Abstract:In order to find out the conversion factors between chemiluminescence immunoassay systems of different manufacturers which can be used as reference for indoor quality control and inter-room quality assessment. 19 kinds of national certified reference materials were tested as samples on 181 instruments from 9 manufacturers and the results were analyzed by statistical method. The results demonstrate that tPSA and TSH projects can be compared among different systems with the conversion factors, CEA projects can be compared among a part of different systems with the conversion factors, HCG projects can not be compared among different systems with the conversion factors, HBsAg projects can be compared among different systems with the conversion factors in different concentration ranges respectively, the comparability of AFP projects among different systems needs to be further studied.
汤尧旭,杨晓东,张轩溥. 国家标准物质在不同化学发光免疫分析系统上换算系数的研究[J]. 计量学报, 2021, 42(7): 964-970.
TANG Yao-xu,YANG Xiao-dong,ZHANG Xuan-pu. Research on Conversion Factors of the Certified Reference Materials on Different Chemiluminescence Immunity Platforms. Acta Metrologica Sinica, 2021, 42(7): 964-970.
[1]肖勤, 林金明. 化学发光免疫分析方法的应用研究进展[J]. 化学分析, 2015, 43(6): 929-938.
Xiao Q, Lin J M. Advances and applications of chemiluminescence immunoassay in clinical diagnosis and foods safety[J]. Chinese Journal of Analytical Chemistry, 2015, 43(6): 929-938.
[2]吴炜杰, 景建敏, 高建青. UniCel DxI800化学发光仪的检测间隔保养[J]. 医疗装备, 2018, 31(7): 123-124.
Wu W J, Jing J M, Gao J Q. Test interval maintenance of UniCel DxI 800[J]. Medical Equipment, 2018, 31(7): 123-124.
[3]陈福祥, 彭弈冰, 盛慧明. 临床检验一万个为什么(免疫学检验分册)[M]. 北京: 人民卫生出版社, 2018: 67-69.
[4]王建琼, 牛华, 陈玲, 等. 两套不同检测系统甲状腺激素测定结果的可比性分析[J]. 国际检验医学杂志, 2014, 35(21): 2953-2954.
Wang J Q, Niu H, Chen L, et al. The research on the comparability of thyroid hormone test results using two different detection systems[J]. International Journal of Laboratory Medicine, 2014, 35(21): 2953-2954.
[5]高原, 陈川, 王晶. 2019新型冠状病毒的抗原抗体检测[J]. 计量学报, 2020,41(5): 513-517.
Gao Y, Chen C, Wang J. Antigen and antibody detection of SARS-CoV-2[J]. Acta Metrologica Sinica, 2020, 41(5): 513-517.
[6]李达, 王军, 杨忠, 等. 核酸标准物质定值的实验体系研究[J]. 计量学报, 2020,41(11): 1436-1442.
Li D, Wang J, Yang Z, et al. Experimental design analysis of developing quantitative nucleic acid reference materials[J]. Acta Metrologica Sinica, 2020,41(11): 1436-1442.
[7]王耿媛, 赖官铨. 全自动化学发光免疫分析仪的校准方法研究及不确定度评定[J]. 医疗卫生装备, 2016, 37(3): 100-101.
Wang G Y, Lai G Q. Calibration method and uncertainty evaluation of automatic chemiluminescence immunoassay analyzer[J]. Chinese Medical Equipment Journal, 2016, 37(3): 100-101.
[8]ISO 17511: 2003体外诊断医疗器械生物样品中量的测量校准品和控制物质赋值的计量学溯源性[S]. 2003.
[9]李兰英, 徐勤, 许丽, 等. 化学发光分析仪计量校准用生物化学反应标准体系研究[J]. 中国测试, 2015, 41(3): 46-50.
Li L Y, Xu Q, Xu L, et al. Research of a biochemical reaction system for the calibration of the microplate luminometer[J]. China Measurement and Test, 2015, 41(3): 46-50.
[10]杨方华, 杨宝瑞, 马东礼, 等. 应用CLSI EP10-A2文件对DX1800化学发光仪性能评价的结果分析[J]. 检验医学与临床, 2014, 11(6): 763-767.
Yang F H, Yang B R, Ma D L, et al. Evaluation of detection performance of DXI 800 chemiluminescence analyzer according to EP10-A2 document of CLSI[J]. Laboratory Medicine and Clinic, 2014, 11(6): 763-767.
[11]黄传政, 朱海波, 邓建平. ACCESS化学发光仪室内质控血清的评价[J]. 实验与检验医学, 2014, 32(1): 39-40.
Huang C Z, Zhu H B, Deng J P, et al. Evaluation of internal quality control serum of ACCESS chemilumin-escence analyzer[J]. Experimental and Laboratory Medicine, 2014, 32(1): 39-40.
[12]张丽敏, 吕虹, 刘志伟, 等. 两种化学发光仪检测甲状腺激素的性能评价[J]. 检验医学与临床, 2016, (21): 3001-3003.
Zhang L M, Lv H, Liu Z W, et al. Evaluation of the performance of two chemiluminescence apparatus in detecting thyroid hormone[J]. Laboratory Medicine and Clinic, 2016, (21): 3001-3003.
[13]陈剑锋, 李英莲, 常乐. 两家化学发光系统用于血液筛查HIV的性能评价[J]. 中国输血杂志, 2018, 31(8): 846-850.
Chen J F, Li Y L, Chang L. Evaluation of two CLIA reagents for blood screening HIV[J]. Chinese Journal of Blood Transfusion, 2018, 31(8): 846-850.
[14]王小艳, 李志雄, 董志宁, 等. 激素6项化学发光试剂盒性能比较[J]. 分子诊断与治疗杂志, 2017, 9(6): 408-415.
Wang X Y, Li Z X, Dong Z N, et al. Comparison of the performance of the 6 hormone CLIA kits[J]. Journal of Molecular Diagnosis and Therapy, 2017, 9(6): 408-415.
[15]赵辉, 赵华, 刘原栋, 等. 基于国家标准物质资源共享平台探讨我国标准物质发展现状与趋势[J]. 化学试剂, 2017, 39(8): 856-860.
Zhao H, Zhao H, Liu Y D, et al. Status and tendency of reference materials based on national sharing platform for reference materials resource[J]. China Reagent, 2017, 39(8): 856-860.
[16]卢晓华, 汪斌, 郭敬, 等. 2015—2016国家有证标准物质资源发展分析[J]. 中国计量, 2017, (3): 82-85.
Lu X H, Wang B, Guo J, et al. Resources development analysis of national certified reference materials from 2015 to 2016[J]. China Metrology, 2017, (3): 82-85.
[17]刘宝言. 不同的仪器标准液hCG分子变异体对hCG结果的影响分析[J]. 世界最新医学信息文摘, 2019, 19(1): 131-132.
Liu B Y. Analysis of molecular variants of hCG on hCG results in different instrument standard liquids effect[J]. World Latest Medicine Information, 2019, 19(1): 131-132.
[18]陈宝荣, 邵燕, 刘春龙, 等. 不同评价方法对标准物质互换性评价结果的影响[J]. 临床检验杂志, 2016, 34(11): 809-812.
Chen B R, Shao Y, Liu C L, et al. Effect of different evaluation methods on evaluation results of commutability[J]. Chinese Journal of Clinical Laboratory Science, 2016, 34(11): 809-812.
[19]王凤超, 朱安友, 葛鑫, 等. AFP、CEA在2种不同化学发光分析系统间的对比分析和偏倚评估[J]. 实用全科医学, 2008, 6(2): 194-196.
Wang F C, Zhu A Y, Ge X, et al. Comparative analysis and bias evaluation on results of AFP and CEA between different chemiluminescence analysis[J]. Applied Journal of General Practice, 2008, 6(2): 194-196.