AroCell TK 210 ELISA 联合前列腺健康指数或前列腺特异性抗原密度检测可提高区分前列腺癌与非癌性病变的能力。

The combination of AroCell TK 210 ELISA with Prostate Health Index or prostate-specific antigen density can improve the ability to differentiate prostate cancer from noncancerous conditions.

机构信息

Department of Anatomy, Physiology, and Biochemistry, Swedish University of Agricultural Sciences, Uppsala, Sweden.

Research and Development Division, AroCell AB, Uppsala, Sweden.

出版信息

Prostate. 2019 Jun;79(8):856-863. doi: 10.1002/pros.23791. Epub 2019 Mar 19.

DOI:10.1002/pros.23791

PMID:30889628

Abstract

BACKGROUND

Prostate-specific antigen (PSA) is an established tumour marker for prostate cancer (PCa). Serum thymidine kinase 1 is a possible new marker for the detection of PCa. The aim of the study was to investigate the diagnostic value of the AroCell TK 210 enzyme-linked immunosorbent assay (ELISA) together with free PSA, [-2]proPSA, and Prostate Health Index (PHI) in differentiating PCa from benign urological conditions.

METHODS

Serum samples from 140 patients with PSA values in the range between 2 and 10 µg/L were collected at the Ljubljana University Medical Centre and the Maribor University Medical Centre. Thymidine kinase (TK1) protein levels were determined using the AroCell TK 210 ELISA and PSA-related parameters analysed with commercial assays.

RESULTS

Serum TK1 protein, total and free PSA, proPSA, PSA density (PSAD), and PHI levels in patients with confirmed PCa were significantly higher than in patients with benign urological conditions (P < 0.05). Overall, the AroCell TK 210 ELISA results showed a significant correlation with PHI ( r = 0.25, P = 0.0031). Receiver-operating characteristic curve analyses were used to compare the area under the curve (AUC) of TK 210 ELISA, PHI, and PSA density. For PHI, the AUC was 0.73, comparable to those of TK 210 ELISA (0.67) and PSAD (0.66), with no significant differences in pairwise comparisons (PHI vs TK 210 ELISA P = 0.32, PHI vs PSAD P = 0.24, and TK 210 ELISA vs PSAD P = 0.95). The AUC for the combination of TK1 plus PSAD was significantly higher than those for the individual PSA-related biomarkers and marginally PHI, while the AUC for the combination of TK1 plus PHI was significantly higher than those for the individual PSA-related biomarkers except for PHI and marginally for PSAD. Total PSA concentration was the only marker, that was significantly higher in patients with an increasing Gleason grade.

CONCLUSIONS

These results suggest that TK1 protein determinations together with PHI or PSAD could be a valuable additional tool in PCa management.

摘要

背景

前列腺特异性抗原（PSA）是前列腺癌（PCa）的一种已确立的肿瘤标志物。血清胸苷激酶 1 是一种可能的新标志物，可用于检测 PCa。本研究旨在探讨 AroCell TK 210 酶联免疫吸附试验（ELISA）联合游离 PSA、[-2]前列腺特异性抗原（proPSA）和前列腺健康指数（PHI）在区分 PCa 与良性泌尿科疾病方面的诊断价值。

方法

在卢布尔雅那大学医学中心和马里博尔大学医学中心收集了 140 例 PSA 值在 2 至 10μg/L 之间的患者的血清样本。使用 AroCell TK 210 ELISA 测定胸苷激酶（TK1）蛋白水平，并使用商业检测方法分析与 PSA 相关的参数。

结果

确诊为 PCa 的患者的血清 TK1 蛋白、总 PSA、游离 PSA、proPSA、PSA 密度（PSAD）和 PHI 水平显著高于良性泌尿科疾病患者（P<0.05）。总体而言，AroCell TK 210 ELISA 结果与 PHI 呈显著相关（r=0.25，P=0.0031）。使用受试者工作特征曲线分析比较 TK 210 ELISA、PHI 和 PSAD 的曲线下面积（AUC）。对于 PHI，AUC 为 0.73，与 TK 210 ELISA（0.67）和 PSAD（0.66）相当，两两比较无显著性差异（PHI 与 TK 210 ELISA 比较，P=0.32；PHI 与 PSAD 比较，P=0.24；TK 210 ELISA 与 PSAD 比较，P=0.95）。TK1 加 PSAD 的组合 AUC 明显高于单个 PSA 相关生物标志物，略高于 PHI，而 TK1 加 PHI 的组合 AUC 明显高于单个 PSA 相关生物标志物，除 PHI 外，略高于 PSAD。总 PSA 浓度是唯一在 Gleason 分级增加的患者中显著升高的标志物。