Abstract
Rapid and accurate diagnosis of healthcare-associated infections (HAIs) is an unmet need for improving outcomes in intensive care units (ICUs). Traditional culture-based methods, while the gold standard, are time-consuming and can delay therapeutic interventions. In this study, we evaluated the diagnostic utility of pathogen-specific immunoglobulin G (IgG) binding levels using an enzyme-linked immunosorbent assay (ELISA). We measured IgG binding against pathogens including Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Enterococcus faecalis, Enterococcus faecium, and Staphylococcus aureus. Diagnostic performance was evaluated through receiver operating characteristic (ROC) curve analysis, with culture results as the reference. The assay demonstrated an overall diagnostic accuracy of 83.2%, with a sensitivity of 85.4%, a specificity of 81.4%, and an area under the curve (AUC) of 0.910. Pathogen-specific cutoff values ranged from 0.918 to 1.534. Especially, A. baumannii showed the highest performance metrics, achieving a sensitivity of 94.7%, a specificity of 93.6%, and an AUC of 0.975. The pathogen-specific IgG binding levels can offer a novel and effective diagnostic tool for the initial assessment of HAIs, enhancing early detection and improving patient management across healthcare settings.
Data availability
The data that support the findings of this study are not openly available due to sensitivity reasons and are available from the corresponding author upon reasonable request. The data are stored in controlled-access storage systems by the corresponding author.
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Acknowledgements
The authors would like to thank Prof. Dr. Can Günay from Cerrahpaşa University Hospital for statistical assistance and Mürsel Baydemir from Bogazici University for helping with the acquisition of data.
Funding
This study was funded by the Turkish Scientific and Technological Research Council [Project Number: 20170294 to Asiye Karakullukçu].
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AK has full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors contributed to the study’s conception and design. Material preparation and analysis were performed by AK, data collection was performed by MA, and visualization was performed by MAK. The first draft of the manuscript was written by AK. YD and GA provided critical revisions and supervision. All authors revised it critically for important intellectual content. All authors read and approved the final manuscript. All authors gave final approval for the version to be published.
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Karakullukçu, A., Akker, M., Kuşkucu, M.A. et al. Evaluating a pathogen-specific IgG binding assay for rapid detection of healthcare-associated infections. Sci Rep (2026). https://doi.org/10.1038/s41598-025-30459-7
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DOI: https://doi.org/10.1038/s41598-025-30459-7