The LAVA (Lateral flow Antigen Validation and Applicability) Study [COVID-19]
Research type
Research Study
Full title
The LAVA (Lateral flow Antigen Validation and Applicability) Study for COVID-19
IRAS ID
290989
Contact name
Rachel Harwood
Contact email
Sponsor organisation
Alder Hey in the Park
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 0 months, 14 days
Research summary
This is a pilot study which aims to assess the validity and applicability of lateral flow assays (LFAs) which can be used as a point of care test for COVID-19. The study will focus on children admitted to hospital or planned to have a procedure for which they require an anaesthetic. RT-PCR is the current gold standard test for COVID-19, but it usually takes approximately 24-48 hours for a test result to be returned which can slow the clinical care given to a patient and can potentially increase the risk of healthcare worker (HWC) exposure to COVID-19. LFAs are a point of care test which can identify children who have a high viral load of COVID-19 and are performed using a more acceptable method of swabbing for children, just inside the nostril. Using LFA potentially enables the identification of infectious children with COVID-19 to aid with immediate care of patients and limiting HWC and other patients' contact with the virus. This study aims to assess the test failure rate and identify reasons for this which can be addressed. It also aims to assess the discomfort of both tests for children, provide a comparison between the time to LCA and RT-PCR result and provide data for a trial to adequately power a prospective trial comparing RT-PCR and LFA.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
20/WM/0288
Date of REC Opinion
26 Oct 2020
REC opinion
Favourable Opinion