COVID-19NCT06127108
Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel
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
The study is designed as a prospective, multicentric, clinical study to investigate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A\&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, Roche cobas® SARS-CoV-2 (K231306)… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- COVID-19, Influenza A, Influenza B
- What is being tested?
- Panbio™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 2 Feb 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 suspected of acute viral respiratory infection by a healthcare professional, and
- Participant is age two (2) years or older, 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 enrollment
- 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
1 site in 1 country.
About this study
Official title: Multi-center Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel
The study is designed as a prospective, multicentric, clinical study to investigate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A\&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay(K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider.
Read the detailed description
Approximately 2,000 symptomatic Participants to achieve at least 80 COVID-19 PCR confirmed positives, 80 Flu A PCR confirmed positives, 80 Flu B PCR confirmed positives, and 500 COVID-19 and Influenza PCR-confirmed negatives.
Site staff will collect two (2) anterior nasal swabs from each Participant from whom informed consent has been obtained. Participants ages two (2) years and older meeting eligibility criteria will be enrolled.
One anterior nasal swab will be immediately eluted in an extraction buffer tube and tested with the Panbio™ COVID-19/Flu A\&B Panel. If immediate testing is not possible, the swab specimen can be kept in an extraction buffer tube filled with extraction buffer at room temperature (59-86°F /15-30 °C) for up to one (1) hour prior to testing.
The other anterior nasal swab will be rotated vigorously in VTM, and the swab head will be left in the VTM, by snapping the shaft or clipping the base of the swab if necessary.
Anterior nasal swab sample collection will be as follows:
With the swab designated for Panbio testing, use gentle rotation to push the swab into the right nostril until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then slowly remove from the nostril. Using the swab designated for PCR testing, repeat sample collection in the left nostril.
With the swab designated for PCR testing, use gentle rotation to push the swab into the right nostril until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then slowly remove from the nostril. Using the swab designated for Panbio testing, repeat sample collection in the left nostril.
The VTM samples will be stored, handled, and tested with comparator assays according to the manufacturers' product instructions. VTM 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.
Swab eluate samples containing the swab head in VTM will be tested at the central laboratory with the Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236) per product instructions. All discordant samples (i.e., samples with the Roche cobas® SARS-CoV-2 (K231306) or Quidel Lyra® Influenza A+B Assay (K230236) results that conflict with the Panbio™ COVID-19/Flu A\&B Panel results) will be evaluated with the Hologic SARS-CoV-2/Flu A/B/RSV Assay (Panther Fusion® System) for information only. Samples may also be tested for viral culture.
Note: For the purposes of the COVID-19 method comparison, Roche cobas® SARS-CoV-2 results will be interpreted per the package insert. Roche cobas® SARS-CoV-2 results where the ORF1a/b (Target 2) is Negative or Invalid and the E-Gene (Target 3) is Positive are considered Presumptive Positive for COVID-19. These samples will be further evaluated with the Hologic SARS-CoV-2/Flu A/B/RSV Assay (Panther Fusion® System).
Each Participant's demographic data, inclusion/exclusion data, days of symptom onset, comparator results, Panbio™ COVID-19/Flu A\&B Panel results and other data elements will be recorded as detailed in Section 10 of this document. Defined Participant data will be recorded on source documentation and entered into an Electronic Data Capture (EDC) system. Panbio™ results and the comparator method results will not be provided to study Participants. Panbio™ COVID-19/Flu A\&B Panel test operators will be blinded to a Participant's standard of care COVID-19 and/or Flu test results.
- Conditions
- COVID-19, Influenza A, Influenza 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 Panel
The Panbio™ COVID-19/Flu A\&B Panel is a visual lateral flow in vitro immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2, Influenza A, and Influenza B in anterior nasal swab samples from individuals with symptoms and suspected of COVID-19 or Flu infection by their healthcare provider.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Nasal sampling/Testing (professional use) | Experimental | Operator or delegated study staff will collect one anterior nasal swab sample from both nostrils. The collected anterior nasal swab will the tested with the Panbio™ COVID-19/Flu A\&B Panel by the operator at the study site in a near patient testing setting (e.g. GP center or hospital clinic). 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. Receives: Diagnostic Test: Panbio™ |
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
- Primary Outcome: The primary objective of this study is to demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A\&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, the Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider. Samples may also be tested for viral culture.
Measured: "up to 24 months"
Secondary outcomes (1)
Demonstrate the accuracy of the Panbio™ COVID-19/Flu A&B Panel in the hands of untrained users by a usability questionnaire.
Secondary Outcome:
The secondary objective of this study is to demonstrate the accuracy of the Panbio™ COVID-19/Flu A\&B Panel in the hands of untrained 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.
Each test operator will be given a user evaluation questionnaire once to assess the usability of the device.
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 posted13 Nov 2023
- Study start14 Nov 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 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
- Model description
- Study staff will collect two (2) anterior nasal swabs from each Participant. One anterior nasal swab will be collected by a study staff member and tested immediately on the Panbio™ COVID-19/Flu A\&B Panel by an untrained test operator. The other anterior nasal swab will be eluted in VTM within 10 minutes of sample collection. The swab will be rotated vigorously in the VTM, and the swab head will be left in the VTM, by snapping the shaft or clipping the base of the swab if necessary. VTM samples will be stored, handled and tested with comparator assays according to the manufacturers' product instructions. VTM 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.
- Masking
- None (open label)
- Enrolment
- 447 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
- NCT06127108
- Sponsor's protocol ID
- 2319801
- Status last verified
- Apr 2024
- First submitted
- 6 Nov 2023
- Last updated
- 25 Apr 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 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Panel
- ClinicalTrials.gov ID
- NCT06127108
- Acronym / sponsor ID
- 2319801
- Conditions
- COVID-19, Influenza A, Influenza B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Abbott Rapid DxIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 13 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.
The study is designed as a prospective, multicentric, clinical study to investigate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A\&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay(K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider.
Detailed description
Approximately 2,000 symptomatic Participants to achieve at least 80 COVID-19 PCR confirmed positives, 80 Flu A PCR confirmed positives, 80 Flu B PCR confirmed positives, and 500 COVID-19 and Influenza PCR-confirmed negatives.
Site staff will collect two (2) anterior nasal swabs from each Participant from whom informed consent has been obtained. Participants ages two (2) years and older meeting eligibility criteria will be enrolled.
One anterior nasal swab will be immediately eluted in an extraction buffer tube and tested with the Panbio™ COVID-19/Flu A\&B Panel. If immediate testing is not possible, the swab specimen can be kept in an extraction buffer tube filled with extraction buffer at room temperature (59-86°F /15-30 °C) for up to one (1) hour prior to testing.
The other anterior nasal swab will be rotated vigorously in VTM, and the swab head will be left in the VTM, by snapping the shaft or clipping the base of the swab if necessary.
Anterior nasal swab sample collection will be as follows:
With the swab designated for Panbio testing, use gentle rotation to push the swab into the right nostril until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then slowly remove from the nostril. Using the swab designated for PCR testing, repeat sample collection in the left nostril.
With the swab designated for PCR testing, use gentle rotation to push the swab into the right nostril until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then slowly remove from the nostril. Using the swab designated for Panbio testing, repeat sample collection in the left nostril.
The VTM samples will be stored, handled, and tested with comparator assays according to the manufacturers' product instructions. VTM 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.
Swab eluate samples containing the swab head in VTM will be tested at the central laboratory with the Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236) per product instructions. All discordant samples (i.e., samples with the Roche cobas® SARS-CoV-2 (K231306) or Quidel Lyra® Influenza A+B Assay (K230236) results that conflict with the Panbio™ COVID-19/Flu A\&B Panel results) will be evaluated with the Hologic SARS-CoV-2/Flu A/B/RSV Assay (Panther Fusion® System) for information only. Samples may also be tested for viral culture.
Note: For the purposes of the COVID-19 method comparison, Roche cobas® SARS-CoV-2 results will be interpreted per the package insert. Roche cobas® SARS-CoV-2 results where the ORF1a/b (Target 2) is Negative or Invalid and the E-Gene (Target 3) is Positive are considered Presumptive Positive for COVID-19. These samples will be further evaluated with the Hologic SARS-CoV-2/Flu A/B/RSV Assay (Panther Fusion® System).
Each Participant's demographic data, inclusion/exclusion data, days of symptom onset, comparator results, Panbio™ COVID-19/Flu A\&B Panel results and other data elements will be recorded as detailed in Section 10 of this document. Defined Participant data will be recorded on source documentation and entered into an Electronic Data Capture (EDC) system. Panbio™ results and the comparator method results will not be provided to study Participants. Panbio™ COVID-19/Flu A\&B Panel test operators will be blinded to a Participant's standard of care COVID-19 and/or Flu test results.
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. One anterior nasal swab will be collected by a study staff member and tested immediately on the Panbio™ COVID-19/Flu A\&B Panel by an untrained test operator. The other anterior nasal swab will be eluted in VTM within 10 minutes of sample collection. The swab will be rotated vigorously in the VTM, and the swab head will be left in the VTM, by snapping the shaft or clipping the base of the swab if necessary. VTM samples will be stored, handled and tested with comparator assays according to the manufacturers' product instructions. VTM 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Nasal sampling/Testing (professional use) | Experimental | Diagnostic Test: Panbio™Operator or delegated study staff will collect one anterior nasal swab sample from both nostrils. The collected anterior nasal swab will the tested with the Panbio™ COVID-19/Flu A\&B Panel by the operator at the study site in a near patient testing setting (e.g. GP center or hospital clinic). 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. |
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 suspected of acute viral respiratory infection by a healthcare professional, and
- Participant is age two (2) years or older, 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
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 enrollment
- 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™Also: Panbio™ COVID-19/Flu A&B PanelThe Panbio™ COVID-19/Flu A\&B Panel is a visual lateral flow in vitro immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2, Influenza A, and Influenza B in anterior nasal swab samples from individuals with symptoms and suspected of COVID-19 or Flu infection by their healthcare provider. | Diagnostic test | Experimental: Nasal sampling/Testing (professional use) |
Primary outcome
Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA
Time frame: "up to 24 months"
1. Primary Outcome: The primary objective of this study is to demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA) of the Panbio™ COVID-19/Flu A\&B Panel using anterior nasal swab specimens tested directly, relative to the comparator methods, the Roche cobas® SARS-CoV-2 (K231306) and Quidel Lyra® Influenza A+B Assay (K230236) (RT-PCR) in symptomatic patients suspected of respiratory viral infection by a healthcare provider. Samples may also be tested for viral culture.
1 secondary outcome
Demonstrate the accuracy of the Panbio™ COVID-19/Flu A&B Panel in the hands of untrained users by a usability questionnaire.
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 25 Apr 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.
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 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 25 Apr 2024. 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?
Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA (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 25 Apr 2024.