2026-04-29T00:59:41Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/189722024-09-27T21:45:16Zcom_20.500.12105_2052com_20.500.12105_2051col_20.500.12105_19609

00925njm 22002777a 4500 dc Moy, James N author Amin, Ariff Mohammed author Chalmers-Watson, Claire author Chowdhury, Rezwona author Forssten, Camilla author Fu, Jun author Ghosh, Sarit author Harris, Jeffrey D author Kordowich, Simon author Li, Yin author Lin, Wenchi author Mackay-Thomas, Stuart author Mickiewicz, Marc author Patel, Nikesh author Resino, Salvador author Sevenoaks, Tamsin author Tugetman, Michael A author Valencia, Jorge author Vijesurier, Roy author White, Nikki author Woods, Christopher W author Kennedy, Patrick T author Ryan, Pablo author 2023-12 Background: 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. Heliyon. 2023 Nov 22;9(12):e22612. 2405-8440 http://hdl.handle.net/20.500.12105/18972 38125420 10.1016/j.heliyon.2023.e22612 Heliyon Evaluation of the Panbio™ COVID-19 IgG rapid test device performance