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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1
Exer Urgent Care
Pasadena, California, United States, 91107