COVID-19NCT05715515
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device
A study testing Panbio™ in people with COVID-19 and Influenza A, run by Abbott Rapid Dx at 1 site in United States.
Trial summary
This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, Influenza A, Influenza Type B
- What is being tested?
- Panbio™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 903 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2023to 29 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects from all age groups, able and willing to provide written informed consent or assent, suspected of having a respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches, loss of smell, loss of taste or shortness of breath, will be prospectively enrolled.
Who cannot join
- Subject has had a nasal or a NP swab taken within the last 4 hours and is not available for further testing after 4 hours has elapsed.
- Subject has active nose bleeds or acute facial injuries/trauma.
- Subject has received a nasal vaccine (i.e., FluMist®) within the previous fourteen (14) days.
- Subject is currently taking or has taken an antiviral medication- e.g., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza or COVID-19 within the previous thirty (30) days.
- Subject is currently enrolled in a study to evaluate an investigational drug.
- Self-tester or caregiver has prior medical or laboratory training.
Show all 10Show fewer
- Self-tester or caregiver has a visual impairment that cannot be restored using glasses or contact lenses or lay user is unable to read the Instructions for Use.
- Subject has a condition deemed unfit to safely perform the test.
- Subject is unwilling or unable to provide informed consent.
- Vulnerable populations as deemed inappropriate for the study by the site's PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCCT @ AFC Urgent Care- Easley
Easley, South Carolina, 29640
About this study
This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human nasopharyngeal (NP) and mid-turbinate nasal swabs, respectively.
This study is part of the performance evaluation to support the CE conformity assessment procedures.
Read the detailed description
In total, a minimum of 1531 male and female subjects will be prospectively enrolled at multiple clinical sites. A minimum of 100 lay users will also be asked to interpret randomly assigned mock devices.
After obtaining written informed consent, a study-specific subject identification number (ID) will be assigned to the subject. All eligible subjects will be assigned to both Professional Use arm and the Self-Test arm of the study. Subject demographics and a brief medical history will be collected.
Lay users (self-tester or caregiver) will first collect one mid-turbinate nasal swab from both nostrils, and perform and interpret the Panbio™ Rapid Panel ST device, under the observation of a trained observer. All procedures for testing and result interpretation, including sample collection and extraction, will be conducted following the IFU provided in the kit. Each Panbio™ Rapid Panel ST result will be interpreted firstly by the lay user and followed immediately by the observer who will also photograph the test at the time of interpretation. Each lay user will fill out a user evaluation questionnaire, and a study staff member will complete an observer questionnaire for each lay user. A minimum of 100 lay users will also read mock device tests presented by a study staff member. Mock devices (simulated to represent testing results) will be used for usability testing (result interpretation).
A study staff member will then collect two NP swabs (one swab from each nostril) from all subjects. The first NP swab sample will be used to conduct a Panbio™ Rapid Panel PU test, following the IFU. The test result will be photographed at the time of result interpretation. Each study staff member who performs a Panbio™ Rapid Panel PU test will fill out a user evaluation questionnaire once, to assess the usability of the device.
The second NP swab sample will be eluted in Universal Transport Medium (UTM) provided by Abbott/the Core Laboratory, labelled and stored, according to the laboratory manual. UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, according to the laboratory manual.
Each subject's demographic information, education, symptomology data, test results and questionnaires, where relevant, will be recorded on source documentation and transferred to an Electronic Data Capture system.
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Being tested
- Panbio™
- 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™Diagnostic test
Also called Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Product, Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device
The Panbio™ COVID-19/Flu A\&B Rapid Panel Professional use device is a visual lateral flow assay, for rapid immunochromatographic qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in nasopharyngeal swabs, collected by a trained health worker.
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 |
|---|---|---|
| Nasal sampling/Testing (Self-Test) + Nasopharyngeal sampling/Testing (Professional Use) | 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.
The first NP swab sample will be used to conduct a Panbio™ COVID- 19/FluA\&B Rapid Panel Professional Use test.
The second NP swab sample will be eluted in Universal Transport Medium (UTM) provided by Abbott/the Core Laboratory, labelled and stored, according to the laboratory manual. UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, according to the laboratory manual. Receives: Diagnostic Test: Panbio™ |
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.
To assess the clinical performance (sensitivity/specificity) of the Panbio™ COVID-19/Flu A\&B Rapid Panel in fresh collected mid-turbinate nasal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms in a Near Patient Testing setting, compared to Flu and SARS-CoV-2 RT-PCR tested using NP swab samples. Concordance analyisis of investigational device and reference method. Acceptance criterion: Sensitivity >80%, Specificity >95%
To assess the clinical performance (sensitivity/specificity) of the Panbio™ COVID- 19/Flu A\&B Rapid Panel Self-Test device, as performed by lay users (self-testers or caregivers) using fresh collected mid-turbinate nasal self- collected samples, when compared to Flu and SARS-CoV-2 RT- PCR using NP swab samples.
Measured: "up to 24 months"
Secondary outcomes (3)
Concordance of self-test and professional use device
To assess concordance between the Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test device using mid-turbinate nasal self-collected samples and the Professional Use device using NP samples collected by a trained health worker.
Measured: "up to 24 months"
Usability of the professional use device
To assess the usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel professional use device when used by trained healthcare workers. Usability is assessed by a questionnaire.
Measured: "up to 24 months"
Usability of the self test device
To assess the usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel Self-Test device, as performed by lay users with no laboratory or clinical experience. Usability testing will also comprise of the interpretation of mock devices. User and observer questionnaires will also be utilized to assess usability.
Measured: "up to 24 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start6 Jan 2023
- Primary completion29 May 2023
- Study completion29 May 2023
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
- 903 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
- NCT05715515
- Sponsor's protocol ID
- SDRD-H-029-P
- Status last verified
- Nov 2023
- First submitted
- 9 Jan 2023
- Last updated
- 9 Nov 2023
- 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 9 Nov 2023. 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 Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device
- ClinicalTrials.gov ID
- NCT05715515
- Acronym / sponsor ID
- SDRD-H-029-P
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 8 Feb 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 as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human nasopharyngeal (NP) and mid-turbinate nasal swabs, respectively.
This study is part of the performance evaluation to support the CE conformity assessment procedures.
Detailed description
In total, a minimum of 1531 male and female subjects will be prospectively enrolled at multiple clinical sites. A minimum of 100 lay users will also be asked to interpret randomly assigned mock devices.
After obtaining written informed consent, a study-specific subject identification number (ID) will be assigned to the subject. All eligible subjects will be assigned to both Professional Use arm and the Self-Test arm of the study. Subject demographics and a brief medical history will be collected.
Lay users (self-tester or caregiver) will first collect one mid-turbinate nasal swab from both nostrils, and perform and interpret the Panbio™ Rapid Panel ST device, under the observation of a trained observer. All procedures for testing and result interpretation, including sample collection and extraction, will be conducted following the IFU provided in the kit. Each Panbio™ Rapid Panel ST result will be interpreted firstly by the lay user and followed immediately by the observer who will also photograph the test at the time of interpretation. Each lay user will fill out a user evaluation questionnaire, and a study staff member will complete an observer questionnaire for each lay user. A minimum of 100 lay users will also read mock device tests presented by a study staff member. Mock devices (simulated to represent testing results) will be used for usability testing (result interpretation).
A study staff member will then collect two NP swabs (one swab from each nostril) from all subjects. The first NP swab sample will be used to conduct a Panbio™ Rapid Panel PU test, following the IFU. The test result will be photographed at the time of result interpretation. Each study staff member who performs a Panbio™ Rapid Panel PU test will fill out a user evaluation questionnaire once, to assess the usability of the device.
The second NP swab sample will be eluted in Universal Transport Medium (UTM) provided by Abbott/the Core Laboratory, labelled and stored, according to the laboratory manual. UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, according to the laboratory manual.
Each subject's demographic information, education, symptomology data, test results and questionnaires, where relevant, will be recorded on source documentation and transferred to an Electronic Data Capture system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal sampling/Testing (Self-Test) + Nasopharyngeal sampling/Testing (Professional Use) | Experimental | Diagnostic Test: Panbio™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. The first NP swab sample will be used to conduct a Panbio™ COVID- 19/FluA\&B Rapid Panel Professional Use test. The second NP swab sample will be eluted in Universal Transport Medium (UTM) provided by Abbott/the Core Laboratory, labelled and stored, according to the laboratory manual. UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, according to the laboratory manual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects from all age groups, able and willing to provide written informed consent or assent, suspected of having a respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches, loss of smell, loss of taste or shortness of breath, will be prospectively enrolled.
Key exclusion criteria (10 listed)
- Subject has had a nasal or a NP swab taken within the last 4 hours and is not available for further testing after 4 hours has elapsed.
- Subject has active nose bleeds or acute facial injuries/trauma.
- Subject has received a nasal vaccine (i.e., FluMist®) within the previous fourteen (14) days.
- Subject is currently taking or has taken an antiviral medication- e.g., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza or COVID-19 within the previous thirty (30) days.
- Subject is currently enrolled in a study to evaluate an investigational drug.
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™Also: Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Product, Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test DeviceThe Panbio™ COVID-19/Flu A\&B Rapid Panel Professional use device is a visual lateral flow assay, for rapid immunochromatographic qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in nasopharyngeal swabs, collected by a trained health worker. 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 | Diagnostic test | Nasal sampling/Testing (Self-Test) + Nasopharyngeal sampling/Testing (Professional Use) |
Primary outcome
Sensitivity and specificity of the Panbio™ COVID-19/Flu A&B Rapid Panel device.
Time frame: "up to 24 months"
To assess the clinical performance (sensitivity/specificity) of the Panbio™ COVID-19/Flu A\&B Rapid Panel in fresh collected mid-turbinate nasal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 and/or Flu by their healthcare provider within the first five days of the onset of symptoms in a Near Patient Testing setting, compared to Flu and SARS-CoV-2 RT-PCR tested using NP swab samples. Concordance analyisis of investigational device and reference method. Acceptance criterion: Sensitivity >80%, Specificity >95% To assess the clinical performance (sensitivity/specificity) of the Panbio™ COVID- 19/Flu A\&B Rapid Panel Self-Test device, as performed by lay users (self-testers or caregivers) using fresh collected mid-turbinate nasal self- collected samples, when compared to Flu and SARS-CoV-2 RT- PCR using NP swab samples.
3 secondary outcomes
Concordance of self-test and professional use device
Time frame: "up to 24 months"
Usability of the professional use device
Time frame: "up to 24 months"
Usability of the self test device
Time frame: "up to 24 months"
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 9 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panbio™ in people with COVID-19 and Influenza A, run by Abbott Rapid Dx 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 1 inclusion and 10 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 9 Nov 2023. 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?
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: "up to 24 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 9 Nov 2023.