SARS-CoV-2 InfectionCorDx 4in1NCT07875270
Usability and Clinical Validation of the Flu A/B/COVID-19 + RSV Multiplex Rapid Test
A study testing Flu A/B/COVID-19 + RSV Multiplex Rapid Test in people with SARS-CoV-2 Infection and Influenza A, run by CorDx, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- SARS-CoV-2 Infection, Influenza A, Influenza B
- What is being tested?
- Flu A/B/COVID-19 + RSV Multiplex Rapid Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Dec 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 6 months 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 6 months of age and older.
- 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 symptom(s) on the day of sample collection.
- or Participant, aged 6 to <24 months, is currently exhibiting one or more symptoms (i.e. symptomatic) associated with COVID-19, influenza or RSV (such as, but not limited to, fever, cough, short and shallow breathing, unusual tiredness, decrease in appetite, runny nose, vomiting, irritability, diarrhea, flaring of the nostrils, straining of the chest or stomach while breathing, or turning blue around the lips and fingertips) and must present within 6 days of symptoms onset. Participant must still be exhibiting symptoms on the day of sample collection.
- These symptoms (i.e. flaring of the nostrils, straining of the chest or stomach while breathing or turning blue around the lips and fingertips) may be signs of possible severe RSV infection or advanced disease such as bronchiolitis, pneumonia and possible progression to respiratory failure and participants should seek medical attention immediately.
Who cannot join
- Participant who has had a positive SARS-CoV-2, Influenza A, Influenza B and/or RSV result within the past 14 days.
- Participant or participant's legally acceptable representative (for minors) 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.
- Participant has had seasonal influenza, SARS-CoV-2, and/or RSV vaccine within the past 5 days.
- Participant is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
- Participant is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), peramivir (Rapivab®), and ribavirin (Copegus®, Rebetol®, Virazole®).
- Participant is currently undergoing treatment with prescription medication to treat RSV which may include antiviral treatment such as Ribavirin (tribavirin) or monoclonal antibodies such as Palivizumab (Synagis) and Nirsevimab (Beyfortus).
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- Participant currently undergoing treatment and/or has undergone treatment 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.
- Participant who has 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.
- Participant who has had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
CorDx
Alpharetta, Georgia, 30005
Angie Han, 8588886916, angie@cordx.com
About this study
Official title: 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
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).
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B, RSV
- Being tested
- Flu A/B/COVID-19 + RSV 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.
Flu A/B/COVID-19 + RSV Multiplex Rapid TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Diagnostic Testing | Experimental | 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. Receives: Device: Flu A/B/COVID-19 + RSV 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 + RSV 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 + RSV Multiplex Rapid Test for qualitative and differential detection of SARS-CoV-2, Influenza A, and Influenza B antigens in anterior nasal 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, COVID-19, and RSV.
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-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 posted15 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective single-group diagnostic device clinical study designed to evaluate the clinical performance and usability of the investigational Flu A/B/COVID-19 + RSV Multiplex Rapid Test. All enrolled participants will undergo investigational testing according to the study protocol. The clinical performance of the investigational device will be evaluated by comparing its results with those obtained using the reference molecular assay, Cepheid Xpert Xpress CoV-2/Flu/RSV plus. The study will also evaluate the ability of intended users to perform the test and interpret the results correctly. No randomization or assignment to separate treatment groups is planned.
- Masking
- None (open label)
- Enrolment
- 1,500 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
- NCT07875270
- Sponsor's protocol ID
- 17602
- Acronym
- CorDx 4in1
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07875270
- Acronym / sponsor ID
- CorDx 4in1 / 17602
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B, RSV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- CorDx, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Oct 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.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single-group diagnostic device clinical study designed to evaluate the clinical performance and usability of the investigational Flu A/B/COVID-19 + RSV Multiplex Rapid Test. All enrolled participants will undergo investigational testing according to the study protocol. The clinical performance of the investigational device will be evaluated by comparing its results with those obtained using the reference molecular assay, Cepheid Xpert Xpress CoV-2/Flu/RSV plus. The study will also evaluate the ability of intended users to perform the test and interpret the results correctly. No randomization or assignment to separate treatment groups is planned.
| Arm | Type | Receives |
|---|---|---|
| Investigational Diagnostic Testing | Experimental | Device: Flu A/B/COVID-19 + RSV Multiplex Rapid TestParticipants 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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent obtained prior to study enrollment.
- Male or female aged 6 months of age and older.
- 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 symptom(s) on the day of sample collection.
- or Participant, aged 6 to <24 months, is currently exhibiting one or more symptoms (i.e. symptomatic) associated with COVID-19, influenza or RSV (such as, but not limited to, fever, cough, short and shallow breathing, unusual tiredness, decrease in appetite, runny nose, vomiting, irritability, diarrhea, flaring of the nostrils, straining of the chest or stomach while breathing, or turning blue around the lips and fingertips) and must present within 6 days of symptoms onset. Participant must still be exhibiting symptoms on the day of sample collection.
- These symptoms (i.e. flaring of the nostrils, straining of the chest or stomach while breathing or turning blue around the lips and fingertips) may be signs of possible severe RSV infection or advanced disease such as bronchiolitis, pneumonia and possible progression to respiratory failure and participants should seek medical attention immediately.
Key exclusion criteria (9 listed)
- Participant who has had a positive SARS-CoV-2, Influenza A, Influenza B and/or RSV result within the past 14 days.
- Participant or participant's legally acceptable representative (for minors) 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.
- Participant has had seasonal influenza, SARS-CoV-2, and/or RSV vaccine within the past 5 days.
- Participant is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
- Participant is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), peramivir (Rapivab®), and ribavirin (Copegus®, Rebetol®, Virazole®).
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 |
|---|---|---|
| Flu A/B/COVID-19 + RSV Multiplex Rapid TestThe 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. | Device | Investigational Diagnostic Testing |
Primary outcome
Performance of CorDx Tyfast Flu A/B & COVID-19 + RSV 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 + RSV Multiplex Rapid Test for qualitative and differential detection of SARS-CoV-2, Influenza A, and Influenza B antigens in anterior nasal 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, COVID-19, and RSV.
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flu A/B/COVID-19 + RSV Multiplex Rapid Test in people with SARS-CoV-2 Infection and Influenza A, run by CorDx, Inc. at 1 site in United States.
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 5 inclusion and 9 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Angie Han (8585683281, angie@cordx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of CorDx Tyfast Flu A/B & COVID-19 + RSV 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 15 Oct 2026.