COVID-19 Antigen Rapid Test Evaluation in Low-Prevalence Setting
Condition: Corona Virus Infection
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

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.
    

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.
    

Intervention name(s): The Abbott Panbio™ COVID-19 Ag Rapid Test
Intervention type(s): Diagnostic Test
Intervention description(s): This is the intervention or medical device(s) intended to be used with a study participant according to the study protocol.
Observational model: Other
Time perspective: Cross-Sectional
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.
      
Keywords: Covid 19