ArticleThe Prostate2025
Analytical and Real-World Clinical Characterization of S2,3PSA% Test in MRI Fusion Targeted Prostate Biopsy Population.
Article in The Prostate, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Prostate cancer detection in routine clinical practice: a large cohort study in Japan.Scientific reports · 2026Article
- Beyond Total PSA: Clinical Significance of S2,3PSA% in Reducing Unnecessary Prostate Biopsies.International journal of urology : official journal of the Japanese Urological Association · 2026Review
- Integrated Assessment of Percentage α2,3-Linked Sialylated Prostate-specific Antigen and the Prostate Health Index with Magnetic Resonance Imaging for Detection of Clinically Significant Prostate Cancer.European urology open science · 2026Article
- The Effects of the Blood-Based S2,3PSA% Test on Prostate Cancer Screening: A Novel Approach to Reduce the Need for MRI and Unnecessary Biopsies.The Prostate · 2025Article
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Authors and funding
15 authors.
Funding
Abstract
backgroundThe α2,3-sialyl N-glycosylated free prostate-specific antigen ratio (S2,3PSA%) was approved in Japan as a prostate cancer (PCa) diagnostic test. We evaluated the analytical characterization and real-world diagnostic performance of S2,3PSA%.
methodsThe precision testing, dilution linearity, measurement sensitivity, preanalytical stability, and interferences of S2,3PSA, α2,6-sialyl N-glycosylated 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-RADS) and in 145 men (Cohort 2, vs. PI-RADS, prostate health index, phi) who scheduled MRI-targeted biopsy by area under the receiver operating characteristics curve (AUC).
resultsThe precision of the S2,3PSA, S2,6PSA, and S2,3PSA% were all < 3.4% coefficient of variation. The dilution linearity of S2,3PSA had a correlation coefficient of 0.9949-0.9987. The detection limit of S2,3PSA and S2,6PSA was 0.044 and 0.029 ng/mL, respectively. Serum S2,3PSA and S2,6PSA concentrations were stable at 6°C for 24 h and -20°C for 90 days, while S2,3PSA% was unchanged at 6°C and -20°C for 90 days or under five freeze-thaw 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 0.719-0.832) detecting PCa was comparable to that of PI-RADS (0.746, 0.685-0.807, p = 0.7996). In Cohort 2, AUC of S2,3PSA% detecting PCa (0.837, 0.774-0.901) was comparable to PI-RADS (0.779, 0.703-0.854, p = 0.3037), and phi (0.867, 0.809-0.926, p = 0.3000).
conclusionsAnalytical characteristics of S2,3PSA% perform well and the diagnostic performance of S2,3PSA% was comparable to phi and MRI.
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