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

James N Moy; Ariff Mohammed Amin; Claire Chalmers-Watson; Rezwona Chowdhury; Camilla Forssten; Jun Fu; Sarit Ghosh; Jeffrey D Harris; Simon Kordowich; Yin Li; Wenchi Lin; Stuart Mackay-Thomas; Marc Mickiewicz; Nikesh Patel; Salvador Resino; Tamsin Sevenoaks; Michael A Tugetman; Jorge Valencia; Roy Vijesurier; Nikki White; Christopher W Woods; Patrick T Kennedy; Pablo Ryan

doi:10.1016/j.heliyon.2023.e22612

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

Heliyon. 2023 Nov 22;9(12):e22612. doi: 10.1016/j.heliyon.2023.e22612. eCollection 2023 Dec.

Authors

James N Moy¹, Ariff Mohammed Amin², Claire Chalmers-Watson³, Rezwona Chowdhury², Camilla Forssten⁴, Jun Fu¹, Sarit Ghosh⁵, Jeffrey D Harris⁶, Simon Kordowich⁷, Yin Li⁸, Wenchi Lin⁹, Stuart Mackay-Thomas¹⁰, Marc Mickiewicz¹¹, Nikesh Patel¹², Salvador Resino^{13

14}, Tamsin Sevenoaks¹⁵, Michael A Tugetman¹⁶, Jorge Valencia¹⁷, Roy Vijesurier¹⁸, Nikki White¹⁹, Christopher W Woods²⁰, Patrick T Kennedy²¹, Pablo Ryan^{13

17

22}

Affiliations

¹ Department of Internal Medicine, Rush University Medical Center, Chicago, IL, USA.
² Bridgewater Surgeries, Watford, UK.
³ Parliament Hill Medical Centre, London, UK.
⁴ Abbott Rapid and Molecular Diagnostics, Bedford, UK.
⁵ Medicus Health Partners, Enfield, UK.
⁶ Urgent Care Clinical Trials at AFC Urgent Care, Easley and Powdersville, SC, USA.
⁷ Abbott Rapid and Molecular Diagnostics, Jena, Germany.
⁸ Abbott Rapid and Molecular Diagnostics, Carlsbad, CA, USA.
⁹ Abbott Rapid and Molecular Diagnostics, Galway, Ireland.
¹⁰ Hampstead Group Practice, London, UK.
¹¹ Urgent Care Clinical Trials at Complete Urgent Care, Nashville, TN, USA.
¹² Millway Medical Practice, London, UK.
¹³ Centro de Investigación Biomédica en Red en Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain.
¹⁴ Unidad de Infección Viral e Inmunidad, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain.
¹⁵ Brockwood Medical Practice Betchworth, UK.
¹⁶ Urgent Care Clinical Trials, Bronx, NY, USA.
¹⁷ Servicio de Medicina Interna, Hospital Universitario Infanta Leonor, Madrid, Spain.
¹⁸ Abbott Rapid and Molecular Diagnostics, Abbott Park, IL, USA.
¹⁹ The Princess Alexandra Hospital NHS Trust, Essex, UK.
²⁰ Center for Infectious Disease Diagnostic and Innovation, Duke University School of Medicine, Durham, NC, USA.
²¹ Barts Health NHS Trust, London, UK.
²² Universidad complutense de Madrid, Madrid, Spain.

Abstract

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.