NCT07430410

Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test

Human Factors and Clinical Validation of the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test Using Anterior Nares Nasal Samples for Over-The-Counter (OTC) Use

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: CorDx, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B \& COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samples collected by lay users, compared to 510(k)-cleared RT-PCR tests. Secondary objectives are to assess usability and instruction comprehension and reproducibility with untrained operators at Clinical Laboratory Improvement Amendments (CLIA)-waived sites.

Conditions

• SARS-CoV-2 Infection
• Influenza A
• Influenza B

Interventions

Type	Name	Description
DEVICE	CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test	Each subject will provide two anterior nares samples (both nostrils). One sample will be tested using the investigational CorDx Tyfast At-Home Test by the subject or a lay tester following the Quick Reference Instructions. The second sample will be collected by study personnel and sent to a reference laboratory for comparator RT-PCR testing.

Timeline

• Start date: 2026-02-12
• Primary completion: 2026-12-12
• Completion: 2027-02-12
• First posted: 2026-02-24
• Last updated: 2026-02-25

Regulatory

• FDA-regulated device study