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10.1136/jclinpath-2020-207128

http://scihub22266oqcxt.onion/10.1136/jclinpath-2020-207128
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suck abstract from ncbi


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pmid34049977      J+Clin+Pathol 2021 ; 74 (8): 496-503
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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 #MMPMID34049977
  • 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
  • J Clin Pathol 2021[Aug]; 74 (8): 496-503 PMID34049977show ga
  • 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.
  • |*COVID-19 Nucleic Acid Testing[MESH]
  • |*Emergency Service, Hospital[MESH]
  • |*Laboratories, Hospital[MESH]
  • |*Real-Time Polymerase Chain Reaction[MESH]
  • |COVID-19/*diagnosis/virology[MESH]
  • |Humans[MESH]
  • |Predictive Value of Tests[MESH]
  • |Reproducibility of Results[MESH]


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