COVID-19NCT05630365
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Product Using Mid-Turbinate Nasal Swabs
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 of the Panbio™ COVID-19/Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in human mid-turbinate nasal swabs collected by a trained… 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
- 1,129 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 31 Mar 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCCT @ Complete Health Partners- Nashville
Nashville, Tennessee, 37209
About this study
This study is designed as an international, 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, and Influenza B antigen in human mid-turbinate nasal swabs collected by a trained health worker. This study is part of the performance evaluation to support the CE conformity assessment procedures.
Read the detailed description
A minimum of 1531 male and female subjects will be prospectively enrolled at multiple clinical sites to assess the performance of the Panbio™ Rapid Panel in detecting predominant Covid-19 and Flu variants currently in global circulation. A minimum of 120 Flu A reference positive subjects, a minimum of 120 Flu B reference positive subjects and a minimum of 300 SARS-CoV-2 reference positive subjects will be enrolled. In addition, a minimum of 991 reference negative subjects will be enrolled.
After informed consent has been obtained, operators will collect one mid-turbinate nasal swab sample from both nostrils from each subject. The nasal collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. Mid-turbinate nasal samples must be collected prior to the NP sampling. The collected mid-turbinate nasal swab will be tested with the Panbio™ Rapid Panel by an operator at the study site in a Near Patient Testing setting (e.g. GP centre or hospital clinic).
After the mid-turbinate nasal sampling, the operators will collect one NP swab sample from one nostril of each subject. NP sampling should be performed by trained healthcare professionals who routinely conduct NP sampling as part of their other standard of care and clinical duties. The collected NP swab will be eluted in 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, as per the laboratory manual. The RT-PCR methods used by the Core Laboratory will be CE marked and FDA cleared, with COVID-19 and Flu assay clearance for NP specimens. Leftover UTM from running RT-PCR should be labelled with subject ID and frozen at -80oC.Discordant results will be investigated as outlined in the laboratory manual.
All other aspects of the subject's care will remain the same with no deviation from prescribed practice. If additional Nasal/NP sampling is required, this must be done after the study procedures outlined in this clinical protocol.
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.
Each subject's demographic information, symptomology data, and professionally performed test result and questionnaire 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
The Panbio™ COVID-19/Flu A\&B Rapid Panel device, hereafter referred to as the Panbio™ Rapid Panel, is a visual lateral flow assay for the rapid immuno-chromatographic qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in mid-turbinate nasal swabs
| Study group | Role | What they receive |
|---|---|---|
| Nasal sampling/Testing (Professional Use) | Experimental | operators will collect one mid-turbinate nasal swab sample from both nostrils from each subject. The collected mid-turbinate nasal swab will be tested with the Panbio™ Rapid Panel by an operator at the study site in a Near Patient Testing setting (e.g. GP centre or hospital clinic). After the mid-turbinate nasal sampling, the operators will collect one NP swab sample from one nostril of each subject.UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, as per the laboratory manual Receives: Diagnostic Test: Panbio™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome:
Evaluate 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%
Measured: immediate
Secondary outcomes (1)
Secondary Outcome:
To assess the usability of the Panbio™ Rapid Panel when used by trained healthcare workers using a questionnaire.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start15 Dec 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 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
- 1,129 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
- NCT05630365
- Sponsor's protocol ID
- SDRD-H-027-P
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2022
- 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 Product Using Mid-Turbinate Nasal Swabs
- ClinicalTrials.gov ID
- NCT05630365
- Acronym / sponsor ID
- SDRD-H-027-P
- Conditions
- COVID-19, Influenza A, Influenza Type B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,129 participants (actual)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 29 Nov 2022 (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 of the Panbio™ COVID-19/Flu A\&B Rapid Panel for the qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in human mid-turbinate nasal swabs collected by a trained health worker. This study is part of the performance evaluation to support the CE conformity assessment procedures.
Detailed description
A minimum of 1531 male and female subjects will be prospectively enrolled at multiple clinical sites to assess the performance of the Panbio™ Rapid Panel in detecting predominant Covid-19 and Flu variants currently in global circulation. A minimum of 120 Flu A reference positive subjects, a minimum of 120 Flu B reference positive subjects and a minimum of 300 SARS-CoV-2 reference positive subjects will be enrolled. In addition, a minimum of 991 reference negative subjects will be enrolled.
After informed consent has been obtained, operators will collect one mid-turbinate nasal swab sample from both nostrils from each subject. The nasal collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. Mid-turbinate nasal samples must be collected prior to the NP sampling. The collected mid-turbinate nasal swab will be tested with the Panbio™ Rapid Panel by an operator at the study site in a Near Patient Testing setting (e.g. GP centre or hospital clinic).
After the mid-turbinate nasal sampling, the operators will collect one NP swab sample from one nostril of each subject. NP sampling should be performed by trained healthcare professionals who routinely conduct NP sampling as part of their other standard of care and clinical duties. The collected NP swab will be eluted in 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, as per the laboratory manual. The RT-PCR methods used by the Core Laboratory will be CE marked and FDA cleared, with COVID-19 and Flu assay clearance for NP specimens. Leftover UTM from running RT-PCR should be labelled with subject ID and frozen at -80oC.Discordant results will be investigated as outlined in the laboratory manual.
All other aspects of the subject's care will remain the same with no deviation from prescribed practice. If additional Nasal/NP sampling is required, this must be done after the study procedures outlined in this clinical protocol.
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.
Each subject's demographic information, symptomology data, and professionally performed test result and questionnaire 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 (Professional Use) | Experimental | Diagnostic Test: Panbio™operators will collect one mid-turbinate nasal swab sample from both nostrils from each subject. The collected mid-turbinate nasal swab will be tested with the Panbio™ Rapid Panel by an operator at the study site in a Near Patient Testing setting (e.g. GP centre or hospital clinic). After the mid-turbinate nasal sampling, the operators will collect one NP swab sample from one nostril of each subject.UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, as per 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 (7 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 ProductThe Panbio™ COVID-19/Flu A\&B Rapid Panel device, hereafter referred to as the Panbio™ Rapid Panel, is a visual lateral flow assay for the rapid immuno-chromatographic qualitative detection of COVID-19 antigen, Influenza A antigen, and Influenza B antigen in mid-turbinate nasal swabs | Diagnostic test | Nasal sampling/Testing (Professional Use) |
Primary outcome
Primary Outcome:
Time frame: immediate
Evaluate 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%
1 secondary outcome
Secondary Outcome:
Time frame: immediate
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 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 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?
Primary Outcome: (time frame: immediate). 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.