Wisnom C, DePaola L, Saville R D, Constantine N T, Falkler W
University of Maryland School of Dentistry, Department of Oral Medicine and Diagnostic Sciences, Baltimore 21201, USA.
Oral Dis. 1997 May;3 Suppl 1:S85-7. doi: 10.1111/j.1601-0825.1997.tb00382.x.
The purpose of this research was to determine if the accuracy of HIV saliva and serum test results were influenced by changes in collection sites. In order to do so, serum and saliva samples were collected from 615 subjects in eight different geographic settings. The oral fluid collection/testing systems utilized were the Orapette SalivaCard HIV-1/HIV-2 antibody test (Trinity Biotech, Ireland) and the Omni-SAL/ImmunoComb II HIV 1 & 2 Saliva Test (Orgenics Ltd, Israel). For comparison, serum samples were tested by ELISA (Ortho) with reactive results confirmed via HIV-1 and HIV-2 Western blots (Biotech/Dupont, Institute Pasteur). The HIV serum and oral fluid collections were conducted in numerous test sites, which provided a great diversity in temperature, lighting and physical layout. The tests proved to be 99.8% and 100% specific, and both were 100% sensitive, regardless of the physical setting of the collections. While these systems are not currently available in the US, this study clearly demonstrates they can accurately be utilized in a variety of clinical settings, providing great promise for future applications.
本研究的目的是确定人类免疫缺陷病毒(HIV)唾液和血清检测结果的准确性是否会受到采集地点变化的影响。为此,从八个不同地理区域的615名受试者中采集了血清和唾液样本。所使用的口腔液体采集/检测系统为Orapette SalivaCard HIV-1/HIV-2抗体检测(爱尔兰Trinity生物技术公司)和Omni-SAL/ImmunoComb II HIV 1 & 2唾液检测(以色列Orgenics有限公司)。作为对照,血清样本通过酶联免疫吸附测定(ELISA,Ortho公司)进行检测,阳性结果通过HIV-1和HIV-2免疫印迹法(Biotech/Dupont公司、巴斯德研究所)予以确认。HIV血清和口腔液体采集在众多检测地点进行,这些地点在温度、光照和物理布局方面差异很大。结果表明,无论采集的物理环境如何,这些检测的特异性均为99.8%和100%,敏感性均为100%。虽然这些检测系统目前在美国尚未上市,但本研究清楚地表明,它们可在各种临床环境中准确应用,为未来的应用带来了巨大希望。