@article {1512,
	title = {Price, performance, and the FDA approval process: the example of home HIV testing.},
	journal = {Medical decision making : an international journal of the Society for Medical Decision Making},
	volume = {30},
	year = {2010},
	month = {2010 Mar-Apr},
	pages = {217-23},
	abstract = {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{\textquoteright}s performance. It has asked the manufacturer to conduct field studies of the test{\textquoteright}s sensitivity and specificity when employed by untrained users. In this article, the authors argue that additional information should be sought to evaluate the prevalence of undetected HIV in the end-user POPULATION: The 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{\textquoteright}s retail price. This finding has profound implications for the FDA{\textquoteright}s approval process.},
	keywords = {Device Approval, HIV Infections, Humans, Predictive Value of Tests, Reagent Kits, Diagnostic, United States, United States Food and Drug Administration},
	issn = {1552-681X},
	doi = {10.1177/0272989X09334420},
	author = {Paltiel, A David and Pollack, Harold A}
}
