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

Sequenom

Status

Completed

Conditions

Influenza A

COVID-19 Respiratory Infection

RSV Infection

Influenza Type B

Treatments

Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit

Study type

Observational

Funder types

Industry

Identifiers

NCT06008457

SQNM-VIR-403

Details and patient eligibility

About

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).

Enrollment

990 patients

Sex

All

Ages

2 to 89 years old

Volunteers

No Healthy Volunteers

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

no personal access to the internet and no email address
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.