MedTrace Logo

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

NCT05614427 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2022-11-14

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Innova Lateral Flow Test

Lateral flow test performed on anterior nasal or buccal swabs

Sponsors & Collaborators

  • Alder Hey Children's NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2021-12-20
Completion
2022-04-20

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614427 on ClinicalTrials.gov