Diagnostics of COVID-19 (V1) [COVID-19]
Research type
Research Study
Full title
Development and Assessment of Rapid Testing for SARS-CoV-2 outbreak (DARTS
IRAS ID
282104
Contact name
Timothy D Planche
Contact email
Sponsor organisation
St George’s, University of London & St George’s University Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
On 12 January 2020, a novel coronavirus was identified as the cause of an outbreak of unexplained pneumonia in Wuhan City, Hubei Province, China. This coronavirus was later named SARS-CoV-2, and the disease it causes COVID-19. As of 15 March 2020, over 152,000 of COVID-19 have been diagnosed in 147 countries with a total of over 5,700 deaths; with 1,543 confirmed cases in the UK as of 16 March 2020. Because of the lack of a serological test, the number, and so proportion, of people that develop asymptomatic infection remains unknown. This means that an accurate infection fatality estimate remains elusive. Additionally, it is currently unknown why some patients develop severe COVID-19, while others have mild symptoms. Although general predisposing factors, such as hypertension, kidney disease and diabetes are well established, the exact mechanisms for these processes are not well characterised yet. We propose to use antibody detection. Antigen and antibody lateral flow assay (LFA) development has been led by Mologic as a quick diagnostic test for COVID-19. LFA and ELISA (enzyme-linked immunosorbent assay) have been developed for SARS-CoV-2 antigen detection in throat/ nose swabs and detection of antibodies in blood/serum (IgG, IgM) and saliva (IgG, IgM, IgA). This study proposes to use these newly developed tests, for preliminary evaluation and subsequently on-site validation. The use of the diagnostics developed here will improve management of cases of COVID-19, since these are designed to be non-expensive alternatives, easy to use and very rapid. The rapid diagnosis of SARS-CoV-2 with antigen detection will allow patients to be rapidly triaged in hospital or in GP surgeries. They are sufficiently cheap that they will be appropriate for use in low/middle-income countries. Additionally, antibody detection will allow both for diagnosis of immunity and infection before the manifestation of symptoms or even in asymptomatic cases.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0171
Date of REC Opinion
2 Apr 2020
REC opinion
Further Information Favourable Opinion