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

Completed

Conditions studied: COVID-19 Respiratory Infection, Influenza A, Influenza Type B, RSV Infection

In brief

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).

Key facts

Study ID

NCT06008457

Run by

Sequenom, Inc.

People needed

1600

Starts

2023-04-17

Expected to finish

2025-05-31

Last updated by the study team

2025-06-25

Who can join

Age: 2 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Exer Urgent Care — Pasadena, California, United States

Full record on ClinicalTrials.gov

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