Evaluation of the Panbio? COVID-19 IgG rapid test device performance

Background: The Panbio (TM) COVID-19 IgG Rapid Test Device ("Panbio (TM)") detects IgG antibodies against the SARS-CoV-2 spike protein from viral infection or vaccination.Objectives: To determine the diagnostic sensitivity and specificity of the Panbio (TM) professional use test, using fingerstick whole blood and venous plasma.Study design: Fingerstick whole blood and venous plasma from each participant were tested with Panbio (TM) and compared against the SARS-CoV-2 IgG II assay on the Abbott Architect (TM) platform (Europe) or the equivalent AdviseDx SARS-CoV-2 IgG II Abbott Alinity i (TM) platform (US). 447 evaluable participants were enrolled across 6 US and 9 European clinical centers.Results: For unvaccinated participants with PCR-confirmed infection >= 21 days post-symptom onset, the Panbio (TM) sensitivity with fingerstick whole blood was 92.6 % (95 % CI: 85.9, 96.7), and the specificity was 97.0 % (95 % CI: 93.1, 99.0). For venous plasma, the sensitivity was 90.0 % (95 % CI: 79.5, 96.2) for participants with PCR-confirmed infection and symptom onset 22-180 days ago; the specificity was 96.3 % (92.2, 98.6). For vaccinated participants, the sensitivity was 98.4 % (95 % CI: 91.2, 100.0) for fingerstick whole blood and 96.7 % (95 % CI: 88.7, 99.6) for venous plasma.Conclusion: The Panbio (TM) test had high sensitivity and specificity for detecting IgG against the SARS-CoV-2 spike protein.