The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2—Evaluation of the accuracy and ease-of-use
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Abstract
Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).
Methods
This prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub-analyses accordingly to cycle-threshold values, days after symptom onset, disease severity and study site. Additionally, an ease-of-use assessment (EoU) and System Usability Scale (SUS) were performed.
Results
1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9.6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86.8% (95% CI: 79.0% - 92.0%) and a specificity of 99.9% (95% CI: 99.4%-100%). The sub-analyses indicated that sensitivity was 95.8% in Ct-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of-care settings.
Conclusion
The Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.
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SciScore for 10.1101/2020.11.27.20239699: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethic statement: The study protocol was approved in March 2020 by the ethical review committee at the Heidelberg University Hospital for the two study sites Heidelberg and Berlin in Germany (Registration number S-180/2020). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data management: All data were collected and managed using Research Electronic Data Capture (REDCap) tools hosted at Heidelberg University. REDCapsuggested: (REDCap, RRID:SCR_003445)Results from OddPub: We did not detect open data. We also did not detect open code. …
SciScore for 10.1101/2020.11.27.20239699: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethic statement: The study protocol was approved in March 2020 by the ethical review committee at the Heidelberg University Hospital for the two study sites Heidelberg and Berlin in Germany (Registration number S-180/2020). Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data management: All data were collected and managed using Research Electronic Data Capture (REDCap) tools hosted at Heidelberg University. REDCapsuggested: (REDCap, RRID:SCR_003445)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Within the limitation of what can be concluded due to the small sample size of asymptomatic participants and the fact that these participants were asymptomatic high-risk contacts and presenting early in the disease, the performance of the test was as good as in symptomatic patients with a sensitivity respectively of 85∙7% versus 86∙8%. This suggests the Panbio to be an option for screening independent of symptoms and is in line with recent data suggesting that viral load in adults does not differ between asymptomatic and symptomatic infections.20 Further research with a larger asymptomatic cohort is needed to confirm our findings, however a truly representative sample of asymptomatic patients would only be possible in a large surveillance study. Considering the test’s ease-of-use and the rapid turn-around time between 15 and 20 minutes, along with its high specificity, it could be considered for several use-cases: (1) screening of patients in advance of admission for elective procedures; (2) screening in advance of events at high-risk of transmission (e.g. aggregated settings where contact cannot be avoided); or (3) planned encounters with persons at high-risk for severe disease of SARS-CoV-2 (e.g. visitor in nursing homes) in addition to (4) the use in symptomatic patients when PCR is not available or together with PCR, when a rapid decision is necessary. Furthermore, given that supervised self-sampling from the anterior nose is a reliable alternative to professional nasopha...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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