Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China.
Department of Laboratory Medicine, Shenzhen Integrated Traditional Chinese and Western Medicine Hospital, Shenzhen, China.
Sci Rep. 2024 May 29;14(1):12289. doi: 10.1038/s41598-024-63261-y.
Hemoglobin A (HbA) plays a crucial role in diabetes management. We aimed to evaluate the analytical performance of a new enzymatic method kit for HbA measurement. The performance of the enzymatic method, including precision, accuracy, and linearity, was evaluated. Moreover, the interference effect from conventional interferents, Hb derivatives, Hb variants, and common drugs were assessed. In addition, the agreement of HbA results was compared between enzymatic methods, cation-exchange high-performance liquid chromatography (HPLC), and immunoassays. The intra-assay, between-assay, and total precision of HbA were all lower than 2%. HbA showed good linearity within the range of 3.96-20.23%. The enzymatic assay yielded results consistent with the external quality control samples, with a bias of less than ± 6% from the target values. The enzymatic method showed no interference from bilirubin, intralipid, vitamin C, Hb derivatives, common Hb variants, as well as antipyretic analgesics and hypoglycemic drugs. The HbA results of the enzymatic assay showed good agreement and accuracy compared to those obtained from the HPLC method and the immunoassay. The enzymatic method kit performed on the BS-600M chemistry analyzer is a reliable and robust method for measuring HbA. It is suitable for routine practice in clinical chemistry laboratories.
血红蛋白 A（HbA）在糖尿病管理中起着至关重要的作用。我们旨在评估一种新的用于 HbA 测量的酶法试剂盒的分析性能。评估了酶法的性能，包括精密度、准确性和线性。此外，评估了常规干扰物、Hb 衍生物、Hb 变体和常见药物的干扰效应。此外，还比较了酶法与阳离子交换高效液相色谱（HPLC）和免疫测定法之间的 HbA 结果的一致性。HbA 的日内、日间和总精密度均低于 2%。HbA 在 3.96-20.23%范围内显示出良好的线性。酶法测定结果与外部质量控制样品一致，与靶值的偏差小于±6%。该酶法测定未受到胆红素、脂肪乳、维生素 C、Hb 衍生物、常见 Hb 变体以及解热镇痛药和降血糖药的干扰。与 HPLC 方法和免疫测定法相比，酶法测定的 HbA 结果具有良好的一致性和准确性。BS-600M 化学分析仪上的酶法试剂盒是一种可靠且强大的 HbA 测量方法。它适用于临床化学实验室的常规实践。
