Affiliation:
1. Department of Clinical Laboratory , 74639 Beijing Chao-Yang Hospital, Capital Medical University , Beijing , P.R. China
2. Department of Laboratory Medicine , 74573 Peking University Shenzhen Hospital , Shenzhen , Guangdong , P.R. China
Abstract
Abstract
Objectives
The impact of seven hemoglobin variants (Hb Q-Thailand, Hb G-Honolulu, Hb Ube-2, Hb New York, Hb J-Bangkok, Hb G-Coushatta, and Hb E) on the outcome of HbA1c was investigated for six methods by comparing with liquid chromatography-tandem mass spectrometry (LC/MS/MS) reference method.
Methods
Twenty-nine normal and 112 variant samples were measured by LC/MS/MS, Sebia Capillarys 3 TERA, Intelligene Biosystems QuanTOF, Premier Hb9210, Arkray HA-8190V, Bio-Rad D-100, and Tosoh G11, then evaluated for correlation, consistency, and mean relative bias among six methods. The lowest biological variation bias of ±2.8 % was an acceptable standard.
Results
All methods showed poor correlation and consistency with LC/MS/MS for Hb E. The unacceptable biases were observed for Capillarys 3 TERA (−14.4 to −3.7 % for Hb Q-Thailand, Hb Ube-2, Hb New York, Hb J-Bangkok and Hb E), QuanTOF (−8.3 to −2.9 % for Hb Ube-2, Hb New York and Hb G-Coushatta), Premier Hb9210 (−18.3 to −3.6 % for Hb Q-Thailand, Hb Ube-2, Hb New York, Hb J-Bangkok and Hb E), HA-8190V variant mode (−17.3 to 6.6 % for Hb G-Honolulu, Hb Ube-2, Hb New York, Hb G-Coushatta and Hb E). All variant samples showed larger biases than ±2.8 % comparing HA-8190V fast mode, D-100, and G11 with LC/MS/MS.
Conclusions
The accuracy of different HbA1c methods was influenced by some Hb variants, especially Hb Ube-2 and Hb New York. Thus, laboratories need to choose appropriate methods to measure HbA1c with different Hb variants.
Funder
Beijing Chaoyang Hospital Science and Technology Innovation Fund
Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support