Por favor, use este identificador para citar o enlazar este Item:http://hdl.handle.net/20.500.12105/18972
Título
Evaluation of the Panbio™ COVID-19 IgG rapid test device performance
Autor(es)
Moy, James N | Amin, Ariff Mohammed | Chalmers-Watson, Claire | Chowdhury, Rezwona | Forssten, Camilla | Fu, Jun | Ghosh, Sarit | Harris, Jeffrey D | Kordowich, Simon | Li, Yin | Lin, Wenchi | Mackay-Thomas, Stuart | Mickiewicz, Marc | Patel, Nikesh | Resino, Salvador ISCIII | Sevenoaks, Tamsin | Tugetman, Michael A | Valencia, Jorge | Vijesurier, Roy | White, Nikki | Woods, Christopher W | Kennedy, Patrick T | Ryan, Pablo
Fecha de publicación
2023-12
Cita
Heliyon. 2023 Nov 22;9(12):e22612.
Idioma
Inglés
Tipo de documento
research article
Resumen
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.
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DOI
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