一种血液艾滋病病毒抗体免疫印迹试剂的现场评估

Evaluation on the Cambridge Biotech HIV-1 Western blot kit

目的对Cambridge血液艾滋病病毒(HIV)-1抗体免疫印迹(WB)试剂进行现场评估并考核其在不同的HIV感染状态的人群中确认试验检测的敏感性和特异性。方法选取不同的现场,分别采集不同的HIV感染状态人群的血液样品,共计645份。经酶联免疫吸附试验(ELISA)检测后,分别使用Cambridge血液HIV-1抗体WB试剂盒和HIV blot 2．2 HIV-1／2型WB确认试剂盒进行平行对比试验。结果在已知既往HIV感染者中,Cambridge血液WB与Genelabs WB检测结果均为阳性,在此人群中上述2种确认试剂的敏感性均为100％。在398例HIV抗体ELISA检测为阴性的人群中,Cambridge血液WB试验23例为不确定;Genelabs血液WB试验86例为不确定,在此类人群中上述2种确认试剂的特异性分别为94．22％(375/398)和78．39％(312／398)。结论Cambridge血液HIV-1抗体WB试剂盒与Genelabs诊断公司的HIV blot 2．2 HIV-1／2型WB试剂盒的试验结果对比,在特异性方面前者优于后者。

Objective To evaluate the Cambridge Biotech HIV-1 Western blot kit and to assay the Sensitivity and Specificity in the different HIV infected status groups in the fields. Methods To collect the serum specimens from 645 cases, using Cambridge Biotech HIV-1 Western blot kit and using Genelabs Diagnostics HIV blot 2.2 Western blot kit to confirm the presence of HIV antibody through ELISA test. Results On HIV antibody positive individuals, Cambridge Biotech HIV-1 Western blot kit and Genelabs Diagnostics HIV blot 2.2 Western blot kit showed positive reaction. The sensitivity of both western blot kits was 100 %. Of 398 serum specimens from ELISA testing on HIV antibody negative individuals, 23 showed indeterminate when tested by Cambridge Biotech HIV-1 Western blot kit and 86 showed indeterminate when tested by Genelabs Diagnostics HIV blot 2.2 Western blot kit. In such HIV screen test negative groups, the rates of specificity of Cambridge kit were 94.22% and 78.39% for Genelabs kit respectively. Conclusion The Cambridge Biotech HIV-1 Western blot kit had much higher specificity then Genelabs Diagnostics HIV blot 2.2 Western blot kit.