About: Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting

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About: Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting 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
has title	Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting
Creator	Kluge, Stefan Lütgehetmann, Marc Pfefferle, Susanne Aepfelbacher, Martin Fischer, Nicole Nörz, Dominik Mayer-Runge, Ulrich Schultze, Alexander
Source	Elsevier; Medline; PMC
abstract	BACKGROUND: The ongoing SARS-CoV-2 pandemic presents a unique challenge for diagnostic laboratories around the world. Automation of workflows in molecular diagnostics is instrumental for coping with the large number of tests ordered by clinicians, as well as providing fast-tracked rapid testing for highly urgent cases. In this study we evaluated a SARS-CoV-2 LDT for the NeuMoDx 96 system, a fully automated device performing extraction and real-time PCR. METHODS: A publicly available SARS-CoV-2 RT-PCR assay was adapted for the automated system. Analytical performance was evaluated using in-vitro transcribed RNA and clinical performance was compared to the cobas 6800-based reference assay within the lab. RESULTS: The Envelope (E) Gene-LDT displayed good analytical performance with an LoD of 95.55 cp/ml and no false positives during evaluation of cross-reactivity. A total of 176 patient samples were tested with both the E-Gene-LDT and the reference assay. Positive and negative agreement were 100% and 99.2% respectively. Invalid-rate was 6.3%. CONCLUSION: The E-Gene-LDT showed analytical and clinical performance comparable to the cobas6800-based reference assay. Due to its random-access workflow concept and rapid time-to-result of about 80 minutes, the system is very well suited for providing fast-tracked SARS-CoV-2 diagnostics for urgent clinical samples in the hospital setting.
has issue date	2020-04-28(xsd:dateTime)
bibo:doi	10.1016/j.jcv.2020.104390
bibo:pmid	32388471
has license	no-cc
sha1sum (hex)	2960ef3fe10a67912b05d95080f13eb380c066db
schema:url	https://doi.org/10.1016/j.jcv.2020.104390
resource representing a document's title	Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting
has PubMed Central identifier	PMC7187839
has PubMed identifier	32388471
schema:publication	J Clin Virol
resource representing a document's body	covid:2960ef3fe10a67912b05d95080f13eb380c066db#body_text
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