光激化学发光法在检测抗-HCV、抗-HIV、抗-TP检测性能分析

Performance analysis of light initiated chemiluminescence assay in detecting anti-HCV,anti-HIV and syphilis

目的评价光激化学发光法在抗-HCV、抗-HIV、抗-TP检测中的性能。方法参照CNAS-GL038:2019《临床免疫学定性检验程序性能验证指南》和CNAS-GL037:2019《临床化学定量检验程序性能验证指南》对全自动光激化学发光检测系统LICA500检测抗-HCV、抗-HIV、抗-TP的符合率、检出限、精密度、临界值进行验证。结果 LICA500与酶联免疫吸附试验在抗-HCV、抗-HIV检测方面的符合率为100%。在抗-TP检测方面,与TPPA结果的符合率为95%。检出限实验显示LICA500对抗-HCV、抗-HIV和抗-TP的检出限分别达到了0.04 NCU/mL、0.5 NCU/mL、0.25 NCU/mL,均超过厂家声明的检出限0.2 NCU/mL、1 NCU/mL、0.5 NCU/mL。LICA500检测抗-HCV、抗-HIV、抗-TP的批内CV和总CV均<10%。临界值实验显示,临界浓度抗-HCV、抗-HIV和抗-TP的阳性结果占比分别为45%、45%、48%,C50验证通过;(临界浓度-20%)的阴性结果占比为98%,(临界浓度+20%)的阳性结果占比为100%,说明(临界值-20%)至(临界值+20%)的浓度范围位于这种方法的95%区间。结论 LICA500对抗-HCV、抗-HIV、抗-TP的检测与目前常用的检测方法有较高的符合率,适合于患者手术及输血前的快速筛查和批量检查。

Objective To evaluate the performance of light initiated chemiluminescence assay in the detection of hepatitis c virus(HCV), human immunodeficiency virus(HIV) and Treponema pallidum(TP) antibodies. Methods According to Guidance on the Verification of Qualitative Measurement Procedures used in the Clinical Immunology(CNAS-GL038:2019) and Guidance on the Verification of Quantitative Measurement Procedures used in the Clinical Chemistry(CNAS-GL037:2019),the coincidence rate, detection limit, precision and critical value of the detection of HCV, HIV and TP antibodies by the automatic light initiated chemiluminescence assay system LICA500 were verified. Results The concordance rate of LICA500 and ELISA in HCV antibody and HIV antibody detection was 100%. In terms of syphilis antibody detection, the concordance rate with TPPA results was 95%. The detection limit test showed that the detection limits of LICA500 against HCV antibody, HIV antibody and TP antibody reached 0.04 NCU/mL, 0.5 NCU/mL and 0.25 NCU/mL, respectively, which were all higher than the manufacturer′s declared detection limits of 0.2 NCU/mL, 1 NCU/mL and 0.5 NCU/mL. The in-batch CV and total CV of LICA500 for HCV, HIV and TP antibodies were less than 10%. The C50 was verified by critical value experiment, and the positive results of HCV antibody, HIV antibody and TP antibody at the critical concentration accounted for 45%, 45% and 48%, respectively. The percentage of negative results for(critical concentration-20%) was 98%, and the percentage of positive results for(critical concentration +20%) was 100%, indicating that the concentration range from(critical concentration-20%) to(critical concentration +20%) was in the 95% range of this method. Conclusion The detection of HCV, HIV and TP antibodies by LICA500 has a high concordance rate with the current commonly used detection methods, suitable for rapid screening and batch examination before surgery and blood transfusion.