Rapid HIV self-testing: long in coming but opportunities beckon
Rapid HIV self-testing: long in coming but opportunities beckon
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DOI：
10.1097/qad.0b013e32835fd7a0
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发表时间：
2013-07-17
期刊：
影响因子：
3.8
通讯作者：
Branson, Bernard M.
中科院分区：
文献类型：
--
作者：
Myers, Julie E.;El-Sadr, Wafaa M.;Branson, Bernard M.
美国食品和药物管理局最近批准了艾滋病毒快速自我检测，这是艾滋病毒检测方法演变过程中的一个重要里程碑。在美国，近五分之一的艾滋病毒感染者仍未被诊断出来，而在全球范围内，更高比例的人不知道自己感染了艾滋病毒，这一决定反映了一种新的意愿，即提供多种选择来进行艾滋病毒检测。快速自我检测提供了几个不同的机会，以改善对未确诊艾滋病毒感染者的检测：鼓励对那些本来可能无法进行检测的人进行检测，增加对新感染风险最高的人进行检测的频率，并促进与性伴侣进行相互艾滋病毒检测。迄今为止，获得监管批准的道路漫长但富有启发性。美国监管部门批准所需的研究和临床试验提供了对艾滋病毒自我检测的性能和潜在影响的深入了解，因为它们可以直接销售给消费者。虽然对艾滋病毒自我检测仍然存在一些持续的保留意见，包括目前检测工具包的“窗口期”、其成本及其促进接受医疗护理的有效性，但其他保留意见已经消除。在资源有限的情况下进行自我检测也很有希望，包括保健专业人员的自我检测。目前，虽然影响尚未确定，但这一新的选择可能为改进艾滋病毒诊断和促进治疗和预防提供潜在的机会。(C)2013威科健康垂直酒吧Lippincott威廉姆斯& Wilkins
The recent approval by the United States Food and Drug Administration of a rapid HIV self-test marks a significant milestone in the evolution of HIV testing approaches. With nearly one in five people living with HIV in the United States still undiagnosed and an even higher proportion unaware of their infection globally, this decision reflects a new willingness to offer diverse options to get tested for HIV. Rapid self-testing offers several distinct opportunities to improve testing among those with undiagnosed HIV: to encourage testing among those who might not otherwise be tested, to increase the frequency of testing among persons at highest risk for new infection, and to facilitate mutual HIV testing with sex partners. To date, the path to regulatory approval has been long but instructive. The studies and clinical trials required for regulatory approval in the United States provide insight into the performance and potential implications of HIV self-tests as they become available for sale directly to consumers. Although some persistent reservations about self-testing for HIV remain, including the window period' of the current test kit, its cost, and its effectiveness for facilitating entry to medical care, others have been dispelled. Self-testing in resource-constrained settings is also promising, including self-testing of health professionals. At present, although the impact has yet to be determined, availability of this new option might offer potential opportunities to improve HIV diagnosis and facilitate both treatment and prevention. (C) 2013 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins