Moy, James NAmin, Ariff MohammedChalmers-Watson, ClaireChowdhury, RezwonaForssten, CamillaFu, JunGhosh, SaritHarris, Jeffrey DKordowich, SimonLi, YinLin, WenchiMackay-Thomas, StuartMickiewicz, MarcPatel, NikeshResino, SalvadorSevenoaks, TamsinTugetman, Michael AValencia, JorgeVijesurier, RoyWhite, NikkiWoods, Christopher WKennedy, Patrick TRyan, Pablo2024-03-182024-03-182023-12Heliyon. 2023 Nov 22;9(12):e22612.2405-8440http://hdl.handle.net/20.500.12105/18972Background: The Panbio™ COVID-19 IgG Rapid Test Device ("Panbio™") 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™ 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™ and compared against the SARS-CoV-2 IgG II assay on the Abbott Architect™ platform (Europe) or the equivalent AdviseDx SARS-CoV-2 IgG II Abbott Alinity i™ 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™ 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™ test had high sensitivity and specificity for detecting IgG against the SARS-CoV-2 spike protein.engVoRAttribution-NonCommercial-NoDerivatives 4.0 Internacional38125420912e2261210.1016/j.heliyon.2023.e22612Heliyonopen access