三种新型冠状病毒抗体检测系统一致性评价  

Consistency evaluation of three detection systems for anti-SARS-CoV-2 antibodies

作　　者：张华 耿亚松[1] 王倩[1] 付东鹤 唐洪影 杨玲[1] 董莉真 吴高鹏[1] 李桂柃 李天宁 袁玉华[1] ZHANG Hua;GENG Yasong;WANG Qian;FU Donghe;TANG Hongying;YANG Ling;DONG Lizhen;WU Gaopeng;LI Guiling;LI Tianning;YUAN Yuhua(Tianjin Medical University General Hospital Airport Hospital,Tianjin 300308,China)

机构地区：[1]天津医科大学总医院空港医院,天津300308

出　　处：《山东医药》2021年第14期33-36,共4页Shandong Medical Journal

基　　金：科技部国家重点研发计划项目(2020YFC0843100)。

摘　　要：目的评价三种新型冠状病毒(SARS-CoV-2)特异性IgG、IgM抗体化学发光检测系统的一致性。方法收集46份血清标本,其中SARS-CoV-2阳性23例、阴性23例。使用A、B、C三种系统及配套试剂对46份血清标本进行SARS-CoV-2抗体检测。参考CLSI EP15-A3及EP9-A3方案进行精密度评价和方法学比对,对定量结果采用passing-bablok进行比对分析;采用χ^(2)检验将定性结果之间进行差异性分析,并分别与核酸最终检测结果进行差异性分析。结果A、B、C三种系统IgG抗体检测精密度分别为4.59%~5.08%、4.40%~4.91%、4.25%~8.09%,IgM抗体检测精密度分别为4.92%~5.39%、3.97%~4.19%、4.18%~8.44%。三种检测系统IgG抗体定量结果间回归方程的相关系数为0.835~0.871,截距为0.017~0.025,斜率为0.034~0.173,IgM抗体定量检测结果间回归方程的相关系数为0.671~0.885,截距为-0.090~0.025,斜率为0.098~0.437;IgG抗体定性结果与最终临床诊断结果符合率为91.4%~95.6%,IgM抗体定性结果与最终临床诊断结果符合率为65.2%~86.9%。结论三种系统IgG抗体检测结果一致性较好,IgM抗体的检测结果之间存在差异;血清抗体检测可作为SARS-CoV-2感染诊断和流行病学调查的有效指标。Objective To evaluate the consistency of three chemiluminescence detection systems for specific IgG and IgM antibodies of novel coronaviruses(SARS-CoV-2).Methods Forty-six serum samples,including 23 positive cases of SARS-CoV-2 and 23 negative cases,were collected.We used the three systems A,B,C and their supporting re⁃agents to detect SARS-CoV-2 antibodies on 46 serum samples.Referring to CLSI EP15-A3 and EP9-A3 protocols,preci⁃sion evaluation and methodological comparison were carried out.The quantitative results were compared and analyzed by using passing-bablok.Chi-square test was used to analyze the difference among qualitative results.The difference was re⁃spectively analyzed between the qualitative results and final nucleic acid test results.Results The precision of IgG anti⁃body detection of systems A,B and C was 4.59%-5.08%,4.4%-4.91%,and 4.25%-8.09%while the precision of IgM was 4.92%-5.39%,3.97%-4.19%and 4.18%-8.44%,respectively.The correlation coefficient(r)of regression equa⁃tion among the specific IgG antibody quantitative results of the three detection systems was within 0.835-0.871,the inter⁃cept was 0.017-0.025,and the slope was 0.034-0.173,respectively.The correlation coefficient(r)of the regression equation among the specific IgM antibody quantitative test results was within 0.671-0.885,the intercept was-0.090-0.025,and the slope was 0.098-0.437,respectively.The coincidence rate between the specific IgG antibody test results and the final clinical diagnosis was 91.4%-95.6%;and the coincidence rate between the specific IgM antibody test results and the final clinical diagnosis was 65.2%-86.9%.Conclusion The results of detection of IgG antibodies by the three systems are in good agreement,but the results of detection of IgM antibodies are different from those of nucleic acid detec⁃tion and clinical diagnosis;the serum antibody detection will play an important role in the clinical diagnosis and epidemio⁃logical investigation for SARS-CoV-2 infection.

关 键 词：新型冠状病毒 核酸检测 抗体检测 化学发光法 一致性评价 

分 类 号：R512.[医药卫生—内科学]