id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-331719-uijwq8gx	Russek-Cohen, Estelle	FDA Perspectives on Diagnostic Device Clinical Studies for Respiratory Infections	2011-05-01		.txt	text/plain	4838	205	41	In the former circumstance, a clinical reference method is considered to be the best available method for establishing the presence or absence of the target organism [1] but the reference method cannot incorporate results reported by the new device; for example, a new enzymelinked immunosorbent assay (ELISA) could not be used as one of the diagnostic criteria for the reference method in a study used to evaluate the performance of the assay. In a clinical study with only 5 specimens positive for a specific pathogen (via the reference method) and an observed sensitivity of 5/5 (100%) results in a lower confidence bound of only 55.6%, meaning diagnostic performance is very uncertain. Detailed information regarding the design of studies for a CLIA waiver application, including the minimal performance criteria acceptable for a CLIA-waived device, is described in ''FDA guidance for industry and FDA staff: recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices'' [9] .	./cache/cord-331719-uijwq8gx.txt	./txt/cord-331719-uijwq8gx.txt