COVID-19 Respiratory Infection, Influenza A, Influenza Type B, RSV Infection
Conditions
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 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).
Interventions
DEVICELabcorp 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.
Sponsors
Labcorp Corporation of America Holdings, Inc
Sequenom, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection method comparison | 1 day | To evaluate the concordance between the results of a self-collected AN swab specimen using the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as analyzed by the Labcorp Seasonal Respiratory Virus RT-PCR Test and an HCP-collected AN swab as analyzed by the comparator assays in subjects presenting with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Whole blood specimen collection | 1 day | The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays. |
Countries
United States
Outcome results
None listed