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NCT Number: NCT07430410

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

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.

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza A Influenza B Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test

Device

Each subject will provide two anterior nares samples (both nostrils). One sample will be tested using the investigational CorDx Tyfast At-Home Test by the subject or a lay tester following the Quick Reference Instructions. The second sample will be collected by study personnel and sent to a reference laboratory for comparator RT-PCR testing.

Primary outcomes

  1. Performance of CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test measured by agreement with RT-PCR

    Time frame: The estimated length of the sample collection and testing phase is expected to be 6~35 weeks

    The primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test for qualitative and differential detection of SARS-CoV-2, Influenza A, and Influenza B antigens in anterior nasal (AN) samples collected by lay users. Performance will be assessed by calculating positive percent agreement (PPA), negative percent agreement (NPA), and corresponding 95% confidence intervals, compared to FDA-cleared high-sensitivity RT-PCR tests for Influenza A/B and COVID-19.

Secondary outcomes

  1. Usability of investigational test measured by observation of task completion

    Time frame: The estimated length of the sample collection and testing phase is expected to be 6- 35 weeks

    Study personnel will observe and record all procedures completed by the subject/tester, including critical and non-critical tasks and any difficulties encountered with labeling.

Other outcomes

  1. Comprehension and labeling understanding measured by questionnaire

    Time frame: The estimated length of the sample collection and testing phase is expected to be 6~35 weeks

    Comprehension and labeling understanding assessed using a study-specific usability and labeling comprehension questionnaire.

    Upon completion of testing, subjects complete a questionnaire evaluating usability, labeling clarity, and comprehension related to sample collection, test operation, and result interpretation.

    For usability and clarity questions (Questions 1-3 and 6-12), responses are reported as the percentage of subjects selecting "Clear and easy to follow/perform." For labeling comprehension questions (Questions 4-5 and 13-18), outcomes are reported as the percentage of subjects who selected the correct answer for each question.

    Higher percentages indicate better usability, labeling comprehension, and understanding of the test instructions.

  2. Accuracy of mock test interpretation

    Time frame: The estimated length of the sample collection and testing phase is expected to be 6~35 weeks

    The subject/tester will interpret a panel of mock investigational tests with various results prepared according to FDA premarket validation guidance (e.g., negative, positive for Flu A/COVID-19, Flu B/COVID-19, etc.).

Sponsors and collaborators

Lead sponsor

CorDx, Inc.

Industry

Registry information

Official study title

Human Factors and Clinical Validation of the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test Using Anterior Nares Nasal Samples for Over-The-Counter (OTC) Use

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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