开发一种用于 sPSP94 的 ELISA 方法，并利用 sPSP94/sPSA 比值作为诊断指标来区分良性前列腺增生和前列腺癌。

Development of an ELISA for sPSP94 and utility of the sPSP94/sPSA ratio as a diagnostic indicator to differentiate between benign prostatic hyperplasia and prostate cancer.

机构信息

Department of Biochemistry & Clinical Nutrition, Seth G.S. Medical College & K.E.M Hospital, Parel, Mumbai, India.

Division of Structural Biology, National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, India.

出版信息

Clin Chim Acta. 2014 Sep 25;436:256-62. doi: 10.1016/j.cca.2014.06.006. Epub 2014 Jun 18.

DOI:10.1016/j.cca.2014.06.006

PMID:24952364

Abstract

BACKGROUND

The serum PSA (sPSA) test has low specificity for prostate cancer (PCa), since sPSA also rises in benign prostatic hyperplasia (BPH). Serum PSP94 (sPSP94), a major secreted prostate protein, is indicated as a PCa marker. The potential of sPSP94 and sPSA in conjunction with each other to improve specificity of diagnostic test for PCa needs to be evaluated.

METHODS

PCa patients (n=33), BPH patients (n=44) and healthy controls (n=50) were recruited. A serum-based sandwich ELISA was developed to measure sPSP94 concentrations. Utility of sPSP94 in improving specificity of sPSA test was evaluated by studying sPSP94/sPSA ratios of study participants.

RESULTS

Considerable decrease in overlap among sPSP94/sPSA ratio values of BPH and PCa patients was observed, as compared to sPSP94 or sPSA alone. For differentiating between BPH and PCa patients, this ratio had a maximum area under the curve (AUC) of 0.859 (P=0.0132) and had a comparable sensitivity (90.91%) to sPSA with an increased specificity of 70.45%. Further, decision curve analysis (DCA) showed that sPSP94/sPSA ratio had a superior net benefit in identifying PCa, in patients opting for biopsy.

CONCLUSION

The sPSP94/sPSA ratio can be a better differentiating marker between BPH and PCa, than sPSP94 or sPSA alone.

摘要

背景

血清 PSA（sPSA）检测对前列腺癌（PCa）的特异性较低，因为 sPSA 也会在良性前列腺增生（BPH）中升高。血清 PSP94（sPSP94）是一种主要的分泌性前列腺蛋白，被认为是 PCa 的标志物。需要评估 sPSP94 和 sPSA 联合应用对提高 PCa 诊断试验特异性的潜力。

方法

招募了 PCa 患者（n=33）、BPH 患者（n=44）和健康对照者（n=50）。开发了一种基于血清的夹心 ELISA 来测量 sPSP94 浓度。通过研究研究参与者的 sPSP94/sPSA 比值，评估 sPSP94 在提高 sPSA 试验特异性方面的效用。

结果

与 sPSP94 或 sPSA 单独相比，观察到 BPH 和 PCa 患者的 sPSP94/sPSA 比值的重叠有了相当大的减少。为了区分 BPH 和 PCa 患者，该比值的曲线下面积（AUC）最大为 0.859（P=0.0132），与 sPSA 的灵敏度（90.91%）相当，但特异性提高到 70.45%。此外，决策曲线分析（DCA）表明，在选择活检的患者中，sPSP94/sPSA 比值在识别 PCa 方面具有更好的净获益。