id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-310160-55yltan1	Pham, Jimmykim	Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection	2020-09-22		.txt	text/plain	2745	147	48	In this study, we report the analytical and clinical performance characteristics of a new, high-throughput, fully automated nucleic acid amplification test system for the detection of SARS-CoV-2. Clinical nasopharyngeal swab specimen testing (n = 140) showed 100%, 98.7%, and 99.3% positive, negative, and overall agreement, respectively, with a validated reverse transcription-PCR nucleic acid amplification test (NAAT) for SARS-CoV-2 RNA. The analytical sensitivity of the SARS-CoV-2 TMA assay was assessed using 2 lots of reagents to test 60 replicates each of dilution panels containing cultured SARS-CoV-2 virus strain USA-WA1/2020 (BEI Resources, Manassas, VA) and diluted in Aptima specimen transport medium (STM) matrix to a range of 0.03 to 0.0003 50% tissue culture infectious dose (TCID 50 )/ml. This analysis resulted in positive, negative, and overall agreements of 100% (95% CI, 94.3% to 100%), Clinical performance of the SARS-CoV-2 TMA assay was also assessed by testing sets of NP swab, OP swab, and nasal swab specimens co-collected from 35 symptomatic patients suspected of being infected with SARS-CoV-2.	./cache/cord-310160-55yltan1.txt	./txt/cord-310160-55yltan1.txt