Frontiers in Virology · Published 2026-07-08 · DOI 10.3389/fviro.2026.1867243
Alexandra Wolf, Florian Heger, Abdallah Helal, Andreas Moritz, Apostolos Georgopoulos
BackgroundThe assessment of immune responses plays a central role in evaluating the degree of protection after SARS-CoV-2 vaccination. The Abbott Alinity-I SARS-CoV-2 IgG II Quant Assay is widely used as a laboratory-based reference method for the quantitative assessment of anti-SARS-CoV-2 antibodies. In 2021, numerous rapid point-of-care antibody assays entered the market; however, their analytical performance and comparability with established automated platforms have not been comprehensively evaluated. The EDELVITAL fluorescence immunochromatographic assay is a fluorescence-based rapid test designed to assess neutralizing antibodies at the point of care. Early data demonstrated substantially increased infection risks among frontline healthcare personnel compared with the general population. In this context, reliable information on post-vaccination humoral immunity was of particular occupational and public health relevance. Given the limited independent validation data available for rapid assays, at this time, it was uncertain whether they reliably detected an adequate post-vaccination antibody response in comparison to gold standard methods. Therefore, this study aimed to evaluate the performance of a rapid point-of-care neutralizing antibody assay in vaccinated healthcare workers and to assess its concordance with the established Abbott Alinity I IgG assay. Because the two assays measure different aspects of the humoral immune response, the study also explored the potential complementary value of rapid neutralizing antibody testing in occupational health settings.MethodsA total of 334 serum samples from 291 COVID-19-vaccinated individuals were analyzed. IgG antibodies were quantified using the automated Abbott Alinity I CMIA, while neutralizing antibodies were measured using the EDELVITAL fluorescence immunochromatography test, calibrated to the WHO International Standard NIBSC 20/136 and SOP. Correlation and diagnostic analyses were performed.ResultsThe two assays showed a high level of agreement (95.5% of the EDELVITAL neutralizing assay results agreed with those from the Abbott Alinity I system) when it came to detecting positive results. The rapid point-of-care device presented reproducible neutralizing antibody results (positive/negative) within 15–20 min, aligning closely with the laboratory-based Abbott measurements.ConclusionsThe EDELVITAL fluorescence immunochromatographic assay showed analytical comparability with the Abbott Alinity I SARS-CoV-2 IgG II Quant Assay and may represent a practical complementary tool for antibody monitoring in healthcare workers. The rapid availability of its results can facilitate timely decisions regarding booster vaccination and occupational health management.
Abstract from DOAJ. Public domain (CC0 1.0).
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Wolf, A., Heger, F., Helal, A., et al. (2026). Analytical performance evaluation of the EDELVITAL neutralizing antibody test in COVID-19-vaccinated staff of the University Dental Clinic Vienna. Frontiers in Virology. https://doi.org/10.3389/fviro.2026.1867243