Journal
JOURNAL OF CLINICAL PATHOLOGY
Volume 74, Issue 8, Pages 496-503Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/jclinpath-2020-207128
Keywords
diagnosis; diagnostic techniques and procedures; laboratory manual; microbiology; virology
Categories
Funding
- Centers for Disease Control and Prevention [U01 CK000490]
- National Institutes of Health/National Institute of Allergy and Infectious Diseases [NIH/NIAID 2U19AI110818-06]
- Flu Lab
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Developing and deploying new diagnostic tests, especially during a pandemic like COVID-19, is crucial. Laboratories play a key role in detecting active infection, with PCR remaining the gold standard of nucleic acid-based assays. Some hospitals are actively developing new testing methods to address local testing capacity shortages.
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.
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