N/A
Completed N=322
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 · Covid19
Source: ClinicalTrials.gov NCT04629157 ↗
Enrolled (actual)
322
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Acceptability of Test — 0; 0; 6; 4 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Test |
0; 0; 6; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Children aged 0 - <18 years undergoing combined nose and throat swabbing for an elective diagnostic or surgical procedure.
- Children aged 0 - <18 years undergoing combined nose and throat swabbing on admission to hospital when there is a differential diagnosis of COVID-19.
- Children aged 0 - <18 years undergoing routine combined nose and throat swabbing during a stay on the intensive care unit, the high dependency unit or a transplant ward.
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT04629157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.