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

Completed

• Conditions: Influenza A; RSV Infection; COVID-19 Respiratory Infection; Influenza Type B
• Interventions: Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit

• Registration Number: NCT06008457
• Lead Sponsor: Sequenom, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-17
• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-23
• Primary Completion: 2024-05-03
• Study Completion: 2024-05-03
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 990

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCP-collection first	Labcorp COVID-19+Flu+RSV Test Home Collection Kit	Subjects will have their healthcare provider collect an anterior nasal swab first
Self-collection first	Labcorp COVID-19+Flu+RSV Test Home Collection Kit	Subjects will self-collect an anterior nasal swab first

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Exer Urgent Care; 🇺🇸 Pasadena, California, United States