Evaluation of the Sebia Capillarys 3 Tera and the Bio-Rad D-100 Systems for the Measurement of Hemoglobin A1c.

OBJECTIVES: We evaluated the Bio-Rad (Irvine, CA) D-100 and the Sebia (Lisses, France) Capillarys 3 Tera for the measurement of hemoglobin A1c (HbA1c) in venous blood samples. METHODS: Whole-blood samples and control material were analyzed with the D-100 and Capillarys 3 Tera and compared with our routine method, HLC-723G7 (Tosoh, Tokyo, Japan). An evaluation protocol to test precision, trueness, linearity, carryover, and selectivity was set up according to Clinical and Laboratory Standards Institute guidelines. The results were presented in National Glycohemoglobin Standardization Program and International Federation of Clinical Chemistry (IFCC) units. RESULTS: Both systems showed excellent precision (total coefficients of variation <2%, IFCC) and bias (<0.3% or 3 mmol/mol). Linearity was demonstrated for HbA1c values from 3.8% (18 mmol/mol) to 18.5% (179 mmol/mol). Results were correlated with the routine method using Bland-Altman analysis, showing a mean difference of 0.33% or 3.6 mmol/mol for the D-100 and of 0.25% or 2.6 mmol/mol for the Capillarys 3 Tera vs HLC-723G7. None of the automated instruments were prone to interferences by labile HbA1c (≤10 g/L glucose), carbamylated hemoglobin (≤0.5 mmol/L potassium cyanate), hemoglobin variants, bilirubin (≤15 mg/dL), and triglycerides (≤3,360 mg/dL). CONCLUSIONS: The Bio-Rad D-100 and the Sebia Capillarys 3 Tera instruments performed well for the determination of HbA1c in terms of quality criteria as well as for sample throughput.

Evaluation of the Sebia CAPILLARYS 2 flex piercing for the measurement of HbA(1c) on venous and capillary blood samples.

OBJECTIVES: We evaluated the Sebia CAPILLARYS 2 Flex Piercing (Cap 2FP; Sebia, Lisses, France) for measurement of hemoglobin A1c (HbA1c) on venous and capillary blood samples. METHODS: We analyzed whole-blood samples and control materials with the Cap 2FP and Tosoh G8 (Tosoh Corporation, Tokyo, Japan). Capillary blood samples were analyzed on the Cap 2FP on different storage conditions and were compared with venous samples. RESULTS: Both instruments achieved total imprecision of less than 2.5% (International Federation of Clinical Chemistry units). Bias was 1 mmol/mol or less and 4 mmol/mol or less for the Cap 2FP and Tosoh G8, respectively. The Cap 2FP was not prone to common interferences. The Tosoh G8 showed significant bias only for carbamylated hemoglobin and did not completely separate hemoglobin D and hemoglobin E. On the Cap 2FP, storage of capillary blood at room temperature showed no significant bias. There was good agreement with venous blood. CONCLUSIONS: The Cap 2FP and Tosoh G8 perform excellently for HbA1c determination. Capillary blood can be analyzed on the Cap 2FP as an acceptable alternative to venous blood and point-of-care testing. Home collection and central analysis of capillary blood could contribute to a reduction of health care costs without reducing quality of HbA1c determination.