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

Study acronym: CorDx 4in1
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Study First Submitted
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).
Trial Details
NCT Number NCT07875270
Lead Sponsor CorDx, Inc.
Conditions
(from sponsor)		 SARS-CoV-2 Infection, Influenza A, Influenza B, RSV
Related terms COVID-19
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov