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.
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。