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

COVID-19 Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06008457
• Other study ID #: SQNM-VIR-403
• Status: Completed
• Start date: April 17, 2023
• Est. completion date: May 3, 2024

Study information

• Verified date: August 2023
• Source: Sequenom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 990
• Est. completion date: May 3, 2024
• Est. primary completion date: May 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Influenza A
• Influenza Type B
• Influenza, Human
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections
• 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.

Locations

Country	Name	City	State
United States	Exer Urgent Care	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Sequenom, Inc.	Labcorp Corporation of America Holdings, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Whole blood specimen collection	The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays.	1 day