University of Illinois at Chicago, Chicago, Illinois, USA.
Rev Panam Salud Publica. 2013 Jun;33(6):427-32.
To compare the sensitivity and specificity of an Oral Rapid Test (ORT) to that of the Enzyme-Linked Immunosorbent Assay (ELISA) for HIV testing in Santiago, Chile; to track the number of study participants returning for ELISA testing results; and to analyze the participants' perceptions of the ORT compared to the ELISA.
A total of 497 people were recruited in Santiago, Chile: 153 had previously tested positive for HIV, and 344 were of unknown status. Participants were tested for HIV using both the ELISA and the ORT to examine and compare specificity and sensitivity. Qualitative data were collected from 22 participants to compare perceptions of the testing experience with ORT versus ELISA.
The ELISA reported 184 (37%) of the 497 participants as being "positive" for HIV antibodies; the ORT showed 181 (36.4%) as being "reactive" for HIV. The ORT showed a sensitivity of 98.4% (95.7%-99.9%, 95% Confidence Interval) and specificity of 100%. The Kappa test produced K = 0.983 (P < 0.0001). Of the 344 participants whose HIV status was unknown at the start of the study, 55 failed to return for their ELISA results. Participants positively perceived ORT as having reduced both waiting time and anxiety over obtaining their test results. ORT oral swabbing appeared more practical and less invasive than drawing blood for the ELISA.
The ORT and ELISA were statistically equal in specificity and sensitivity. ORT provides quicker results, potentially ensuring that more people receive them, and does not require handling of or exposure to potentially hazardous blood products.
比较智利圣地亚哥市口服快速检测(ORT)和酶联免疫吸附试验(ELISA)用于 HIV 检测的灵敏度和特异性;跟踪研究参与者返回接受 ELISA 检测结果的人数;分析参与者对 ORT 与 ELISA 的看法。
在智利圣地亚哥共招募了 497 人:153 人先前 HIV 检测呈阳性,344 人 HIV 状态未知。用 ELISA 和 ORT 对参与者进行 HIV 检测,以检查和比较特异性和灵敏度。从 22 名参与者收集定性数据,以比较他们对 ORT 与 ELISA 检测体验的看法。
ELISA 报告 497 名参与者中有 184 人(37%)HIV 抗体“阳性”;ORT 显示 181 人(36.4%)HIV 呈“反应性”。ORT 的灵敏度为 98.4%(95.7%-99.9%,95%置信区间),特异性为 100%。Kappa 检验产生 K = 0.983(P < 0.0001)。在研究开始时 HIV 状态未知的 344 名参与者中,有 55 人未能返回接受 ELISA 结果。参与者对 ORT 有积极的看法,认为它减少了等待时间和获得检测结果时的焦虑。ORT 口腔拭子比 ELISA 采血更实用,侵入性更小。
ORT 和 ELISA 在特异性和灵敏度方面统计学上相等。ORT 提供更快的结果,可能确保更多的人获得结果,并且不需要处理或接触潜在危险的血液制品。