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目的:探讨第4代人类免疫缺陷病毒(HIV)抗原抗体酶联检测试剂在血液筛查中的质量。方法:分别使用第3代酶联试剂和第4代试剂检测HIV1 0.5NCU/ml质控血清、卫生部HIV室间质评标本及72 693例无偿献血者标本的HIV标志物。结果:对质控血清的检测显示第4代试剂灵敏度大于第3代;对72 693例献血者标本HIV初筛检测,第3代试剂初筛阳性32例,阳性率0.044 0%,第4代试剂初筛阳性为53例,阳性率0.072 9%,显示2种试剂初筛阳性结果差异有统计学意义(χ2=5.18,P<0.05),但2种试剂的敏感性均为100%。在特异性方面,第4代试剂(99.94%)略低于第3代试剂(99.97%)。结论:未开展核酸检测的采供血机构,使用第4代HIV抗原抗体酶联试剂用于血液的常规筛查,能有效降低HIV传播风险,保证血液安全。
Objective: To investigate the quality of the 4th generation anti-HIV antibody ELISA test in blood screening. Methods: HIV1 0.5 NCU / ml quality control serum, HIV inter-laboratory quality assessment of HIV-1 and 72 693 HIV-free blood donors were detected by the third generation enzyme-linked reagent and the fourth-generation reagent respectively. Results: The detection of quality control sera showed that the sensitivity of the 4th generation reagent was higher than that of the third generation. In 72 693 blood donors, the first HIV screening test, the third generation reagent screening positive 32 cases, the positive rate of 0.044%, the fourth generation The results showed that the positive results of the two reagents were statistically significant (χ2 = 5.18, P <0.05), but the sensitivity of the two reagents was 100%. In specificity, the 4th generation reagent (99.94%) was slightly lower than the 3rd generation reagent (99.97%). Conclusion: Blood collection and donation institutions that do not carry out nucleic acid testing, using the 4th generation of HIV antigen antibody enzyme-linked reagent for routine blood screening, can effectively reduce the risk of HIV transmission and ensure blood safety.