Department of Medical Sciences, Section of Clinical Chemistry, Uppsala University, Uppsala, Sweden.
Scand J Clin Lab Invest. 2024 Feb;84(1):11-15. doi: 10.1080/00365513.2024.2303720. Epub 2024 Jan 19.
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; R = 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.
本研究旨在评估 Capitainer 的定量干血斑（qDBS）卡用于糖化血红蛋白（HbA1c）检测。qDBS 卡可用于瑞典实验室环境下的家庭采样，以确定 HbA1c。在这项对微流控卡（qDBS）的评估中，共使用了 153 例常规要求的 HbA1c 样本。从圆盘提取 HbA1c，并使用免疫技术在 cobas 6000 仪器上测定 HbA1c。将结果与传统静脉 HbA1c 检测的结果进行比较。以 51mmol/mol 的 HbA1c 浓度测量的洗脱程序重复性为 4.0%，变异系数为 4.0%。使用 DBS 卡（c501）对 HbA1c < 52mmol/mol 的分析性能规格与 Capillarys 3 的分配值进行比较为（y）= 1.03 x Capillarys 3（x）-0.87；R = 0.97。传统 HbA1c 检测和 Capitainer 的 qDBS 卡测定的 HbA1c 之间具有良好的一致性。这表明该技术可用于医生办公室外的检测。
