Status:

COMPLETED

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

Lead Sponsor:

Sequenom, Inc.

Collaborating Sponsors:

Labcorp Corporation of America Holdings, Inc

Conditions:

COVID-19 Respiratory Infection

Influenza A

Eligibility:

All Genders

2-89 years

Brief 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 sw...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 17 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 31 2025

Estimated Enrollment :

1600 Patients enrolled

Trial Details

Trial ID

NCT06008457

Start Date

April 17 2023

End Date

May 31 2025

Last Update

June 25 2025

Active Locations (1)

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Exer Urgent Care

Pasadena, California, United States, 91107