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现场快速 HIV 检测敏感性差:对母婴传播项目的影响。

Poor sensitivity of field rapid HIV testing: implications for mother-to-child transmission programme.

机构信息

Reproductive Health and HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.

出版信息

BJOG. 2009 Dec;116(13):1805-8. doi: 10.1111/j.1471-0528.2009.02357.x. Epub 2009 Sep 9.

Abstract

We validated rapid HIV tests among pregnant women in a clinical setting. Field testing was performed using First Response 1,2,3 or Standard Diagnostic and Pareekshak tests. Results were confirmed by third generation HIV ELISA. Discordant or negative, specimens were confirmed by RNA PCR and a fourth generation ELISA test. Sensitivity and specificity were 94.5% (CI: 85.8-98.2) and 100% for First Response; 87.5% (CI: 46.7-99.3) and 100% (CI: 87.7-100%) for Standard Diagnostic and 90.2% (CI: 81.2-95.4) and 100% (CI: 98-100%) for Pareekshak. These sensitivities were lower than laboratory validation which approached 100%. The low-field sensitivity results have implications for Prevention of Mother-to-Child Transmission services.

摘要

我们在临床环境中验证了孕妇用快速 HIV 检测试剂。现场检测使用的是 First Response 1、2、3 或 Standard Diagnostic 和 Pareekshak 检测试剂。结果用第三代 HIV ELISA 确认。不一致或阴性的样本用 RNA PCR 和第四代 ELISA 检测确认。First Response 的灵敏度和特异性分别为 94.5%(置信区间:85.8-98.2)和 100%;Standard Diagnostic 的灵敏度和特异性分别为 87.5%(置信区间:46.7-99.3)和 100%(置信区间:87.7-100%);Pareekshak 的灵敏度和特异性分别为 90.2%(置信区间:81.2-95.4)和 100%(置信区间:98-100%)。这些灵敏度低于接近 100%的实验室验证结果。低现场灵敏度的结果对母婴传播预防服务有影响。

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