The LAVA (Lateral flow Antigen Validation and Applicability) 2 Study [COVID-19]
Research type
Research Study
Full title
The LAVA (Lateral flow Antigen Validation and Applicability) 2 Study for COVID-19
IRAS ID
292509
Contact name
Rachel Harwood
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
Research Summary
The Lateral Flow Antigen Validity and Applicability (LAVA) 2 study aims to determine the validity of lateral flow antigen devices (LFDs) used to perform point of care testing for COVID-19, compared to the current gold standard test of RT-PCR in children.
In a pilot study we have shown that the anterior nose swabs used to perform a LFD test are associated with significantly lower pain scores than the nose and throat swabs used to perform RT-PCR tests and that the results are available significantly more quickly. RT-PCR is an excellent diagnostic test but one drawback includes remaining positive for a prolonged period, potentially when the person is no longer infective, as it can pick up viral particulate rather than live virus. LFDs are more likely to be positive at the point that a person has a high viral load and is therefore infectious to others, but this has not been studied in non-laboratory settings in children. The study aims to determine the correlation between LFD and viral load detected on RT-PCR in children to enable the utility of the test in different clinical and non-clinical settings to be better determined.Summary of Results
This study looked at the performance of lateral flow tests performed on children in hospital undergoing routine testing and compared these tests to the standard PCR tests. Swabs for the lateral flow tests were taken from just inside the nostril and from inside the mouth.
This study found that lateral flow tests taken from swabs just inside the nose are very good at identifying that children do not have COVID-19 but are less good at picking up that they do have COVID-19. Swabbing from just inside the nose appears to be slightly less accurate than swabbing the back of the nose and the throat. Swabs taken from inside the mouth were poor at picking up children who have COVID-19.
We concluded that when swabbing for COVID-19 is being considered for a child, careful consideration of why the swab is being performed, the tolerance of the child to where the swab is taken from and the requirements for test processing (eg, rapidity of results) should be undertaken within hospital settings.REC name
London - City & East Research Ethics Committee
REC reference
20/HRA/6152
Date of REC Opinion
3 Feb 2021
REC opinion
Further Information Favourable Opinion