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
Affiliations
James N. Moy
Department of Internal Medicine, Rush University Medical Center, Chicago, IL, USA
Ariff Mohammed Amin
Bridgewater Surgeries, Watford, UK
Claire Chalmers-Watson
Parliament Hill Medical Centre, London, UK
Rezwona Chowdhury
Bridgewater Surgeries, Watford, UK
Camilla Forssten
Abbott Rapid and Molecular Diagnostics, Bedford, UK
Jun Fu
Department of Internal Medicine, Rush University Medical Center, Chicago, IL, USA
Sarit Ghosh
Medicus Health Partners, Enfield, UK
Jeffrey D. Harris
Urgent Care Clinical Trials at AFC Urgent Care, Easley and Powdersville, SC, USA
Simon Kordowich
Abbott Rapid and Molecular Diagnostics, Jena, Germany
Yin Li
Abbott Rapid and Molecular Diagnostics, Carlsbad, CA, USA
Wenchi Lin
Abbott Rapid and Molecular Diagnostics, Galway, Ireland
Stuart Mackay-Thomas
Hampstead Group Practice, London, UK
Marc Mickiewicz
Urgent Care Clinical Trials at Complete Urgent Care, Nashville, TN, USA
Nikesh Patel
Millway Medical Practice, London, UK
Salvador Resino
Centro de Investigación Biomédica en Red en Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain; Unidad de Infección Viral e Inmunidad, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Spain
Tamsin Sevenoaks
Brockwood Medical Practice Betchworth, UK
Michael A. Tugetman
Urgent Care Clinical Trials, Bronx, NY, USA
Jorge Valencia
Servicio de Medicina Interna, Hospital Universitario Infanta Leonor, Madrid, Spain
Roy Vijesurier
Abbott Rapid and Molecular Diagnostics, Abbott Park, IL, USA
Nikki White
The Princess Alexandra Hospital NHS Trust, Essex, UK
Christopher W. Woods
Center for Infectious Disease Diagnostic and Innovation, Duke University School of Medicine, Durham, NC, USA
Patrick T. Kennedy
Barts Health NHS Trust, London, UK
Pablo Ryan
Centro de Investigación Biomédica en Red en Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain; Servicio de Medicina Interna, Hospital Universitario Infanta Leonor, Madrid, Spain; Universidad complutense de Madrid, Madrid, Spain; Corresponding author. Servicio de Medicina Interna, Hospital Universitario Infanta Leonor, Gran Vía del Este, 80 -28031-Madrid, Spain.
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.
