TY - JOUR
T1 - Multi-site assessment of rapid, point-of-care antigen testing for the diagnosis of SARS-CoV-2 infection in a low-prevalence setting
T2 - A validation and implementation study
AU - Muhi, Stephen
AU - Tayler, Nick
AU - Hoang, Tuyet
AU - Ballard, Susan A.
AU - Graham, Maryza
AU - Rojek, Amanda
AU - Kwong, Jason C.
AU - Trubiano, Jason A.
AU - Smibert, Olivia
AU - Drewett, George
AU - James, Fiona
AU - Gardiner, Emma
AU - Chea, Socheata
AU - Isles, Nicole
AU - Sait, Michelle
AU - Pasricha, Shivani
AU - Taiaroa, George
AU - McAuley, Julie
AU - Williams, Eloise
AU - Gibney, Katherine B.
AU - Stinear, Timothy P.
AU - Bond, Katherine
AU - Lewin, Sharon R.
AU - Putland, Mark
AU - Howden, Benjamin P.
AU - Williamson, Deborah A.
N1 - Publisher Copyright:
© 2021
PY - 2021/4
Y1 - 2021/4
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85103754681&partnerID=8YFLogxK
U2 - 10.1016/j.lanwpc.2021.100115
DO - 10.1016/j.lanwpc.2021.100115
M3 - Article
AN - SCOPUS:85103754681
SN - 2666-6065
VL - 9
JO - The Lancet Regional Health - Western Pacific
JF - The Lancet Regional Health - Western Pacific
M1 - 100115
ER -