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

NCT06008457 | Completed

• 1 other identifier: SQNM-VIR-403
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (1)

• Whole blood specimen collection

  1 day

Study Arms (2)

Self-collection first

Subjects will self-collect an anterior nasal swab first

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

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

Interventions

Labcorp COVID-19+Flu+RSV Test Home Collection Kit DEVICE

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; Self-collection first

Eligibility Criteria

• Age: 2 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female patients ≥2 years of age who present to the participating study clinics with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19 and who meet all study inclusion criteria and no exclusion criteria will be considered for enrollment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sequenom, Inc.: lead
• Labcorp Corporation of America Holdings, Inc: collaborator

Study Sites (1)

Exer Urgent Care

Pasadena, California, 91107, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Remnant swab samples from all subjects (positive and negative) and isolated viral DNA will be maintained for future related research. No human DNA will be maintained.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Graham McLennan, MS

  Laboratory Corporation of America

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 23, 2023
• Study Start: April 17, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)