id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
ajlm-494	Cowan, Elliot P.	A framework for the assessment and implementation of diagnostics in outbreak situations	2016		.htm	text/html	3679	154	42	In the context of an outbreak situation, this includes the identification of the outbreak agent, the clinical course of the disease, and availability of potential targets around which a test could be developed (i.e., nucleic acid sequences, antigens, etc.), variants of the agent, epidemiology (location, movement, etc.), well-characterised specimens for test development and monitoring of test performance once the outbreak-use IVD is in clinical use, and simple and clear policies and procedures to accept a test for outbreak use. There are a number of additional challenges that must be addressed at this step, including technical barriers (for example, it is much easier to develop a nucleic acid test than a serological test); the time required to develop a test that is adequate to meet the needs of the outbreak situation; access to specimens from endemic areas for test development; the ability to manufacture the test at a scale sufficient to meet the need; and identifying manufacturers willing to develop and produce tests that will likely only be used during an outbreak situation.	cache/ajlm-494.htm	txt/ajlm-494.txt