CV006: SARS-CoV-2 Antigen RDT Evaluation COVID-19 Antigen Rapid Diagnostic Tests and Algorithms in Low-Prevalence Settings
Study Details
Study Description
Brief 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 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.
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Diagnostic Test: The Abbott Panbio™ COVID-19 Ag Rapid Test
This is the intervention or medical device(s) intended to be used with a study participant according to the study protocol.
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Outcome Measures
Primary Outcome Measures
- Point estimates of sensitivity, specificity and accuracy of the RDTs compared to the reference standard reverse transcription polymerase chain reaction. [6 months]
To assess the performance characteristics of two currently available Ag-RDTs for the detection of SARS-CoV-2 antigens in nasal swabs, against established molecular tests, when used at ports of entry
Secondary Outcome Measures
- Assessment of the performance of each of the candidate algorithms in terms of sensitivity and specificity compared to the reference test reverse transcription-polymerase chain reaction RTPCR, as well as in terms of time and cost efficiency. [6 months]
To assess the performance of a set of multi test algorithms based on Ag RDTs for screening low prevalence populations at ports of entry, relative to established protocols based on reverse transcription polymerase chain reaction RTPCR testing. To assess agreement between testing results of nasal and OP sampling on a subset participants.
- Assessment of the performance of each of the candidate algorithms in terms of sensitivity and specificity compared to the reference test RTPCR, as well as in terms of time and cost efficiency. [6 months]
To assess the performance of a set of multi-test algorithms based on AgRDTs for screening low-prevalence populations at ports of entry, relative to established protocols based on RTPCR testing. To assess agreement between testing results of nasal and OP sampling on a subset participants
Eligibility Criteria
Criteria
Inclusion Criteria:
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In order to meet the study objectives, study recruitment will focus on the population meeting the following eligibility criteria:
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Age ≥ 18 years crossing ports of entry in Greater Gaborone Health District [including International Airport, Ports within Gaborone Health Districts ((as above)
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Able to understand the scope of the study and provided written informed consent
Exclusion Criteria:
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Participants are excluded from the study if any of the following exclusion criteria apply:
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Participants who are less than 18 years or who are unable to provide informed consent.
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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
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Vulnerable populations as deemed inappropriate for study by site PI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Botswana Harvard AIDS Institute Partnership | Gaborone | Gabonone | Botswana | 267 |
Sponsors and Collaborators
- Foundation for Innovative New Diagnostics, Switzerland
- Botswana Harvard AIDS Institute Partnership
Investigators
- Principal Investigator: Sikulile Moyo, Phd, Botswana Harvard Aids Initiative Partneship
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CV006