biostudies-literatureAnahtar MNMacKenzie ScottCenters for Disease Control and PreventionNational Institutes of Health/National Institute of Allergy and Infectious DiseasesNIAID NIH HHSELMA FoundationFlu LabOpen PhilanthropySkoll FoundationNCEZID CDC HHS496-503https://www.ebi.ac.uk/biostudies/studies/S-EPMC8311084biostudies-literatureUnknown74(8)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 Journal of clinical pathologyDevelopment 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.PMC8311084U01 CK000490NIH/NIAID 2U19AI110818-06U19 AI110818Slater DTurbett SEGeorgantas NZShaw BMSiddle KJLennerz JPierce VMAnahtar MNMcGrath GEGByrne EHLemieux JEBotti-Lodovico YMarble HDSignorelli SRosenberg ESRitterhouse LLSchaffner SFNdiaye DLaRocque RCMehta SBBatten JMEversley JAdams GHarris JBGrant DSKemball MBranda JAHappi CThierauf JRyan ETGogakos TSabeti PCPellerin RfalseDevelopment 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.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 2021-01-01T00:00:00Z2021 Aug2026-06-10T05:50:59.825Z2022-02-11T07:38:37.255ZS-EPMC83110843404997710.1136/jclinpath-2020-207128