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

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

  • COVID-19 Respiratory Infection
  • Influenza A
  • Influenza Type B
  • RSV Infection

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.