COVID-19NCT06124638
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use
A study testing Panbio™ COVID-19/Flu A&B Panel in people with COVID-19 and Influenza A, run by Abbott Rapid Dx at 2 sites in United States.
Trial summary
This study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A\&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subjects/lay-users who are symptomatic and suspected of viral respiratory infection. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- COVID-19, Influenza A, Influenza Type B
- What is being tested?
- Panbio™ COVID-19/Flu A&B Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2023to 3 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 seven (7) days of symptom onset, and
- Participant is experiencing two or more of the following symptoms
- Fever of >100.0°F/ 37.8°C
- Cough
Show all 15Show fewer
- Fatigue
- New loss of taste or smell
- Congestion or runny nose
- Shortness of breath or difficulty breathing
- Sore throat
- Muscle or body aches
- Headache
- Nausea or vomiting
- Diarrhea
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 received a nasal spray or mist Influenza vaccine (i.e. FluMist) within the last 30 days
- Participant has tested positive for COVID-19 within the last 45 days (excluding test results received after current onset of symptoms)
- 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, convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Maimonides Medical Center
Brooklyn, New York, 11219
Cahaba Research Inc
Pelham, Alabama, 35124
About this study
This study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A\&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subjects/lay-users who are symptomatic and suspected of viral respiratory infection. They will perform, read, and interpret the test result. The test is intended for nonprescription home use for qualitative detection of COVID-19, Influenza A antigen, and Influenza B antigen.
Read the detailed description
The total number of anterior nasal swabs collected from each consented Participant is two (2). Participants at least two (2) years of age 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 Panbio™ COVID-19/Flu A\&B Panel Self Test and which is to be eluted into VTM for comparator testing. Site staff should allow for a minimum 15 minute period between the 2 swabs to allow for normalization of the swabbing site. For Participants with an odd numbered Participant ID, the first swab collected will be used for Panbio™ COVID-19/Flu A\&B Panel Self Test and the second swab collected will be eluted into VTM for comparator testing. For Participants with an even numbered Participant ID, the first swab collected will be eluted into VTM for comparator testing and the second swab collected will be used for Panbio™ COVID-19/Flu A\&B Panel Self Test.
Sample collection for the Self Test:
Each Participant (lay user who will be a self-tester or caregiver) from whom informed consent has been obtained will be provided a single use test kit containing a Panbio™ COVID-19/Flu A\&B Panel Self Test and a sterile nasal swab. The Participant will self-collect one (1) anterior nasal swab, perform the Panbio™ COVID- 19/Flu A\&B Panel Self Test, then interpret and record the result. Parents of pediatric participants under the age of 14 or Legally Authorized Representatives of adult Participants unable to perform self-collection will collect one (1) anterior nasal swab from the Participant, perform the Panbio™ COVID-19/Flu A\&B Panel Self Test, then interpret and record the result. To simulate a home environment testing will occur in a designated room/area that does not contain medical equipment. The designated room/area will at minimum contain a table/counter, chair and lamp for testing. The participant will be provided with the Instructions for Use prior to testing. Participants will not be able to observe other participants conducting testing. The Participant will follow Panbio instructions to insert the swab up to one inch first into the right nostril, to rotate/swirl the swab five (5) times to obtain sample, then remove and insert the same swab into the left nostril, repeating the rotate/swirl technique. After sample collection, Participants will test the sample on the Panbio™ COVID-19/Flu A\&B Panel Self Test and interpret the results. Participants will be asked to document their result interpretation, and will pass the completed test to site staff, who will independently and separately document their interpretation of the result. Site staff will interpret the test immediately and at the same time photograph the test result. Site staff will be blinded to the test result recorded by the Participant. Participants/lay users, caregivers, and site staff will be blinded to a Participant's standard of care COVID-19 and/or Flu test results.
Sample collection for the comparator:
Site staff will collect one (1) anterior nasal swab from the Participant by inserting the swab 1-2 cm into one of the anterior nares. Staff will rotate the swab against the nasal mucosa for about 3 seconds and withdraw. Staff will repeat with the other anterior nare using the same swab, and vigorously elute the swab in Viral Transport Medium (VTM). VTM will be send to the central lab and be tested with reverse transcriptase - Polymerase Chain Reaction (RT-PCR).
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Being tested
- Panbio™ COVID-19/Flu A&B Panel
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panbio™ COVID-19/Flu A&B PanelDiagnostic test
The Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test device is a visual lateral flow assay, for rapid immunochromatographic qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in self-collected mid-turbinate nasal swabs. The test is designed to be used by lay users.
| Study group | Role | What they receive |
|---|---|---|
| Self-Testing Group | Experimental | Lay users (self-tester or caregiver) will be provided with a Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test kit. Each lay user will collect one mid-turbinate nasal swab from both nostrils, perform and interpret the Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test. All procedures for testing and result interpretation, including sample collection and extraction will be conducted by the lay user following the Instructions for Use provided in the kit. Participants will be asked to document their result interpretation and will pass the test to site staff, who will document their interpretation of the result. In addition, a second swab will be collected by study staff and eluted in Viral Transport Medium (VTM). Receives: Diagnostic Test: Panbio™ COVID-19/Flu A&B Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device
The primary objective of this study is to demonstrate the positive and negative percent agreement (PPA and NPA) of the Panbio™ COVID-19/Flu A\&B Panel Self Test against the comparator Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236), in symptomatic patients suspected of respiratory viral 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: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start4 Dec 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Masking
- None (open label)
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124638
- Sponsor's protocol ID
- 2324101
- Status last verified
- Jan 2024
- First submitted
- 8 Nov 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel to Support Home Use
- ClinicalTrials.gov ID
- NCT06124638
- Acronym / sponsor ID
- 2324101
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 9 Nov 2023 (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 study is designed to demonstrate the performance and usability of the the Panbio™ COVID-19/Flu A\&B Panel Self Test in the hands of patients/lay-users. Nasal swabs will be self-collected by subjects/lay-users who are symptomatic and suspected of viral respiratory infection. They will perform, read, and interpret the test result. The test is intended for nonprescription home use for qualitative detection of COVID-19, Influenza A antigen, and Influenza B antigen.
Detailed description
The total number of anterior nasal swabs collected from each consented Participant is two (2). Participants at least two (2) years of age 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 Panbio™ COVID-19/Flu A\&B Panel Self Test and which is to be eluted into VTM for comparator testing. Site staff should allow for a minimum 15 minute period between the 2 swabs to allow for normalization of the swabbing site. For Participants with an odd numbered Participant ID, the first swab collected will be used for Panbio™ COVID-19/Flu A\&B Panel Self Test and the second swab collected will be eluted into VTM for comparator testing. For Participants with an even numbered Participant ID, the first swab collected will be eluted into VTM for comparator testing and the second swab collected will be used for Panbio™ COVID-19/Flu A\&B Panel Self Test.
Sample collection for the Self Test:
Each Participant (lay user who will be a self-tester or caregiver) from whom informed consent has been obtained will be provided a single use test kit containing a Panbio™ COVID-19/Flu A\&B Panel Self Test and a sterile nasal swab. The Participant will self-collect one (1) anterior nasal swab, perform the Panbio™ COVID- 19/Flu A\&B Panel Self Test, then interpret and record the result. Parents of pediatric participants under the age of 14 or Legally Authorized Representatives of adult Participants unable to perform self-collection will collect one (1) anterior nasal swab from the Participant, perform the Panbio™ COVID-19/Flu A\&B Panel Self Test, then interpret and record the result. To simulate a home environment testing will occur in a designated room/area that does not contain medical equipment. The designated room/area will at minimum contain a table/counter, chair and lamp for testing. The participant will be provided with the Instructions for Use prior to testing. Participants will not be able to observe other participants conducting testing. The Participant will follow Panbio instructions to insert the swab up to one inch first into the right nostril, to rotate/swirl the swab five (5) times to obtain sample, then remove and insert the same swab into the left nostril, repeating the rotate/swirl technique. After sample collection, Participants will test the sample on the Panbio™ COVID-19/Flu A\&B Panel Self Test and interpret the results. Participants will be asked to document their result interpretation, and will pass the completed test to site staff, who will independently and separately document their interpretation of the result. Site staff will interpret the test immediately and at the same time photograph the test result. Site staff will be blinded to the test result recorded by the Participant. Participants/lay users, caregivers, and site staff will be blinded to a Participant's standard of care COVID-19 and/or Flu test results.
Sample collection for the comparator:
Site staff will collect one (1) anterior nasal swab from the Participant by inserting the swab 1-2 cm into one of the anterior nares. Staff will rotate the swab against the nasal mucosa for about 3 seconds and withdraw. Staff will repeat with the other anterior nare using the same swab, and vigorously elute the swab in Viral Transport Medium (VTM). VTM will be send to the central lab and be tested with reverse transcriptase - Polymerase Chain Reaction (RT-PCR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-Testing Group | Experimental | Diagnostic Test: Panbio™ COVID-19/Flu A&B PanelLay users (self-tester or caregiver) will be provided with a Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test kit. Each lay user will collect one mid-turbinate nasal swab from both nostrils, perform and interpret the Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test. All procedures for testing and result interpretation, including sample collection and extraction will be conducted by the lay user following the Instructions for Use provided in the kit. Participants will be asked to document their result interpretation and will pass the test to site staff, who will document their interpretation of the result. In addition, a second swab will be collected by study staff and eluted in Viral Transport Medium (VTM). |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 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 seven (7) days of symptom onset, and
- Participant is experiencing two or more of the following symptoms
Key exclusion criteria (7 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 received a nasal spray or mist Influenza vaccine (i.e. FluMist) within the last 30 days
- Participant has tested positive for COVID-19 within the last 45 days (excluding test results received after current onset of symptoms)
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 |
|---|---|---|
| Panbio™ COVID-19/Flu A&B PanelThe Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test device is a visual lateral flow assay, for rapid immunochromatographic qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in self-collected mid-turbinate nasal swabs. The test is designed to be used by lay users. | Diagnostic test | Self-Testing Group |
Primary outcome
Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device
Time frame: 6 months
The primary objective of this study is to demonstrate the positive and negative percent agreement (PPA and NPA) of the Panbio™ COVID-19/Flu A\&B Panel Self Test against the comparator Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236), in symptomatic patients suspected of respiratory viral 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panbio™ COVID-19/Flu A&B Panel in people with COVID-19 and Influenza A, run by Abbott Rapid Dx at 2 sites 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 15 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: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device (time frame: 6 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 19 Aug 2024.