Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test

Starting soon · Not applicable

Conditions studied: SARS-CoV-2 Infection, Influenza A, Influenza B

In brief

The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B \& COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samples collected by lay users, compared to 510(k)-cleared RT-PCR tests. Secondary objectives are to assess usability and instruction comprehension and reproducibility with untrained operators at Clinical Laboratory Improvement Amendments (CLIA)-waived sites.

Key facts

Study ID

NCT07430410

Run by

CorDx, Inc.

People needed

200

Starts

2026-02-12

Expected to finish

2027-02-12

Last updated by the study team

2026-02-25

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent obtained prior to study enrollment.
• Male or female aged 2 years or older.
• Subjects were tested with a Food Drug and Administration (FDA) cleared molecular assay no more than 2 days prior to the study visit.
• Subject, aged 2 years or older, is currently exhibiting one or more symptoms associated with COVID-19 or influenza 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 5 days of symptom onset. Subject must still be exhibiting symptoms on the day of sample collection.

You may not qualify if…

• Subject who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.
• Subject has had seasonal influenza vaccine within the past 5 days.
• Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
• Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
• Subjects currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
• Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
• Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.