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Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit | Clinical Trials | Clareo Health

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Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit

Prospective Clinical Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as Offered Commercially by Labcorp - A Registry Study

NCT06008457•Sequenom, Inc.

View on ClinicalTrials.gov

Summary

To compare the results obtained by analysis of a self-collected anterior nasal (AN) swab as part of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit to a healthcare provider (HCP)-collected AN swab in patients with symptoms of viral respiratory infection consistent with influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV) and/or SARS-CoV-2 (C-19).

Eligibility

Age

2 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•presents with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19;
•Subject can read and understand written instructions in English; and
•Subject is able, in the professional opinion of the investigator, to provide up to 18.5mL of whole blood at the clinic visit. NOTE - the blood draw will be optional for subjects \<12 years of age.

Exclusion Criteria

•Subject is 14-17 years of age and their parent or legal guardian is unable to supervise the collection of the AN swab sample from the subject;
•Subject is \<14 years of age and their parent or legal guardian refuses to collect the AN swab sample from the subject; or
•Previous participation in this protocol.

Locations (1)

Exer Urgent Care

Pasadena, California, United States

Key Dates

Start Date

April 17, 2023

Primary Completion Date

May 31, 2025

Completion Date

May 31, 2025

Last Updated

June 25, 2025

Enrollment

1,600

ACTUAL participants

Conditions

COVID-19 Respiratory InfectionInfluenza AInfluenza Type BRSV Infection

Interventions

Labcorp COVID-19+Flu+RSV Test Home Collection Kit

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit

Inclusion Criteria

Exclusion Criteria

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