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
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).
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent obtained prior to study enrollment. 2. Male or female aged 6 months of age and older. 3. Participant, aged 2 years and older, is currently exhibiting at least one or more symptoms (i.e. symptomatic) associated with COVID-19, influenza and RSV (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) and must present within 6 days of symptom onset (equates to 5 DPSO). Subject must still be exhibiting…
Interventions
- DeviceFlu 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.
Location
- CorDxAlpharetta, Georgia