FASTER II V1.0 [COVID-19]
Research type
Research Study
Full title
Facilitating A SARS CoV-2 TEst for Rapid triage II (FASTER II)
IRAS ID
287693
Contact name
Tom Fletcher
Contact email
Sponsor organisation
Liverpool School of Tropical Medicine
Clinicaltrials.gov Identifier
20-065, Sponsor study protocol
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This project will evaluate point-of-need (PON) tests for the detection of the novel strain of coronavirus SARS-COV-2 (COVID-19) causing the rapidly growing deadly outbreak.
Our research team is closely working with foundation of novel diagnostics (FIND, https://www.finddx.org/covid-19/) to complete a comparative evaluation of lateral flow assay (LFA) tests and enzyme-linked immunosorbent assays (ELISAs) that detect antigens and human antibodies specific to SARS-CoV-2 to determine exposure status, for use to support patient triage for diagnosis and determination of prior infection in convalescent patients. These PON tests are intended for the rapid triage of patients with fever and/or cough. Furthermore, the PON tests will be formatted as self-tests, offering the additional benefit of deploying widely in the home and community settings.We will use the RT-PCR in COVID-19 on nasal and throat swabs as our reference standard diagnostic and collect paired saliva samples.
We are proposing to co-enrol patients with suspected COVID-19 and being screened for COVID-19 trials AGILE and RAPTOR-C19. Participants will not need additional visits for FASTER II and sampling will be synchronised with AGILE and RAPTOR-C19 screening slots. Additionally, if participants do not fit screening or inclusion criteria for AGILE and RAPTOR-C19, we will enrol them into FASTER II if suitable.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0333
Date of REC Opinion
4 Dec 2020
REC opinion
Further Information Favourable Opinion