Analysis of HbA1c using microfluidic card (Capitainer qDBS card) as a pre-step before determination of the HbA1c value with an immunological method.

Abstract

The objective of the study was to evaluate Capitainer's quantitative dried blood spots (qDBS) card for Hemoglobin A1c (HbA1c) testing. qDBS cards can be used for at-home sampling for HbA1c determination in a Swedish laboratory setting. A total of 153 routine requested HbA1c samples were used in this evaluation of microfluidic cards (qDBS). The HbA1c was extracted from the disc and HbA1c was determined at cobas 6000 instruments with immunological technology. The results were compared with results from traditional venous HbA1c testing. The reproducibility of using this elution procedure was 4.0% measured as coefficient of variation at a HbA1c concentration of 51 mmol/mol. Analytical performance specifications for HbA1c < 52 mmol/mol using DBS card (c501) compared with assigned values from Capillarys 3 was (y) = 1.03 x Capillarys 3(x) - 0.87; R² = 0.97. There is a good agreement between HbA1c determined by traditional HbA1c testing and determination from Capitainer's qDBS cards. This shows that the technology could be used for out-of doctor's office testing.