Evaluation of the Sebia CAPILLARYS 2 Flex Piercing for the Measurement of HbA1c on Venous and Capillary Blood Samples

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Abstract

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.

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