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1 Accu-Chek Inform II test strip Results of the evaluation study on newborns, conducted by the Flevo Hospital (FVZH) Almere and the Maxima Medical Center (MMC) Veldhoven in the Netherlands COBAS, ACCU-CHECK INFORM, MODULAR and LIFE NEEDS ANSWERS are trademarks of Roche. 212 Roche Roche Diagnostics International Ltd. CH-6343 Rotkreuz Switzerland
2 Evaluation of the Accu-Chek II test strip for neonatal patients The current Accu-Chek Inform II test strip is the successor of the Performa test strip for point-of-care glucose testing. The current test strip is an optimized version of the previous Performa test strip and is used in combination with the Accu-Chek Inform II meter. In November 21, this test strip was evaluated by two Dutch laboratories and approved for use on adults.* The results of neonatal samples were also recently tested with this test strip at the clinical chemistry laboratory for comparison with glucose tests performed with the Modular P analyzer. This method comparison was carried out as described below by the laboratory of the Flevo Hospital (FVZH) in Almere and the Maxima Medical Center (MMC) in Veldhoven. * Accu-Chek Inform II test strip, report from November 21, data from Roche Diagnostics Netherlands. Method comparison Samples from neonatal patients; only samples with glucose concentrations below 7 mmol/l were included in the method comparison. Sample collection; lithium-heparin whole blood taken from the heel. Measurements; MMC: glucose from blood taken from the heel with the Accu-Chek Inform II test strip was measured directly on the Accu-Chek Inform II. After the whole blood had been centrifuged, the glucose was also tested with the Modular P analyzer. During this process, the time difference between the two measurements was kept at a minimum (less than 2 minutes). FVZH: the lithium-heparin sample was taken from the heel of the newborn. Then the same sample was used to measure the glucose with the Accu-Chek Inform II test strip and the Modular P analyzer. Measurements were performed on different weekdays within a time span of several weeks.
3 Results of the method comparison: Fig Hospital n Method X Lot number of test strip Method Y Lot number of test strip Slope () Intercept () 1 FVZH 22 Modular p ACI II* ( ).19 (.54.84) 2 FVZH 21 Modular p ACI II ( ).1 (.52.67) 3 FVZH 21 ACI II 4711 ACI II ( ).1 (.58.18) 4 MMC 13 Modular p ACI II ( ).22 ( ) 5 MMC 13 Modular p ACI II ( ).2 ( ) 6 MMC 13 ACI II ACI II ( ).37 ( ) r: correlation coefficient; : 95 % confidence interval; all results are indicated in mmol/l. *ACI II: Accu-Chek Inform II The table above shows the results of the method comparison in neonate samples with glucose concentrations below 7 mmol/l at the Flevo Hospital (FVZH) and the Maxima Medical Center (MMC). A regression analysis was conducted in accordance with the Passing-Bablok method. Conclusion The validation shows that the results from the Accu-Chek Inform II test strip are highly comparable to glucose measurements performed with the Modular P analyzer at the central clinical chemistry laboratory. This demonstrates that the Accu-Chek Inform II test strip is also reliable for use on newborns. Fig 1: Results of the method comparison: Modular P versus Accu-Chek Inform II lot 4711 n 22 Modular P 1 Range ACI II (4711) 1 ACI II lot 4711 Passing-Bablok fit ( x) Constant Proportional H: Proportional bias = 1. H1: Proportional bias 1. plot
4 Fig 2: Results of the method comparison: versus Accu-Chek Inform II lot 4733 Fig 3: Results of the method comparison: Accu-Chek Inform II lot 4711 versus Accu-Chek Inform II lot 4733 n 21* 1 Constant n 21* ACI II (4711) 1 Constant Range ACI II (4733) 1 Proportional Range ACI II (4733) 1 Proportional *cases excluded: 1 due to missing values. H: Proportional bias = 1. H1: Proportional bias 1. *cases excluded: 1 due to missing values. H: Proportional bias = 1. H1: Proportional bias 1. ACI II lot 4733 Passing-Bablok fit ( x) ACI II lot 4733 Passing-Bablok fit ( x) ACI II lot 4711 plot plot
5 Fig 4: Results of the method comparison: versus Accu-Chek Inform II lot 4711 Fig 5: Results of the method comparison: versus Accu-Chek Inform II lot n 13 1 Constant n 13 1 Constant Range ACI II (4711) 1 Proportional Range ACI II (37242) 1 Proportional H: Proportional bias = 1. H1: Proportional bias 1. H: Proportional bias = 1. H1: Proportional bias 1. ACI II lot 4711 Passing-Bablok fit ( x) ACI II lot Passing-Bablok fit ( x) plot plot
6 Fig 6: Results of the method comparison: Accu-Chek Inform II lot versus Accu-Chek Inform II lot 4711 n 13 ACI II (37242) 1 Range 5.4 ACI II (4711) 1 Constant Proportional H: Proportional bias = 1. H1: Proportional bias 1. ACI II lot 4711 Passing-Bablok fit ( x) ACI II lot plot
(a) y = 1.0x + 0.0; r = ; N = 60 (b) y = 1.0x + 0.0; r = ; N = Lot 1, Li-heparin whole blood, HbA1c (%)
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The performance of Microdot Test Strips has been evaluated both in laboratory and in clinical tests.
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