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

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

James N Moy  1 , Ariff Mohammed Amin  2 , Claire Chalmers-Watson  3 , Rezwona Chowdhury  2 , Camilla Forssten  4 , Jun Fu  1 , Sarit Ghosh  5 , Jeffrey D Harris  6 , Simon Kordowich  7 , Yin Li  8 , Wenchi Lin  9 , Stuart Mackay-Thomas  10 , Marc Mickiewicz  11 , Nikesh Patel  12 , Salvador Resino  13   14 , Tamsin Sevenoaks  15 , Michael A Tugetman  16 , Jorge Valencia  17 , Roy Vijesurier  18 , Nikki White  19 , Christopher W Woods  20 , Patrick T Kennedy  21 , Pablo Ryan  13   17   22
Affiliations

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

James N Moy et al. Heliyon. .

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.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Roy Vijesurier, Camilla Forssten, Simon Kordowich, Yin Li and Wenchi Lin report financial support was provided by 10.13039/100001316Abbott Laboratories. Pablo Ryan and Patrick T. Kennedy report financial support was provided by 10.13039/100001316Abbott Laboratories. Roy Vijesurier, Camilla Forssten, Simon Kordowich, Yin Li and Wenchi Lin report a relationship with Abbott Laboratories that includes: employment. Pablo Ryan and Patrick T. Kennedy report a relationship with Abbott Laboratories that includes: consulting or advisory. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Consort diagram reporting patient flow.
See this image and copyright information in PMC

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