Evaluation of the accuracy and ease-of-use of Abbott PanBio - A WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test forSARS-CoV-2

Abstract

BackgroundDiagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic is needed to support testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).MethodsThis prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with 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 of symptoms, disease severity and study site. Additionally, an ease-of-use assessment and System Usability Scale (SUS) were performed.Findings1108 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.InterpretationThe 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.FundingThe Foundation of Innovative New Diagnostics supplied the test kits for the study. The internal funds from the Heidelberg University as well as the Charité Berlin supported this study.

Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test

“…Both sampling techniques, NP and NMT sampling, yielded a specificity of 99.2%. Our findings for performance are similar to findings of other studies that evaluated the Panbio [6,9,10]. Also, the performance in our study is corroborated by an evaluation of analytical sensitivity and exclusivity in a study by Corman et al showing the Ag-RDT to have excellent performance with the viral load as observed in the first week of disease [11].…”

“…Study methods were rigorous and included standardized sampling and two independent blinded readers. The study population is representative, judging from the similar sensitivity of the Panbio test with NP sampling observed in our study in comparison to two large validation studies [9,10]. All samples for routine RT-PCR were tested via the same RT-PCR assay (Table 1).…”

Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™-Antigen-detecting point-of-care device for SARS-CoV-2

“…However, as we were not able to perform the tests head-to-head to allow a direct comparison, the differences may be attributable to different phases of the pandemic with different test-positive ratios. Although the test-positive ratio during the LumiraDx™ study was higher, absolute viral load and viral load distribution were similar in our PanBio study that immediately preceded this study (4).…”

“…The clinical sensitivity of the LumiraDx™ in this study was not better than well performing lateral flow assays that can be read with the naked eye in other studies (4, 5). The two WHO-recommended Ag-RDTs, the SD Biosensor Standard Q and Abbott PanBio demonstrated sensitivities ranging from 76.6-85.0% in our studies preceding this study (4, 14). However, as we were not able to perform the tests head-to-head to allow a direct comparison, the differences may be attributable to different phases of the pandemic with different test-positive ratios.…”

Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2

“…The sensitivity observed in a clinical setting of the LumiraDx™ in this study was not better than well performing lateral flow assays that can be read with the naked eye in other studies [ 8 , 9 ]. The two WHO-recommended Ag-RDTs, the SD Biosensor Standard Q and Abbott PanBio demonstrated sensitivities ranging from 76.6 to 85.0% in our studies preceding this study [ 8 , 24 ].…”