Performance analysis of light initiated chemiluminescence assay in detecting anti-HCV, anti-HIV and syphilis
10.13303/j.cjbt.issn.1004-549x.2021.06.022
- VernacularTitle:光激化学发光法在检测抗-HCV、抗-HIV、抗-TP检测性能分析
- Author:
Shizhen GUAN
1
;
Hongjing ZHANG
1
;
Jun FANG
1
;
Yi WANG
1
Author Information
1. Department of Clinical Laboratory, Tianjin Hospital of Tianjin, Tianjin 300211, China
- Publication Type:Journal Article
- Keywords:
light initiated chemiluminescence assay;
HCV;
HIV;
syphilis
- From:
Chinese Journal of Blood Transfusion
2021;34(6):649-652
- CountryChina
- Language:Chinese
-
Abstract:
【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.
