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The LAVA (Lateral Flow Antigen Validation and Applicability) Study for COVID-19
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.
Details
| Lead sponsor | Alder Hey Children's NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 400 |
| Start date | Thu Nov 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Feb 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- 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
- Covid19
Interventions
- Innova Lateral Flow Device
Countries
United Kingdom