test report on the il gem premier 3000 ph/blood gas ...de.werfen.com/~/media/il shared/docs/critical...

Test Report on theIL GEM® Premier 3000pH/Blood Gas, Electrolyte, Hematocrit, Glucose & Lactate Analyzer

Bénédicte Beneteau-BurnatCatherine MartinAnne LorinMichel Vaubourdolle

8CRITICALCARE

Test Report on theIL GEM® Premier 3000pH/Blood Gas, Electrolyte, Hematocrit, Glucose & Lactate Analyzer

Report on pH/Blood Gas, Electrolytes, Hematocrit, Glucose & Lactate

Bénédicte Beneteau-Burnat - Catherine MartinAnne Lorin - Michel Vaubourdolle

Biochemical Department “A”, Saint-Antoine Hospital, AP-HP75571 Paris Cedex 12

3Introduction

Testing of the GEM Premier 3000 analyzer manufactured by InstrumentationLaboratory, Inc., was undertaken by the Biochemical Department ‘A’ of the Saint-Antoine Hospital in Paris from April to June 2001, using the VALTEC protocol proposed by the “Technique Validation” Commission of SFBC (1).

The designated objectives included an evaluation of the analytical qualities and practicality of the system in order to verify the suitability of the analyzer’s performances for laboratory use, especially in emergency and decentralized clinical environments.

The study included the following analytes:• pH, PCO2, PO2• Whole blood Na+

• Whole blood K+

• Whole blood Ca++

• Hematocrit• Whole Blood Glucose• Whole Blood Lactate

4

1.1.DescriptionThe IL GEM Premier 3000 analyzer is a compact, reliable and portable system (Figure 1) used for blood gas analysis and the measurement of electrolyte, metabolite, and hematocrit values.

The GEM Premier 3000 offers definite advantages over other blood gas systems, such as the unique cartridge, which contains all of the device’s required operational components: reagents, rinse fluid, specialized sensors, calibrators, sampler, and waste container (Figure 2).

The cartridge requires no preparation or handling; once installed in the device, the analyzer becomes operational within 30 minutes.

1.2.Various Parameters

DEVICE DESCRIPTION

1. GENERAL CHARACTERISTICS OF THE DEVICE

Measured parameters include:

pH, PCO2, PO2, Na+, K+, Ca++, Hematocrit, Glucose, and Lactate

Calculated parameters include:HCO3

- Actual bicarbonateHCO3

- (Std) Standard bicarbonateTCO2 Total CO2BE Standard base excessSO2 Oxygen saturationCa++ (7.4) Ionized Ca corrected to a pH of 7.40

Patient parameters that can be manually entered include:• Patient temperature • Oxygen saturation (SO2)• FiO2 • Methemoglobin (MetHb)• Oxyhemoglobin (O2Hb) • Carboxyhemoglobin (COHb)• Total hemoglobin (THb) • Reduced hemoglobin (RHb)• And, if necessary, other coagulation parameters

1.3 Physical CharacteristicsDevice dimensions: 30.5 cm / 12.0 in (Width) x

30.7 cm / 12.0 in (Depth) x 43.2 cm / 17.0 in (He

Weight: 13.4 kg / 29.5 Ibs

The device is equipped with a color touch screen.The instrument can remain disconnected for 60 minutes, after which the cartridge must be replaced.The sensor housing is maintained at +37°C ± 0.1°C.The system uses 3 RS-232, 1 parallel and 1 Ethernet port interface

5

Figure 1: IL GEM Premier 3000

Figure 2: IL GEM Premier 3000 cartridge

6

2.1.Sample Processing and Identification SystemThe GEM Premier 3000 measures blood samples taken through capillary tubes or heparin-treated syringes. The sample is drawn into the device by a peristaltic pump. The device draws 135 µL of whole blood.A micro-bubble, micro-clot and/or insufficient volume detection device is employed.

Patient identification is ensured by a bar-code reader attached to the device, or by means of an alphanumeric keypad incorporated in the software. User-selected patient information, which could be useful towardsinterpreting test results, or computing any additional software-generated values, can be selected.

Test results appear on the screen according to various color codes:Green: when values are within the reference rangeYellow: when values are out of the reference rangeRed: when values are beyond the critical range

Following screen validation, results are printed on a thermal printer, alongwith message codes when values are either beyond the reference range, or if they are beyond the critical range.

2.2.Reagent Processing System

2.2.1.GEM Premier 3000 PAKAll required components are included in the GEM Premier 3000 cartridge(Figure 2): specialized sensors, sampler, tonometered calibrators, rinse fluid, and waste container.

These ready-to-use cartridges can be stored at room temperature (between 20°C and 25°C), and have the following characteristics:

Dimensions: Width: 21.6 cm (8.1 in) / Depth: 7.6 cm (3.0 in)Height: 15.2 cm (6.0 in) / Weight: 1.9 kg / 4.2 Ibs

They come in 75, 150, 300 or 450-test foil-wrapped packages, depending on the type of cartridge, and remain stable for 21 days following their installation on the device.

The number of remaining tests available and the cartridge’s expiration date are displayed on the screen at all times.

Since they are self-contained, used cartridges can be thrown directly into a waste container for blood products. Hence, they meet all GBEA requirements, and are well adapted to clinical use.

2. OPERATING PROCEDURE

7

2.2.2.Calibration• Nature of the calibrators contained in the GEM Premier 3000 cartridge:

The exact values of the solution concentrations for each analyte are includedin a barcode, then read by the device once the cartridge is inserted.

• Frequency of calibrationThe device automatically performs 1 and 2-point calibrations, and the frequency varies over time, as indicated in the following diagram.

The device is automatically rinsed and calibrated after each sample.A 2-point calibration can be manually requested at any time.

• Calibration time1-point calibrations take 1 minute and 40 seconds.2-point calibrations take 4 minutes and 20 seconds.

2.3.Measurement Processing System2.3.1.Methods of MeasurementThe measurement methods used for the various parameters are as follows:- pH, PCO2, Na+, K+ and Ca++: potentiometric analysis- PO2 ,Glucose and Lactate: amperometric analysis- Hematocrit: conductivity

Calibrator A Calibrator BpH 6.90 7.4PCO2 63 mmHg 34 mmHgPO2 0 mmHg 190 mmHgNa+ 155 mmol/L 135 mmol/LK+ 2.0 mmol/L 6.0 mmol/LCa++ 0.2 mmol/L 2.0 mmol/LGlucose 140 mg/dL 0.0 mg/dLLactate 30 mmol/L 0.0 mmol/L

Time following Frequency Frequencycartridge installation 1-point calibration 2-point calibration1/2 - 5 hours every 2 minutes every 20 minutes5 - 10 hours every 4 minutes every 30 minutes10 - 14 hours every 6 minutes every hours14 - 40 hours every 10 minutes every 2 hours40 - 80 hours every 15 minutes every 4 hours80 - 504 hours every 20 minutes every 6 hours

2.3.2. Published Measurement Ranges

2.3.3.Rate- Total measurement time required to view results on screen: 104 seconds- Total cycle: 4 minutes- Minimal time interval between two samples: 4 minutes- Sample per hour analysis rate: 15 samples per hour

2.4 Quality ControlThe GEM Check Plus quality control system is composed of 3-levels of aqueous solutions (acidosis, normal, alkalosis), and is used for monitoringblood pH, blood gases, and electrolytes.

Critical Care QC ControIL®9 3-level aqueous solutions (low, normal, high) are used to monitor blood pH, blood gases, electrolytes, and metabolites.

GEM Crit Check 2-level aqueous solutions (low, normal) are used to monitor the Hematocrit.

Quality control identification (lot, values, etc.) is entered either manually, or by using the barcode scanner.

Quality control results are shown on the screen for validation, then printed. Aberrant results can be rejected, but will be stored in an independent file.

The software provides statistical calculations (mean, CV and standard deviation).

2.5 Data Processing SystemThe GEM Premier 3000 has sufficient memory to store the equivalent of 20 cartridges (i.e., 3000 quality control or patient tests using the 150-test cartridge and up to 6,000 tests using the 300-test cartridge).

Results stored in the database can be searched by patient sample, quality control sample, all samples, or previous sample.

3. ENVIRONMENT- Required ambient temperature: 15 - 34°C- Admissible humidity range: 5 - 85 %- Power source: 220 V, 45/65 Hz, 0.7 A- 60-minute cartridge back-up in case of power failure.- In all cases, information stored in the device’s memory will be saved.- Noise level: < 50 dB- Barometric pressure: N/A

8

Measured Parameters Measurement Ranges ResolutionpH 6.80 - 7.80 0.01PCO2 5 - 115 mmHg 1 mmHgPO2 0 - 760 mmHg 1 mmHgNa+ 100 - 200 mmol/L 1 mmol/LK+ 0.1 - 20.0 mmol/L 0.1 mmol/LCa++ 0.1 - 5.0 mmol/L 0.01 mmol/LGlucose 20 to 500 mg/dL 1 mg/dLLactate 0.3 to 10 mmol/L 0.1 mmol/LHct 15 - 65% 1%

9

1.1.Subject ProceduresThe procedures subjected to testing included: pH, PCO2, PO2Na+, K+, Ca++, Glucose, Lactate and Hematocrit.

1.2.Validation MethodsThe procedures were validated by comparison to a Radiometer ABL 725,which is designed to measure blood pH, blood gas, electrolytes (Na+, K+ and Ca++) and metabolites (Glucose and Lactate) using the same methodology as those used by the GEM Premier 3000. This device is routinely used in laboratory environments and is used daily in our laboratory. We also compared PO2 and PCO2 results to those obtained using a DiaMed Equilibrator tonometer.

The hematocrit was validated by comparison to the reference procedure, which consists of micro-centrifugation (Jouan micro-centrifugation) for hematocrit percentages ranging from 10 to 75 %.

Patient specimens were chosen according to the recommendations of Appendix 6 of the VALTEC Protocol, in order to cover the widest possiblerange of physiopathological variables.

We used fresh, heparinized blood from healthy donors for the tonometry sequences, and fresh, heparinized blood from hospitalized patients for comparing procedures.

Blood gas samples were obtained using pre-heparinized Pico 70 (Radiometer)blood gas syringes with electrolyte compensation.

EQUIPMENT & METHODS

1. Procedures

2. Patient Specimens

10

GEM Check Plus Level 1 (low), Level 2 (normal) and Level 3 (high) were the three Instrumentation Laboratory test specimen concentrations used on the following six parameters: pH, PCO2, PO2, Na+, K+ and Ca++.

Critical Care QC ContoIL®9 Multipack, level1(low), level2 (normal), and level3 (high) were the test specimen concentrations used for Glucose and Lactate.

Two Instrumentation Laboratory Hematocrit-specific test specimen concentrations were also selected: GEM Crit Check Level 4 (low) and Level 5 (normal).

These were used for evaluating measurement inaccuracies according to the VALTEC protocol. DiaMed EQUIL solutions were also used. These are bovine hemoglobin-based test solutions which, when tonometered using a gaseous mixture of CO2 and O2, give PO2 and PCO2 similar to those of tonometered human blood. We used three clinically representative levels:EQUIL 1 (CO2 = 9.8 %, O2 = 14 %), EQUIL 2 (CO2 = 5.6 %, O2 = 9.8 %), and EQUIL 3 (CO2 = 2.8 %, O2 = 5.6 %).

Calibrations and the corresponding frequencies were established according to the manufacturer’s recommendations.

The testing protocol was established according to the recommendations of the “Procedure Validation” Commission of SFBC.

Calculations were performed using VALTEC’s 97 V1.0.4 PC software.

3. Test Specimens

4. Calibration

5. Testing Protocol

6. Statistics

11ANALYTIC TEST RESULTS

1. Precision and accuracy assessmentMeasurement inaccuracies were tested on three levels for blood pH, blood gas and electrolytes, and on two levels for the Hematocrit.Accuracy (pH, PCO2 and PO2) was also tested using three tonometeredEQUIL solutions, with measurements taken on six different days.

In addition, precision was assessed on a group of 20 samples using a pool of whole blood in equilibrium with ambient air and kept for the duration of the test at +4°C in a sealed glass tube.

Precision and Accuracy results are summarized in Chart I.

All test specimen results complied with the acceptability criteria of the protocol, with CVs 3% for all parameters and levels. However, the precisionof Lactate on whole blood shows a CV of 6.3% suggesting sample instabilityand confirming that samples have to be analyzed very quickly. In fact, erythrocytes continuously produce Lactate in vitro leading to an artificial elevation.

The Hematocrit results for the two test levels indicated (low and normal) were very constant. Values obtained were all the same, hence the 0 % CVs

Linearity limits were assessed for each of the following parameters:

- pH: the limit was evaluated at between 6.8 and 7.80, using blood with a highly basic pH (7.80) and a buffer pH of 6.84, according to the VALTEC protocol (Figure 3).

- PCO2 and PO2: these were checked using tonometered blood from healthy subjects with partial O2 and CO2 pressures that varied (respectively)from 0 % – 100 % and 0% - 15 %. Six levels were tested (Figure 3).

- Individual electrolyte linearity was checked using whole blood containing excess amounts of the respective electrolytes (Figure 4):Na+: using a 100-mmol/l NaCl solution.K+: using a 20-mmol/l KCl solution.Ca++: using a 10-mmol/l Ca Cl2 solution.

- For Glucose: from diluted solutions of glucose at 27.8 mmol/L (E) in 0.15M (B) NaCl in order to obtain theoretical concentrations ranging from 1.2 to 27.8 mmol/L.

- For Lactate: from diluted solutions of Ringer’s Lactate at 10 mmol/L (E) in 0.15 M (B) NaCl in order to obtain theoretical concentrations ranging from 0.5 to 10 mmol/L.

The Glucose and Lactate dilutions were analyzed three times. The straight lines of linear regression between the observed values and the theoretical values are presented in Figure 5.

- Hematocrit: linearity was tested according to the VALTEC protocol, using a mixture of blood with a hematocrit of 95 % and plasma (Figure 6).

In conclusion, the linearity of all the parameters complied with those published by the manufacturer (Chart II).

Beyond the limits indicated by the supplier, the device shows the value ofthe upper or lower limit of the field of analysis. It shows a “>” or “<” sign,depending on whether that value is situated above or below the limit.

2. Linearity limits assessment

12

CHART I: PRECISION AND ACCURACY ASSESSMENTUsing Instrumentation Laboratory test solutions

Using DiaMed Equil solutions

Analyte Precision (n = 20) Accuracy (n = 20)Mean SD CV% Mean SD CV%

pH level 1 7.159 0.0067 0.0 7.153 0.0085 0.1level 2 7.430 0.0022 <0.1 7.428 0.0064 0.1level 3 7.620 0.0020 <0.1 7.618 0.0079 0.1

PCO2 level 1 64.55 1.468 2.3 66.15 1.531 2.3level 2 37.35 0.489 1.3 37.05 0.999 2.7level 3 18.45 0.510 2.8 18.35 0.489 2.7

PO2 level 1 61.80 1.399 2.3 62.40 1.465 2.3level 2 102.35 0.988 1.0 102.90 2.174 2.1level 3 149.20 2.462 1.7 152.05 3.034 2.0

Na+ level 1 119.2 0.59 0.5 118.3 1.41 1.2level 2 135.9 0.45 0.3 135.9 0.88 0.6level 3 150.0 1.08 0.7 151.9 1.90 1.3

K+ level 1 2.51 0.031 1.2 2.48 0.055 2.2level 2 3.89 0.032 0.8 3.86 0.060 1.5level 3 6.05 0.061 1.0 6.02 0.106 1.8

Ca++ level 1 0.823 0.0108 1.3 0.811 0.236 2.9level 2 1.059 0.0121 1.1 1.061 0.0231 2.2level 3 1.407 0.0154 1.8 1.384 0.0422 3.1

Glucose level 1 3.78 0.04 11.1 3.63 0.126 3.5level 2 5.44 0.109 2.0 5.27 0.099 1.9level 3 15.92 0.280 1.8 15.51 0.316 2.0

Lactate level 1 0.97 0.047 4.8 0.86 0.050 5.8level 2 2.78 0.064 2.3 2.69 0.081 3.0level 3 5.33 0.080 1.5 5.07 0.104 2.1

Hematocrit level 4 24 0.00 0.0 24 0.00 0.0level 5 44 0.00 0.0 44 0.00 0.0

Analyte Accuracy (n = 20)Mean SD CV%

pH Equil 1 7.1617 0.0040 0.1Equil 2 7.3383 0.0147 0.2Equil 3 7.6100 0.0109 0.1

PCO2 Equil 1 68.83 1.941 2.8Equil 2 38.33 0.516 1.3Equil 3 17.67 0.516 2.9

PO2 Equil 1 99.17 1.169 1.2Equil 2 71.50 1.378 1.9Equil 3 40.67 1.211 3.0

With the pool of whole blood

Analyte Precision (n = 20)Mean SD CV%

Glucose 7.38 0.186 2.5Lactate 3.09 0.196 6.3

13

6.8406.840

7.032

7.032

7.224

7.224

7.416

7.416

7.608

7.608

7.800

7.800

Test Field: 6.840 - 7.800pH

Theoretical Measured Deviation (%)

6.840 6.850 100.17.000 7.030 100.47.200 7.210 100.17.400 7.410 100.17.600 7.610 100.17.800 7.790 99.9

Procedure: GEM Premier 3000

Least Squares

y = 0.98x + 0.19Correlation: 1.00

Measured

Theoretical

5.05.0

27.0

27.0

49.0

49.0

71.0

71.0

93.0

93.0

115.0

115.0

Test Field: 5.0 - 115.0 mm Hg PCO2


5.0 5.0 100.035.0 36.0 102.955.9 65.0 96.771.0 73.0 102.886.0 85.0 98.8115.0 112.0 97.4


Least Squares

y = 0.98x + 0.03Correlation: 1.00

Measured

Theoretical

35.035.0

180.0

180.0

325.0

325.0

470.0

470.0

615.0

615.0

760.0

760.0

Test Field: 35.0 - 760.0 mm HgPO2


35.0 37.0 105.771.0 73.0 102.8179.0 187.0 104.5355.0 358.0 100.8537.0 539.0 100.4711.0 727.0 102.3


Least Squares

y = 1.01x + 1.37Correlation: 1.00

Measured

Theoretical

Figure 3: Linearity: pH, PCO2, PO2.

14

100100

120

120

140

140

160

160

180

180

200

200

Test Field: 100 - 200 mmol/lSodium


100 102 102.0120 118 98.3140 138 98.6150 149 99.3160 158 98.8180 186 103.0200 199 99.5


Least Squares

y = 1.01x + 1.93Correlation: 1.00

Measured

Theoretical

0.00.0

4.0

4.0

8.0

8.0

12.0

12.0

16.0

16.0

20.0

20.0

Test Field: 0.0 - 20.0 mmol/lPotassium


0.0 0.1 .02.0 2.2 110.04.0 4.1 102.57.0 7.5 107.18.5 8.7 102.49.5 9.4 98.912.0 12.8 106.714.0 14.7 105.016.5 16.3 98.820.0 19.8 99.0


Least Squares

y = 0.99x + 0.27Correlation: 1.00

Measured

Theoretical

0.500.50

1.39

1.39

2.28

2.28

3.17

3.17

4.06

4.06

4.95

4.95

Test Field: 0.50 - 4.95 mmol/lIonized Calcium


0.50 0.58 116.00.81 0.95 117.31.02 1.10 107.81.40 1.43 102.11.55 1.58 101.91.75 1.85 105.72.12 2.18 102.84.95 4.86 98.2


Least Squares

y = 0.96x + 0.13Correlation: 1.00

Measured

Theoretical

Figure 4: Electrolyte Linearity: Na+, K+, Ca++.

15

1.20

6.52

1.206.52

11.84

11.84

17.16

17.16

22.48

22.48

27.80

27.80

Tested range: 1.20 - 27.80 mmol/lGlucose


1.39 1.20 86.32.78 2.40 86.35.56 5.10 91.78.34 7.70 92.311.12 10.30 92.613.90 12.80 92.116.68 15.50 92.922.24 21.20 95.325.02 23.80 95.127.80 27.60 99.3


Least Squares

y = 0.98x + 0.46Correlation: 1.00

Actual

Theoretical

0.5

2.4

0.52.4

4.3

4.3

6.2

6.2

8.1

8.1

10.0

10.0

Tested range: 0.5 - 10.0 mmol/lLactate


0.5 0.5 98.01.0 1.1 110.02.0 2.2 110.04.0 4.0 100.05.0 5.0 100.06.0 6.0 100.08.0 8.0 100.09.0 9.0 100.010.0 9.9 99.0


Least Squares

y = 0.98x + 0.10Correlation: 1.00

Actual

Theoretical

Figure 5: Linearity Limits: Glucose and Lactate.

1 Value obtained using ABL7252 Value obtained using GEM Premier 3000* Value obtained using Jouan micro-centrifuge

The upper linearity limits seemed satisfactory for the majority of the pathologies encountered in actual hospital environments where the various analytes are implicated.

Only K+ shows an unsatisfactory limit in pre-operative monitoring of liver transplants where K+ doses in the liver flushing fluids can go well beyond20 mmol/L. In such cases, preliminary dilution of the sample would be necessary, which would be incompatible with the urgency associated with grafting procedures, and which cannot be performed by unqualifiedpersonnel.

Chart II: MEASUREMENT FIELD VERIFICATION:UPPER LINEARITY LIMIT

Analyte Published Tested 1 Verified 2 Units

pH 6.80-7.80 7.80 7.79PCO2 5-115 115 112 mmHgPO2 0-760 748 752 mmHgNa+ 100-200 200 199 mmol/LK+ 0.1-20 20.0 19.8 mmol/LCa++ 0.1-5.0 4.95 4.86 mmol/LGlucose 1.1-27.7 27.80 27.60 mmol/LLactate 0.3-10.0 10.0 9.9 mmol/LHematocrit 15-65 66* 65 %

Figure 6: Hematocrit Linearity.

1515

25

25

35

35

46

46

56

56

66

66

Test Field: 15 - 66%Hematocrit


15 15 100.020 22 110.026 26 100.034 34 100.042 43 102.456 56 100.066 65 98.5


Least Squares

y = 0.97x + 0.29Correlation: 1.00

Measured

Theoretical

16

17

3. Correlation study on patient samples

Accuracy was tested on 110 samples of blood gas using a Radiometer ABL 725 for blood pH, blood gas and electrolytes, 100 samples using a Radiometer ABL 725 for metabolites and on 60 samples for Hematocrit testing using a JOUAN micro-centrifuge as reference methods, respectively.A summary of the results (number of samples, Deming straight-line equation, coefficient of variation and notes) is indicated in Chart III.

Deming straight lines and the respective variations are indicated in Figures 7, 8, 9 and 10 for blood pH, blood gas, electrolytes, metabolites,and Hematocrit.

The results obtained for the majority of the parameters were acceptable, even excellent for pH, PCO2, PO2, K+, Glucose, Lactate and Hematocrit.

The accuracy of the Ca++ results is correct, although the graphic representation indicates a systematic error of approximately 0.05, which is considered negligible and is most likely due to differences in calibrators used. There was, however, a slight difference between the two methods in the Na+ results.

The results of the practicability study on the GEM Premier 3000 are summarized in Chart IV. Once again, the exceptional user-friendliness of the GEM Premier 3000 resides in the GEM cartridge, which contains all the necessary components; electrodes, calibrators, rinse fluid, andwaste container.

No preparation or manipulation is necessary. Maintenance is literally reduced to passing quality control and changing the paper. A 2-hour training program would seem sufficient for ensuring total command of thedevice by all laboratory technicians and hospital personnel.

Such short training requirements are partly due to the user-friendliness of the analyzer’s software.

Remote control of the GEM Premier 3000 was tested using the IMPACT information management software offered by Instrumentation Laboratory.

Chart III: CORRELATION RESULTS

Analyte N Correlation Deming NotesCoefficient Straight Line

pH 110 0.99 0.98x + 0.14 AcceptablePCO2 110 0.99 1.01x - 0.10 AcceptablePO2 110 1.00 1.01x + 1.31 AcceptableNa+ 110 0.94 1.01x - 0.96 AcceptableK+ 110 0.99 1.06x - 0.18 AcceptableCa++ 110 0.91 1.08x - 0.04 AcceptableGlucose 100 1.00 1.02x - 0.02 AcceptableLactate 100 1.00 1.01x - 0.05 AcceptableHematocrit 60 0.98 1.02x + 0.09 Acceptable

4. Practicability assessment

18

-0.200

-0.100

0.000

0.100

0.200

7.120 7.206 7.292 7.378 7.464 7.550

7.520

7.446

7.372

7.298

7.224

7.1507.124 7.204 7.284 7.364 7.444 7.524

Test Field: 7.124 - 7.524pH

Validation Period: Deming Straight Line

Validation Period: Y - X/X Variation Graph

Level X Y Allowable Observed Conclusions(calculated) Deviation Deviation

Low 7.200 7.212 0.270 0.012 AcceptedMedium 7.400 7.409 0.280 0.009 AcceptedHigh 7.550 7.556 0.290 0.006 Accepted

Pairs: 110

ABL 725 (X)

Average: 7.4087Standard Deviation: 0.067

GEM Premier 3000 (Y)


Deming Straight Line

Y= 0.98x + 0.14Correlation: 0.99

ABL 725 (X)




pH ( )

Pairs: 110Beyond limits: 0

Y

Y-X

X

X

Figure 7: Deming Straight Line and Variation Graph: pH.

19

115.0

96.4

77.8

59.2

40.6

22.022.0 40.6 59.2 77.8 96.4 115.0

Test Field: 22.0 - 115.0 mm HgPCO2




Pairs: 110

ABL 725 (X)





Y= 1.01x - 0.10Correlation: 0.99

Y

Y-X

X

X-28.3

-14.1

0.0

14.1

28.3

20.0 39.0 58.0 77.0 96.0 115.0


ABL 725 (X)




pCO2 (mm Hg)


Figure 7: Deming Straight Line and Variation Graph: PCO2.

20

302.0

248.2

194.4

140.6

86.8

33.031.9 85.1 138.3 191.4 244.6 297.8

Test Field: 31.9 - 297.8 mm HgPO2




Pairs: 110

ABL 725 (X)





Y= 1.00x + 1.31Correlation: 1.00

Y

Y-X

X

X-76.0

-38.0

0.0

38.0

76.0

20.0 78.0 136.0 194.0 252.0 310.0


ABL 725 (X)




pO2 (mm Hg)


Figure 7: Deming Straight Line and Variation Graph: PO2.

21

160

148

135

123

110

98100 112 124 136 148 160

Test Field: 100 - 160 mmol/lSodium



Low 120 120 4 0 AcceptedMedium 140 141 4 1 AcceptedHigh 160 161 4 1 Accepted

Pairs: 110

ABL 725 (X)






Y

X

-8

-4

0

4

8

100 112 124 136 148 160


ABL 725 (X)




Sodium (mmol/l )


Y-X

X

Figure 8: Deming Straight Line and Variation Graph: Sodium.

22

5.4

4.8

4.2

3.7

3.1

2.52.5 3.1 3.7 4.2 4.8 5.4

Test Field: 2.5 - 5.4 mmol/lPotassium



Low 2.0 1.9 0.1 -0.1 AcceptedMedium 4.0 4.1 0.2 0.1 AcceptedHigh 6.0 6.2 0.4 0.2 Accepted

Pairs: 110

ABL 725 (X)






Y

Y-X

X

X-0.8

-0.4

0.0

0.4

0.8

2.0 2.8 3.6 4.4 5.2 6.0


ABL 725 (X)




Potassium (mmol/l)


Figure 8: Deming Straight Line and Variation Graph: Potassium.

23

1.49

1.36

1.23

1.11

0.98

0.860.86 0.99 1.12 1.24 1.37 1.50

Test Field: 0.86 - 1.50 mmol/lIonized Calcium




Pairs: 110

ABL 725 (X)






Y

X

Y-X

X-0.20

-0.10

0.00

0.10

0.20

0.80 0.94 1.08 1.22 1.36 1.50


ABL 725 (X)




Calcium ionized (mmol/l)

Pairs 110Beyond limits: 15

Figure 8: Deming Straight Line and Variation Graph: Ionized Calcium.

27.00

21.80

16.60

11.40

6.20

1.000.70 5.96 11.22 16.48 21.74 27.00

Test Field: 0.70 - 27.00 mmol/lGlucose




Pairs: 100

ABL 725 (X)

Mean: 9.282Standard Deviation: 4.535


Mean: 9.498 Standard Deviation: 4.629



Y

Y-X

X

X-3.97

-1.99

0.0

1.99

3.97

0.70 5.96 11.22 16.48 21.74 27.00


ABL 725 (X)

Mean: 9.282 Standard Deviation: 9.535



Glucose (mmol/l)


Figure 9: Deming straight line and graph of differences: Glucose.

24

25

Figure 9: Deming straight line and graph of differences: Lactate.

10.00

8.1

6.2

4.3

2.4

0.50.5 2.4 4.3 6.2 8.1 10.00

Test Field: 0.5 - 10.0 mmol/lLactate




Pairs: 100

ABL 725 (X)






Y

Y-X

X

X-3.5

-1.7

0.0

1.7

3.5

0.3 2.2 4.2 6.1 8.1 10.0


ABL 725 (X)




Lactate (mmol/l)


60

52

44

36

28

2020 28 36 44 52 60

Test Field: 20 - 60%Hematocrit


Level X Y Admissible Observed Conclusions(calculated) Deviation Deviation

Low 20 21 3 1 AcceptedMedium 40 41 5 2 AcceptedHigh 60 61 6 1 Accepted

Pairs: 60

Microcentrifuge (X)



Average: 40.7 Standard Deviation: 7.46



Y

Y-X

X

X-12

-6

0

6

12

20 28 36 44 52 60


Microcentrifuge (X)




Hematocrit (%)

Pairs: 60 Beyond limits: 2

Figure 10: Deming Straight Line and Variation Graph: Hematocrit.

26

27

Chart IV: GEM PREMIER 3000 PRACTICABILITY ASSESSMENT

The analyzer was installed in the Medical Resuscitation Unit, and after a week of training, blood gases were treated directly in the unit, under our supervision. The IMPACT system was loaded into the blood gas laboratory’sPC and connected to the GEM Premier 3000.

We were able to constantly monitor the analyzer’s performance.

We were able to access, visualize and validate patient results, quality control results and calibrations. Color-coded warning messages indicatedanalyzer malfunctions. Analytes on the GEM Premier 3000 can be selectedby choosing a pre-defined panel or selected individually.

We found the IMPACT software to be user-friendly, and it seems to answerthe management control and data-archiving needs of decentralized clinicalsettings.

Advantages DisadvantagesEnvironment • compact

• portable

Training • fast and easy

Maintenance • none

Organization • adapted to emergency use

• barcode ID scanner

Sample Processing • results showing >or< if beyond measurement range

• color-coded test results:green: within acceptable rangeyellow: beyond acceptable rangered: beyond critical range

Reagent Processing • none • 30-minute wait following

• cartridge life of 21 days cartridge replacement

• no maintenance required

• display showing # of remaining tests & cartridge expiration date

Data Processing • color touch screen • signal values accessible

• quality control processing only on floppy

• patient visualization

• speed of result display:104 seconds

Biological Security • device autonomy

• sampling system: samplercleaned after each sample

• no waste bottle, since incorporated in the cartridge

28

Few incidents occurred during our evaluation:- A problem with the quality control barcode scanner.

We have verified the absence of interferences from hemolysis, turbidity and bilirubin on plasma samples that have these characteristics. We haveadded dosages of Lactate and Glucose to 4 hemolyzed plasma samples,3 turbid samples and 3 icteric samples on both the ABL 725 and the GEM 3000, as well as for Glucose on the AU 400 (Olympus).

We have not observed any significant differences.

The results of this evaluation show the GEM Premier 3000 to be an excellentblood gas/electrolyte/metabolite/Hematocrit analyzer.

The measured analytical performances obtained using the various test parameters (inaccuracy, linearity and precision) proved very satisfactory for use in a human clinical environment.

The GEM Premier 3000 cartridge is an innovation and gives this device amajor advantage over other blood gas devices, especially in a decentralizedenvironment.

The great operational simplicity of the GEM Premier 3000, along with the user-friendliness of its software, makes it easy to learn with very little training, thereby promoting its possibilities for use in clinical units.

1- A. VASSAULT, D. GRAFMAYER, C. NAUDIN, G. DUMONT, M. BAILLY,J. HENRY, M.F. GERHARDT, P. GEORGES, and the Members of the Procedure Validation Commission of SFBC.Procedure validation protocol:Ann. Biol. Clin., 1986; 44: 686-745.

5. Incidents

6. Study of Interferences

CONCLUSION

REFERENCE

© 2002 Instrumentation Laboratory - Printed in Italy - Speed 2000 - 07/02

Par

t.N

o 98

086-

18

test report on the il gem premier 3000 ph/blood gas ...de.werfen.com/~/media/il shared/docs/critical...

Documents