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目的通过对一种艾滋病病毒(HIV)自助采样包采集的样本进行检测,探讨其临床应用的可行性。方法针对已知感染状态的男男性行为者(MSM)、静脉吸毒者(IDUs)和健康体检人群,共807人;未知感染状态的暗娼283人;由专业人员分发并回收HIV的自助采样包。利用酶联免疫吸附试验对收集的尿液及干血斑样本进行HIV抗体检测,并对暗娼进行干血斑核酸检测,分析不同方法检测结果的一致性。结果尿液样本抗体检测结果与已知感染状态比较,健康体检人群、MSM、IDUs以及总人群的检测一致率分别为96.55%、98.99%、95.20%、97.03%;干血斑样本抗体检测结果与已知感染状态比较,健康体检人群、MSM、IDUs以及总人群的检测一致率分别为98.47%、100%、98.80%、99.13%。对未知感染状态的暗娼,将抗体检测结果与干血斑核酸检测结果进行比较,干血斑样本与尿液样本的一致率分别为96.82%、97.88%;将干血斑与尿液样本的抗体检测结果比较,检测一致率为96.82%。结论对采用自助采样包采集的样本进行检测,发现具有较高的检测效能,说明自助采样包采集的样本,不仅适用于高危人群,在自然人群中也有实用价值。
Objective To test the samples collected from a HIV self-sampling kit to explore the feasibility of its clinical application. Methods A total of 807 MSM, IDUs and health examination populations with known infection status were included; 283 FSWs with unknown status were infected; and self-service sampling kits were distributed and recovered by professionals. Enzyme-linked immunosorbent assay (ELISA) was used to detect the HIV antibody in collected urine and dried blood spot samples. The dry blood spot nucleic acid was detected in commercial sex workers, and the consistence of different methods was analyzed. Results Compared with the known infection status, the detection rate of urine sample antibody was 96.55%, 98.99%, 95.20% and 97.03% respectively in the health examination population, MSM, IDUs and the total population. The detection results of dry blood spot antibody The known prevalence of infection was 98.47%, 100%, 98.80% and 99.13% respectively for the health examination population, MSM, IDUs and the total population. For the commercial sex workers with unknown infection status, the antibody test results were compared with the dried blood spot nucleic acid test results. The consistency rates of dry blood spot samples and urine samples were 96.82% and 97.88% respectively. The dry blood spot and urine samples’ The test results were compared, the detection rate was 96.82%. Conclusion The samples collected by self-service sampling kit were tested and found to have high detection efficiency. The samples collected by self-service sampling kit are not only applicable to high-risk groups but also have practical value in natural populations.