About: Rapid implementation of SARS-CoV-2 emergency use authorization RT-PCR testing and experience at an academic medical institution

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About: Rapid implementation of SARS-CoV-2 emergency use authorization RT-PCR testing and experience at an academic medical institution Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Rapid implementation of SARS-CoV-2 emergency use authorization RT-PCR testing and experience at an academic medical institution
Creator	Cushing, M Loda, M Cong, L Craney, A Hissong, Erika Rennert, H Ruggiero, P Sipley, J Velu, P Westblade, F
source	MedRxiv
abstract	An epidemic caused by an outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China in December 2019 has since rapidly spread internationally, requiring urgent response from the clinical diagnostics community. We present a detailed overview of the clinical validation and implementation of the first laboratory-developed real-time reverse-transcription-PCR (rRT-PCR) test offered in the NewYork-Presbyterian Hospital system following the emergency use authority (EUA) guidance issued by the US Food and Drug Administration. Validation was performed on nasopharyngeal and sputum specimens (n=124) using newly designed dual-target rRT-PCR (altona RealStar SARS-CoV-2 Reagent) for detecting of SARS-CoV-2 in upper respiratory and lower respiratory tract specimens, including bronchoalveolar lavage and tracheal aspirates. Accuracy testing demonstrated excellent assay agreement between expected and observed values. The limit of detection (LOD) was 2.7 and 23.0 gene copies/reaction for nasopharyngeal and sputum specimens, respectively. Retrospective analysis of 1,694 tests from 1,571 patients revealed increased positivity in older patients and males compared to females, and an increasing positivity rate from approximately 20% at the start of testing to 50% at the end of testing three weeks later. Our findings demonstrate that the assay accurately and sensitively identifies SARS-CoV-2 in multiple specimen types in the clinical setting and summarizes clinical data from early in the epidemic in New York City.
has issue date	2020-06-08(xsd:dateTime)
bibo:doi	10.1101/2020.06.05.20109637
has license	medrxiv
sha1sum (hex)	8e711780fd1caffd33f78fda3d6e6d48dc1a9a09
schema:url	https://doi.org/10.1101/2020.06.05.20109637
resource representing a document's title	Rapid implementation of SARS-CoV-2 emergency use authorization RT-PCR testing and experience at an academic medical institution
resource representing a document's body	covid:8e711780fd1caffd33f78fda3d6e6d48dc1a9a09#body_text
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