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

NCT05614427 | Completed

• 1 other identifier: 292509
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

Brief 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

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (2)

• The association of LFD result (positive/negative) taken from an anterior nares swab compared to RT-qPCR finding (Cycle Threshold Values)

  Swabs will be taken within 30 minutes of each other

• The association of LFD result (positive/negative) taken from a buccal swab compared to RT-qPCR finding (Cycle Threshold Values)

  Swabs will be taken within 30 minutes of each other

Secondary Outcomes (2)

• The overall sensitivity of the LFD compared to RT-PCR.

  Swabs will be taken within 30 minutes of each other

• The overall specificity of the LFD compared to RT-PCR.

  Swabs will be taken within 30 minutes of each other

Study Arms (2)

Anterior nasal swab

ACTIVE COMPARATOR

Lateral flow tests performed on anterior nasal swabs compared to routinely taken nose and throat swabs with RT-PCR

Diagnostic Test: Innova Lateral Flow Test

Buccal swab

ACTIVE COMPARATOR

Lateral flow tests performed on buccal swabs compared to routinely taken nose and throat swabs with RT-PCR

Diagnostic Test: Innova Lateral Flow Test

Interventions

Innova Lateral Flow Test DIAGNOSTIC_TEST

Lateral flow test performed on anterior nasal or buccal swabs

Anterior nasal swab; Buccal swab

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child undergoing routine RT-PCR testing for SARS-CoV-2 using a nose and throat or ET sample
• Child with positive RT-PCR for SARS-CoV-2 within the last 72 hours

You may not qualify if:

• None

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (1)

Alder Hey Children's NHS Foundation Trust

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 14, 2022
• Study Start: March 26, 2021
• Primary Completion: December 20, 2021
• Study Completion: April 20, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)