– Associate Professor / HLA Laboratory Director, SUNY Upstate Medical University, United States
Aim: As HLA laboratories increasingly adopt high-resolution typing for solid organ transplant patients, there is a growing need for antibody detection methods that offer broader allele coverage. To address this clinical need, Werfen is developing the NEXA Single Antigen Extended Panel, which expands class I allele representation from ~100 alleles in the current LIFECODES Single Antigen Bead (SAB) assay to over 150 specificities. The goal of this study is to evaluate the performance and limitations of the NEXA Single Antigen Extended Panel and to assess the concordance in antibody detection in comparison to the LIFECODES class I SAB assay. Additionally, the study aims to explore the clinical utility of the expanded panel.
Methods: Thirty-eight serum samples were thawed and processed for IgM depletion using the Zeba™ Spin Desalting Plate followed by the Melon™ Gel IgG Spin Purification Kit to isolate IgG antibodies. The sera were then run in parallel using the LIFECODES Single Antigen Class I SAB kit and the NEXA Single Antigen Extended Panel class I kit on the Luminex™ FlexMap 3D platform. Mean Fluorescence intensity values were collected and antibody patterns were analyzed.
Results: A good correlation was observed between the LIFECODES and NEXA kits for antibody specificities included in both panels. The inclusion of additional alleles in the extended panel enhanced antibody analysis by providing more information on reactivity patterns, which contributed to a better understanding of the patient's antibody profile and to an improved discrimination between specific and non-specific antibodies. Specific cases/examples will be discussed.
Conclusion: The NEXA Single Antigen Extended Panel enables enhanced antibody analysis and interpretation, making it especially valuable for highly sensitized patients. Its ability to provide additional information compared to the standard antibody panel has the potential to improve patient care and outcomes, and to guide clinical decision making, particularly in complex transplant scenarios.
Footnotes: This study was conducted as part of a beta evaluation of the NEXA Single Antigen Extended Panel, which was provided by Werfen for research purposes only. The assay is currently under development and has not been released for commercial use. All findings and interpretations are based on preliminary data. Performance characteristics and specifications are subject to change upon final product release. The results presented herein are intended solely for research and evaluation purposes.
