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TRACEABILITY and UNCERTAINTY Hitachi - PreciControl® ClinChem Multi 2

Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)

Roche Diagnostics GmbH März 2018

Routine Method

Hitachi SystemsACN Reference Method Reference Material

Selected Measurement

ProcedureAssigned Value Uncertainty 1 Unit

ATRYP

Antitrypsin alpha 1

immunoturbidimetric

048 ERM-DA470k/IFCC9 136

1.36

1.84

0.0184

mg/dL

g/L

GPROT

Acid glycoprotein alpha 1

immunoturbidimetric

229 CRM 4702 88.5

0.885

1.39

0.0139

mg/dL

g/L

ACPAcid phosphatase total

1-naphthyl phosphate

021Roche reagent, manual measurement

0.72043.1

0.007030.421

µkat/LU/L

ACP-NPPAcid phosphatase, non-prostatic

1-naphthyl phosphate(Inhib.:tartrate)


0.41825.0

0.008050.482

µkat/LU/L

ACP-PAcid phosphatise, prostatic

1-naphthyl phosphate(Inhib.:tartrate)

- calculated0.30218.1

0.01070.640

µkat/LU/L

ALB

Albumin BCG plus


48.3

52.9

0.529

mg/dL

g/L

ALB

Albumin BCP


45.0

46.0

0.460

mg/dL

g/L

ALB2

Albumin immunoturbidimetric

412 ERM-DA470k/IFCC9 4.42

44.2

0.0668

0.668

g/dL

g/L

ALP

Alkaline phosphataseIFCC liquid

158Original formulation

IFCC5 (Tietz, 1983),

manual measurement

202 1.48 U/L

ALP

Alkaline phosphatase

IFCC liquid


IFCC5 (Schumann, 2011),

manual measurement

230 2.16 U/L

ALP

Alkaline phosphatase

opt. (DGKC)

683Roche reagent, manual

measurement413 4.19 U/L

ALT

Alanine aminotransferase

IFCC with pyridoxal phosphate


IFCC5 (2002), manual

measurement

1.94

116

0.0153

0.917

µkat/L

U/L


Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)


Routine Method




ALT


IFCC without pyridoxal phosphate


IFCC5 (2002) modified,

manual measurement

1.94

116

0.0153

0.917

µkat/L

U/L

ALT


IFCC without pyridoxal phosphate HiCo



manual measurement

1.94

116

0.0153

0.917

µkat/L

U/L

AMY-L

Amylase alpha

IFCC liquid

570Roche reagent according

to IFCC5 (1998), manual

measurement

2.94

176

0.0261

1.56

µkat/L

U/L

AMY-L

Amylase alpha

IFCC liquid STAT

566Roche reagent according

to IFCC5 (1998), manual

measurement

2.94

176

0.0261

1.56

µkat/L

U/L

P-AMY

Amylase alpha pancreatic

ESP liquid


measurement

1.57

94.0

0.0105

0.628

µkat/L

U/L

APOAT

Apolipoprotein A-I

immunoturbidimetric ver. 2

168WHO international

reference material

SP1-01

144

1.44

4.24

0.0424

mg/dL

g/L

APOALApolipoprotein A-I


436WHO international reference material

SP1-01

1441.44

4.240.0424

mg/dLg/L

APOBTApoliprotein B



SP3-07

61.50.615

4.700.0470

mg/dLg/L

APOBLApoliprotein B



SP3-07

61.50.615

4.700.0470

mg/dLg/L

ASLOAntistreptolysin 0

immunoturbidimetric

037Internal standard material

248 2.92 IU/mL

AST

Aspartate aminotransferaseIFCC with pyridoxal phosphate



measurement

2.27

136

0.0163

0.979

µkat/L

U/L


Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)


Routine Method




AST

Aspartate aminotransferase

IFCC without pyridoxal phosphate



manual measurement

2.27

136

0.0163

0.979

µkat/L

U/L

BILD2

Bilirubin direct

Diazo Gen. 2Jendrassik-Grof


measurement(Jendrassik-Grof)

2.16

37.0

0.0153

0.262

mg/dL

µmol/L

BILD2Bilirubin direct

Diazo Gen. 2 Doumas


(Doumas)

1.8431.5

0.01300.223

mg/dL µmol/L

TBILIBilirubin total

liquid STAT

018acc. to Doumas 3.80

65.00.08541.46

mg/dLµmol/L

BILT3Bilirubin total

DPD Gen. 3

712 acc. to Doumas 3.8265.3

0.05650.966

mg/dLµmol/L

BUN Blood urea nitrogen

kinetic UV

421 ID-MS4 66.123.6

1.280.456

mg/dLmmol/L

BUN

Blood urea nitrogenkinetic UV STAT

427 ID-MS4 66.1

23.6

1.28

0.456

mg/dL

mmol/L

Ca

Calcium o-cresolphthaleine complexone

726 SRM 956c L33 13.4

3.34

0.0838

0.0209

mg/dL

mmol/L

Ca

Calcium o-cresolphthaleine complexone STAT

706 SRM 956c L33 13.4

3.34

0.0838

0.0209

mg/dL

mmol/L

Ca2

Calcium nM-BAPTA

698 SRM 956c L23 13.5

3.36

0.158

0.0394

mg/dL

mmol/L

Ca2

Calcium

nM-BAPTA STAT

699 SRM 956c L23 13.5

3.36

0.158

0.0394

mg/dL

mmol/L

C3C

Complement C3c

immunoturbidimetric

036 CRM 4702 149

1.49

1.26

0.0126

mg/dL

g/L


Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)


Routine Method




C4

Complement C4

immunoturbidimetric

032 ERM-DA470k/IFCC9 25.3

0.253

0.295

0.00295

mg/dL

g/L

CPLA2

Ceruloplasmin

immunoturbidimetric

709 CRM 4702 30.5

0.305

0.507

0.00507

mg/dL

g/L

CHECholinesterase

acethylthiocholine


51.43080

0.53832.2

µkat/LU/L

CHECholinesterase

butyrylthiocholine Gen.2


1026120

0.96958.0

µkat/LU/L

CHOLCholesterol

CHOD-PAP stand. ID/MS

433 ID-MS4 5.10 0.036510

mmol/L

CHOLCholesterol

CHOD-PAP stand. Abell-Kendall

433 Abell-Kendall 5.18 0.037110

mmol/L

CK

Creatine kinase IFCC liquid



measurement

4.99

299

0.0287

1.72

µkat/L

U/L

CK-MB

Creatine kinase-MBliquid



manual measurement

1.26

75.7

0.0187

1.12

µkat/L

U/L

CREA

Creatinine

plus

652 ID-MS4 3.73

330

0.0314

2.78

mg/dL

µmol/L

CREA

Creatinine

Jaffé compensated STAT

773 ID-MS4 3.86

342

0.0571

5.05

mg/dL

µmol/L

CREACreatinine

Jaffé rate-blanked and compensated

690 ID-MS4 4.16368

0.04904.34

mg/dLµmol/L


Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)


Routine Method




CRPL3

C-Reactive Protein

immunoturbidimetric Gen. 3

Mod P: 210Mod D: 200

CRM 4702

32.9

3.29

313

0.664

0.0664

6.32

mg/L

mg/dL

nmol/L

Fe

Iron

FerroZine

661 SRM 9373 231

41.3

2.72

0.486

µg/dL

µmol/L

Ferr4Ferritin

particle enhanced test Gen. 4

692NIBSC

8Reagent Ferritin

(human liver) 08/602199447

2.285.12

µg/Lpmol/L

GGT

Glutamyltransferase gamma

liquid stand. Szasz


Persijn/v.d. Slik (1976),

manual measurement

3.41

204

0.0473

2.83

µkat/L

U/L

GGTGlutamyltransferase gamma

liquid stand. Szasz HiCo

480Original formulation Persijn/v.d. Slik (1976),

manual measurement

3.41204

0.04732.83

µkat/LU/L


liquid stand. IFCC

219Original formulation IFCC

5 (2002), manual

measurement

3.86231

0.06103.65

µkat/LU/L


liquid stand. IFCC HiCo

220Original formulation IFCC

5 (2002), manual

measurement

3.86231

0.06103.65

µkat/LU/L

GLDHGlutamate dehydrogenase

opt. (DGKC)


0.67140.2

0.01040.622

µkat/LU/L

GLU

Glucose GOD-PAP

525 ID-MS4 229

12.7

2.61

0.145

mg/dL

mmol/L

GLU

Glucose HK

668 ID-MS4 229

12.7

2.61

0.145

mg/dL

mmol/L

GLU

Glucose HK STAT

767 ID-MS4 229

12.7

2.61

0.145

mg/dL

mmol/L

GLUH2

Glucose hemolysate Gen. 2

409 ID-MS4 229

12.7

2.61

0.145

mg/dL

mmol/L


Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)


Routine Method




HBDH

Hydroxybutyrate dehydrogenase

alphaopt. (DGKC)


measurement

5.03

301

0.0705

4.22

µkat/L

U/L

HDLC3

HDL-Cholesterolplus 3

rd generation

435

According to the CDC7

referencemethod [Precipitation by

dextran

sulphate and Abell-Kendall]

1.49 0.0399 mmol/L

HGLOB

Haptoglobin

immunoturbidimetric


1.19

1.63

0.0163

mg/dL

g/L

IGA-2

Immunoglobulin A

immunoturbidimetric Gen.2 standard

458 CRM 4702

2.29 0.027111

g/L

IGG-2

Immunoglobulin G



11.6

8.88

0.0888

mg/dL

g/L

IGM-2Immunoglobulin M


465 CRM 4702

1.01 0.015011

g/L

KAPPAKappa

immunoturbidimetric

283CRM 470

2

(calculated over Lievens

equation)

3233.23

4,390.0439

mg/dLg/L

LAC

Lactateenzymatic colorimetric test

040Primary reference

material (weighed in purified material)

3.63 0.0264 mmol/L

LAMBD

Lambdaimmunoturbidimetric

284CRM 470

2

(calculated over Lievens equation)

177

1.77

2.51

0.0251

mg/dL

g/L

LDH

Lactate dehydrogenase IFCC liquid



measurement

5.06

303

0.0357

2.14

µkat/L

U/L


Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)


Routine Method




LDH

Lactate dehydrogenase

IFCC liquid with automatic sample pre-dilution



measurement

5.06

303

0.0357

2.14

µkat/L

U/L

LDH

Lactate dehydrogenaseopt.(DGKC)


measurement

9.67

579

0.106

6.35

µkat/L

U/L

LDLC2

LDL-Cholesterol

plus 2nd generation

059

According to CDC7beta

quantificationmethod [Precipitation by heparinmanganese(ultracentrifugation) and

Abell-Kendall]

2.60 0.0421 mmol/L

LIP

Lipase

enzymatic colorimetric test


measurement

1.58

94.4

0.0169

1.01

µkat/L

U/L

LIP

Lipase

enzymatic colorimetric test STAT


measurement

1.58

94.4

0.0169

1.01

µkat/L

U/L

MG

Magnesium

xylidyl blue method

693 Atomic absorption1.32

3.21

0.00646

0.0157

mmol/L

mg/dL

MGMagnesium

xylidyl blue method STAT

770 Atomic absorption1.323.21

0.006460.0157

mmol/Lmg/dL

PALB2Prealbumin

immunoturbidimetric

710ERM-DA470k/IFCC

9

27.80.278

0.4170.00417

mg/dLg/L

PALBLPrealbumin

immunoturbidimetric

546ERM-DA470k/IFCC

9

27.80.278

0.4170.00417

mg/dLg/L

PHOSPhosphate (inorganic)

molybdate UV

714

Primary reference material (NERL)

(weighed in purified

material)

6.202.00

0.05830.0188

mg/dLmmol/L


Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)


Routine Method




PHOS

Phosphate (inorganic)

molybdate UV STAT

675

Primary reference

material (NERL)

(weighed in purified material)

6.20

2.00

0.0583

0.0188

mg/dL

mmol/L

TRSF2

Transferinimmunoturbidimetric

Mod P: 187Mod D: 231

CRM 4702

3.37

337

0.0462

4.62

g/L

mg/dL

TG

Triglycerides

GPO-PAP

781 ID-MS4 2.47 0.0278 mmol/L

TG

Triglycerides

GPO-PAP GB

783 SRM 909b 349.6

0.560

0.735

0.00830

mg/dL

mmol/L

TP

Total protein

Biuret

678 SRM 927d 37.65

76.5

0.0516

0.516

g/dL

g/L

TP

Total protein

Biuret STAT

679 SRM 927d 37.65

76.5

0.0516

0.516

g/dL

g/L

UAUric acid

plus

700 ID-MS4 12.1722

0.05583.32

mg/dLµmol/L

UREAUrea

kinetiv UV

418 ID-MS4 14223.6

2.740.456

mg/dLmmol/L

UREAUrea

kinetiv UV STAT

419 ID-MS4 14223.6

2.740.456

mg/dLmmol/L

1 This uncertainty (expanded uncertainty; k = 2) was calculated in accordance with the “Guide to the expression of uncertainty in measurement” (GUM: 1993). For the estimation of the single standard uncertainties normal distribution of the measurement results is assumed; the level of confidence of the expanded uncertainty is about 95% with the coverage factor k=2 (analogue to the 2sd of the standard uncertainty).

2 CRM = Certified Reference Material, European3 SRM = Standard Reference Material4 ID-MS = Isotope Dilution - Mass Spectrometry5 IFCC = International Federation of clinical chemistry and laboratory medicine


Cat. No. 05 947 774 190, 05 117 216 190, 05 117 291 922 (Q.C.S.)


6 WHO = World Health Organisation7 CDC = Centre for Disease Control8 NIBSC = National Institute for Biological Standards and Control9 ERM-DA470k/IFCC = European Reference Materials10 The value describes the uncertainty within a system class. By transferring the setpoint from one system class to another an additional systematic deviation can arise. This deviation

is limited by the instrument to instrument specification. The relative maximum deviation is 5 %, resp. CHOL 0.1 mmol/L.11 The value describes the uncertainty within a system class. By transferring the setpoint from one system class to another an additional systematic deviation can arise. This deviation

is limited by the instrument to instrument specification. The relative maximum deviation is 10 %, resp. 0.1 g/L IgA or 0.03 g/L IgM.

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