Corona Virus Infection Clinical Trial
— CV006Official title:
Performance Assessment of COVID-19 Antigen Rapid Diagnostic Tests and Algorithms in Low-Prevalence Settings
NCT number | NCT05911074 |
Other study ID # | CV006 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | March 31, 2023 |
Verified date | October 2023 |
Source | Foundation for Innovative New Diagnostics, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 7274 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Botswana | Botswana Harvard AIDS Institute Partnership | Gaborone | Gabonone |
Lead Sponsor | Collaborator |
---|---|
Foundation for Innovative New Diagnostics, Switzerland | Botswana Harvard AIDS Institute Partnership |
Botswana,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 months | |
Secondary | 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 |
6 months |
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