id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-317720-gbi11oxx	Lefferts, Joel A.	Implementation of an Emergency Use Authorization Test During an Impending National Crisis	2020-05-14		.txt	text/plain	2148	80	39	Concerned that the efforts of state laboratories would be further impacted by lack of resources, we began to identify sources -including the WHO, the CDC, and commercial vendors -of the required primers and probes for the reverse transcriptase polymerase chain reaction (RT-PCR) detection of the virus and placed orders for test reagents from potential suppliers. The document provided guidance for high complexity testing laboratories developing SARS-CoV-2 tests for submission for Emergency Use Authorization (EUA) status with respect to required validation experiments and reporting to the FDA. Initially laboratories were required to spike RNA transcripts into previously extracted nucleic acid from negative samples for the CDC assay to determine the limit of detection but this had its own challenges of not representing extraction of true clinical samples and issues with degradation were identified. Our plan included the production of enough contrived clinical specimens and control material to proceed with validation or verification of the multiple (laboratory-developed and CDC EUA) tests that we were evaluating.	./cache/cord-317720-gbi11oxx.txt	./txt/cord-317720-gbi11oxx.txt