id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-350172-w3yoxhsg	Mertens, Pascal	Development and Potential Usefulness of the COVID-19 Ag Respi-Strip Diagnostic Assay in a Pandemic Context	2020-05-08		.txt	text/plain	7563	336	47	Introduction: COVID-19 Ag Respi-Strip, an immunochromatographic (ICT) assay for the rapid detection of SARS-CoV-2 antigen on nasopharyngeal specimen, has been developed to identify positive COVID-19 patients allowing prompt clinical and quarantine decisions. Regarding the COVID-19 pandemic and the urgency of sharing relevant data, in this original research article we describe the analytical performance of the COVID-19 Ag Respi-Strip according to the requirements of the current European Directive 98/79/EC (9) , the future European Regulation 2017/746 on in vitro diagnostic (IVD) medical devices (10) , the Scandinavian SKUP-protocol (11) used for the validation of qualitative tests and the clinical performance obtained with a multi-centric retrospective study. Overall, 328 nasopharyngeal samples from symptomatic patients suspected of SARS-CoV-2 infections attending from 19th to 30th March 2020 in three university laboratories located in Belgium were tested following the manufacturer's instructions to assess the clinical sensitivity, clinical specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy in order to propose a diagnostic algorithm adapted to the current situation.	./cache/cord-350172-w3yoxhsg.txt	./txt/cord-350172-w3yoxhsg.txt