SARS-CoV-2 InfectionNCT07430410
Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test
A study testing CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test in people with SARS-CoV-2 Infection and Influenza A, run by CorDx, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, Influenza A, Influenza B
- What is being tested?
- CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 12 Feb 2026to 12 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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
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.
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Being tested
- CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: CorDx Tyfast Flu A/B & COVID-19 At-Home Test | Experimental | All participants will provide two anterior nares samples. One sample will be tested using the investigational CorDx Tyfast Flu A/B \& COVID-19 At-Home Multiplex Rapid Test, and the other sample will be tested using a 510(k)-cleared high-sensitivity Reverse transcriptase polymerase chain reaction (RT-PCR) assay for Influenza A/B and SARS-CoV-2. This arm evaluates the diagnostic performance, usability, and reproducibility of the investigational test in lay users. Receives: Device: CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test measured by agreement with RT-PCR
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.
Measured: The estimated length of the sample collection and testing phase is expected to be 6~35 weeks
Secondary outcomes (1)
Usability of investigational test measured by observation of task completion
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.
Measured: The estimated length of the sample collection and testing phase is expected to be 6- 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start12 Feb 2026 (estimated)
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorDx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430410
- Sponsor's protocol ID
- 2512158
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07430410
- Acronym / sponsor ID
- 2512158
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CorDx, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (estimated)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Feb 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: CorDx Tyfast Flu A/B & COVID-19 At-Home Test | Experimental | Device: CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid TestAll participants will provide two anterior nares samples. One sample will be tested using the investigational CorDx Tyfast Flu A/B \& COVID-19 At-Home Multiplex Rapid Test, and the other sample will be tested using a 510(k)-cleared high-sensitivity Reverse transcriptase polymerase chain reaction (RT-PCR) assay for Influenza A/B and SARS-CoV-2. This arm evaluates the diagnostic performance, usability, and reproducibility of the investigational test in lay users. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid TestEach 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. | Device | Single Arm: CorDx Tyfast Flu A/B & COVID-19 At-Home Test |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test in people with SARS-CoV-2 Infection and Influenza A, run by CorDx, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.