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NOT YET RECRUITING
NCT07875270
NA

Usability and Clinical Validation of the Flu A/B/COVID-19 + RSV Multiplex Rapid Test

Sponsor: CorDx, Inc.

View on ClinicalTrials.gov

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

DEVICE

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