COVID-19 patients with negative SARS-CoV-2 PCR: An Observational Study [COVID-19]
Research type
Research Study
Full title
Investigation of patients admitted to hospital with presumed COVID-19 and negative SARS-CoV-2 diagnostic tests: an observational cohort study
IRAS ID
285815
Contact name
Ashley Whittington
Contact email
Sponsor organisation
London North West University Healthcare NHS trust
Duration of Study in the UK
0 years, 10 months, 27 days
Research summary
COVID-19 is a severe disease caused by infection with the SARS-CoV-2 virus. Definitive diagnosis of COVID-19 requires detecting the virus in patients. This is usually performed by taking a nasopharyngeal swab for polymerase chain reaction (PCR) testing which detects the viral genome. The sensitivity of this test is variable, and up to 30% of tests are falsely negative in patients with clear clinical and radiological features of COVID-19. \n\nIt is unclear if these false negative tests are simply due to technical variation in nasopharyngeal sampling technique and the laboratory PCR test, or if there is a subgroup of COVID-19 patients with low levels of virus in the nasopharynx who are more likely to test negative. Such a subgroup may have distinctive clinical features and prognosis from PCR positive patients. Understanding this is important as PCR negative COVID-19 patients are usually excluded from clinical trials or observational studies of COVID-19. Identifying which patients are likely to test falsely-negative also has important implications for case management and infection prevention and control measures as they may still be infectious.\n\nWe will perform a retrospective observational study of all patients tested for COVID-19 by PCR at our Trust during the peak of the coronavirus outbreak. Using electronic patient records, we will identify patients with COVID-19 that tested PCR negative and compare the clinical characteristics and outcomes in this group to the PCR-positive patients. This will identify factors that predict a false-negative test and determine if PCR negative COVID-19 patients have distinctive clinical features and outcomes. [Study relying on COPI notice] \n
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/HRA/3473
Date of REC Opinion
9 Jul 2020
REC opinion
Favourable Opinion