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

NCT05911074 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7274

Last updated 2023-10-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Botswana Harvard AIDS Institute Partnership

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Sikulile Moyo, Phd · Botswana Harvard Aids Initiative Partneship

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Botswana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05911074 on ClinicalTrials.gov