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

June 18, 2025 updated by: Sequenom, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91107
        • Exer Urgent Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male or female patients ≥2 years of age who present to the participating study clinics with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19 and who meet all study inclusion criteria and no exclusion criteria will be considered for enrollment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Self-collection first
Subjects will self-collect an anterior nasal swab first
Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit
The self-collected Labcorp COVID-19+Flu+RSV Test Home Collection Kit results as generated by the commercially available Labcorp Seasonal Respiratory Virus RT-PCR Test will be compared to the HCP-collected results as generated by Labcorp R&D using the comparator assays.
HCP-collection first
Subjects will have their healthcare provider collect an anterior nasal swab first
Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit
The self-collected Labcorp COVID-19+Flu+RSV Test Home Collection Kit results as generated by the commercially available Labcorp Seasonal Respiratory Virus RT-PCR Test will be compared to the HCP-collected results as generated by Labcorp R&D using the comparator assays.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection method comparison
Time Frame: 1 day
To evaluate the concordance between the results of a self-collected AN swab specimen using the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as analyzed by the Labcorp Seasonal Respiratory Virus RT-PCR Test and an HCP-collected AN swab as analyzed by the comparator assays in subjects presenting with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole blood specimen collection
Time Frame: 1 day
The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Collaborators

Labcorp Corporation of America Holdings, Inc

Investigators

  • Study Director: Graham McLennan, MS, Laboratory Corporation of America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQNM-VIR-403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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