%0 Journal Article
%T Interference of hemoglobin variants with HbA1c measurements: comparison of 6 commonly used HbA1c methods with the IFCC reference method.
%A Li M
%A Ge S
%A Shu X
%A Wu X
%A Liu H
%A Xu A
%A Ji L
%J Lab Med
%V 0
%N 0
%D 2024 May 27
%M 38801245
%F 1.865
%R 10.1093/labmed/lmae034
%X <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>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).<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>Elevated levels of HbF can severely affect HbA1c measurements by borate affinity, immunoassays, and enzyme assays.