Price, performance, and the FDA approval process: the example of home HIV testing.
Price, performance, and the FDA approval process: the example of home HIV testing.
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DOI：
10.1177/0272989x09334420
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发表时间：
2010-03
期刊：
影响因子：
--
通讯作者：
Pollack HA
中科院分区：
文献类型：
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作者：
Paltiel AD;Pollack HA
美国食品和药物管理局（FDA）正在考虑批准一种用于家庭使用的非处方快速艾滋病毒检测方法。为了支持这一决定，美国食品和药物管理局正在寻找测试性能的证据。它要求制造商在未经培训的用户使用时对该测试的敏感性和特异性进行实地研究。在本文中，我们认为应该寻求更多的信息来评估最终用户人群中未检测到的艾滋病毒的流行程度。我们的分析框架得出了一个基本但违反直觉的发现，即家用艾滋病毒检测的性能——以其正确检测购买者是否感染艾滋病毒的能力来衡量——主要取决于制造商的零售价格。这一发现对FDA的批准程序有着深远的影响。
The Food and Drug Administration (FDA) is considering approval of an over-the-counter, rapid HIV test for home use. To support its decision, the FDA seeks evidence of the test’s performance. It has asked the manufacturer to conduct field studies of the test’s sensitivity and specificity when employed by untrained users. In this paper, we argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user population. Our analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test – measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it – depends critically on the manufacturer’s retail price. This finding has profound implications for the FDA’s approval process.