruments 12 0.294 0.017 5.7 0.30 0.00 - 1.20 12 8.980 0.403 4.5 9.08 6.28 - 11.68 TOSOH ST AIA 10 0.294 0.018 6.3 0.30 0.00 - 1.20 10 8.960 0.443 4.9 9.03 6.27 - 11.65

Thyroglobulin (ng/mL)

Specimen TM-5 Specimen TM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 6 3.75 1.60 42.7 4.2 0.5 - 7.0 6 82.27 32.69 39.7 64.1 16.8 - 147.7

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CEA (ng/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 7 7.77 0.78 10.0 9.0 5.4 - 10.2 7 14.57 1.98 13.6 16.7 10.1 - 19.0 All TOSOH Instruments 8 9.44 0.35 3.7 9.4 6.6 - 12.3 8 17.15 0.87 5.1 17.2 12.0 - 22.3 Beckman ACCESS / 2 / DxI 4 8.35 0.35 4.2 8.4 5.8 - 10.9 4 15.83 1.63 10.3 15.4 11.0 - 20.6 TOSOH ST AIA 6 9.45 0.41 4.3 9.4 6.6 - 12.3 6 17.05 1.00 5.9 17.1 11.9 - 22.2

DHEA-S (µg/dL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 13 161.45 27.38 17.0 156.0 113.0 - 209.9 12 277.91 36.10 13.0 270.8 194.5 - 361.3 Beckman ACCESS / 2 / DxI 5 152.70 8.35 5.5 148.0 106.8 - 198.6 4 - - - 255.5 194.5 - 361.3

Ferritin (ng/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 51 82.8 15.3 18.5 63 57 - 108 52 149.3 26.3 17.6 116 104 - 195 All Abbott Instruments 10 105.2 5.3 5.0 105 73 - 137 10 188.4 10.1 5.3 193 131 - 245 All TOSOH Instruments 28 54.2 2.7 5.0 54 37 - 71 29 100.6 4.0 4.0 100 70 - 131 Abbott Architect 10 105.2 5.3 5.0 105 73 - 137 10 188.4 10.1 5.3 193 131 - 245 Beckman ACCESS / 2 / DxI 32 61.4 3.4 5.6 62 42 - 80 33 112.3 10.2 9.1 114 78 - 146 Siemens Dimension 12 83.4 2.7 3.3 84 58 - 109 12 148.1 3.8 2.6 150 103 - 193 TOSOH AIA 11 53.4 2.9 5.4 54 37 - 70 11 99.6 4.9 4.9 99 69 - 130 TOSOH ST AIA 18 55.3 3.4 6.2 55 38 - 72 18 101.1 3.4 3.4 101 70 - 132

Estradiol (pg/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 37 219.1 64.7 29.5 199 89 - 349 37 391.0 97.8 25.0 347 195 - 587 All TOSOH Instruments 10 315.7 18.9 6.0 311 277 - 354 10 538.4 16.2 3.0 541 506 - 571

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Folate (ng/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 30 2.19 0.58 26.6 2.7 1.2 - 3.1 31 4.09 1.17 28.7 5.2 2.8 - 5.4 All Roche Elecsys/Cobas Instruments 7 1.84 0.34 18.2 2.0 0.9 - 2.8 8 3.14 0.61 19.4 3.1 2.1 - 4.1 All Siemens Dimension Instruments 5 1.78 0.24 13.4 1.8 0.8 - 2.7 5 3.06 0.22 7.2 3.0 2.1 - 4.0 All TOSOH Instruments 15 2.48 0.77 31.2 2.2 1.5 - 3.4 14 3.93 0.84 21.5 4.1 2.7 - 5.2 Abbott Architect 7 2.83 0.43 15.1 2.8 1.9 - 3.8 7 5.61 0.31 5.6 5.7 3.9 - 7.3 Beckman ACCESS / 2 / DxI 32 2.87 0.16 5.6 2.9 1.9 - 3.8 32 5.60 0.32 5.7 5.6 3.9 - 7.3 Roche cobas e 411 5 1.96 0.09 4.6 2.0 1.0 - 2.9 6 3.05 0.69 22.8 3.0 2.1 - 4.0 TOSOH AIA 13 2.51 0.77 30.6 2.2 1.6 - 3.5 12 4.03 0.76 18.8 4.1 2.8 - 5.3

FSH (mIU/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 44 20.64 1.77 8.6 21.0 15.4 - 25.8 43 34.83 3.07 8.8 34.4 26.1 - 43.6 All TOSOH Instruments 11 21.29 1.30 6.1 21.2 15.9 - 26.7 11 34.99 1.82 5.2 35.4 26.2 - 43.8 Beckman ACCESS / 2 / DxI 13 20.58 1.16 5.6 20.7 15.4 - 25.8 13 33.62 5.32 15.8 34.2 25.2 - 42.1

Homocysteine (mol/L)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 12 15.0 5.0 33.2 17 11 - 19 12 24.9 3.4 13.8 26 18 - 32

LH (mIU/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 42 16.33 2.31 14.1 16.0 11.7 - 21.0 41 29.79 3.79 12.7 29.3 22.2 - 37.4 Beckman ACCESS / 2 / DxI 14 15.62 1.23 7.9 15.3 13.1 - 18.1 14 27.72 4.72 17.0 28.4 18.2 - 37.2

Progesterone (ng/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 28 15.99 3.44 21.5 16.1 11.1 - 20.8 28 26.20 5.19 19.8 26.8 18.3 - 34.1

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Transferrin (mg/dL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 121.4 5.6 4.6 122 109 - 134 18 177.1 7.7 4.4 176 159 - 195

Vitamin B12 (pg/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 98 470.9 82.9 17.6 453 329 - 613 97 826.1 135.6 16.4 806 578 - 1074 All Roche Elecsys/Cobas Instruments 11 487.4 104.9 21.5 461 341 - 634 11 917.1 275.5 30.0 854 641 - 1193 All TOSOH Instruments 17 579.5 38.7 6.7 583 405 - 754 17 1000.4 104.5 10.4 1031 700 - 1301 Abbott Architect 11 520.4 128.3 24.7 498 364 - 677 11 817.7 138.1 16.9 875 572 - 1064 Beckman ACCESS / 2 / DxI 38 408.6 21.6 5.3 409 286 - 532 37 735.6 34.3 4.7 728 514 - 957 TOSOH AIA 14 587.9 30.8 5.2 586 411 - 765 14 1021.9 85.9 8.4 1037 715 - 1329

Prolactin (ng/mL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 21.35 1.70 8.0 21.4 14.9 - 27.8 30 40.52 3.23 8.0 40.8 28.3 - 52.7 Beckman ACCESS / 2 / DxI 10 20.46 1.50 7.4 20.3 14.3 - 26.6 10 36.23 6.58 18.1 39.0 25.3 - 47.1

Testosterone (ng/dL)

Specimen SC-5 Specimen SC-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 83 920.6 186.5 20.3 867 644 - 1197 82 1468.3 291.1 19.8 1442 1027 - 1909 All Immulite Instruments 8 1150.8 187.9 16.3 1168 805 - 1496 8 1580.3 55.9 3.5 1600 1106 - 2055 All Roche Elecsys/Cobas Instruments 7 944.7 22.7 2.4 952 661 - 1229 6 1603.2 253.2 15.8 1500 1122 - 2085 All TOSOH Instruments 16 1148.2 71.6 6.2 1150 803 - 1493 16 1880.1 103.6 5.5 1885 1316 - 2445 Abbott Architect 8 900.3 62.3 6.9 898 630 - 1171 8 1218.5 232.9 19.1 1151 852 - 1585 Beckman ACCESS / 2 / DxI 32 814.7 39.6 4.9 813 570 - 1060 33 1371.3 101.2 7.4 1378 959 - 1783 Siemens Immulite/1000 6 1237.5 115.1 9.3 1242 866 - 1609 6 1600.0 0.1 0.0 1600 1120 - 2080 TOSOH AIA 7 1158.7 93.0 8.0 1136 811 - 1507 7 1884.9 124.3 6.6 1855 1319 - 2451 TOSOH ST AIA 9 1140.0 54.3 4.8 1164 798 - 1482 9 1876.4 92.2 4.9 1921 1313 - 2440

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Serum Alcohol (mg/dL)

Specimen ETH-11 Specimen ETH-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 129.7 11.4 8.8 133 97 - 163 5 128.0 13.1 10.2 134 96 - 160

Specimen ETH-13 Specimen ETH-14

All Method 5 148.3 14.2 9.5 156 111 - 186 5 108.7 9.3 8.6 113 81 - 136

Specimen ETH-15

All Method 5 170.7 16.3 9.5 178 128 - 214

Acetone

Specimen ETH-11 Specimen ETH-12

Method Labs Negative Small Moderate Large Labs Negative Small Moderate Large

ALL METHODS 10 10 - - - 10 - - 6 4 Siemens Acetest 9 9 - - - 9 - - 5 4

Specimen ETH-13 Specimen ETH-14

ALL METHODS 10 10 - - - 10 - 5 4 1 Siemens Acetest 9 9 - - - 9 - 4 4 1

Specimen ETH-15

ALL METHODS 10 10 - - -

Siemens Acetest 9 9 - - -

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Anti-Thyroglobulin Antibody (IU/mL)

Specimen THY-5 Specimen THY-6

Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 20 4.674 7.999 171.1 0.10 0.00 - 20.68 21 920.487 303.685 33.0 980.40 313.11 - 1527.86 Beckman ACCESS / 2 / DxI 9 - - - 0.10 0.00 - 20.68 10 1079.246 119.448 11.1 1072.28 840.34 - 1318.15

Anti-Microsomal Antibody (IU/mL)

Specimen THY-5 Specimen THY-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 17 1.854 3.895 210.1 0.00 0.00 - 9.65 21 56.751 36.740 64.7 35.10 0.00 - 130.24

Ammonia (µmol/L)

Specimen AMM-5 Specimen AMM-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 296.6 12.5 4.2 297 271 - 322 5 23.4 8.5 36.3 25 6 - 41

Urine Drug Screen

Acetaminophen (µg/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 5 - 5 5 - 5

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Amphetamines (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 83 - 83 83 - 83 Cut-off 250 Alere iCup 1 - 1 1 - 1 Medica EasyRA 1 - 1 1 - 1 All Cut-off 250 2 - 2 2 - 2 Cut-off 300 Alere iCup 1 - 1 1 - 1 All Cut-off 300 3 - 3 3 - 3 Cut-off 500 Alere iCup 1 - 1 1 - 1 Beckman AU 2 - 2 2 - 2 ImmTox 1 - 1 1 - 1 Immunalysis 2 - 2 2 - 2 Indiko Plus 1 - 1 1 - 1 Medica EasyRA 1 - 1 1 - 1 MEDTOX Diagnostics 4 - 4 4 - 4 Microgenics DRI 1 - 1 1 - 1 Roche Integra 1 - 1 1 - 1 Siemens Dimension 1 - 1 1 - 1 Siemens EMIT II Plus 1 - 1 1 - 1 Synermed IR 500 1 - 1 1 - 1 All Cut-off 500 17 - 17 17 - 17 Cut-off 1000 Alere iCassette 4 - 4 4 - 4 Alere iCup 5 - 5 5 - 5 Alere iScreen 1 - 1 1 - 1 Alere Triage 1 - 1 1 - 1 AMBC Rapid Drug/Tox 1 - 1 1 - 1 Beckman AU 1 - 1 1 - 1 Bio-Rad TOX/See 2 - 2 2 - 2 BMC QuickTox Drug Screen 1 - 1 1 - 1 Carolina Chemistries BioLis 24i 1 - 1 1 - 1 Clarity Diagnostics Urine Panels/Cassettes 1 - 1 1 - 1 Innovacon Multi-Drug One Step 1 - 1 1 - 1 Integrated E-Z Split Key Cup / II 1 - 1 1 - 1 Lin-Zhi International 7 - 7 7 - 7 MEDTOX Diagnostics 1 - 1 1 - 1 Microgenics DRI 4 - 4 4 - 4 Mindray BS-200 1 - 1 1 - 1 Noble Medical Inc. 1 - 1 1 - 1 Redwood Toxicology Reditest 1 - 1 1 - 1 USDiagnostics UScreen Cup 6 - 6 6 - 6 All Cut-off 1000 50 - 50 50 - 50

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Amphetamines/Methamphetamines (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 20 - 20 20 - 20 Cut-off 500 Alere iCup 1 - 1 1 - 1 Beckman AU 2 - 2 2 - 2 Microgenics DRI 1 - 1 1 - 1 Siemens EMIT II Plus 1 - 1 1 - 1 All Cut-off 500 6 - 6 6 - 6 Cut-off 1000 Abbott Architect 1 - 1 1 - 1 Alere iCup 1 - 1 1 - 1 AMBC Rapid Drug/Tox 1 - 1 1 - 1 Bio-Rad TOX/See 1 - 1 1 - 1 Clarity Diagnostics Urine Panels/Cassettes 1 - 1 1 - 1 Microgenics DRI 2 - 2 2 - 2 Siemens EMIT II Plus 1 - 1 1 - 1 All Cut-off 1000 10 - 10 10 - 10 All Methods 20 - 20 20 - 20

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Barbiturates (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 79 1 78 79 78 1 Cut-off 200 Abbott Architect 1 - 1 1 1 - Beckman AU 5 - 5 5 5 - Carolina Chemistries BioLis 24i 1 - 1 1 1 - ImmTox 1 - 1 1 1 - Immunalysis 1 - 1 1 1 - Indiko Plus 1 - 1 1 1 - Lin-Zhi International 3 - 3 3 3 - Medica EasyRA 2 - 2 2 2 - MEDTOX Diagnostics 5 - 5 5 5 - Microgenics DRI 4 - 4 4 4 - Roche Integra 1 - 1 1 1 - Siemens Dimension 1 - 1 1 1 - Siemens EMIT II Plus 1 - 1 1 1 - All Cut-off 200 28 - 28 28 28 - Cut-off 300 Alere iCassette 4 - 4 4 4 - Alere iCup 8 - 8 8 8 - Alere iScreen 1 - 1 1 1 - Alere Triage 1 - 1 1 1 - Amedica Biotech 1 - 1 1 1 - Bio-Rad TOX/See 2 1 1 2 1 1 BMC QuickTox Drug Screen 1 - 1 1 1 - Clarity Diagnostics Urine Panels/Cassettes 1 - 1 1 1 - Microgenics DRI 1 - 1 1 1 - Redwood Toxicology Reditest 1 - 1 1 1 - USDiagnostics UScreen Cup 6 - 6 6 6 - All Cut-off 300 38 1 37 38 37 1

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Benzodiazepines (ng/mL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 91 87 4 91 - 91 Cut-off 100 Beckman AU 2 2 - 2 - 2 ImmTox 1 1 - 1 - 1 Immunalysis 1 1 - 1 - 1 Roche Integra 1 1 - 1 - 1 All Cut-off 100 5 5 - 5 - 5 Cut-off 150 Medica EasyRA 2 2 - 2 - 2 MEDTOX Diagnostics 4 1 3 4 - 4 All Cut-off 150 6 3 3 6 - 6 Cut-off 200 Abbott Architect 1 1 - 1 - 1 Beckman AU 3 3 - 3 - 3 Carolina Chemistries BioLis 24i 1 1 - 1 - 1 Immunalysis 1 1 - 1 - 1 Indiko Plus 1 1 - 1 - 1 Lin-Zhi International 7 7 - 7 - 7 Microgenics DRI 5 5 - 5 - 5 Mindray BS-200 1 1 - 1 - 1 Siemens Dimension 1 1 - 1 - 1 Siemens EMIT II Plus 4 4 - 4 - 4 Synermed IR 500 1 1 - 1 - 1 All Cut-off 200 27 27 - 27 - 27 Cut-off 300 Alere iCassette 4 4 - 4 - 4 Alere iCup 8 8 - 8 - 8 Alere iScreen 2 2 - 2 - 2 Alere Triage 1 1 - 1 - 1 Alfa Scientific Instant-View 1 1 - 1 - 1 Bio-Rad TOX/See 2 1 1 2 - 2 BMC QuickTox Drug Screen 2 2 - 2 - 2 Clarity Diagnostics Urine Panels/Cassettes 1 1 - 1 - 1 MEDTOX Diagnostics 1 1 - 1 - 1 Microgenics DRI 1 1 - 1 - 1 Redwood Toxicology Reditest 1 1 - 1 - 1 USDiagnostics UScreen Cup 6 6 - 6 - 6 All Cut-off 300 41 40 1 41 - 41

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Buprenorphine (ng/mL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 48 1 47 48 - 48 Cut-off 5 Beckman AU 3 - 3 3 - 3 ImmTox 1 - 1 1 - 1 Immunalysis 2 - 2 2 - 2 Lin-Zhi International 6 - 6 6 - 6 Medica EasyRA 2 - 2 2 - 2 Microgenics CEDIA 6 - 6 6 - 6 Synermed IR 500 1 - 1 1 - 1 All Cut-off 5 21 - 21 21 - 21 Cut-off 10 Alere iCup 2 - 2 2 - 2 Alere iScreen 1 - 1 1 - 1 Clarity Diagnostics Urine Panels/Cassettes 1 - 1 1 - 1 MEDTOX Diagnostics 4 - 4 4 - 4 Microgenics CEDIA 1 - 1 1 - 1 Mindray BS-200 1 - 1 1 - 1 Siemens EMIT II Plus 1 - 1 1 - 1 USDiagnostics UScreen Cup 2 - 2 2 - 2 All Cut-off 10 20 - 20 20 - 20 Cut-off 20 Indiko Plus 1 - 1 1 - 1 All Cut-off 20 1 - 1 1 - 1

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Cannabinoids (THC) (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 102 102 - 102 - 102 Cut-off 50 Abbott Architect 1 1 - 1 - 1 Alere iCassette 4 4 - 4 - 4 Alere iCup 9 9 - 9 - 9 Alere iScreen 1 1 - 1 - 1 Alere Triage 1 1 - 1 - 1 Alfa Scientific Instant-View 4 4 - 4 - 4 Beckman AU 5 5 - 5 - 5 Bio-Rad TOX/See 2 2 - 2 - 2 BMC QuickTox Drug Screen 2 2 - 2 - 2 Carolina Chemistries BioLis 24i 1 1 - 1 - 1 Clarity Diagnostics Urine Panels/Cassettes 1 1 - 1 - 1 Germaine Laboratories AimScreen 2 2 - 2 - 2 ImmTox 1 1 - 1 - 1 Immunalysis 2 2 - 2 - 2 Indiko Plus 1 1 - 1 - 1 Innovacon Multi-Drug One Step 1 1 - 1 - 1 Integrated E-Z Split Key Cup / II 2 2 - 2 - 2 Lin-Zhi International 7 7 - 7 - 7 Medica EasyRA 1 1 - 1 - 1 MEDTOX Diagnostics 5 5 - 5 - 5 Microgenics DRI 8 8 - 8 - 8 Noble Medical Inc. 1 1 - 1 - 1 Redwood Toxicology Reditest 1 1 - 1 - 1 Roche Integra 1 1 - 1 - 1 Siemens Dimension 1 1 - 1 - 1 Siemens EMIT II Plus 3 3 - 3 - 3 USDiagnostics UScreen Cup 6 6 - 6 - 6 All Cut-off 50 87 87 - 87 - 87

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Cocaine Metabolites (ng/mL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 104 - 104 104 104 - Cut-off 50

All Cut-off 50 1 - 1 1 1 -

Cut-off 100 Beckman AU 2 - 2 2 2 -

ImmTox 1 - 1 1 1 -

Immunalysis 1 - 1 1 1 - Medica EasyRA 2 - 2 2 2 -

All Cut-off 100 6 - 6 6 6 -

Cut-off 150 Alere iCup 3 - 3 3 3 -

Beckman AU 2 - 2 2 2 -

Immunalysis 1 - 1 1 1 - Indiko Plus 2 - 2 2 2 -

MEDTOX Diagnostics 4 - 4 4 4 -

Microgenics DRI 2 - 2 2 2 - Siemens Dimension 1 - 1 1 1 -

Siemens EMIT II Plus 2 - 2 2 2 -

Synermed IR 500 1 - 1 1 1 - All Cut-off 150 18 - 18 18 18 -

Cut-off 300

Abbott Architect 1 - 1 1 1 - Alere iCassette 4 - 4 4 4 -

Alere iCup 6 - 6 6 6 -

Alere iScreen 1 - 1 1 1 - Alere Triage 1 - 1 1 1 -

Alfa Scientific Instant-View 4 - 4 4 4 -

Beckman AU 1 - 1 1 1 - Bio-Rad TOX/See 2 - 2 2 2 -

BMC QuickTox Drug Screen 2 - 2 2 2 -

Carolina Chemistries BioLis 24i 1 - 1 1 1 - Clarity Diagnostics Urine Panels/Cassettes 1 - 1 1 1 -

Germaine Laboratories AimScreen 2 - 2 2 2 -

Innovacon Multi-Drug One Step 1 - 1 1 1 - Integrated E-Z Split Key Cup / II 2 - 2 2 2 -

Lin-Zhi International 5 - 5 5 5 -

MEDTOX Diagnostics 1 - 1 1 1 - Microgenics DRI 5 - 5 5 5 -

Mindray BS-200 1 - 1 1 1 -

Noble Medical Inc. 1 - 1 1 1 - Redwood Toxicology Reditest 1 - 1 1 1 -

Roche Integra 1 - 1 1 1 -

Siemens EMIT II Plus 2 - 2 2 2 - USDiagnostics UScreen Cup 6 - 6 6 6 -

All Cut-off 300 64 - 64 64 64 -

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Cotinine (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 3 - 3 3 - 3 Cut-off 500 Beckman AU 1 - 1 1 - 1 All Cut-off 500 1 - 1 1 - 1

EDDP (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 3 1 2 3 - 3 Cut-off 300 Microgenics DRI 1 1 - 1 - 1 All Cut-off 300 1 1 - 1 - 1 Ethanol (Alcohol) (mg/dL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 17 14 3 17 - 17 Cut-off 20 Microgenics DRI 1 1 - 1 - 1 Siemens EMIT II Plus 1 1 - 1 - 1 All Cut-off 20 2 2 - 2 - 2 Cut-off 100 Beckman AU 2 2 - 2 - 2 Indiko Plus 1 1 - 1 - 1 Lin-Zhi International 5 5 - 5 - 5 Microgenics DRI 1 1 - 1 - 1 Synermed IR 500 1 1 - 1 - 1 All Cut-off 100 10 10 - 10 - 10 Cut-off 3 All Cut-off 3 1 1 - 1 - 1

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Fentanyl (ng/mL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 8 - 8 8 - 8 Cut-off 2 Beckman AU 1 - 1 1 - 1 ImmTox 1 - 1 1 - 1 Immunalysis 2 - 2 2 - 2 Medica EasyRA 1 - 1 1 - 1 All Cut-off 2 5 - 5 5 - 5

LSD (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 2 - 2 2 - 2

MDMA (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 38 - 38 38 - 38 Cut-off 100 All Cut-off 100 1 - 1 1 - 1 Cut-off 500 Alere iCassette 1 - 1 1 - 1 Alere iCup 7 - 7 7 - 7 Amedica Biotech 1 - 1 1 - 1 Bio-Rad TOX/See 2 - 2 2 - 2 BMC QuickTox Drug Screen 1 - 1 1 - 1 Microgenics DRI 2 - 2 2 - 2 Redwood Toxicology Reditest 1 - 1 1 - 1 Siemens EMIT II Plus 1 - 1 1 - 1 USDiagnostics UScreen Cup 6 - 6 6 - 6 All Cut-off 500 30 - 30 30 - 30

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Methadone (ng/mL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 80 6 74 80 76 4 Cut-off 150 Siemens EMIT II Plus 2 - 2 2 2 - All Cut-off 150 2 - 2 2 2 - Cut-off 200 MEDTOX Diagnostics 4 - 4 4 4 - All Cut-off 200 4 - 4 4 4 - Cut-off 300 Abbott Architect 1 - 1 1 1 - Alere iCassette 3 - 3 3 3 - Alere iCup 6 - 6 6 4 2 Alere iScreen 1 - 1 1 1 - Beckman AU 4 1 3 4 4 - Bio-Rad TOX/See 2 - 2 2 2 - BMC QuickTox Drug Screen 2 - 2 2 2 -

Carolina Chemistries BioLis 24i 1 - 1 1 1 - ImmTox 1 - 1 1 1 - Immunalysis 2 2 - 2 2 - Indiko Plus 1 - 1 1 1 - Lin-Zhi International 6 - 6 6 6 - Medica EasyRA 2 2 - 2 2 - Microgenics DRI 7 - 7 7 7 - Mindray BS-200 1 - 1 1 1 - Redwood Toxicology Reditest 1 - 1 1 1 - Roche Integra 1 - 1 1 1 - Siemens EMIT II Plus 1 - 1 1 1 - Synermed IR 500 1 - 1 1 1 - USDiagnostics UScreen Cup 6 - 6 6 6 - All Cut-off 300 60 5 55 60 56 4 Cut-off 1000 Alere iCup 1 - 1 1 1 - All Cut-off 1000 1 - 1 1 1 -

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Methamphetamines (ng/mL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 59 - 59 59 1 58 Cut-off 500 Alere iCup 2 - 2 2 1 1 Alere iScreen 1 - 1 1 - 1 Beckman AU 2 - 2 2 - 2 BMC QuickTox Drug Screen 1 - 1 1 - 1 ImmTox 1 - 1 1 - 1 Immunalysis 2 - 2 2 - 2 Lin-Zhi International 2 - 2 2 - 2 Medica EasyRA 1 - 1 1 - 1 MEDTOX Diagnostics 4 - 4 4 - 4 Redwood Toxicology Reditest 1 - 1 1 - 1 All Cut-off 500 19 - 19 19 1 18 Cut-off 1000 Alere iCassette 3 - 3 3 - 3 Alere iCup 5 - 5 5 - 5 Alfa Scientific Instant-View 1 - 1 1 - 1 AMBC Rapid Drug/Tox 1 - 1 1 - 1 Bio-Rad TOX/See 2 - 2 2 - 2 Clarity Diagnostics Urine Panels/Cassettes 1 - 1 1 - 1 Innovacon Multi-Drug One Step 1 - 1 1 - 1 Integrated E-Z Split Key Cup / II 1 - 1 1 - 1 USDiagnostics UScreen Cup 6 - 6 6 - 6 All Cut-off 1000 29 - 29 29 - 29

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Methanol (mg/dL)

Specimen UDS-5 Specimen UDS-6

Labs Positive Negative Labs Positive Negative

All Methods 2 - 2 2 - 2

Methaqualone (ng/mL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 3 - 3 3 - 3 Cut-off 300 Microgenics DRI 1 - 1 1 - 1 All Cut-off 300 1 - 1 1 - 1

6-MAM (ng/mL) Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 8 - 8 8 - 8 Cut-off 10 Beckman AU 1 - 1 1 - 1 Indiko Plus 1 - 1 1 - 1 Microgenics CEDIA 1 - 1 1 - 1 Microgenics DRI 1 - 1 1 - 1 Siemens EMIT II Plus 1 - 1 1 - 1 All Cut-off 10 5 - 5 5 - 5

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Opiates (Morphine Trihydrate) (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 108 6 102 108 108 - Cut-off 100 Beckman AU 2 - 2 2 2 - ImmTox 1 - 1 1 1 - Immunalysis 1 - 1 1 1 - Medica EasyRA 2 - 2 2 2 - MEDTOX Diagnostics 4 1 3 4 4 - All Cut-off 100 10 1 9 10 10 - Cut-off 300 Abbott Architect 1 - 1 1 1 - Alere iCup 3 - 3 3 3 - Alere iScreen 2 - 2 2 2 - Alere Triage 1 - 1 1 1 - Alfa Scientific Instant-View 2 - 2 2 2 - Beckman AU 3 - 3 3 3 - Bio-Rad TOX/See 2 - 2 2 2 - BMC QuickTox Drug Screen 1 1 - 1 1 - Carolina Chemistries BioLis 24i 1 - 1 1 1 - Immunalysis 1 - 1 1 1 - Indiko Plus 2 - 2 2 2 - Lin-Zhi International 7 - 7 7 7 - MEDTOX Diagnostics 1 - 1 1 1 - Microgenics DRI 6 - 6 6 6 - Mindray BS-200 1 - 1 1 1 - Redwood Toxicology Reditest 1 1 - 1 1 - Roche Integra 1 - 1 1 1 - Siemens Dimension 1 - 1 1 1 - Siemens EMIT II Plus 4 - 4 4 4 - Synermed IR 500 1 - 1 1 1 - USDiagnostics UScreen Cup 2 1 1 2 2 - All Cut-off 300 47 3 44 47 47 -

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Opiates (Morphine Trihydrate) (ng/mL) cont’d Specimen UDS-5 Specimen UDS-6

Labs Positive Negative Labs Positive Negative

All Cut-off 300 Cut-off 2000 47 3 44 47 47 - Alere iCassette Alere iCup 4 - 4 4 4 - Alfa Scientific Instant-View 7 - 7 7 7 - BMC QuickTox Drug Screen 2 1 1 2 2 - Clarity Diagnostics Urine Panels/Cassettes 1 - 1

1 1 - Germaine Laboratories AimScreen 1 - 1

1 1 - Innovacon Multi-Drug One Step 2 - 2

2 2 - Integrated E-Z Split Key Cup / II 1 - 1 1 1 - Microgenics DRI 2 - 2 2 2 - Noble Medical Inc. 1 - 1 1 1 - USDiagnostics UScreen Cup 1 - 1 1 1 - All Cut-off 2000 4 1 3 4 4 -

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Oxycodone (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 75 - 75 75 - 75 Cut-off 100 Alere iCassette 3 - 3 3 - 3 Alere iCup 8 - 8 8 - 8 Alere iScreen 2 - 2 2 - 2 Beckman AU 4 - 4 4 - 4 Bio-Rad TOX/See 3 - 3 3 - 3 BMC QuickTox Drug Screen 2 - 2 2 - 2 Clarity Diagnostics Urine Panels/Cassettes 1 - 1 1 - 1 Diagnostic Reagents, Inc. 1 - 1 1 - 1 ImmTox 1 - 1 1 - 1 Immunalysis 2 - 2 2 - 2 Indiko Plus 1 - 1 1 - 1 Lin-Zhi International 4 - 4 4 - 4 Medica EasyRA 2 - 2 2 - 2 MEDTOX Diagnostics 4 - 4 4 - 4 Microgenics DRI 8 - 8 8 - 8 Mindray BS-200 1 - 1 1 - 1 Redwood Toxicology Reditest 1 - 1 1 - 1 Roche Integra 1 - 1 1 - 1 USDiagnostics UScreen Cup 4 - 4 4 - 4 All Cut-off 100 62 - 62 62 - 62 Cut-off 300 Carolina Chemistries BioLis 24i 1 - 1 1 - 1 Indiko Plus 1 - 1 1 - 1 Microgenics DRI 1 - 1 1 - 1 All Cut-off 300 3 - 3 3 - 3

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Phencyclidine (PCP) (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 68 68 - 68 - 68 Cut-off 25 Abbott Architect 1 1 - 1 - 1 Alere iCassette 4 4 - 4 - 4 Alere iCup 5 5 - 5 - 5 Alere Triage 1 1 - 1 - 1 Beckman AU 5 5 - 5 - 5 Bio-Rad TOX/See 2 2 - 2 - 2 BMC QuickTox Drug Screen 2 2 - 2 - 2 Carolina Chemistries BioLis 24i 1 1 - 1 - 1 Clarity Diagnostics Urine Panels/Cassettes 1 1 - 1 - 1 ImmTox 1 1 - 1 - 1 Innovacon Multi-Drug One Step 1 1 - 1 - 1 Integrated E-Z Split Key Cup / II 2 2 - 2 - 2 MEDTOX Diagnostics 5 5 - 5 - 5 Microgenics DRI 4 4 - 4 - 4 Noble Medical Inc. 1 1 - 1 - 1 Redwood Toxicology Reditest 1 1 - 1 - 1 Siemens EMIT II Plus 1 1 - 1 - 1 Synermed IR 500 1 1 - 1 - 1 USDiagnostics UScreen Cup 6 6 - 6 - 6 All Cut-off 25 57 57 - 57 - 57

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Propoxyphene (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 19 17 2 19 - 19 Cut-off 300 Alere iCassette 2 2 - 2 - 2 Alere iCup 3 3 - 3 - 3 Carolina Chemistries BioLis 24i 1 1 - 1 - 1 MEDTOX Diagnostics 4 4 - 4 - 4 Microgenics DRI 2 2 - 2 - 2 Siemens EMIT II Plus 2 2 - 2 - 2 All Cut-off 300 14 14 - 14 - 14

Propoxyphene (ng/mL) Specimen UDS-5 Specimen UDS-6

Labs Positive Negative Labs Positive Negative

All Methods 9 - 9 9 - 9 Cut-off 100 All Cut-off 100 1 - 1 1 - 1 Cut-off 200 Beckman AU 2 - 2 2 - 2 ImmTox 1 - 1 1 - 1 Immunalysis 2 - 2 2 - 2 All Cut-off 200 5 - 5 5 - 5

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Tricyclic Antidepressants (ng/mL)

Specimen UDS-5 Specimen UDS-6

Method Labs Positive Negative Labs Positive Negative

All Methods 30 25 5 30 - 30 Cut-off 300 Beckman AU 2 2 - 2 - 2 MEDTOX Diagnostics 4 4 - 4 - 4 All Cut-off 300 6 6 - 6 - 6 Cut-off 1000 Alere iCassette 1 1 - 1 - 1 Alere iCup 4 2 2 4 - 4 Alere iScreen 1 1 - 1 - 1 Alere Triage 1 1 - 1 - 1 Amedica Biotech 1 1 - 1 - 1 Bio-Rad TOX/See 3 3 - 3 - 3 BMC QuickTox Drug Screen 1 - 1 1 - 1 USDiagnostics UScreen Cup 2 2 - 2 - 2 All Cut-off 1000 19 15 4 19 - 19

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Whole Blood Glucose (mg/dL)

Specimen WBG-11 Specimen WBG-12 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 310 66.5 21.5 32.3 60 53 - 80 309 392.5 73.0 18.6 385 313 - 471 All Abbott Methods 22 57.1 4.0 7.0 56 45 - 70 22 404.5 47.6 11.8 404 323 - 486 All Arkray Methods 22 71.6 7.5 10.5 75 57 - 86 14 457.7 88.9 19.4 420 366 - 550 All Bayer Methods 57 43.3 2.4 5.5 43 31 - 56 62 345.0 26.3 7.6 348 276 - 415 All Hemocue Methods 64 100.2 7.7 7.7 102 80 - 121 62 397.1 10.4 2.6 399 317 - 477 All Lifescan Methods 30 59.5 7.2 12.1 59 47 - 72 30 410.6 35.7 8.7 408 328 - 493 All Roche Methods 32 59.7 1.9 3.2 60 47 - 72 33 365.6 14.9 4.1 368 292 - 439 Abbott FreeStyle Lite/Freedom Lite 8 56.4 3.9 6.9 56 44 - 69 8 373.4 33.6 9.0 371 298 - 449 Abbott Precision XceedPro 10 55.5 2.5 4.6 55 43 - 68 10 405.2 42.4 10.5 404 324 - 487 Arkray Platinum 20 72.6 6.3 8.6 75 58 - 88 12 437.3 78.0 17.8 415 349 - 525 Bayer Contour 57 43.3 2.4 5.5 43 31 - 56 62 345.0 26.3 7.6 348 276 - 415 HemoCue 201 62 100.2 7.7 7.7 102 80 - 121 61 397.1 10.5 2.6 398 317 - 477 Home Diagnostics True Balance / TrueTrack 21 190.3 8.8 4.6 193 152 - 229 11 574.6 59.4 10.3 600 459 - 690 Home Diagnostics True Result 10 40.5 6.1 15.0 40 28 - 53 10 236.0 39.2 16.6 235 188 - 284 Lifescan One Touch Ultra/2/Mini 21 58.1 7.5 12.8 57 46 - 71 21 427.0 27.2 6.4 417 341 - 513 LifeScan OneTouch Verio 7 65.0 3.9 6.0 65 52 - 78 7 371.0 15.7 4.2 373 296 - 446 Medline EvenCare G2 / G3 15 73.9 6.7 9.1 74 59 - 89 15 418.4 29.8 7.1 421 334 - 503 NOVA Biomedical StatStrip 21 54.6 3.7 6.8 54 42 - 67 20 334.8 16.8 5.0 332 267 - 402 PSS Quintet Glucose Monitoring System 16 59.8 3.8 6.4 61 47 - 72 16 488.4 12.6 2.6 492 390 - 587 Roche Accu-Chek Aviva 5 59.0 2.3 4.0 60 47 - 71 5 357.2 20.2 5.6 367 285 - 429 Roche Accu-Chek Inform II 14 59.7 0.8 1.4 60 47 - 72 14 368.1 9.2 2.5 368 294 - 442 Roche Accu-Chek Performa 12 59.8 2.6 4.4 60 47 - 72 12 369.4 13.6 3.7 371 295 - 444

Specimen WBG-13 Specimen WBG-14

All Method 14 106.4 13.2 12.4 101 85 - 128 14 126.7 14.9 11.8 126 101 - 153 All Abbott Methods 2 - - - 122 97 - 147 2 - - - 140 112 - 168 All Lifescan Methods 8 105.6 9.6 9.1 101 84 - 127 8 128.0 11.4 8.9 126 102 - 154 All Roche Methods 2 - - - 96 76 - 115 2 - - - 112 89 - 135 Lifescan One Touch Ultra/2/Mini 7 106.6 10.0 9.4 101 85 - 128 7 129.1 11.8 9.1 127 103 - 155 LifeScan OneTouch Verio 1 - - - 99 84 - 127 1 - - - 120 102 - 154 Medline EvenCare G2 / G3 1 - - - 124 85 - 128 1 - - - 147 101 - 153 Roche Accu-Chek Inform II 1 - - - 94 85 - 128 1 - - - 109 101 - 153 Roche Accu-Chek Performa 1 - - - 97 85 - 128 1 - - - 115 101 - 153

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Whole Blood Glucose (mg/dL) cont’d

Specimen WBG-15

All Method 14 279.5 31.9 11.4 284 223 - 336 All Abbott Methods 2 - - - 317 253 - 380 All Lifescan Methods 8 287.4 19.4 6.8 288 229 - 345

All Roche Methods 2 - - - 240 192 - 288 Lifescan One Touch Ultra/2/Mini 7 292.0 15.5 5.3 294 233 - 351

LifeScan OneTouch Verio 1 - - - 255 229 - 345

Medline EvenCare G2 / G3 1 - - - 286 223 - 336 Roche Accu-Chek Inform II 1 - - - 238 223 - 336

Roche Accu-Chek Performa 1 - - - 242 223 - 336

Fructosamine (mmol/L)

Specimen FR-3 Specimen FR-4 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 1 - - - 1450 Not graded 1 - - - 1325 Not graded

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Urine Glucose (mg/dL)

Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 6 148.0 1.4 1.0 148 118 - 178 6 272.0 5.7 2.1 272 217 - 327

Urine Magnesium (mg/dL)

Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 7 5.27 1.27 24.2 5.9 3.9 - 6.6 7 8.00 1.25 15.7 8.1 6.0 - 10.0 Siemens Healthcare All Chemistry Instruments 5 6.00 0.14 2.4 6.0 4.5 - 7.5 5 8.65 0.78 9.0 8.7 6.4 - 10.9

Urine Amylase (U/L)

Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 1 - - - 220 Not graded 1 - - - 330 Not graded

Urine Calcium (mg/dL) Specimen UCH-5 Specimen UCH-6

Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 6.15 0.82 13.3 6.4 4.2 - 8.1 6 4.50 0.58 13.0 4.6 3.1 - 5.9

Urine Chloride (mmol/L)

Specimen UCH-5 Specimen UCH-6

Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 160.3 3.8 2.4 162 118 - 203 6 233.3 4.6 2.0 236 172 - 294

Urine Creatinine (mg/dL)

Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 14 126.59 8.72 6.9 128.9 105.0 - 148.2 14 188.54 11.61 6.2 192.6 156.4 - 220.6

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Urine Osmolality (mOsm/kg)

Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 5 592.0 2.8 0.5 592 583 - 601 5 803.5 0.7 0.1 804 801 - 806 No Reagent Required All Chemistry Instruments 5 592.0 2.8 0.5 592 583 - 601 5 803.5 0.7 0.1 804 801 - 806

Urine Phosphorus (mg/dL) Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 30.67 5.22 17.0 32.9 23.6 - 37.8 5 54.37 8.89 16.4 59.4 41.8 - 66.9

Urine Potassium (mmol/L) Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 60.13 4.01 6.7 61.6 42.6 - 77.6 5 96.10 8.09 8.4 98.5 68.2 - 124.0

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Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700

Washington, DC 20001-7401

800-338-2746 202-261-4500 Fax: 202-835-0440

www.acponline.org/mle

Urine Sodium (mmol/L)

Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 131.6 5.9 4.5 129 97 - 166 5 174.0 7.1 4.1 172 128 - 220

Urine Total Protein (mg/dL)

Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 13 38.75 4.62 11.9 39.1 21.7 - 55.9 13 105.32 13.90 13.2 103.1 58.9 - 151.7

Urine Urea Nitrogen (mg/dL)

Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 482.0 9.0 1.9 482 380 - 584 6 633.7 31.3 4.9 629 500 - 767

Urine Uric Acid (mg/dL) Specimen UCH-5 Specimen UCH-6 Method Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 1 - - - 5.0 Not graded 1 - - - 7.0 Not graded