NCT06008457

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (actual)
• Sponsor: Sequenom, Inc. · Industry
• Sex: All
• Age: 2 Years – 89 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-17
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2023-08-23
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States