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Multi-site assessment of rapid, point-of-care antigen testing for the diagnosis of SARS-CoV-2 infection in a low-prevalence setting: A validation and implementation study.
Muhi, Stephen; Tayler, Nick; Hoang, Tuyet; Ballard, Susan A; Graham, Maryza; Rojek, Amanda; Kwong, Jason C; Trubiano, Jason A; Smibert, Olivia; Drewett, George; James, Fiona; Gardiner, Emma; Chea, Socheata; Isles, Nicole; Sait, Michelle; Pasricha, Shivani; Taiaroa, George; McAuley, Julie; Williams, Eloise; Gibney, Katherine B; Stinear, Timothy P; Bond, Katherine; Lewin, Sharon R; Putland, Mark; Howden, Benjamin P; Williamson, Deborah A.
  • Muhi S; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Australia.
  • Tayler N; Department of Microbiology and Immunology, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Hoang T; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Ballard SA; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Graham M; Department of Emergency Medicine, Royal Melbourne Hospital, Melbourne, Australia.
  • Rojek A; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Kwong JC; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Trubiano JA; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Smibert O; Department of Microbiology, Monash Health, Melbourne, Australia.
  • Drewett G; Department of Emergency Medicine, Royal Melbourne Hospital, Melbourne, Australia.
  • James F; Department of Microbiology and Immunology, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Gardiner E; Department of Infectious Diseases, Austin Hospital, Melbourne, Australia.
  • Chea S; Department of Infectious Diseases, Austin Hospital, Melbourne, Australia.
  • Isles N; Department of Infectious Diseases, Austin Hospital, Melbourne, Australia.
  • Sait M; Department of Infectious Diseases, Austin Hospital, Melbourne, Australia.
  • Pasricha S; Department of Infectious Diseases, Austin Hospital, Melbourne, Australia.
  • Taiaroa G; Department of Emergency Medicine, Royal Melbourne Hospital, Melbourne, Australia.
  • McAuley J; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Williams E; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Gibney KB; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Stinear TP; Department of Microbiology and Immunology, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Bond K; Microbiological Diagnostic Unit Public Health Laboratory, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Lewin SR; Department of Microbiology and Immunology, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Australia.
  • Putland M; Department of Microbiology, Royal Melbourne Hospital, Melbourne, Australia.
  • Howden BP; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Melbourne, Australia.
  • Williamson DA; Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infectious Diseases and Immunity, Melbourne, Australia.
Lancet Reg Health West Pac ; 9: 100115, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1117260
Semantic information from SemMedBD (by NLM)
1. Point-of-Care Testing DIAGNOSES COVID-19
Subject
Point-of-Care Testing
Predicate
DIAGNOSES
Object
COVID-19
2. Hospital LOCATION_OF C5244026
Subject
Hospital
Predicate
LOCATION_OF
Object
C5244026
3. COVID-19 PROCESS_OF Participant
Subject
COVID-19
Predicate
PROCESS_OF
Object
Participant
4. Point-of-Care Testing DIAGNOSES COVID-19
Subject
Point-of-Care Testing
Predicate
DIAGNOSES
Object
COVID-19
5. Hospitals, Urban LOCATION_OF COVID-19 Testing
Subject
Hospitals, Urban
Predicate
LOCATION_OF
Object
COVID-19 Testing
6. COVID-19 PROCESS_OF Participant
Subject
COVID-19
Predicate
PROCESS_OF
Object
Participant
ABSTRACT

BACKGROUND:

In Australia, COVID-19 diagnosis relies on RT-PCR testing which is relatively costly and time-consuming. To date, few studies have assessed the performance and implementation of rapid antigen-based SARS-CoV-2 testing in a setting with a low prevalence of COVID-19 infections, such as Australia.

METHODS:

This study recruited participants presenting for COVID-19 testing at three Melbourne metropolitan hospitals during a period of low COVID-19 prevalence. The Abbott PanBioTM COVID-19 Ag point-of-care test was performed alongside RT-PCR. In addition, participants with COVID-19 notified to the Victorian Government were invited to provide additional swabs to aid validation. Implementation challenges were also documented.

FINDINGS:

The specificity of the Abbott PanBioTM COVID-19 Ag test was 99.96% (95% CI 99.73 - 100%). Sensitivity amongst participants with RT-PCR-confirmed infection was dependent upon the duration of symptoms reported, ranging from 77.3% (duration 1 to 33 days) to 100% in those within seven days of symptom onset. A range of implementation challenges were identified which may inform future COVID-19 testing strategies in a low prevalence setting.

INTERPRETATION:

Given the high specificity, antigen-based tests may be most useful in rapidly triaging public health and hospital resources while expediting confirmatory RT-PCR testing. Considering the limitations in test sensitivity and the potential for rapid transmission in susceptible populations, particularly in hospital settings, careful consideration is required for implementation of antigen testing in a low prevalence setting.

FUNDING:

This work was funded by the Victorian Department of Health and Human Services. The funder was not involved in data analysis or manuscript preparation.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Observational study / Prognostic study Language: English Journal: Lancet Reg Health West Pac Year: 2021 Document Type: Article Affiliation country: J.lanwpc.2021.100115

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Observational study / Prognostic study Language: English Journal: Lancet Reg Health West Pac Year: 2021 Document Type: Article Affiliation country: J.lanwpc.2021.100115