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NOT YET RECRUITING
NCT07430410
NA

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

Sponsor: CorDx, Inc.

View on ClinicalTrials.gov

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

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.