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Purpose

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).

Conditions

Eligibility

Eligible Ages
Between 2 Years and 89 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Self-collection first Subjects will self-collect an anterior nasal swab first
  • Device: 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
  • Device: 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.

Recruiting Locations

More Details

NCT ID
NCT06008457
Status
Completed
Sponsor
Sequenom, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.