Accuracy Test Omnitest 3 Blood Glucose Monitoring System. B. Braun Diabetes Care

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1 Accuracy Test Omnitest Blood Glucose Monitoring System B. Braun Diabetes Care

2 Accuracy Test Omnitest blood glucose monitoring system according to ISO 97 The accuracy study of Omnitest blood glucose monitoring system was assessed by comparing patients blood glucose results obtained with Omnitest with those obtained using the YSI 2 auto analyzer, a standard laboratory instrument. Glucose levels were measured in patients from three different hospitals. Test information A) Test date: ~ E) Standard/Guidance documents referenced: B) Test meter serial number: C) Test strip lot numbers: GAA2RDMC49 ~ GAA2RDMC4 ISO/DIS 97:2 In Vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for GMJ24, GMJ2, GMJ26 self-testing in managing diabetes mellitus (during clinical trial) D) Sample numbers: 6 x Omnitest meters 6 x Omnitest test strips (three lots) x YSI 2 auto analyzer ISO 97:2 In Vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (for data analysis) CLSI EP9-A2: 24 Method comparison and bias estimating using patient samples Acceptance criteria 9 % of the individual glucose results shall deviate max. ±.8 mmol/l from the results obtained by the hospital laboratory device (YSI 2) at glucose concentration. mmol/l and the deviation should be per maximum ± % at glucose concentration. mmol/l (according to ISO 97:2). Test results Sample distribution Glucose concentration mmol/l Percentage of sample Sample # Preparation of sample 2.77 % glycolyzed % unaltered % 2 unaltered % unaltered. 6.6 % unaltered % unaltered 22.2 % supplemented with glucose SUM % Table Distribution of glucose concentrations of samples for system accuracy evaluation 2

3 Lot # - - Test results 2 2 System accuracy plot-difference (mmol/l) - - Lot # Lot # Lot # Difference, mmol/l System System accuracy plot-difference (mmol/l) Lot # Lot # Glucose Glucose concentration, concentration, mmol/l mmol/l 2 2 ) System accuracy plot-difference (mmol/l) Difference, mmol/l - -difference (mmol/l) Lot # Lot # System accuracy plot-difference (mmol/l) - - System accuracy ( plot-difference Lot combination) (mmol/l) ( Lot combination) ( Lot combination) Glucose Glucose concentration, concentration, mmol/l mmol/l ) Figure -differences of the x 2 blood glucose samples with the Omnitest BGMS vs. YSI 2 at hospital ( using Lot combination) lots of test strips

System accuracy plot-difference (mmol/l) - - System accuracy ( plot-difference Lot combination) (mmol/l) ( Lot combination) ( Lot combination) - 2 2 - - 2 2 2 2-2 2 Glucose Glucose

4 Omnitest, mmol/l 2 2 Lot # y =,96x +,8 R² =, Omnitest, mmol/l 2 2 YSI 2, mmol/l Test results Omnitest, mmol/l 2 2 System accuracy System plot accuracy plot y =,96x +,8 y =,96x +,8 R² =,984 2 R² =,984 2 Omnitest, mmol/l Lot # Lot # Lot # YSI 2, mmol/l YSI 2, mmol/l Omnitest, mmol/l plot System accuracy System Lot accuracy #2 plot plot Lot # y =,962x +,2 y =,962x +,2 y =,96x R² =,982 +,26 2 R² =,982 R² =, YSI 2, mmol/l YSI 2, mmol/l YSI 2, mmol/l Omnitest Omnitest, mmol/l, mmol/l Lot # Omnitest, mmol/l 2 2 ot Omnitest, mmol/l, mmol/l System Lot accuracy System # accuracy plot plot Lot # y =,962x +,2 y =,96x +,26 y = R²,96x =,982 +,26 R² =, R² =, YSI 2, mmol/l YSI 2, mmol/l YSI 2, mmol/l Omnitest, mmol/l Omnitest, mmol/l System ( Lot combination) accuracy plot ( Lot Combination) ( Lot Combination) y =,99x +,9 y =,99x +,9 R² =, R² =, Omnitest, mmol/l YSI 2, mmol/l YSI 2, mmol/l Figure 2 Linear regression of the x 2 blood glucose samples with the Omnitest BGMS vs. YSI 2 at hospital using lots of test strips ot ( Lot Combination) Omnitest, mmol/l 2 2 y =,99x +,9 R² =, YSI 2, mmol/l 4

=,982 +,26 2 R² =,982 R² =,98672 2 2 2 2 2 2 2 2 2 YSI 2, mmol/l YSI 2, mmol/l YSI 2, mmol/l Omnitest Omnitest, mmol/l, mmol/l Lot # Omnitest, mmol/l 2 2 ot Omnitest, mmol/l, mmol/l 2 2 2 2 System

5 Data analysis Bias distribution analysis against YSI 2 Strip Lot Within ±.28 mmol/l Within ±.6 mmol/l Within ±.8 mmol/l Lot 46/62 (74.2 %) 8/62 (9. %) 62/62 (. %) Lot 2 4/62 (64. %) 9/62 (9.2 %) 62/62 (. %) Lot 6/62 (8. %) 8/62 (9. %) 62/62 (. %) Combined 22/86 (6.6 %) 7/86 (94. %) 86/86 (. %) Table 2 System accuracy results for Glucose concentration. mmol/l Strip Lot Within ± % Within ± % Within ± % Lot 77/8 (.8 %) 26/8 (9. %) 2/8 (9.7 %) Lot 2 7/8 (.7 %) 22/8 (88.4 %) 4/8 (97. %) Lot 68/8 (49. %) 8/8 (8. %) /8 (96.4 %) Combined 2/44 (.9 %) 66/44 (88.4 %) 99/44 (96.4 %) Table System accuracy results for Glucose concentrations. mmol/l Consensus error grid analysis against YSI 2: The evaluation of the distribution of the test results within the consensus error grid shows that 6 out of 6 measurements ( %) are within the zones A and B. Conclusion A good and direct correlation between a standard hospital laboratory device (YSI 2) and Omnitest were confirmed in the 6 blood samples ( patients) with a combined correlation coefficient R2 =.987. The results indicate that the use of the Omnitest blood glucose monitoring system generate similar results as the YSI 2 auto analyzer, a laboratory instrument used in hospitals to test for glucose concentration. The data shown prove that the results are within the accuracy standard of the ISO 97:2 thus within the acceptance criteria. References. ISO/DIS 97:2 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus 2. ISO 97:2 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. CLSI EP9-A2: 24 Method comparison and bias estimating using patient samples 4. Parkes J.L. et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood-glucose. Diabetes Care. 2, 2 (8) pp. 448

mmol/l Strip Lot Within ± % Within ± % Within ± % Lot 77/8 (.8 %) 26/8 (9. %) 2/8 (9.7 %) Lot 2 7/8 (.7 %) 22/8 (88.4 %) 4/8 (97. %) Lot 68/8 (49. %) 8/8 (8. %) /8 (96.4 %) Combined 2/44 (.

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Evaluation of Accuracy and User Performance of the TRUE METRIX Self-Monitoring Blood Glucose System *

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