| 著者 |
Miura, Yuki
Yoneyama, Tohru
| en |
Yoneyama, Tohru
Department of Glycotechnology Hirosaki University Graduate School of Medicine
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| ja |
弘前大学大学院医学研究科 糖鎖工学講座
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Search repository
Yamamoto, Hayato
| en |
Yamamoto, Hayato
Department of Urology Division of Medical Science Graduate School of Medical Sciences Hirosaki University
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| ja |
弘前大学大学院医学研究科 医科学専攻 泌尿器科学講座
|
Search repository
Suzuki, Hiromu
Otsubo, Takuma
Fujita, Eriko
Tsushima, Fumiyasu
Goto, Shintaro
Okamoto, Teppei
Fujita, Naoki
Ishiyama, Masahiro
Yoshizawa, Tadashi
Kakeda, Shingo
Hatakeyama, Shingo
Ohyama, Chikara
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内容記述 |
Background
The 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%.
Methods
The 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).
Results
The 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).
Conclusions
Analytical characteristics of S2,3PSA% perform well and the diagnostic performance of S2,3PSA% was comparable to phi and MRI. |
The Prostate_2025_85(9)_Pages 869-887.pdf (2 MB)
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