Parisi Maria Rita, Soldini Laura, Di Perri Giovanni, Tiberi Simon, Lazzarin Adriano, Lillo Flavia B
Laboratory of Virology, AIDS Center San Luigi, Scientific Institute San Raffaele, Milan, Italy.
New Microbiol. 2009 Oct;32(4):391-6.
Implementation of HIV testing has the objective to increase screening, identify and counsel persons with infection, link them to clinical services and reduce transmission. Rapid tests and/or alternative biological samples (like oral fluid) give the option for a better general consent in approaching screening, immediate referral of HIV positives to medical treatment and partner notification. We tested the performance characteristics of an oral fluid-based rapid HIV test (Rapidtest HIV lateral flow-Healthchem diag. LLC) in comparison with routinely utilized methods in a selected population of known positive (N = 121) or negative (N = 754) subjects. The sensitivity of the rapid test was 99.1% (one false negative sample) and the specificity 98.8%. Five negatives showed a faint reactivity, 3 of these were reactive also in the reference test, one with a p24 only reaction in Western blot. If these 3 samples were excluded from the analysis the specificity increases to 99.2%. Results from our study confirm that, although a continuous improvement of the test performance is still needed to minimize false negative and positive results, rapid test and alternative biological samples may contribute to HIV prevention strategies by reaching a larger population particularly when and where regular screening procedures are difficult to obtain.
实施艾滋病毒检测的目的是增加筛查、识别和咨询感染者、将他们与临床服务联系起来并减少传播。快速检测和/或替代生物样本(如口腔液)为在进行筛查时获得更好的一般同意、将艾滋病毒阳性者立即转诊接受治疗以及通知性伴侣提供了选择。我们在一组已知阳性(N = 121)或阴性(N = 754)的特定人群中,将基于口腔液的艾滋病毒快速检测(Rapidtest HIV lateral flow - Healthchem diag. LLC)的性能特征与常规使用的方法进行了比较。快速检测的灵敏度为99.1%(1例假阴性样本),特异性为98.8%。5例阴性样本显示出微弱反应性,其中3例在参考检测中也呈反应性,1例在蛋白质印迹法中仅p24呈反应性。如果将这3个样本排除在分析之外,特异性将提高到99.2%。我们的研究结果证实,尽管仍需要持续改进检测性能以尽量减少假阴性和假阳性结果,但快速检测和替代生物样本可能有助于艾滋病毒预防策略,尤其是在难以获得常规筛查程序的时间和地点,从而覆盖更多人群。