HIV抗体快速检测试剂的临床评估

目的:通过对HIV抗体快速检测试剂的临床评估,为HIV检测试剂的临床应用提供参考.方法:对快速试剂的使用性能进行比较,并采用美国输血协会(AABB)血清盘、临床样品血清盘、特性血清盘(阳性样品盘)、稀释系列血清盘评估快速试剂的敏感性和特异性.结果:三种快速试剂在检测AABB血清盘时,敏感性分别是86.4%、86.4%、100%,特异性皆为100%;三种快速试剂在检测临床样品血清盘时,敏感性分别是88.6%、91.4%、97.1%,特异性皆为100%.快速试剂具有很高的阳性预期值,对于低危人群(感染率很低人群)也具有很高的阴性预期值.快速试剂检测弱阳性的样品(酶联试剂s/co比值小于6～8的样品)存在漏检.快速试剂与ELISA参考试剂在分析灵敏度方面相差3个以上倍比稀释度.结论:快速试剂具有较好的使用特性,非常适用于样本量较少的实验室及对低危人群的HIV筛查,在对高危人群筛查时,可能有弱阳性样品漏检,同时快速试剂在分析灵敏度方面有待提高.

Clinical Evaluation of Rapid HIV Test

Objective: Through the clinical evaluation with rapid test kits of HIV, give the informations on selecting and using kits in clinical lab.Methods: Implemented a programme for the evaluation of performance and major operational characteristics of commercially rapid test kits of HIV, evaluated the sensitivity and specificity in AABB serum panel, clinical sample panel, the performance in positive serum panel and the analysis sensitivity in dilution serum panel. Results: The sensitivities of three rapid test kits in AABB serum panel were separately 86.4%,86.4% and 100%, the specificities were all 100%; The sensitivitties of three rapid test kits in clinical sample panel were separately 88.6%,91.4% and 97.1%, the specificitties were all 100%. The positive predictive value was very high, the negative predictive value in the population with the lower the prevalence were also high. There were false negative results when the weak postive samples (tested by ELISA kits, s/co value under 6-8) were tested. The analysis sensitivity of ELISA reference kits in dilution serum panel was higher than that of the rapid test kits. Conclusion: The performance and operational characteristics of rapid test kits were better, the kits were suitable for using in small laboratories and screening HIV to the population with the lower the prevalence. When the kits are used in screening HIV to the population with the higher the prevalence, there will be more false negative results. The analysis sensitivity of rapid test kits need to be improved.