CompletedNot Applicable

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

United States1,600 participantsStarted 2023-04-17

Plain-language 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).

Who can participate

Age range2 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Collection method comparison

Timeframe: 1 day

Trial details

NCT IDNCT06008457

SponsorSequenom, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More COVID-19 Respiratory Infection trials