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Completed NCT05614427

The LAVA (Lateral Flow Antigen Validation and Applicability) 2 Study for COVID-19

Conditions: SARS-CoV-2 Infection

Sex: All
Ages: 0 Years – 16 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 449
Sponsor: Alder Hey Children's NHS Foundation Trust

Location: United Kingdom

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 RTPCR 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.

Eligibility Criteria

Inclusion Criteria:Child undergoing routine RT-PCR testing for SARS-CoV-2 using a nose and throat or ET sampleChild with positive RT-PCR for SARS-CoV-2 within the last 72 hoursExclusion Criteria:None

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05614427). StuddyBuddy aggregates publicly available trial information.