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Development of a qualitative real-time RT-PCR assay for the detection of SARS-CoV-2: a guide and case study in setting up an emergency-use, laboratory-developed molecular microbiological assay.

Authors :
Anahtar MN
Shaw BM
Slater D
Byrne EH
Botti-Lodovico Y
Adams G
Schaffner SF
Eversley J
McGrath GEG
Gogakos T
Lennerz J
Marble HD
Ritterhouse LL
Batten JM
Georgantas NZ
Pellerin R
Signorelli S
Thierauf J
Kemball M
Happi C
Grant DS
Ndiaye D
Siddle KJ
Mehta SB
Harris JB
Ryan ET
Pierce VM
LaRocque RC
Lemieux JE
Sabeti PC
Rosenberg ES
Branda JA
Turbett SE
Source :
Journal of clinical pathology [J Clin Pathol] 2021 Aug; Vol. 74 (8), pp. 496-503. Date of Electronic Publication: 2021 May 28.
Publication Year :
2021

Abstract

Developing and deploying new diagnostic tests are difficult, but the need to do so in response to a rapidly emerging pandemic such as COVID-19 is crucially important. During a pandemic, laboratories play a key role in helping healthcare providers and public health authorities detect active infection, a task most commonly achieved using nucleic acid-based assays. While the landscape of diagnostics is rapidly evolving, PCR remains the gold-standard of nucleic acid-based diagnostic assays, in part due to its reliability, flexibility and wide deployment. To address a critical local shortage of testing capacity persisting during the COVID-19 outbreak, our hospital set up a molecular-based laboratory developed test (LDT) to accurately and safely diagnose SARS-CoV-2. We describe here the process of developing an emergency-use LDT, in the hope that our experience will be useful to other laboratories in future outbreaks and will help to lower barriers to establishing fast and accurate diagnostic testing in crisis conditions.<br />Competing Interests: Competing interests: PCS is a founder and shareholder of Sherlock Biosciences, and is both on the Board and serves as shareholder of the Danaher Corporation. JEL is a consultant for Sherlock Biosciences. MNA is a cofounder, equity holder and consultant for Day Zero Diagnostics. PCS, ETR and SET have received CDC funding for this work and other COVID-related work. John Branda has received grant support from Zeus Scientific, bioMerieux, Immunetics, the Bay Area Lyme Foundation and the Lyme Disease Biobank Foundation for work unrelated to this study, and has been a consultant for T2 Biosystems, DiaSorin and Roche Diagnostics.<br /> (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Details

Language :
English
ISSN :
1472-4146
Volume :
74
Issue :
8
Database :
MEDLINE
Journal :
Journal of clinical pathology
Publication Type :
Academic Journal
Accession number :
34049977
Full Text :
https://doi.org/10.1136/jclinpath-2020-207128