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
Stephen Muhi,Stephen Muhi,Nick Tayler,Nick Tayler,Tuyet Hoang,Susan A Ballard,Maryza Graham,Amanda Rojek,Jason C Kwong,Jason C Kwong,Jason A Trubiano,Olivia C Smibert,George P Drewett,Fiona L James,Emma Gardiner,Socheata Chea,Nicole Isles,Michelle Sait,Shivani Pasricha,George Taiaroa,Julie L. McAuley,Eloise Williams,Katherine B Gibney,Katherine B Gibney,Timothy P. Stinear,Katherine Bond,Katherine Bond,Sharon R Lewin,Sharon R Lewin,Sharon R Lewin,Mark Putland,Benjamin P Howden,Benjamin P Howden,Deborah A Williamson,Deborah A Williamson +34 more
- Vol. 9, pp 100115-100115
TLDR
In this paper, the authors evaluated 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.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 9996% (95% CI 9973 - 100%) Sensitivity amongst participants with RT-PCR-confirmed infection was dependent upon the duration of symptoms reported, ranging from 773% (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 preparationread more
Citations
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Journal ArticleDOI
Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis.
Lukas E. Brümmer,Stephan Katzenschlager,Mary Gaeddert,Christian Erdmann,Stephani Schmitz,Marc Bota,Maurizio Grilli,Jan Larmann,Markus A. Weigand,Nira R. Pollock,Aurélien Macé,Sergio Carmona,Stefano Ongarello,Jilian A. Sacks,Claudia M. Denkinger,Claudia M. Denkinger +15 more
TL;DR: A systematic review and meta-analysis of commercially available rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 up until 30 April 2021 was conducted in this paper.
Posted ContentDOI
The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis.
Lukas E. Brümmer,Stephan Katzenschlager,Mary Gaeddert,Christian Erdmann,Stephani Schmitz,Marc Bota,Maurizio Grilli,Jan Larmann,Markus A. Weigand,Nira R. Pollock,Sergio Carmona,Stefano Ongarello,Jilian A. Sacks,Claudia M. Denkinger +13 more
TL;DR: In this article, a systematic review and meta-analysis of commercially available rapid diagnostic tests (Ag-RDTs) is presented, where the clinical accuracy (sensitivity and specificity) of these tests are assessed.
Journal ArticleDOI
Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection
TL;DR: In this article , the second update of this review was published, which was first published in 2020, and included 152 evaluations of single test applications including 100,462 unique samples (16,822 with confirmed SARS-CoV-2 infection or known absence of infection).
Journal ArticleDOI
Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis
Muhammad Fazli Khalid,Kasturi Selvam,Alfeq Jazree Nashru Jeffry,Mohamad Fazrul Salmi,M. Ahmad Najib,Mohd Noor Norhayati,Ismail Aziah +6 more
TL;DR: Although the sensitivity of RATs needs to be enhanced, it may still be a viable option in places where laboratory facilities are lacking for diagnostic purposes in the early phase of disease.
Journal ArticleDOI
Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis
Anastasia Tapari,Georgia G. Braliou,Maria Papaefthimiou,Helen Mavriki,Panagiota I. Kontou,Georgios K. Nikolopoulos,Pantelis G. Bagos +6 more
TL;DR: LFIA tests, though with moderate sensitivity, appear as the most attractive method for use in POCs and for performing seroprevalence studies, and rapid ATs show higher sensitivity in symptomatic patients compared to asymptomatic patients.
References
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Journal ArticleDOI
Implementation and evaluation of a novel real-time multiplex assay for SARS-CoV-2: in-field learnings from a clinical microbiology laboratory.
Eloise Williams,Katherine Bond,Brian Chong,Dawn Giltrap,Malcolm Eaton,Peter Kyriakou,Peter Calvert,Bowen Zhang,Mahendra Siwan,Benjamin P Howden,Julian Druce,Mike Catton,Deborah A Williamson +12 more
TL;DR: In many countries, standard regulatory requirements for the introduction of new assays have been replaced by emergency authorisations and it is critical that laboratories share their post-market validation experiences, as the consequences of widespread introduction of a suboptimal assay for SARS-CoV-2 are profound.
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