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

NCT06008457 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2025-06-25

No results posted yet for this study

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).

Conditions

  • COVID-19 Respiratory Infection
  • Influenza A
  • Influenza Type B
  • RSV Infection

Interventions

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.

Sponsors & Collaborators

  • Labcorp Corporation of America Holdings, Inc

    collaborator INDUSTRY

  • Sequenom, Inc.

    lead INDUSTRY

Principal Investigators

  • Graham McLennan, MS · Laboratory Corporation of America

Eligibility

Min Age
2 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United States

Study Locations

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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 NCT06008457 on ClinicalTrials.gov