Comparison of different methods for HbA 1c measurement
10.3760/cma.j.cn114452-20240304-00106
- VernacularTitle:三种方法检测糖化血红蛋白结果的一致性评价
- Author:
Yichuan SONG
1
;
Anping XU
;
Mo WANG
;
Jie SHI
;
Rui ZHAO
;
Ling JI
;
Rui ZHANG
Author Information
1. 首都医科大学附属北京朝阳医院检验科，北京 100020
- Keywords:
Hemoglobin A, glycosylated;
Capillary electrophoresis;
Cation exchange-high performance liquid chromatography;
Matrix-assisted laser desorption/ionizatio
- From:
Chinese Journal of Laboratory Medicine
2024;47(10):1197-1205
- CountryChina
- Language:Chinese
-
Abstract:
Objectives:To compare the HbA 1c results on capillary electrophoresis (CE), cation exchange-high performance liquid chromatography (CE-HPLC), and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). Methods:902 normal samples without hemoglobin variants and 83 samples with hemoglobin variants were collected in 2020. The variants were divided into α-chain, β-chain, γ-chain, and δ-chain variants. The 902 samples without hemoglobin variants were measured by CE, CE-HPLC, and MALDI-TOF MS. Three methods were used for measuring α-chain, β-chain, and γ-chain compared with the liquid chromatography-tandem mass spectrometry (LC-MS/MS) reference method. According to the EP9-A3 guideline, Passing-Bablok regression and concordance correlation coefficient (CCC) were performed for correlation and consistency, respectively. The imprecision was assessed by coefficient of variance (CV). The mean relative bias was calculated and compared with the lowest biological variation bias of 2.3%.Results:All three methods met the acceptance of imprecision requirements (<2%). The R 2 and CCC for the normal samples were all above 0.95 between the pairwise comparison of CE, CE-HPLC, and MALDI-TOF MS. The mean relative bias between MALDI-TOF MS and CE-HPLC was higher than the lowest biological variation bias of 2.3%. The R 2 results between CE and LC-MS/MS results of α-chain, β-chain, γ-chain variants were>0.95, and the mean relative biases for γ-chain variants exceeded the lowest biological variation bias of 2.3%. A bad correlation ( R2=0.66) for β-chain variants was shown between CE-HPLC and LC-MS/MS and the mean relative biases of all variant samples exceeded 2.3%. MALDI-TOF MS showed good correlations with LC-MS/MS for three groups, and the mean relative biases for γ-chain variants were higher than 2.3%. Conclusion:MALDI-TOF MS and CE-HPLC with CE had good comparability in the measurement of HbA 1c in normal samples, butthe three methods showed interferences from different types of Hb variants and the CE method was affected with less interference.
