{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T06:30:39Z","timestamp":1783837839311,"version":"3.55.0"},"reference-count":33,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2021,5,28]],"date-time":"2021-05-28T00:00:00Z","timestamp":1622160000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000030","name":"Centers for Disease Control and Prevention","doi-asserted-by":"publisher","award":["U01 CK000490"],"award-info":[{"award-number":["U01 CK000490"]}],"id":[{"id":"10.13039\/100000030","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Institutes of Health\/National Institute of Allergy and Infectious Diseases","award":["NIH\/NIAID 2U19AI110818-06"],"award-info":[{"award-number":["NIH\/NIAID 2U19AI110818-06"]}]},{"DOI":"10.13039\/100020166","name":"Flu Lab","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100020166","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100009977","name":"ELMA Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100009977","id-type":"DOI","asserted-by":"crossref"}]},{"name":"MacKenzie Scott"},{"DOI":"10.13039\/100020163","name":"Skoll Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100020163","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Open Philanthropy"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Clin Pathol"],"accepted":{"date-parts":[[2021,1,30]]},"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.1136\/jclinpath-2020-207128","type":"journal-article","created":{"date-parts":[[2021,5,28]],"date-time":"2021-05-28T14:46:57Z","timestamp":1622213217000},"page":"496-503","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":12,"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"],"prefix":"10.1136","volume":"74","author":[{"given":"Melis N","family":"Anahtar","sequence":"first","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bennett M","family":"Shaw","sequence":"additional","affiliation":[{"name":"Infectious Disease and Microbiome Program, Eli and Edythe L. 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Broad Institute of Harvard and MIT, Cambridge, Massachusetts, USA"},{"name":"Center for Systems Biology, Department of Organismic and Evolutionary Biology, Harvard University, Cambridge, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"Eversley","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham E G","family":"McGrath","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tasos","family":"Gogakos","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen","family":"Lennerz","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hetal Desai","family":"Marble","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren L","family":"Ritterhouse","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie M","family":"Batten","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N Zeke","family":"Georgantas","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Pellerin","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvia","family":"Signorelli","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Thierauf","sequence":"additional","affiliation":[{"name":"Department of Pathology and Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA"},{"name":"Department of Otorhinolaryngology, University Hospital Heidelberg, Heidelberg, Baden-W\u00fcrttemberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Molly","family":"Kemball","sequence":"additional","affiliation":[{"name":"Infectious Disease and Microbiome Program, Eli and Edythe L. 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