Rapid Test for COVID-19, Flu, and RSV
(CorDx 4in1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Are You a Good Fit for This Trial?
This trial is for people who have symptoms of respiratory infections like COVID-19, flu (A or B), or RSV. Participants must be able to provide a nasal swab sample. There are no detailed inclusion or exclusion criteria listed.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study is testing the accuracy and usability of a rapid test that can detect and tell apart COVID-19, flu A/B, and RSV from a nasal swab. Results will be compared to those from an established lab-based PCR test.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants enrolled in this study will perform testing using the investigational Flu A/B/COVID-19 + RSV Multiplex Rapid Test according to the study protocol. The study will evaluate the clinical performance and usability of the investigational device, including the ability of intended users to perform the test and interpret the results. Investigational test results will be compared with results obtained using the reference molecular assay, Cepheid Xpert Xpress CoV-2/Flu/RSV plus, to assess diagnostic performance.
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Who Is Running the Clinical Trial?
CorDx, Inc.
Lead Sponsor
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