Original Article
Evaluation of measurement uncertainty for HbA1c by four approaches in clinical laboratory
Zhang Shunli, Cheng Fei, Zhang Tianjiao, Hu Dongmei, Song Zhixin, Wang Mo, Song Yichuan, Zhao Yajun, Zhang Rui, Wang Qingtao, Yue Yuhong
Published 2023-09-19
Cite as Chin J Lab Med, 2023, 46(9): 904-910. DOI: 10.3760/cma.j.cn114452-20230613-00291
Abstract
ObjectiveTo compare results of four glycosylated hemoglobin A1c (HbA1c) detection methods and to evaluate the uncertainty of HbA1C results in clinical laboratory, and to provide method for clinical laboratory on the evaluation of uncertainty.
MethodsAccording to the four uncertainty evaluation methods, which were recommended by "CNAS-TRL-001, the evaluation and expression of measurement uncertainty in medical laboratory", the relative and absolute uncertainty of low, medium and high HbA1c in 33 clinical laboratories measured in 2019 and 35 clinical laboratories measured in 2020 was evaluated by more than 6 months of internal quality control (IQC) data, trueness verification and external quality assessment (EQA) data. The four uncertainty evaluation methods were: IQC data and trueness verification data (method 1), only trueness verification data (method 2), IQC and EQA data (method 3) and only EQA data (method 4). The related statistical methods used in this analysis were Friedman and Wilcoxon signed rank test.
ResultsFor method 1, the median range of relative and absolute uncertainty of low, medium and high HbA1c detection in 2019 and 2020 ranged from 4.21% to 9.24% and from 0.27% to 0.64%, respectively. Compared to method 1, the relative and absolute uncertainties obtained by method 2 were smaller, and the differences were statistically significant (P<0.016 7, P<0.05). Compared to method 1, the relative uncertainties obtained by method 3 and method 4 were smaller, except for the high concentration of HbA1c level in 2020. Among the 6 pairs of comparisons (low, medium and high HbA1c in 2019 and 2020), there were 3 pairs (high HbA1c in 2019, low and medium HbA1c in 2020) and 2 pairs (low and high HbA1c in 2020) of differences with statistical significance (all P<0.016 7).
ConclusionThe uncertainty evaluation of HbA1c detection in clinical laboratory should be evaluated based on IQC and trueness verification data.
Key words:
Hemoglobin A, glycosylated; Uncertainty; External quality assessment; Trueness
Contributor Information
Zhang Shunli
Department of Clinical Laboratory, Beijing Chaoyang Hospital, the Third Clinical Medical College of Capital Medical University, Beijing Center for Clinical Laboratories,Beijing 100020, China
Cheng Fei
Department of Clinical Laboratory, Wangjing Hospital, China Academy of Traditional Chinese Medicine, Beijing 100102,China
Zhang Tianjiao
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing 100730,China
Hu Dongmei
China National Accreditation Service for Conformity Assesment, Beijing 100062,China
Song Zhixin
Beijing mentougou hospital of traditional Chinese Medicine, Beijing 102300,China
Wang Mo
Department of Clinical Laboratory, Beijing Chaoyang Hospital, the Third Clinical Medical College of Capital Medical University, Beijing Center for Clinical Laboratories,Beijing 100020, China
Song Yichuan
Department of clinical laboratory diagnostics, Capital Medical University, Beijing 100069, China
Zhao Yajun
Department of Clinical Laboratory, Beijing Chaoyang Hospital, the Third Clinical Medical College of Capital Medical University, Beijing Center for Clinical Laboratories,Beijing 100020, China
Zhang Rui
Department of Clinical Laboratory, Beijing Chaoyang Hospital, the Third Clinical Medical College of Capital Medical University, Beijing Center for Clinical Laboratories,Beijing 100020, China
Wang Qingtao
Department of Clinical Laboratory, Beijing Chaoyang Hospital, the Third Clinical Medical College of Capital Medical University, Beijing Center for Clinical Laboratories,Beijing 100020, China
Yue Yuhong
Department of Clinical Laboratory, Beijing Chaoyang Hospital, the Third Clinical Medical College of Capital Medical University, Beijing Center for Clinical Laboratories,Beijing 100020, China
