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. 2021 Apr:9:100115.
doi: 10.1016/j.lanwpc.2021.100115. Epub 2021 Mar 2.

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  1   2   3 , Nick Tayler  3   4 , Tuyet Hoang  3 , Susan A Ballard  3 , Maryza Graham  3   5 , Amanda Rojek  4 , Jason C Kwong  2   6 , Jason A Trubiano  6 , Olivia Smibert  6 , George Drewett  6 , Fiona James  6 , Emma Gardiner  4 , Socheata Chea  3 , Nicole Isles  3 , Michelle Sait  3 , Shivani Pasricha  2 , George Taiaroa  3 , Julie McAuley  2 , Eloise Williams  7 , Katherine B Gibney  1   8 , Timothy P Stinear  2 , Katherine Bond  2   7 , Sharon R Lewin  1   8   9 , Mark Putland  4 , Benjamin P Howden  2   3   6 , Deborah A Williamson  2   3   7
Affiliations

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 et al. Lancet Reg Health West Pac. 2021 Apr.

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.

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Conflict of interest statement

SL reports grants from National Institutes of Health (NIH), grants from American Foundation for AIDS Research (amfAR), grants from Gilead Sciences, grants from Merck, grants from ViiV, grants from Leidos, grants from Wellcome Trust, grants from Australian Centre for HIV and Hepatitis Virology Research (ACH2), grants from Melbourne HIV Cure Consortium, grants from Victorian Department of Health and Human Services (DHHS), grants from Medical Research Future Fund (MRFF), outside the submitted work. KG reports grants from Royal Australasian Society of Physicians (RACP), grants from Murdoch Children's Research Institute (MCRI), other from Isabel & John Gilbertson Charitable Trust, grants from Department of Health and Human Services (DHHS) Victoria, outside the submitted work.

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