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A Simple Saliva-Based Test for Detecting Antibodies to Human Immunodeficiency Virus

机译:一种简单的基于唾液的检测方法,用于检测人类免疫缺陷病毒的抗体

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This study was performed to determine the feasibility of using saliva as a diagnostic medium for the detection of antibodies to human immunodeficiency virus type 1 (HIV-1) and HIV-2 under nonlaboratory conditions and to evaluate the performance characteristics of such a test. We developed for this purpose a self-contained kit (Saliva · Strip [ST]), which combines the collection and processing, as well as the analysis, of the specimen. The kit’s performance was evaluated in a blinded study. Saliva collection was facilitated with a specially designed device that contains a sample adequacy indicator, and immunochromatography test strips were used for the analysis. A total of 1,336 matched serum and saliva specimens (684 reactive and 652 nonreactive specimens) were tested. We tested sera using an enzyme immunoassay (EIA) and a rapid strip test. Sera reactive in one of the assays were also analyzed by Western blotting. Sensitivity and specificity were 99.4 and 99.4%, respectively, for ST, 100 and 99.1%, respectively, for EIA, and 99.7 and 100%, respectively, for the serum strip test. The saliva test performed well when HIV-2-positive sera or a low-titer performance panel (HIV-1) of serum or plasma specimens were diluted (1:2,000) in nonreactive saliva. Because the methodology we present here uses a noninvasively obtained medium, the methodology may be suitable for use in the field where laboratory support and personnel are limited, such as community outreach programs, doctors’ offices, surveillance studies, and community hospitals.
机译:进行这项研究是为了确定在非实验室条件下使用唾液作为诊断介质检测人免疫缺陷病毒1型(HIV-1)和HIV-2抗体的可行性,并评估这种测试的性能。为此,我们开发了一套独立的试剂盒(Saliva·Strip [ST]),该试剂盒将标本的收集,处理以及分析结合在一起。该套件的性能是在一项盲法研究中评估的。专门设计的设备(其中包含样品充足性指示剂)有助于唾液收集,并使用免疫色谱试纸进行分析。总共测试了1336个匹配的血清和唾液样本(684个反应性样本和652个非反应性样本)。我们使用酶免疫法(EIA)和快速剥离测试测试了血清。还通过蛋白质印迹分析了一种测定中的反应性血清。对ST的敏感性和特异性分别为99.4%和99.4%,对EIA的敏感性和特异性分别为100和99.1%,对于血清试纸条测试的敏感性和特异性分别为99.7和100%。当将HIV-2阳性血清或血清或血浆样本的低滴度检测组(HIV-1)稀释(1:2,000)于非反应性唾液中时,唾液测试表现良好。由于我们在此介绍的方法使用的是非侵入式获取的介质,因此该方法可能适用于实验室支持和人员有限的领域,例如社区外展计划,医生办公室,监测研究和社区医院。

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