Debattista Joseph, Bryson Gregory, Roudenko Nicole, Dwyer John, Kelly Mark, Hogan Patrick, Patten John
Brisbane Sexual Health and AIDS Service, Northside Health Service District, Brisbane, Qld 4000, Australia.
Sex Health. 2007 Jun;4(2):105-9. doi: 10.1071/sh07014.
The objectives of the present study were: to determine the sensitivity and specificity of oral fluid testing compared with the performance of standard blood-based HIV enzyme immunoassay; to assess the feasibility of oral fluid specimen collection from clients for the purposes of HIV testing within a clinical setting; and to assess the clinical and laboratory impact regarding staffing, material resources, expertise and funding of oral fluid testing.
A parallel comparative trial of oral fluid and blood testing was conducted among a group of HIV positive clients and a group of unknown HIV serostatus clients where each client was offered both tests. An ambulatory HIV clinic recruited 175 known HIV positive clients and 179 persons were recruited through an inner city sexual health clinic while attending for routine sexual health checks. Client responses to oral fluid collection were assessed. The sensitivity and specificity of oral fluid testing were calculated.
Of the 176 confirmed HIV reactive blood test results, the OraSure (OraSure Technologies, Beaverton, OR, USA) assay failed to detect only one of these, demonstrating a sensitivity of 99.4%. Of the 178 blood specimens that were tested as non-reactive by the AxSYM (Abbott Laboratories, Abbott Park, IL, USA) Combo system, OraSure recorded four of the corresponding oral fluid specimens as reactive (assumed to be false-positive), giving a specificity of 97.6%. Although evaluation of patients undergoing the test showed a large proportion (88.6%) preferred the OraSure test to conventional blood testing, a large minority of these (22.6%) made such a preference conditional on the OraSure test being as reliable as current blood testing.
This limited clinic based trial of oral fluid testing for HIV antibodies among an outpatient population has demonstrated the potential of oral fluid as a specimen for HIV testing. However, the lower performance of the test compared with current serum-based tests may limit the usefulness of OraSure to epidemiological studies or as an alternative screening tool in outreach settings among higher risk populations.
本研究的目的是：确定与基于血液的标准HIV酶免疫测定相比，口腔液检测的敏感性和特异性；评估在临床环境中从客户处采集口腔液样本用于HIV检测的可行性；评估口腔液检测在人员配备、物质资源、专业知识和资金方面对临床和实验室的影响。
在一组HIV阳性客户和一组HIV血清学状态未知的客户中进行了口腔液和血液检测的平行比较试验，为每位客户提供两种检测。一家流动HIV诊所招募了175名已知HIV阳性客户，另一家市中心性健康诊所通过招募179人进行常规性健康检查。评估了客户对口腔液采集的反应。计算了口腔液检测的敏感性和特异性。
在176份经确认的HIV血液检测反应性结果中，OraSure（美国俄勒冈州比弗顿市OraSure Technologies公司）检测仅未能检测出其中一份，敏感性为99.4%。在AxSYM（美国伊利诺伊州雅培公园市雅培实验室）组合系统检测为非反应性的178份血液样本中，OraSure将其中4份相应的口腔液样本记录为反应性（假定为假阳性），特异性为97.6%。尽管对接受检测的患者的评估显示，很大一部分（88.6%）患者更喜欢OraSure检测而非传统血液检测，但其中很大一部分少数患者（22.6%）表示，这种偏好的条件是OraSure检测与当前血液检测一样可靠。
这项在门诊人群中进行的关于HIV抗体口腔液检测的有限临床研究表明，口腔液作为HIV检测样本具有潜力。然而，与当前基于血清的检测相比，该检测性能较低，这可能会限制OraSure在流行病学研究中的用途，或作为高风险人群外展环境中的替代筛查工具。
