Corona Virus InfectionCV006NCT05911074
COVID-19 Antigen Rapid Test Evaluation in Low-Prevalence Setting
An observational study of Corona Virus Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Botswana.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the resulting COVID-19 pandemic present important diagnostic challenges. Point-of-care tests that detect SARS-CoV-2 antigen have the potential to allow earlier detection and isolation of confirmed cases compared to PCR-based diagnostic methods, and could… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- The Abbott Panbio™ COVID-19 Ag Rapid Test
- How many people
- 7,274 participants
- Where
- 1 siteBotswana
- Study dates
- 1 Jun 2022to 31 Mar 2023
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be enrolled at PoE at study sites within the Greater Gaborone Health District. 1. Sir Seretse Khama International Airport 2. Tlokweng, Ramotswa, Pioneer and Ramatlabana land borders Participants will be included regardless of symptoms. Individuals younger than 18 years of age or unable to provide informed consent will be excluded from the study. A subset of study subjects are expected to show evidence of negative SARS-CoV-2 RT-PCR testing within the 72 hours prior to study enrolment. These subjects will be eligible for the study; however, based on the sample size considerations described above, the number of subjects with documented negative RT-PCR testing will be capped at 1,000.
Who may be able to join
- In order to meet the study objectives, study recruitment will focus on the population meeting the following eligibility criteria:
- Age ≥ 18 years crossing ports of entry in Greater Gaborone Health District [including International Airport, Ports within Gaborone Health Districts ((as above)
- Able to understand the scope of the study and provided written informed consent
Who cannot join
- Participants are excluded from the study if any of the following exclusion criteria apply:
- Participants who are less than 18 years or who are unable to provide informed consent.
- Any contraindications to nasopharyngeal sample collection: recent nasal trauma or surgery, markedly deviated nasal septum, or a history of chronically blocked nasal passages or severe coagulopathy
- Vulnerable populations as deemed inappropriate for study by site PI
Trial locations and contacts
1 site in 1 country.
Botswana1 site
Botswana Harvard AIDS Institute Partnership
Gaborone, Gabonone, 267
About this study
Official title: Performance Assessment of COVID-19 Antigen Rapid Diagnostic Tests and Algorithms in Low-Prevalence Settings
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the resulting COVID-19 pandemic present important diagnostic challenges. Point-of-care tests that detect SARS-CoV-2 antigen have the potential to allow earlier detection and isolation of confirmed cases compared to PCR-based diagnostic methods, and could be implemented at Ports of Entry (PoE) to screen low-prevalence populations effectively.This study will assess the performance of available antigen Ag-RDTs such as the Panbio and Standard Q SARS-CoV-2 rapid antigen tests. Approximately 15,000 subjects entering Botswana at Ports of Entry will be enrolled over a 6-months period or more. SARS-CoV-2 RT-PCR will be used as a reference standard. A subset of participants will also be contacted, re-evaluated and re-tested at 48-72 hours following initial assessment, to assess for the impact of incubating infection on the performance of the Ag-RDTs.
In order to assess the impact of viral genetic variability on test performance, genomic sequencing will be part of the study. All SARS-CoV-2 PCR positive samples will undergo genomic sequencing to determine the virus lineages or variants.
In addition to assessing the performance of each of the Ag-RDTs, a set of testingalgorithms that could be implemented at Ports of Entry, including the sequential use of multiple Ag-RDTs with or without RT-PCR confirmation, will be assessed.
Read the detailed description
Point-of-care tests to detect active SARS-CoV-2 infection have the potential to allow earlier detection and isolation of confirmed cases compared to PCR-based diagnostic methods performed in centralized laboratories, with the aim of cost-effective reduction of transmission field (Dinnes et al., 2020). In theory, sufficiently sensitive and specific point-of-care format tests could be implemented at PoE and used to screen low-prevalence populations effectively.
In particular, rapid COVID-19 antigen tests in a lateral flow format COVID antigen RDTs or AgRDTs can play a key role in accelerating access to testing and improving turnaround times for COVID-19 test results. COVID antigen RDTs detect specific proteins known as antigens on the surface of the virus and can identify people who are at the peak of infection when virus levels in the body are likely to be high. A number of AgRDTs are now available, some of which have received emergency use authorizations from the World Health Organisation (WHO) and/or the United States Food and Drug Administration (FDA). These tests have the potential to detect an active infection with performance that is close to that of PCR in specific settings. However, the performance of COVID antigen RDTs outside of highly controlled settings is not well defined,particularly in low-prevalence groups of asymptomatic people (Bryan et al., 2020; Lassaunière et al., 2020 Linares et al., 2020; Porte et al., 2020).
Antigen tests with rapid turnaround times and minimal user skill have been recently approved for emergency use listing (EUL) by the WHO. Performance data show sensitivity and specificity levels (at least 80% and 97%, respectively) sufficient for diagnostic purposes of SARS-CoV-2 in targeted individuals, but their role in population-based screening remains to be established. In this evaluation, performance characteristics of rapid SARS-COV-2 detection kits (including but not limited to the Standard Q COVID-19 Antigen Test Standard Q RDT and the Panbio™ COVID-19 Ag Rapid Test Panbio RDT, will be assessed for sensitivity, specificity, and their overall agreement with standard nucleic acid testing using polymerase chain reaction (PCR) tests. Finally, the performance of multi-test algorithms based on Ag-RDTs with or without RTPCR will be assessed for their potential use in low-prevalence screening programmes.
- Conditions
- Corona Virus Infection
- Being tested
- The Abbott Panbio™ COVID-19 Ag Rapid Test
- Keywords
- Covid 19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Abbott Panbio™ COVID-19 Ag Rapid TestDiagnostic test
This is the intervention or medical device(s) intended to be used with a study participant according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| The SD Biosensor COVID-19 Ag test kit | This is one of the Investigational product or medical device(s) intended to be used with a study participant according to the study protocol Receives: Diagnostic Test: The Abbott Panbio™ COVID-19 Ag Rapid Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance characteristics of two currently available Ag-RDTs for the detection of SARS-CoV-2 antigens in nasal swabs
Point estimates of sensitivity and specificity of the COVID-19 antigen RDTs compared to the reference standard reverse transcription polymerase chain reaction when used at ports of entry
Measured: 6 months
Secondary outcomes (1)
Cost estimates of Ag testing compared to PCR testing for COVID-19 case detection
(1) Cost per test performed for each of the Ag RDTs compared to RT-PCR based protocols
(1) Cost per COVID-19 case detected for each of the Ag RDTs compared to RT-PCR based protocols
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 posted20 Jun 2023
- Study start1 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corona Virus InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 7,274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership
- Responsible party
- Sponsor
- Investigators
- Sikulile Moyo, Phd, Principal investigator, Botswana Harvard Aids Initiative Partneship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911074
- Sponsor's protocol ID
- CV006
- Acronym
- CV006
- Status last verified
- Oct 2023
- First submitted
- 19 Jun 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All manuscripts reporting FIND study data and all review articles with FIND authors should be published in an open-access, peer-reviewed journal, regardless of whether they are FIND-led or partner-led
Publications
Hussong D, Damare JM, Limpert RJ, Sladen WJ, Weiner RM, Colwell RR. Microbial impact of Canada geese (Branta canadensis) and whistling swans (Cygnus columbianus columbianus) on aquatic ecosystems. Appl Environ Microbiol. 1979 Jan;37(1):14-20. doi: 10.1128/aem.37.1.14-20.1979.
PubMed 104659
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment of COVID-19 Antigen Rapid Diagnostic Tests and Algorithms in Low-Prevalence Settings
- ClinicalTrials.gov ID
- NCT05911074
- Acronym / sponsor ID
- CV006 / CV006
- Conditions
- Corona Virus Infection
- Keywords
- Covid 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,274 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 20 Jun 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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the resulting COVID-19 pandemic present important diagnostic challenges. Point-of-care tests that detect SARS-CoV-2 antigen have the potential to allow earlier detection and isolation of confirmed cases compared to PCR-based diagnostic methods, and could be implemented at Ports of Entry (PoE) to screen low-prevalence populations effectively.This study will assess the performance of available antigen Ag-RDTs such as the Panbio and Standard Q SARS-CoV-2 rapid antigen tests. Approximately 15,000 subjects entering Botswana at Ports of Entry will be enrolled over a 6-months period or more. SARS-CoV-2 RT-PCR will be used as a reference standard. A subset of participants will also be contacted, re-evaluated and re-tested at 48-72 hours following initial assessment, to assess for the impact of incubating infection on the performance of the Ag-RDTs.
In order to assess the impact of viral genetic variability on test performance, genomic sequencing will be part of the study. All SARS-CoV-2 PCR positive samples will undergo genomic sequencing to determine the virus lineages or variants.
In addition to assessing the performance of each of the Ag-RDTs, a set of testingalgorithms that could be implemented at Ports of Entry, including the sequential use of multiple Ag-RDTs with or without RT-PCR confirmation, will be assessed.
Detailed description
Point-of-care tests to detect active SARS-CoV-2 infection have the potential to allow earlier detection and isolation of confirmed cases compared to PCR-based diagnostic methods performed in centralized laboratories, with the aim of cost-effective reduction of transmission field (Dinnes et al., 2020). In theory, sufficiently sensitive and specific point-of-care format tests could be implemented at PoE and used to screen low-prevalence populations effectively.
In particular, rapid COVID-19 antigen tests in a lateral flow format COVID antigen RDTs or AgRDTs can play a key role in accelerating access to testing and improving turnaround times for COVID-19 test results. COVID antigen RDTs detect specific proteins known as antigens on the surface of the virus and can identify people who are at the peak of infection when virus levels in the body are likely to be high. A number of AgRDTs are now available, some of which have received emergency use authorizations from the World Health Organisation (WHO) and/or the United States Food and Drug Administration (FDA). These tests have the potential to detect an active infection with performance that is close to that of PCR in specific settings. However, the performance of COVID antigen RDTs outside of highly controlled settings is not well defined,particularly in low-prevalence groups of asymptomatic people (Bryan et al., 2020; Lassaunière et al., 2020 Linares et al., 2020; Porte et al., 2020).
Antigen tests with rapid turnaround times and minimal user skill have been recently approved for emergency use listing (EUL) by the WHO. Performance data show sensitivity and specificity levels (at least 80% and 97%, respectively) sufficient for diagnostic purposes of SARS-CoV-2 in targeted individuals, but their role in population-based screening remains to be established. In this evaluation, performance characteristics of rapid SARS-COV-2 detection kits (including but not limited to the Standard Q COVID-19 Antigen Test Standard Q RDT and the Panbio™ COVID-19 Ag Rapid Test Panbio RDT, will be assessed for sensitivity, specificity, and their overall agreement with standard nucleic acid testing using polymerase chain reaction (PCR) tests. Finally, the performance of multi-test algorithms based on Ag-RDTs with or without RTPCR will be assessed for their potential use in low-prevalence screening programmes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The SD Biosensor COVID-19 Ag test kit | – | Diagnostic Test: The Abbott Panbio™ COVID-19 Ag Rapid TestThis is one of the Investigational product or medical device(s) intended to be used with a study participant according to the study protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be enrolled at PoE at study sites within the Greater Gaborone Health District. 1. Sir Seretse Khama International Airport 2. Tlokweng, Ramotswa, Pioneer and Ramatlabana land borders Participants will be included regardless of symptoms. Individuals younger than 18 years of age or unable to provide informed consent will be excluded from the study. A subset of study subjects are expected to show evidence of negative SARS-CoV-2 RT-PCR testing within the 72 hours prior to study enrolment. These subjects will be eligible for the study; however, based on the sample size considerations described above, the number of subjects with documented negative RT-PCR testing will be capped at 1,000.
Key inclusion criteria (3 listed)
- In order to meet the study objectives, study recruitment will focus on the population meeting the following eligibility criteria:
- Age ≥ 18 years crossing ports of entry in Greater Gaborone Health District [including International Airport, Ports within Gaborone Health Districts ((as above)
- Able to understand the scope of the study and provided written informed consent
Key exclusion criteria (4 listed)
- Participants are excluded from the study if any of the following exclusion criteria apply:
- Participants who are less than 18 years or who are unable to provide informed consent.
- Any contraindications to nasopharyngeal sample collection: recent nasal trauma or surgery, markedly deviated nasal septum, or a history of chronically blocked nasal passages or severe coagulopathy
- Vulnerable populations as deemed inappropriate for study by site PI
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 |
|---|---|---|
| The Abbott Panbio™ COVID-19 Ag Rapid TestThis is the intervention or medical device(s) intended to be used with a study participant according to the study protocol. | Diagnostic test | The SD Biosensor COVID-19 Ag test kit |
Primary outcome
Performance characteristics of two currently available Ag-RDTs for the detection of SARS-CoV-2 antigens in nasal swabs
Time frame: 6 months
Point estimates of sensitivity and specificity of the COVID-19 antigen RDTs compared to the reference standard reverse transcription polymerase chain reaction when used at ports of entry
1 secondary outcome
Cost estimates of Ag testing compared to PCR testing for COVID-19 case detection
Time frame: 6 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 12 Oct 2023.
- Results publication: PubMed 104659Hussong D, Damare JM, Limpert RJ, Sladen WJ, Weiner RM, Colwell RR. Microbial impact of Canada geese (Branta canadensis) and whistling swans (Cygnus columbianus columbianus) on aquatic ecosystems. Appl Environ Microbiol. 1979 Jan;37(1):14-20. doi: 10.1128/aem.37.1.14-20.1979.
- Individual participant dataSharing planned: No. All manuscripts reporting FIND study data and all review articles with FIND authors should be published in an open-access, peer-reviewed journal, regardless of whether they are FIND-led or partner-led
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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.
Sikulile Moyo, Phd principal investigator
Botswana Harvard Aids Initiative Partneship
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Botswana.
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 3 inclusion and 4 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 12 Oct 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 Botswana. 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?
Performance characteristics of two currently available Ag-RDTs for the detection of SARS-CoV-2 antigens in nasal swabs (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911074, which also lists 1 linked publication.
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 12 Oct 2023.