Influenza Type ANCT06928129
Clinical Feasibility of the BinaxNOW™ COVID-19/Flu A&B Combo in the Southern Hemisphere
A study testing BinaxNOW™ COVID-19/Flu A&B Combo Self-Test in people with Influenza Type A and Influenza Type B, run by Abbott Rapid Dx.
Trial summary
The study is designed as a clinical feasibility, to investigate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A\&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Influenza Type A, Influenza Type B, COVID-19
- What is being tested?
- BinaxNOW™ COVID-19/Flu A&B Combo Self-Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 1 Nov 2025
- 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
- Participant is at least two (2) years of age, AND Participant is suspected of acute viral respiratory infection by a healthcare professional, AND
- Participant is within five (5) days of symptom onset, AND
- Participant is experiencing two or more of the following symptoms:
- Fever of >100.0°F/ 37.8°C or chills, Cough, Fatigue, New loss of taste or smell, Congestion or runny nose, Shortness of breath or difficulty breathing, Sore throat, Muscle or body aches, Headache
- -The Participant and/or legally authorized representative is willing to undergo the informed consent/Assent process prior to study participation. A minor will need the documented consent of their parent or legal guardian unless the site has an HREC waiver for parental consent for minors.
Who cannot join
- Participant is currently enrolled in a study to evaluate an investigational drug or experimental treatment
- Participants with an active nosebleed
- Participant has undergone a nasal wash or nasal aspirate procedure on day of enrolment
- Participant has tested positive for COVID-19 within the last 45 days
- Participant has received a nasal vaccine (i.e. FluMist®) within the past 30 days.
- Participant has received antiviral medications for Influenza (Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days.
- Participant has received medication or treatment for COVID-19 infection in the last 45 days (including antivirals (such as Paxlovid), convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)
- Participant is unable to meet all inclusion criteria as listed above
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The study is designed as a clinical feasibility, to investigate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A\&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the patient/lay user.
Read the detailed description
Approximately 700 symptomatic participants will be enrolled to achieve at least 61 COVID PCR positive, 45 Flu A PCR positives, 30 Flu B PCR positives and 301 COVID and Influenza PCR negatives.
The total number of research-related anterior nasal swabs collected from each consented Participant is two (2). Participants ages two (2) years and older meeting eligibility criteria will be enrolled.
The order of nasal swab collection will be randomized according to the Participant ID as to which swab is used for BinaxNOW™ COVID-19/Flu A\&B Combo and which is to be eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing.
For Participants with an odd numbered Participant ID, the first swab will be self-collected and used for the BinaxNOW™ COVID-19/Flu A\&B Combo. The second swab will be collected by a healthcare professional and eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing. The Participant will review the Instructions for Use, collect the nasal swab, and perform the BinaxNOW™ COVID-19/Flu A\&B Combo, then interpret and record the result at the time specified in the product instructions.
For Participants with an even numbered Participant ID, the first swab will be collected by a healthcare professional and eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing. The second swab will be self-collected and used for the BinaxNOW™ COVID-19/Flu A\&B Combo. Once the healthcare provider collected the swab for the comparator test the Participant will review the Instructions for Use.
The VTM/UTM samples will be stored, handled, and tested with comparator assays according to the manufacturers' product instructions. VTM/UTM specimens can be stored for up to 48 hours at 2-8°C. If delivery and processing of samples exceeds specified time periods, specimens should be transported in dry ice and once in laboratory frozen at -70°C or colder.
Each Participant's demographic data, inclusion/exclusion data, days of symptom onset, comparator results, Education level, occupation, and socioeconomic status and other data points will be documented on the data collection worksheets and EDC.
- Conditions
- Influenza Type A, Influenza Type B, COVID-19
- Being tested
- BinaxNOW™ COVID-19/Flu A&B Combo Self-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.
BinaxNOW™ COVID-19/Flu A&B Combo Self-TestDiagnostic test
Diagnostic Test: BinaxNOW™ COVID-19/Flu A\&B Combo Self-Test
The BinaxNOW™ COVID-19/Flu A\&B Combo Self-Test is a visually read lateral flow in vitro immunoassay for the qualitative detection and differentiation of the nucleocapsid protein antigen to SARS-CoV-2, Influenza A, and Influenza B directly in anterior nasal swab specimens from individuals with signs and symptoms of respiratory infection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental: Nasal sampling/Testing (Self-Test) | Experimental | Each Participant will be provided a single-use test kit containing a BinaxNOW™ COVID-19/Flu A\&B Combo, buffer and a sterile nasal swab. The Participant will self-collect one (1) anterior nasal swab, perform the BinaxNOW™ COVID-19/Flu A\&B Combo, then interpret and record the result. The testing will be completed in a home like setting. After the anterior nasal swab is collected, the operator or delegated study staff will collect one anterior nasal swab from both nostrils of the subject for RT-PCR testing. VTM samples will be shipped daily to the central lab for testing with the RT-PCR protocols for Flu A, Flu B and SARS-CoV-2.
The order of collections will be based off the subject number. Receives: Diagnostic Test: BinaxNOW™ COVID-19/Flu A&B Combo Self-Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA)
The primary objective of this study is to demonstrate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A\&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the patient/lay user. The patient/lay user will perform the test, read, and interpret the test result.
Measured: 5 months
Secondary outcomes (1)
Demonstrate the accuracy of the BinaxNOW™ COVID-19/Flu A&B Combo Self-Test in patient/lay user
The secondary objective of this study is to demonstrate the accuracy of the BinaxNOW™ COVID-19/Flu A\&B Combo Self-Test in the hands of patients/lay users, which are "intended users" in a point of care (POC) Clinical Laboratory Improvement Amendments of 1988 (CLIA) moderate, high or waived complexity test environment
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start30 Jun 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Type AStudies 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
- Study staff will collect two (2) anterior nasal swabs from each Participant. The Participant will self-collect one (1) anterior nasal swab, perform the BinaxNOW™ COVID-19/Flu A\&B Combo, then interpret and record the result. Site staff will collect one (1) anterior nasal swab from the Participant by inserting the swab up to 1 inch into one of the anterior naris. Staff will rotate the swab against the nasal mucosa five (5) times to obtain sample and withdraw. Staff will repeat with the other anterior naris using the same swab, and vigorously elute the swab in Viral Transport Medium (VTM)/Universal Transport Media (UTM) immediately (within 5 minutes) of sample collection. The swab should be rotated vigorously in the VTM/UTM liquid for 10 seconds. The swab head will be left in the VTM/UTM, by snapping the shaft or clipping the base of the swab if necessary
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928129
- Sponsor's protocol ID
- 2506401
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share as this is a feasibility trial.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of the BinaxNOW™ COVID-19/Flu A&B Combo in the Southern Hemisphere
- ClinicalTrials.gov ID
- NCT06928129
- Acronym / sponsor ID
- 2506401
- Conditions
- Influenza Type A, Influenza Type B, COVID-19
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 15 Apr 2025 (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 is designed as a clinical feasibility, to investigate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A\&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the patient/lay user.
Detailed description
Approximately 700 symptomatic participants will be enrolled to achieve at least 61 COVID PCR positive, 45 Flu A PCR positives, 30 Flu B PCR positives and 301 COVID and Influenza PCR negatives.
The total number of research-related anterior nasal swabs collected from each consented Participant is two (2). Participants ages two (2) years and older meeting eligibility criteria will be enrolled.
The order of nasal swab collection will be randomized according to the Participant ID as to which swab is used for BinaxNOW™ COVID-19/Flu A\&B Combo and which is to be eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing.
For Participants with an odd numbered Participant ID, the first swab will be self-collected and used for the BinaxNOW™ COVID-19/Flu A\&B Combo. The second swab will be collected by a healthcare professional and eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing. The Participant will review the Instructions for Use, collect the nasal swab, and perform the BinaxNOW™ COVID-19/Flu A\&B Combo, then interpret and record the result at the time specified in the product instructions.
For Participants with an even numbered Participant ID, the first swab will be collected by a healthcare professional and eluted into VTM/UTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing. The second swab will be self-collected and used for the BinaxNOW™ COVID-19/Flu A\&B Combo. Once the healthcare provider collected the swab for the comparator test the Participant will review the Instructions for Use.
The VTM/UTM samples will be stored, handled, and tested with comparator assays according to the manufacturers' product instructions. VTM/UTM specimens can be stored for up to 48 hours at 2-8°C. If delivery and processing of samples exceeds specified time periods, specimens should be transported in dry ice and once in laboratory frozen at -70°C or colder.
Each Participant's demographic data, inclusion/exclusion data, days of symptom onset, comparator results, Education level, occupation, and socioeconomic status and other data points will be documented on the data collection worksheets and EDC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study staff will collect two (2) anterior nasal swabs from each Participant. The Participant will self-collect one (1) anterior nasal swab, perform the BinaxNOW™ COVID-19/Flu A\&B Combo, then interpret and record the result. Site staff will collect one (1) anterior nasal swab from the Participant by inserting the swab up to 1 inch into one of the anterior naris. Staff will rotate the swab against the nasal mucosa five (5) times to obtain sample and withdraw. Staff will repeat with the other anterior naris using the same swab, and vigorously elute the swab in Viral Transport Medium (VTM)/Universal Transport Media (UTM) immediately (within 5 minutes) of sample collection. The swab should be rotated vigorously in the VTM/UTM liquid for 10 seconds. The swab head will be left in the VTM/UTM, by snapping the shaft or clipping the base of the swab if necessary
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental: Nasal sampling/Testing (Self-Test) | Experimental | Diagnostic Test: BinaxNOW™ COVID-19/Flu A&B Combo Self-TestEach Participant will be provided a single-use test kit containing a BinaxNOW™ COVID-19/Flu A\&B Combo, buffer and a sterile nasal swab. The Participant will self-collect one (1) anterior nasal swab, perform the BinaxNOW™ COVID-19/Flu A\&B Combo, then interpret and record the result. The testing will be completed in a home like setting. After the anterior nasal swab is collected, the operator or delegated study staff will collect one anterior nasal swab from both nostrils of the subject for RT-PCR testing. VTM samples will be shipped daily to the central lab for testing with the RT-PCR protocols for Flu A, Flu B and SARS-CoV-2. The order of collections will be based off the subject number. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is at least two (2) years of age, AND Participant is suspected of acute viral respiratory infection by a healthcare professional, AND
- Participant is within five (5) days of symptom onset, AND
- Fever of >100.0°F/ 37.8°C or chills, Cough, Fatigue, New loss of taste or smell, Congestion or runny nose, Shortness of breath or difficulty breathing, Sore throat, Muscle or body aches, Headache
- -The Participant and/or legally authorized representative is willing to undergo the informed consent/Assent process prior to study participation. A minor will need the documented consent of their parent or legal guardian unless the site has an HREC waiver for parental consent for minors.
Key exclusion criteria (8 listed)
- Participant is currently enrolled in a study to evaluate an investigational drug or experimental treatment
- Participants with an active nosebleed
- Participant has undergone a nasal wash or nasal aspirate procedure on day of enrolment
- Participant has tested positive for COVID-19 within the last 45 days
- Participant has received a nasal vaccine (i.e. FluMist®) within the past 30 days.
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 |
|---|---|---|
| BinaxNOW™ COVID-19/Flu A&B Combo Self-TestDiagnostic Test: BinaxNOW™ COVID-19/Flu A\&B Combo Self-Test The BinaxNOW™ COVID-19/Flu A\&B Combo Self-Test is a visually read lateral flow in vitro immunoassay for the qualitative detection and differentiation of the nucleocapsid protein antigen to SARS-CoV-2, Influenza A, and Influenza B directly in anterior nasal swab specimens from individuals with signs and symptoms of respiratory infection. | Diagnostic test | Experimental: Experimental: Nasal sampling/Testing (Self-Test) |
Primary outcome
Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA)
Time frame: 5 months
The primary objective of this study is to demonstrate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19/Flu A\&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the patient/lay user. The patient/lay user will perform the test, read, and interpret the test result.
1 secondary outcome
Demonstrate the accuracy of the BinaxNOW™ COVID-19/Flu A&B Combo Self-Test in patient/lay user
Time frame: 5 months
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 Apr 2025.
- Individual participant dataSharing planned: No. No plans to share as this is a feasibility trial.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing BinaxNOW™ COVID-19/Flu A&B Combo Self-Test in people with Influenza Type A and Influenza Type B, run by Abbott Rapid Dx.
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 8 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 Apr 2025. 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?
Contact Samantha Parsons, Manager of Clinical Operations (000-000-0000, samantha.parsons@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) (time frame: 5 months). 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 Apr 2025.