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OpenTrials
Completed

NCT Number: NCT06008457

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

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).

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Key information

Conditions

COVID-19 Respiratory Infection Infections Influenza A Influenza Type B Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections RSV Infection Respiratory Syncytial Virus Infections Virus Diseases

Age range

2 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Exer Urgent Care

Pasadena, California, 91107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • Labcorp Corporation of America Holdings, Inc

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2023
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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