{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Anahtar MN"],"funding":["MacKenzie Scott","Centers for Disease Control and Prevention","National Institutes of Health/National Institute of Allergy and Infectious Diseases","NIAID NIH HHS","ELMA Foundation","Flu Lab","Open Philanthropy","Skoll Foundation","NCEZID CDC HHS"],"pagination":["496-503"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8311084"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["74(8)"],"pubmed_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 "],"journal":["Journal of clinical pathology"],"pubmed_title":["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."],"pmcid":["PMC8311084"],"funding_grant_id":["U01 CK000490","NIH/NIAID 2U19AI110818-06","U19 AI110818"],"pubmed_authors":["Slater D","Turbett SE","Georgantas NZ","Shaw BM","Siddle KJ","Lennerz J","Pierce VM","Anahtar MN","McGrath GEG","Byrne EH","Lemieux JE","Botti-Lodovico Y","Marble HD","Signorelli S","Rosenberg ES","Ritterhouse LL","Schaffner SF","Ndiaye D","LaRocque RC","Mehta SB","Batten JM","Eversley J","Adams G","Harris JB","Grant DS","Kemball M","Branda JA","Happi C","Thierauf J","Ryan ET","Gogakos T","Sabeti PC","Pellerin R"],"additional_accession":[]},"is_claimable":false,"name":"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.","description":"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 ","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Aug","modification":"2026-06-10T05:50:59.825Z","creation":"2022-02-11T07:38:37.255Z"},"accession":"S-EPMC8311084","cross_references":{"pubmed":["34049977"],"doi":["10.1136/jclinpath-2020-207128"]}}