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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06008457
Recruitment Status : Completed
First Posted : August 23, 2023
Last Update Posted : May 9, 2024
Sponsor:
Collaborator:
Labcorp Corporation of America Holdings, Inc
Information provided by (Responsible Party):
Sequenom, Inc.

Study Description
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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
COVID-19 Respiratory Infection Influenza A Influenza Type B RSV Infection Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 990 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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 : April 17, 2023
Actual Primary Completion Date : May 3, 2024
Actual Study Completion Date : May 3, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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.


Outcome Measures
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Primary Outcome Measures :
  1. Collection method comparison [ Time Frame: 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 :
  1. Whole blood specimen collection [ Time Frame: 1 day ]
    The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays.


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.

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06008457


Locations
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United States, California
Exer Urgent Care
Pasadena, California, United States, 91107
Sponsors and Collaborators
Sequenom, Inc.
Labcorp Corporation of America Holdings, Inc
Investigators
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Study Director: Graham McLennan, MS Laboratory Corporation of America
More Information
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Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT06008457    
Other Study ID Numbers: SQNM-VIR-403
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Influenza, Human
Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Orthomyxoviridae Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections