Analytical verification and comparative assessment of the new Atellica IM high-sensitivity prostate specific antigen assay
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Xavier Filella
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Cristina González-Escribano
Abstract
Objectives
Despite standardization efforts, significant inter-assay variability persists among prostate-specific antigen (PSA) tests, impacting prostate cancer (PCa) diagnosis and monitoring. We aimed to evaluate the analytical and clinical performance of the newly developed Atellica IM high-sensitivity PSA (hsPSA Atellica) assay compared with established PSA assays.
Methods
A total of 236 serum samples from healthy individuals and patients with or without PCa were analyzed using the hsPSA Atellica assay and four FDA-approved PSA assays: Hybritech Access, Architect, Atellica, and Cobas. Analytical performance included limit of detection (LOD), limit of quantification (LOQ), linearity, inter-assay precision, and hook effect. Method comparison was performed using Passing-Bablok regression, Bland-Altman analysis, and kappa index concordance.
Results
The hsPSA Atellica assay demonstrated a LOD of 0.01 μg/L and LOQ of 0.028 μg/L (CV: 3.2 %, accuracy: 115 %). Precision was maintained across concentrations, with CVs of 4.2 %, 3.8 %, and 2.4 % at low, medium, and high levels of PSA. Strong agreement was observed with the compared tests, particularly with Cobas and Hybritech PSA assays. Diagnostic sensitivity and specificity at the 4 μg/L clinical decision threshold were 98 % and 35 %, respectively. In 87 samples between 3 and 10 μg/L, concordance between hsPSA Atellica and Hybritech reached 96.6 % (κ=0.82). The assay remained accurate up to PSA concentrations of 13,311 μg/L, showing minimal hook effect.
Conclusions
The hsPSA Atellica assay shows excellent analytical sensitivity and strong agreement with established assays. To our knowledge, this is the first published evaluation of this assay, supporting its clinical utility in both PCa diagnosis and follow-up.
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Research ethics: The study was approved by the Ethics Committee of the hospital (reference number: HCB/2019/0194). The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).
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Informed consent: Not applicable. Not required by the Ethics Committee of our hospital for this study, because the PSA measurement was performed on leftover serum samples from patients who had been requested PSA for healthcare purposes.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. Xavier Filella was responsible for the conception and overall direction of the manuscript. He led the statistical analysis of the results and drafted the initial version of the manuscript, which was subsequently reviewed and revised by all authors. He also took primary responsibility for the final version of the manuscript. Cristina González-Escribano selected samples, performed PSA measurements across different platforms, entered the data into the database, and contributed to the preparation of the study protocol that was submitted to the hospital’s ethics committee. Núria Medina-Esteban participated in the selection of samples and performed PSA measurements across different platforms. She prepared the figures. Esther Fernandez-Galan and María Rodríguez-García contributed to the statistical analysis of the results and drafted the Materials and Methods section of the manuscript. They contributed to the interpretation of the results.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: Xavier Filella, as the principal investigator, entered into a contract with Siemens Diagnostics for the conduct of this study. All other authors state no conflict of interest.
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Research funding: None declared.
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Data availability: The data supporting this study are not publicly available due to privacy restrictions. However, they may be accessed through the corresponding author upon reasonable request under a data sharing agreement and approval from our hospital’s ethics committee.
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Role of the sponsor: The sponsor – Siemens Diagnostics –provided the necessary reagents for conducting this study and contributed funds to support the technical staff required to carry out the analyses, but had no role in study design, data analysis, interpretation, or manuscript preparation.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2025-1431).
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