机构：[1]Department of Clinical Laboratory, Beijing Chaoyang Hospital, Beijing Center for Clinical Laboratories, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China,北京朝阳医院[2]Department of Clinical Laboratory, Wangjing Hospital, China Academy of Traditional Chinese Medicine, Beijing, P.R. China,[3]Department of Clinical Laboratory, China-Japan Friendship Hospital, Beijing, P.R. China,[4]Department of Clinical Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing, P.R. China,医技科室检验科首都医科大学附属北京同仁医院首都医科大学附属同仁医院[5]National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China,[6]Department of Clinical Laboratory, Beijing Hospital, Beijing, P.R. China,[7]Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China北京朝阳医院
This study aimed to assess the comparability among assays using freshly frozen human sera and external quality assessment (EQA) data in China.Twenty-nine serum samples and two commercial EQA materials, obtained from the National Center for Clinical Laboratories (NCCL), were analyzed in triplicate using eight routine TSH assays. The commutability of commercial EQA materials (NCCL materials) was evaluated in accordance with the CLSI EP30-A and IFCC bias analysis. Median values obtained for the NCCL EQA materials were used to determine the systematic and commutability-related biases among immunoassays through back-calculation. The comparability of TSH measurements from a panel of clinical samples and NCCL EQA data was determined on the basis of Passing-Bablok regression. Furthermore, human serum pools were used to perform commutable EQA.NCCL EQA materials displayed commutability among three or five of seven assay combinations according CLSI or IFCC approach, respectively. The mean of systematic bias ranged from -13.78% to 9.85% for the eight routine TSH assays. After correcting for systematic bias, averaged commutability-related biases ranged between -42.26% and 12.19%. After correction for systematic and commutability -related biases, the slopes indicating interassay relatedness ranged from 0.801 to 1.299 using individual human sera, from 0.735 to 1.254 using NCCL EQA data, and from 0.729 to 1.115 using pooled human serum EQA(the commutable EQA).The harmonization of TSH measurement is challenging; hence, systematic and commutability-related biases should be determined and corrected for accurate comparisons among assays when using human individual serum and the commercial EQA materials.
基金：
This study was supported by the National
Natural Science Foundation of China (81601814)
and the Beijing Municipal Administration of
Hospitals Clinical Medicine Development of Special
Funding Support (ZYLX201811).
第一作者机构：[1]Department of Clinical Laboratory, Beijing Chaoyang Hospital, Beijing Center for Clinical Laboratories, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China,
通讯作者：
推荐引用方式(GB/T 7714)：
Shunli Zhang,Fei Cheng,Hua Wang,et al.Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.[J].PLOS ONE.2021,16(6):doi:10.1371/journal.pone.0253324.
APA：
Shunli Zhang,Fei Cheng,Hua Wang,Jiangping Wen,Jie Zeng...&Qingtao Wang.(2021).Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data..PLOS ONE,16,(6)
MLA：
Shunli Zhang,et al."Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.".PLOS ONE 16..6(2021)
