{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T10:31:27Z","timestamp":1783074687463,"version":"3.54.6"},"reference-count":27,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2025,3,30]],"date-time":"2025-03-30T00:00:00Z","timestamp":1743292800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Prostate"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The \u03b12,3\u2010sialyl <jats:italic>N<\/jats:italic>\u2010glycosylated free prostate\u2010specific antigen ratio (S2,3PSA%) was approved in Japan as a prostate cancer (PCa) diagnostic test. We evaluated the analytical characterization and real\u2010world diagnostic performance of S2,3PSA%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The precision testing, dilution linearity, measurement sensitivity, preanalytical stability, and interferences of S2,3PSA, \u03b12,6\u2010sialyl <jats:italic>N<\/jats:italic>\u2010glycosylated free PSA (S2,6PSA), and S2,3PSA% were performed. The diagnostic accuracy detecting PCa of S2,3PSA% was prospectively evaluated in 253 men (Cohort 1, vs. PI\u2010RADS) and in 145 men (Cohort 2, vs. PI\u2010RADS, <jats:italic>prostate health index<\/jats:italic>, <jats:italic>phi<\/jats:italic>) who scheduled MRI\u2010targeted biopsy by area under the receiver operating characteristics curve (AUC).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The precision of the S2,3PSA, S2,6PSA, and S2,3PSA% were all &lt;\u20093.4% coefficient of variation. The dilution linearity of S2,3PSA had a correlation coefficient of 0.9949\u20130.9987. The detection limit of S2,3PSA and S2,6PSA was 0.044 and 0.029\u2009ng\/mL, respectively. Serum S2,3PSA and S2,6PSA concentrations were stable at 6\u00b0C for 24\u2009h and \u221220\u00b0C for 90 days, while S2,3PSA% was unchanged at 6\u00b0C and \u221220\u00b0C for 90 days or under five freeze\u2013thaw cycles. Serum S2,3PSA and S2,3PSA% were not affected by any interferences and drugs. In Cohort 1, AUC of S2,3PSA% (0.776, 95% CI 0.719\u20130.832) detecting PCa was comparable to that of PI\u2010RADS (0.746, 0.685\u20130.807, <jats:italic>p<\/jats:italic>\u2009=\u20090.7996). In Cohort 2, AUC of S2,3PSA% detecting PCa (0.837, 0.774\u20130.901) was comparable to PI\u2010RADS (0.779, 0.703\u20130.854, <jats:italic>p<\/jats:italic>\u2009=\u20090.3037), and <jats:italic>phi<\/jats:italic> (0.867, 0.809\u20130.926, <jats:italic>p<\/jats:italic>\u2009=\u20090.3000).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Analytical characteristics of S2,3PSA% perform well and the diagnostic performance of S2,3PSA% was comparable to <jats:italic>phi<\/jats:italic> and MRI.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pros.24894","type":"journal-article","created":{"date-parts":[[2025,3,31]],"date-time":"2025-03-31T21:19:46Z","timestamp":1743455986000},"page":"869-887","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Analytical and Real\u2010World Clinical Characterization of S2,3PSA% Test in MRI Fusion Targeted Prostate Biopsy Population"],"prefix":"10.1002","volume":"85","author":[{"given":"Yuki","family":"Miura","sequence":"first","affiliation":[{"name":"Department of Urology Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1098-407X","authenticated-orcid":false,"given":"Tohru","family":"Yoneyama","sequence":"additional","affiliation":[{"name":"Department of Glycotechnology Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hayato","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Department of Urology Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiromu","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Medical Systems Research &amp; Development Center, Fujifilm Corporation Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuma","family":"Otsubo","sequence":"additional","affiliation":[{"name":"Medical Systems Research &amp; Development Center, Fujifilm Corporation Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eriko","family":"Fujita","sequence":"additional","affiliation":[{"name":"Clinical Laboratory Department Hirosaki University Hospital Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumiyasu","family":"Tsushima","sequence":"additional","affiliation":[{"name":"Department of Radiology Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shintaro","family":"Goto","sequence":"additional","affiliation":[{"name":"Department of Pathology and Bioscience Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teppei","family":"Okamoto","sequence":"additional","affiliation":[{"name":"Department of Urology Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8284-9582","authenticated-orcid":false,"given":"Naoki","family":"Fujita","sequence":"additional","affiliation":[{"name":"Department of Urology Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Ishiyama","sequence":"additional","affiliation":[{"name":"Clinical Laboratory Department Hirosaki University Hospital Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Yoshizawa","sequence":"additional","affiliation":[{"name":"Department of Pathology and Bioscience Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shingo","family":"Kakeda","sequence":"additional","affiliation":[{"name":"Department of Radiology Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0026-4079","authenticated-orcid":false,"given":"Shingo","family":"Hatakeyama","sequence":"additional","affiliation":[{"name":"Department of Urology Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chikara","family":"Ohyama","sequence":"additional","affiliation":[{"name":"Department of Advanced Transplant and Regenerative Medicine Hirosaki University Graduate School of Medicine Hirosaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,30]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/MED.0b013e328360332a"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-015-0296-5"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.critrevonc.2017.11.007"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2014.10.121"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2014.08.010"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.14082"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms18020470"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clgc.2019.10.011"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.analchem.8b04829"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/glycob\/cwm117"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/glycob\/cwh071"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41416-021-01637-x"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/pros.24239"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000003450"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.4111\/icu.20220056"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-022-04085-1"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000000495"},{"key":"e_1_2_13_19_1","unstructured":"CLSI Evaluation of Precision of Quantitative Measurement Procedures; 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