COVID-19NCT05163730
Clinical Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel
A study testing COVID-19/ Flu A&B Rapid Panel in people with COVID-19 and Influenza A, run by Abbott Rapid Diagnostics Jena GmbH at 1 site in United States.
Trial summary
This study is designed as a prospective, multicentric, clinical study to investigate the performance of the Panbio™ COVID-19/ Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal swabs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Influenza A, Influenza Type B
- What is being tested?
- COVID-19/ Flu A&B Rapid Panel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,472 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 11 Feb 2022
- 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
- Healthy volunteers accepted
- 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 seven days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, extreme 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 nasopharyngeal swab taken within the last 4 hours.
- Subject has active nose bleeds or acute facial injuries/trauma
- Subject has received a nasal vaccine (i.e., FluMist®) within the previous five (5) days.
- Subject is currently taking or has taken an antiviral medication-i.e., Amantadine, Rimantadine, Relenza® (Zanamivir), Tamiflu® (Oseltamivir Phosphate), and Flumadine®-for influenza within the previous thirty (30) days.
- Subject is currently enrolled in a study to evaluate an investigational drug.
- Subject is unwilling or unable to provide informed consent.
- Vulnerable populations as deemed inappropriate for study by the site's PI and/or reviewing REC (Research Ethics Committee).
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed as a prospective, multicentric, clinical study to investigate the performance of the Panbio™ COVID-19/ Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal swabs.
This study is part of the performance evaluation to support the CE conformity assessment procedures.
Read the detailed description
After obtaining written informed consent, a study-specific participant identification number (ID) will be assigned to the participant. Participant demographics and a brief medical history will be collected.
One nasal swab sample will be collected from both nostrils by operators and will be used to perform the Panbio™ COVID-19/ Flu A\&B Rapid Panel test either in a laboratory or in a non-laboratory setting (e.g. GP (general practitioner) centre or hospital clinic). Each Panbio™ COVID-19/ Flu A\&B Rapid Panel result will be photographed by the observer at the time of test interpretation.
Nasopharyngeal samples will be collected and used for RT-PCR (Reverse transcription polymerase chain reaction) testing as per local procedures.
Nasal samples must always be collected prior to the Nasopharyngeal sampling. A minimum of 90 Flu A positive subjects, a minimum of 90 Flu B positive subjects and a minimum of 100 SARS-CoV-2 positive subjects will be enrolled. In addition, a minimum of 385 negative subjects will be enrolled.
In total, a minimum of 665 male and female subjects will be prospectively enrolled at multiple clinical sites.
Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. Nasal samples must be collected prior to the Nasopharyngeal sampling.
The collected swab will be tested with the Panbio™ COVID-19/ Flu A\&B Rapid Panel at the study site. Tubes and swabs should be labelled with the patient ID.
After the nasal sampling, study staff personnel will also collect one nasopharyngeal swab. The nasopharyngeal swab will be eluted in Universal Transport Media (UTM) and used for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2 as per local procedures.
The RT-PCR methods used must have CE marking or FDA approval, with COVID-19 and Flu assay clearance for nasopharyngeal specimens. Nasopharyngeal sampling should be performed by trained healthcare professionals who routinely conduct nasopharyngeal sampling as part of their other standard of care and clinical duties.
Each operator who performs a Panbio™ COVID-19/ Flu A\&B Rapid Panel test will fill out a user evaluation questionnaire once, to assess the usability of the device.
All other aspects of the Subject's care will remain the same with no deviation from prescribed practice.
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Being tested
- COVID-19/ Flu A&B Rapid 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.
COVID-19/ Flu A&B Rapid PanelDevice
Rapid Diagnostic Device
| Study group | Role | What they receive |
|---|---|---|
| Panbio™ COVID-19/ Flu A&B Rapid Panel | Other | One nasal swab sample will be collected from both nostrils by operators and will be used to perform the Panbio™ COVID-19/ Flu A\&B Rapid Panel test either in a laboratory or in a non-laboratory setting (e.g. GP centre or hospital clinic). Each Panbio™ COVID-19/ Flu A\&B Rapid Panel result will be photographed by the observer at the time of test interpretation.
Nasopharyngeal samples will be collected and used for RT-PCR testing as per local procedures.
Nasal samples must always be collected prior to the Nasopharyngeal sampling. Receives: Device: COVID-19/ Flu A&B Rapid Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Sensitivity of 70% is the target at the lower bound of the 95% confidence interval for SARS-CoV-2 and 70% for each Flu. The target specificity is 95% at the lower bound of the 95% confidence interval for each test line.
Measured: 8 months
Secondary outcomes (1)
Usability
The secondary objective of this study is to assess the usability of the Panbio™ Rapid Panel, as collected by trained healthcare workers.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Nov 2021
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
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
- 2,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Rapid Diagnostics Jena GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163730
- Sponsor's protocol ID
- SDRD-G-026-P
- Status last verified
- Jul 2022
- First submitted
- 6 Nov 2021
- Last updated
- 20 Jul 2022
- Results posted
- 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 20 Jul 2022. 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
- ClinicalTrials.gov ID
- NCT05163730
- Acronym / sponsor ID
- SDRD-G-026-P
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,472 participants (actual)
- Lead sponsor
- Abbott Rapid Diagnostics Jena GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 20 Dec 2021 (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 a prospective, multicentric, clinical study to investigate the performance of the Panbio™ COVID-19/ Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal swabs.
This study is part of the performance evaluation to support the CE conformity assessment procedures.
Detailed description
After obtaining written informed consent, a study-specific participant identification number (ID) will be assigned to the participant. Participant demographics and a brief medical history will be collected.
One nasal swab sample will be collected from both nostrils by operators and will be used to perform the Panbio™ COVID-19/ Flu A\&B Rapid Panel test either in a laboratory or in a non-laboratory setting (e.g. GP (general practitioner) centre or hospital clinic). Each Panbio™ COVID-19/ Flu A\&B Rapid Panel result will be photographed by the observer at the time of test interpretation.
Nasopharyngeal samples will be collected and used for RT-PCR (Reverse transcription polymerase chain reaction) testing as per local procedures.
Nasal samples must always be collected prior to the Nasopharyngeal sampling. A minimum of 90 Flu A positive subjects, a minimum of 90 Flu B positive subjects and a minimum of 100 SARS-CoV-2 positive subjects will be enrolled. In addition, a minimum of 385 negative subjects will be enrolled.
In total, a minimum of 665 male and female subjects will be prospectively enrolled at multiple clinical sites.
Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. Nasal samples must be collected prior to the Nasopharyngeal sampling.
The collected swab will be tested with the Panbio™ COVID-19/ Flu A\&B Rapid Panel at the study site. Tubes and swabs should be labelled with the patient ID.
After the nasal sampling, study staff personnel will also collect one nasopharyngeal swab. The nasopharyngeal swab will be eluted in Universal Transport Media (UTM) and used for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2 as per local procedures.
The RT-PCR methods used must have CE marking or FDA approval, with COVID-19 and Flu assay clearance for nasopharyngeal specimens. Nasopharyngeal sampling should be performed by trained healthcare professionals who routinely conduct nasopharyngeal sampling as part of their other standard of care and clinical duties.
Each operator who performs a Panbio™ COVID-19/ Flu A\&B Rapid Panel test will fill out a user evaluation questionnaire once, to assess the usability of the device.
All other aspects of the Subject's care will remain the same with no deviation from prescribed practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panbio™ COVID-19/ Flu A&B Rapid Panel | Other | Device: COVID-19/ Flu A&B Rapid PanelOne nasal swab sample will be collected from both nostrils by operators and will be used to perform the Panbio™ COVID-19/ Flu A\&B Rapid Panel test either in a laboratory or in a non-laboratory setting (e.g. GP centre or hospital clinic). Each Panbio™ COVID-19/ Flu A\&B Rapid Panel result will be photographed by the observer at the time of test interpretation. Nasopharyngeal samples will be collected and used for RT-PCR testing as per local procedures. Nasal samples must always be collected prior to the Nasopharyngeal sampling. |
Who may qualify
- Sex
- All
- Healthy volunteers
- 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 seven days of the onset of symptoms, and presenting at least two of the following symptoms: fever, headache, extreme 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 (7 listed)
- • Subject has had a nasal or a nasopharyngeal swab taken within the last 4 hours.
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 |
|---|---|---|
| COVID-19/ Flu A&B Rapid PanelRapid Diagnostic Device | Device | Panbio™ COVID-19/ Flu A&B Rapid Panel |
Primary outcome
Sensitivity and Specificity
Time frame: 8 months
Sensitivity of 70% is the target at the lower bound of the 95% confidence interval for SARS-CoV-2 and 70% for each Flu. The target specificity is 95% at the lower bound of the 95% confidence interval for each test line.
1 secondary outcome
Usability
Time frame: 8 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 20 Jul 2022.
- 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 COVID-19/ Flu A&B Rapid Panel in people with COVID-19 and Influenza A, run by Abbott Rapid Diagnostics Jena GmbH 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 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 20 Jul 2022. 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 (time frame: 8 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 20 Jul 2022.