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

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.

NCT Number	NCT07430410
Lead Sponsor	CorDx, Inc.
Conditions	SARS-CoV-2 Infection, Influenza A, Influenza B
Enrollment	200 participants
Start Date	2026-02-12
Primary Completion	2026-12-12 (estimated)
Study Completion	2027-02-12 (estimated)
Updated on ClinicalTrials.gov	2026-02-25