Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, China.
Department of Laboratory Medicine, Wuhan Asia General Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China.
Lab Med. 2024 Nov 4;55(6):708-712. doi: 10.1093/labmed/lmae034.
Glycated hemoglobin, or hemoglobin A1c (HbA1c), serves as a crucial marker for diagnosing diabetes and monitoring its progression. We aimed to assess the interference posed by common Hb variants on popular HbA1c measurement systems.
A total of 63 variant and nonvariant samples with target values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)-calibrated methods were included. We assessed 6 methods for measuring HbA1c in the presence of HbS, HbC, HbD, HbE, and fetal hemoglobin (HbF): 2 cation-exchange high-performance liquid chromatography (HPLC) methods (Bio-Rad D-100 and HLC-723 G8), a capillary electrophoresis (CE) method (Sebia Capillarys 3 TERA), an immunoassay (Roche c501), an enzyme assay system (Mindray BS-600M), and a boronate affinity method (Primus Premier Hb9210).
The HbA1c results for nonvariant samples from the 6 methods were in good agreement with the IFCC-calibrated method results. The Bio-Rad D-100, Capillarys 3, Mindray BS-600M, Premier Hb9210, and Roche c501 showed no interference from HbS, HbC, HbD, and HbE. Clinically significant interference was observed for the HLC-723 G8 standard mode. Elevated HbF levels caused significant negative biases for all 6 methods, which increased with increasing HbF concentration.
Elevated levels of HbF can severely affect HbA1c measurements by borate affinity, immunoassays, and enzyme assays.
糖化血红蛋白（HbA1c）是诊断糖尿病和监测其进展的重要标志物。我们旨在评估常见 Hb 变异体对常用 HbA1c 测量系统的干扰。
共纳入 63 个变异和非变异样本，其靶值由国际临床化学和实验室医学联合会（IFCC）校准方法赋值。我们评估了在存在 HbS、HbC、HbD、HbE 和胎儿血红蛋白（HbF）的情况下，6 种测量 HbA1c 的方法：2 种阳离子交换高效液相色谱（HPLC）方法（Bio-Rad D-100 和 HLC-723 G8）、毛细管电泳（CE）方法（Sebia Capillarys 3 TERA）、免疫测定法（罗氏 c501）、酶测定系统（迈瑞 BS-600M）和硼酸亲和法（普瑞姆斯 Premier Hb9210）。
6 种方法的非变异样本的 HbA1c 结果与 IFCC 校准方法结果一致。Bio-Rad D-100、Capillarys 3、迈瑞 BS-600M、Premier Hb9210 和罗氏 c501 对 HbS、HbC、HbD 和 HbE 均无干扰。HLC-723 G8 标准模式观察到临床显著干扰。所有 6 种方法均观察到 HbF 水平升高导致显著的负偏倚，且随着 HbF 浓度的增加而增加。
硼酸亲和法、免疫测定法和酶测定法的升高的 HbF 水平可严重影响 HbA1c 的测量。
