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

Sequenom, Inc.1,600 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,600

Conditions

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

Interventions

Labcorp COVID-19+Flu+RSV Test Home Collection KitDEVICE

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

Sex: ALLMin age: 2 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (1)

Exer Urgent Care

Pasadena, California, United States

Outcomes

Primary Outcomes

Collection method comparison

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.

Time frame: 1 day

Secondary Outcomes

Whole blood specimen collection

The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays.

Time frame: 1 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.