{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T15:05:58Z","timestamp":1783955158284,"version":"3.55.0"},"reference-count":25,"publisher":"Walter de Gruyter GmbH","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2025-1431_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-1431_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-1431_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The hsPSA Atellica assay demonstrated a LOD of 0.01\u202f\u03bcg\/L and LOQ of 0.028\u202f\u03bcg\/L (CV: 3.2\u202f%, accuracy: 115\u202f%). Precision was maintained across concentrations, with CVs of 4.2\u202f%, 3.8\u202f%, and 2.4\u202f% 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\u202f\u03bcg\/L clinical decision threshold were 98\u202f% and 35\u202f%, respectively. In 87 samples between 3 and 10\u202f\u03bcg\/L, concordance between hsPSA Atellica and Hybritech reached 96.6\u202f% (\u03ba=0.82). The assay remained accurate up to PSA concentrations of 13,311\u202f\u03bcg\/L, showing minimal hook effect.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-1431_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2025-1431","type":"journal-article","created":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T10:58:18Z","timestamp":1766401098000},"page":"913-921","source":"Crossref","is-referenced-by-count":1,"title":["Analytical verification and comparative assessment of the new Atellica IM high-sensitivity prostate specific antigen assay"],"prefix":"10.1515","volume":"64","author":[{"given":"Xavier","family":"Filella","sequence":"first","affiliation":[{"name":"Biochemistry and Molecular Genetics Department , 16493 Hospital Clinic , Barcelona , Catalonia , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Gonz\u00e1lez-Escribano","sequence":"additional","affiliation":[{"name":"CORE Laboratory (CDB) , Hospital Clinic de Barcelona , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda","family":"Rodr\u00edguez-Garc\u00eda","sequence":"additional","affiliation":[{"name":"Bioqu\u00edmica y Gen\u00e9tica Molecular , Hospital Cl\u00ednic de Barcelona , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N\u00faria","family":"Medina-Esteban","sequence":"additional","affiliation":[{"name":"Biochemistry and Molecular Genetics Department , 16493 Hospital Clinic , Barcelona , Catalonia , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Fern\u00e1ndez-Galan","sequence":"additional","affiliation":[{"name":"Department of Biochemistry and Molecular Genetics, Biomedical Diagnostic Centre (CDB) , Hospital Clinic de Barcelona , Barcelona , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2025,12,23]]},"reference":[{"key":"2026051215045276018_j_cclm-2025-1431_ref_001","doi-asserted-by":"crossref","unstructured":"Lilja, H, Ulmert, D, Vickers, AJ. 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