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Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test
Sponsor: CorDx, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-02-12
Completion Date
2027-02-12
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
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.