The Prostate · 2025
Analytical and Real-World Clinical Characterization of S2,3PSA% Test in MRI Fusion Targeted Prostate Biopsy Population.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Miura Yuki, Yoneyama Tohru, Yamamoto Hayato, Suzuki Hiromu, Otsubo Takuma, Fujita Eriko, Tsushima Fumiyasu, Goto Shintaro, Okamoto Teppei, Fujita Naoki, Ishiyama Masahiro, Yoshizawa Tadashi, Kakeda Shingo, Hatakeyama Shingo, Ohyama Chikara
Аннотация
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.
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.