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

• ClinicalTrials.gov Identifier: NCT06008457
• Recruitment Status: Completed
• First Posted: August 23, 2023
• Last Update Posted: May 9, 2024
• Sponsor: Sequenom, Inc.
• Collaborator: Labcorp Corporation of America Holdings, Inc
• Information provided by (Responsible Party): Sequenom, Inc.

Tracking Information

• First Submitted Date: August 21, 2023
• First Posted Date: August 23, 2023
• Last Update Posted Date: May 9, 2024
• Actual Study Start Date: April 17, 2023
• Actual Primary Completion Date: May 3, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 21, 2023)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 21, 2023)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit
• Official Title: Prospective Clinical Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as Offered Commercially by Labcorp - A Registry Study
• 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 Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months

Biospecimen

Retention:   Samples With DNA

Description:

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.

• 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.

Condition

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

Intervention

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.

Study Groups/Cohorts

• Self-collection first
  Subjects will self-collect an anterior nasal swab first
  Intervention: 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
  Intervention: Device: Labcorp COVID-19+Flu+RSV Test Home Collection Kit

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2024): 990
• Original Estimated Enrollment (submitted: August 21, 2023): 1000
• Actual Study Completion Date: May 3, 2024
• Actual Primary Completion Date: May 3, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 89 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06008457
• Other Study ID Numbers: SQNM-VIR-403
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: There are no plans to share data

• Current Responsible Party: Sequenom, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Sequenom, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Labcorp Corporation of America Holdings, Inc

Investigators

• Study Director: Graham McLennan, MS; Laboratory Corporation of America

• PRS Account: Sequenom, Inc.
• Verification Date: August 2023