Kassler W J, Haley C, Jones W K, Gerber A R, Kennedy E J, George J R
Division of STD/HIV Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
J Clin Microbiol. 1995 Nov;33(11):2899-902. doi: 10.1128/jcm.33.11.2899-2902.1995.
Rapid, on-site human immunodeficiency virus (HIV) testing has the potential to improve the delivery of prevention services in publicly funded counseling and testing sites. The Single Use Diagnostic System (SUDS) HIV-1 is the only rapid enzyme immunoassay (EIA) approved for diagnostic use in the United States. To evaluate the feasibility of using SUDS in public clinics and to validate the test's performance in a public health laboratory, we conducted blinded SUDS testing on plasma sent for HIV testing. From 19 March through 30 June 1993, 1,923 consecutive samples from a sexually transmitted diseases clinic and an HIV counseling and testing clinic were tested on site with SUDS. Tests done in the first two weeks with a malfunctioning centrifuge n = 402) and those done when there were excessively high temperatures in the laboratory (n = 53) were analyzed separately. Of 1,466 tests, 39 were positive by both SUDS and EIA (with Western blot [immunoblot] confirmation) and 7 were SUDS positive and EIA negative. Western blotting was used as the "gold standard" to adjudicate these discrepancies. There were no SUDS-negative and EIA-positive tests. Compared with that of EIA (with Western blot confirmation), the sensitivity of SUDS was 100% (95% confidence interval, 88.8 to 100%) and the specificity was 99.5% (95% confidence interval, 98.9 to 99.8%). The positive predictive value of SUDS was 88% in the STD clinic and 81% in the HIV counseling and testing clinic. There was a 7.7-fold increase in false positives, from 0.48 to 3.7%, when there was inadequate centrifugation and when the temperature exceeded the manufacturer's recommendations. Rapid, on-site HIV testing by the SUDS assay is feasible and practical in public health settings. The test can be performed accurately, at reasonable cost, and within the time frame of a typical clinic visit. Caution should be used, however, as two conditions adversely affected the accuracy of this test: inadequate specimen preparation and elevated temperature.
快速现场人类免疫缺陷病毒（HIV）检测有潜力改善公共资助的咨询与检测场所预防服务的提供。一次性诊断系统（SUDS）HIV-1是美国唯一被批准用于诊断的快速酶免疫测定（EIA）。为评估在公共诊所使用SUDS的可行性并在公共卫生实验室验证该检测的性能，我们对送去做HIV检测的血浆进行了盲法SUDS检测。1993年3月19日至6月30日，对一家性传播疾病诊所和一家HIV咨询与检测诊所的1923份连续样本进行了SUDS现场检测。对前两周使用故障离心机时进行的检测（n = 402）以及实验室温度过高时进行的检测（n = 53）分别进行了分析。在1466次检测中，39次SUDS和EIA均为阳性（经蛋白质印迹法[免疫印迹法]确认），7次SUDS阳性而EIA阴性。采用蛋白质印迹法作为“金标准”来判定这些差异。没有SUDS阴性而EIA阳性的检测结果。与EIA（经蛋白质印迹法确认）相比，SUDS的灵敏度为100%（95%置信区间，88.8%至100%），特异性为99.5%（95%置信区间，98.9%至99.8%）。SUDS在性传播疾病诊所的阳性预测值为88%，在HIV咨询与检测诊所为81%。当离心不足以及温度超过制造商推荐范围时，假阳性率增加了7.7倍，从0.48%升至3.7%。通过SUDS检测进行快速现场HIV检测在公共卫生环境中是可行且实用的。该检测能够准确进行，成本合理，且能在典型门诊就诊的时间范围内完成。然而，应谨慎操作，因为有两个条件会对该检测的准确性产生不利影响：样本制备不充分和温度升高。
