{"doi":"10.1101/2020.08.26.20157297","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 assay","abstract":"Developing and deploying new diagnostic tests is difficult, but the need to do so in response to a rapidly emerging pandemic such as COVID-19 is crucially important for an effective response. In the early stages of a pandemic, laboratories play a key role in helping health care 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, polymerase chain reaction (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 fast and accurate diagnostic testing in crisis conditions.","journal":"medRxiv","year":2020,"id":120982,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":8,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.957,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":226706,"name":"Bennett Shaw","orcid":"0000-0002-0180-6802","position":1,"is_corresponding":false},{"id":109060,"name":"Damien Slater","orcid":"0000-0002-1115-0894","position":2,"is_corresponding":false},{"id":317231,"name":"Elizabeth H. Byrne","orcid":"0000-0002-4576-8772","position":3,"is_corresponding":false},{"id":560023,"name":"Yolanda Botti-Lodovico","orcid":null,"position":4,"is_corresponding":false},{"id":226707,"name":"Gordon Adams","orcid":"0000-0003-1940-9706","position":5,"is_corresponding":false},{"id":62163,"name":"S. F. Schaffner","orcid":"0000-0001-6699-3568","position":6,"is_corresponding":false},{"id":560024,"name":"Jacqueline S. Eversley","orcid":null,"position":7,"is_corresponding":false},{"id":560025,"name":"Graham McGrath","orcid":null,"position":8,"is_corresponding":false},{"id":257703,"name":"Tasos Gogakos","orcid":"0000-0002-4892-8276","position":9,"is_corresponding":false},{"id":108261,"name":"Jochen K. Lennerz","orcid":"0000-0003-2434-4978","position":10,"is_corresponding":false},{"id":257710,"name":"Hetal D. Marble","orcid":"0000-0001-8203-0622","position":11,"is_corresponding":false},{"id":257711,"name":"Lauren L. Ritterhouse","orcid":"0000-0002-7655-630X","position":12,"is_corresponding":false},{"id":260882,"name":"Julie M. Batten","orcid":null,"position":13,"is_corresponding":false},{"id":260883,"name":"N. Zeke Georgantas","orcid":null,"position":14,"is_corresponding":false},{"id":559424,"name":"Rebecca Pellerin","orcid":"0000-0001-5930-9721","position":15,"is_corresponding":false},{"id":560026,"name":"Sylvia Signorelli","orcid":null,"position":16,"is_corresponding":false},{"id":257705,"name":"Julia Thierauf","orcid":"0000-0002-9607-3866","position":17,"is_corresponding":false},{"id":226708,"name":"Molly Kemball","orcid":"0000-0002-6085-9314","position":18,"is_corresponding":false},{"id":62122,"name":"Christian Happi","orcid":"0000-0002-3056-6705","position":19,"is_corresponding":false},{"id":251097,"name":"Donald S. Grant","orcid":"0000-0002-4329-0795","position":20,"is_corresponding":false},{"id":489313,"name":"Daouda Ndiaye","orcid":null,"position":21,"is_corresponding":false},{"id":251084,"name":"Katherine J. Siddle","orcid":"0000-0002-1799-7295","position":22,"is_corresponding":false},{"id":251085,"name":"Samar Mehta","orcid":"0000-0002-9181-8363","position":23,"is_corresponding":false},{"id":109068,"name":"Jason B. Harris","orcid":"0000-0003-3642-5126","position":24,"is_corresponding":false},{"id":108468,"name":"Edward T. Ryan","orcid":"0009-0005-0169-394X","position":25,"is_corresponding":false},{"id":257713,"name":"Virginia Pierce","orcid":"0000-0002-3723-1326","position":26,"is_corresponding":false},{"id":62201,"name":"Regina C. LaRocque","orcid":"0000-0003-4558-0339","position":27,"is_corresponding":false},{"id":226714,"name":"Jacob E. Lemieux","orcid":"0000-0002-2758-4005","position":28,"is_corresponding":false},{"id":7155,"name":"Pardis C. Sabeti","orcid":"0000-0002-9843-1890","position":29,"is_corresponding":false},{"id":257714,"name":"Eric Rosenberg","orcid":"0000-0002-8217-5458","position":30,"is_corresponding":false},{"id":108260,"name":"John A. Branda","orcid":"0000-0002-6929-1219","position":31,"is_corresponding":false},{"id":109066,"name":"Sarah E. Turbett","orcid":"0000-0002-3603-8110","position":32,"is_corresponding":false},{"id":257704,"name":"Melis N. Anahtar","orcid":"0000-0003-0309-368X","position":0,"is_corresponding":true}],"reference_count":8,"raw_metadata":null,"created_at":"2026-07-18T23:14:38.147936Z","pmid":"32909014","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}