Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain.
PLoS One. 2012;7(10):e46555. doi: 10.1371/journal.pone.0046555. Epub 2012 Oct 8.
Availability of over-the-counter rapid HIV tests could improve access to testing those reluctant or unable to use current services. We aimed to evaluate the feasibility of HIV self-testing using a finger-stick whole-blood rapid test (Determine™ HIV Combo) to detect both antigen and antibody.
Before being tested, 313 participants in a street-based testing program were given adapted instructions and a test kit, and performed the self-test without supervision. These participants, together with another 207 who performed supervised self-testing, received additional instructions on how to interpret the test results shown in six colour photos and filled out a questionnaire. Logistic regression and generalized estimating equations (GEE) were used in the statistical analysis.
About 8.0% (95%CI:4.8%-11.2%) obtained an invalid self-test. An invalid result was inversely associated with male participants who had sex with men (OR=0.3;95%CI:0.1-1.0). Of the 3111 photos interpreted,4.9% (95%CI:4.1-5.7) were incorrect. Only 1.1% (95%CI:0.3-1.8) of the positive results were interpreted as negative. Age 30 or older (OR=2.1; 95%CI:1.2-3.7), having been born in Latin America (OR=1.6; 95%CI:1.1-2.2),and not having university education (OR=2.1;95%CI:1.2-3.7) were associated with misinterpreting test results in the GEE. Participant's perceptions of both their proficiency when conducting the test and interpretation were related with actual outcomes. Most participants (83.9%) were more motivated than before to use the self-test in the future, and 51.7% would pay >10 Euros for the test if it was sold in pharmacies.
This is the first study showing that blood-based self-testing with current technology is feasible in HIV-negative participants demanding the test and without prior training or supervision. Bearing in mind that it was conducted under difficult weather conditions and using a complex kit, over-the-counter tests could be a feasible option to complement current diagnostic strategies. More studies are needed to accommodate technology, minimise interpretation mistakes and provide on-line support.
非处方快速 HIV 检测试剂的普及可以改善那些不愿或不能使用现有服务的人群进行检测的途径。本研究旨在评估使用指尖全血快速检测(Determine™ HIV Combo)进行 HIV 自我检测的可行性,该检测试剂可同时检测抗原和抗体。
在街头检测项目中,313 名参与者在接受了改编后的说明和检测试剂盒后,在无人监督的情况下自行进行检测。这些参与者与另外 207 名接受监督自我检测的参与者一起,接受了如何根据六张彩色照片解释检测结果的额外说明,并填写了一份调查问卷。逻辑回归和广义估计方程(GEE)用于统计分析。
约 8.0%(95%CI:4.8%-11.2%)的检测结果无效。无效结果与男男性行为者(OR=0.3;95%CI:0.1-1.0)参与者呈负相关。在解释的 3111 张照片中,有 4.9%(95%CI:4.1-5.7)是不正确的。只有 1.1%(95%CI:0.3-1.8)的阳性结果被解释为阴性。30 岁或以上(OR=2.1;95%CI:1.2-3.7)、出生于拉丁美洲(OR=1.6;95%CI:1.1-2.2)和没有大学教育(OR=2.1;95%CI:1.2-3.7)与 GEE 中错误解释检测结果有关。参与者对自己进行检测的熟练程度和解释结果的看法与实际结果有关。大多数参与者(83.9%)比以前更有动力在未来使用自我检测,并且如果这种检测在药店出售,有 51.7%的参与者愿意支付超过 10 欧元。
这是第一项表明,在没有事先培训或监督的情况下,使用当前技术进行基于血液的自我检测在要求检测的 HIV 阴性参与者中是可行的。考虑到这是在恶劣的天气条件下进行的,并且使用了复杂的试剂盒,非处方检测可能是补充当前诊断策略的可行选择。需要进一步的研究来适应技术,减少解释错误,并提供在线支持。