Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit
NCT ID: NCT06008457
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1600 participants
OBSERVATIONAL
2023-04-17
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Self-collection first
Subjects will self-collect an anterior nasal swab first
Labcorp COVID-19+Flu+RSV Test Home Collection Kit
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.
HCP-collection first
Subjects will have their healthcare provider collect an anterior nasal swab first
Labcorp COVID-19+Flu+RSV Test Home Collection Kit
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.
Interventions
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Labcorp COVID-19+Flu+RSV Test Home Collection Kit
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
2 Years
89 Years
ALL
No
Sponsors
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Labcorp Corporation of America Holdings, Inc
INDUSTRY
Sequenom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Graham McLennan, MS
Role: STUDY_DIRECTOR
Laboratory Corporation of America
Locations
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Exer Urgent Care
Pasadena, California, United States
Countries
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Other Identifiers
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SQNM-VIR-403
Identifier Type: -
Identifier Source: org_study_id
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