Clinical Evaluation of Rapid Antibody Test for Covid-19 [COVID-19]
Research type
Research Study
Full title
Clinical Evaluation of Rapid Antibody Test for Covid-19
IRAS ID
283264
Contact name
Michael Moore
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 27 days
Research summary
Rapid point-of-care antibody (IgM and IgG) tests for Covid-19 have been developed and are are already being used and marketed in the UK. If accurate, they have the potential to accelerate diagnosis of patients presenting to hospital (who often have already had symptoms for 7 or more days). They may be particularly useful in diagnosing later presentations (e.g. with chest infections post covid), in screening health workers and other key workers before return to work, in screening household contacts of Covid-19 patients, in testing patients with atypical symptoms, and on screening in work places trying to modify risk profile based upon likely pre-infection. \nIn this study we aim to establish the sensitivity of rapid IgM / IgG tests manufactured by Livzon (China) which according to the company has sensitivity and specificity of 90.6% and 99.2% respectively (based on validation in China). These have never before been evaluated in the UK. Preliminary anecdotal evidence suggests that they are easy to use and appear to give valid results. This initial trial aims to establish whether the sensitivity of these tests is above the threshold of 90%. We aim to include 200 inpatients in Watford General Hospital with confirmed Covid-19 on standard PCR testing.
REC name
Wales REC 4
REC reference
20/WA/0148
Date of REC Opinion
6 May 2020
REC opinion
Favourable Opinion