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

Sponsor

Sequenom, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06008457

Collaborator

Labcorp Corporation of America Holdings, Inc (Industry)

1,000

Enrollment

Location

Anticipated Duration (Months)

76.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Respiratory Infection Influenza A Influenza Type B RSV Infection	Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Clinical Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as Offered Commercially by Labcorp - A Registry Study

Actual Study Start Date :

Apr 17, 2023

Anticipated Primary Completion Date :

Apr 17, 2024

Anticipated Study Completion Date :

May 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Self-collection first Subjects will self-collect an anterior nasal swab first	Device: Labcorp 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.
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 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.

Arm

Intervention/Treatment

Self-collection first

Subjects will self-collect an anterior nasal swab first

Device: Labcorp 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.

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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.