Abstract：
BACKGROUND: 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.
METHODS: A total of 63 variant and nonvariant samples with target values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method 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).
RESULTS: The HbA1c results for nonvariant samples from the 6 methods were in good agreement with the IFCC reference 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.
CONCLUSIONS: Elevated levels of HbF can severely affect HbA1c measurements by borate affinity, immunoassays, and enzyme assays.
METHODS: A total of 63 variant and nonvariant samples with target values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method 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).
RESULTS: The HbA1c results for nonvariant samples from the 6 methods were in good agreement with the IFCC reference 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.
CONCLUSIONS: Elevated levels of HbF can severely affect HbA1c measurements by borate affinity, immunoassays, and enzyme assays.
摘要：
背景：糖化血红蛋白，或血红蛋白A1c（HbA1c），作为诊断糖尿病和监测其进展的关键标志物。我们旨在评估常见Hb变体对流行HbA1c测量系统的干扰。
方法：共包括63个变异和非变异样本，其目标值由国际临床化学和实验室医学联合会（IFCC）参考方法指定。我们评估了在HbS存在下测量HbA1c的6种方法，HbC,HBD,HbE,和胎儿血红蛋白（HbF）：2阳离子交换高效液相色谱（HPLC）方法（Bio-RadD-100和HLC-723G8），毛细管电泳（CE）方法（SebiaCapillarys3TERA），免疫测定(罗氏C501)，酶测定系统（迈瑞BS-600M），和硼酸酯亲和方法(PrimusPremierHb9210)。
结果：来自6种方法的非变异样品的HbA1c结果与IFCC参考方法结果非常吻合。Bio-RadD-100，Capillarys3，MindrayBS-600M，PremierHb9210和Rochec501没有显示HbS的干扰，HbC,HBD,还有HbE.对于HLC-723G8标准模式观察到临床上显著的干扰。HbF水平升高导致所有6种方法的显着负偏差，随着HbF浓度的增加而增加。
结论：HbF水平升高可通过硼酸盐亲和力严重影响HbA1c测量，免疫测定，和酶测定。
方法：共包括63个变异和非变异样本，其目标值由国际临床化学和实验室医学联合会（IFCC）参考方法指定。我们评估了在HbS存在下测量HbA1c的6种方法，HbC,HBD,HbE,和胎儿血红蛋白（HbF）：2阳离子交换高效液相色谱（HPLC）方法（Bio-RadD-100和HLC-723G8），毛细管电泳（CE）方法（SebiaCapillarys3TERA），免疫测定(罗氏C501)，酶测定系统（迈瑞BS-600M），和硼酸酯亲和方法(PrimusPremierHb9210)。
结果：来自6种方法的非变异样品的HbA1c结果与IFCC参考方法结果非常吻合。Bio-RadD-100，Capillarys3，MindrayBS-600M，PremierHb9210和Rochec501没有显示HbS的干扰，HbC,HBD,还有HbE.对于HLC-723G8标准模式观察到临床上显著的干扰。HbF水平升高导致所有6种方法的显着负偏差，随着HbF浓度的增加而增加。
结论：HbF水平升高可通过硼酸盐亲和力严重影响HbA1c测量，免疫测定，和酶测定。
