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Usability and Clinical Validation of the Flu A/B/COVID-19 + RSV Multiplex Rapid Test
Sponsor: CorDx, Inc.
Summary
This will be a prospective study for the clinical validation of the CorDx Tyfast Flu A/B/COVID-19 + RSV Multiplex Rapid Test for the qualitative detection and differentiation of SARS-CoV-2, Influenza A, Influenza B and RSV in AN samples. Results from the CorDx Tyfast Flu A/B/COVID-19 + RSV Multiplex Rapid Test will be compared to results from a 510(k) cleared highly sensitive, multi-analyte reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2, Influenza A, Influenza B and RSV, such as the 510(k) cleared Cepheid Xpert Xpress CoV-2/Flu/RSV plus (K250995).
Official title: Usability and Clinical Validation of the CorDx Tyfast Flu A/B/COVID-19 + RSV Multiplex Rapid Test in Anterior Nasal Samples For Over-the-Counter (OTC) Use
Key Details
Gender
All
Age Range
6 Months - Any
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2026-11-01
Completion Date
2027-12-31
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Flu A/B/COVID-19 + RSV Multiplex Rapid Test
The Flu A/B/COVID-19 + RSV Multiplex Rapid Test is an investigational lateral flow immunoassay intended for the qualitative detection and differentiation of Influenza A, Influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) antigens. Participants will perform the investigational test according to the provided instructions. Test results will be evaluated for diagnostic performance against a reference molecular assay, and usability assessments will be conducted according to the study protocol.
Locations (1)
CorDx
Alpharetta, Georgia, United States