COVID-19 Antigen Rapid Test Evaluation in Low-Prevalence Setting

NCT05911074 | Completed

• 1 other identifier: CV006
• Study Type: observational
• Target: 7,274
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection

Keywords

Covid 19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost estimates of Ag testing compared to PCR testing for COVID-19 case detection

  6 months

Study Arms (1)

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

Interventions

The Abbott Panbio™ COVID-19 Ag Rapid Test DIAGNOSTIC_TEST

This is the intervention or medical device(s) intended to be used with a study participant according to the study protocol.

The SD Biosensor COVID-19 Ag test kit

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Both male and female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Botswana Harvard AIDS Institute Partnership: collaborator

Study Sites (1)

Botswana Harvard AIDS Institute Partnership

Gaborone, Gabonone, 267, Botswana

Location

Related Publications (1)

• 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.

  PMID: 104659 RESULT

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sikulile Moyo, Phd

  Botswana Harvard Aids Initiative Partneship

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 20, 2023
• Study Start: June 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)