ELISA法和CLIA法检测HBs Ag和梅毒抗体的对比分析

COMPARATIVE ANALYSIS OF ELISA AND CLIA IN DETECTION OF HBSAG AND SYPHILIS ANTIBODIES

目的:对比分析酶联免疫吸附实验(ELISA)和化学发光免疫测定(CLIA)法检测乙肝表面抗原(HBsAg)和梅毒螺旋体(TP)抗体的结果。方法:分别采用ELISA法和CLIA法平行检测3060份无偿献血标本的HBsAg和TP抗体,其中ELISA法检测HBsAg阴性的标本进行核酸检测(NAT),分析比较两种方法检测结果,检测结果不一致的标本送临检中心进行确证试验。结果:HBsAg检测结果,ELISA、CLIA的灵敏度分别为90.00%、90.00%,特异度分别为99.87%、100.00%;4例ELISA反应性CLIA阴性标本经确认为阴性,1例NAT反应性标本确认为反应性。TP抗体检测结果,ELISA、CLIA检测的灵敏度分别为40.00%、90.00%,特异度分别为99.84%、99.97%;12例ELISA反应性CLIA阴性标本确认阴性11例,反应性1例;8例ELISA阴性CLIA反应性标本有6例确认为反应性,2例为阴性。结论:CLIA检测血液标本的HBsAg和TP抗体具有较高的灵敏度和特异度。

Objective:To analyze the results of enzyme-linked immunosorbent assay(ELISA)and chemiluminescence immunoassay(CLIA)in detection of hepatitis B surface antigen(HBsAg)and Treponema pallidum(TP)antibody.Methods:ELISA and CLIA were used to detect HBsAg and TP antibody of 3060 blood samples.HBsAg negative samples were then detected by nucleic acid test(NAT).All the mismatching results of HBsAg and anti-TP detected by ELISA and CLIA were confirmed in National Center for Clinical Laboratories(NCCL).Results:HBsAg tests results:the sensitivity of ELISA and CLIA were all 90.00%,the specificity was 99.87%and 100.00%respectively.4 cases ELISA positive CLIA negative samples were confirmed negative at last,but 1 positive sample of NAT was confirmed reactive.TP antibody tests results:the sensitivity of ELISA and CLIA was 40.00%and 90.00%respectively,the specificity was 99.84%and 99.97%respectively.12 ELISA reactive CLIA negative samples were confirmed negative in 11 cases and reactive in 1 case;8 CLIA positive ELISA negative samples,6 samples were confirmed reactive while the other 2 were negative.Conclusions:CLIA has high sensitivity and specificity in detecting HBsAg andT P antibody of blood samples.