核基质蛋白 22 用于膀胱癌检测：BladderChek®与 ELISA 的比较分析。

Nuclear matrix protein 22 for bladder cancer detection: comparative analysis of the BladderChek® and ELISA.

机构信息

Technische Universität München, Klinikum rechts der Isar, Department of Urology, Ismaninger Str. 22, 81675 Munich, Germany.

出版信息

Anticancer Res. 2012 Nov;32(11):5093-7.

PMID:23155286

Abstract

AIM

To compare nuclear matrix protein 22 expression by BladderChek® and ELISA, as urine-based assays for bladder cancer (BC) detection.

PATIENTS AND METHODS

Urine samples of 100 BC patients and 100 controls were analyzed. Comparative statistical evaluations were based on sensitivity and specificity.

RESULTS

Seventy-one patients had primary and 29 recurrent BC. The sensitivity of BladderChek® was significantly higher compared to ELISA in the overall cancer cohort and in patients with primary BC (p<0.0001 and p=0.0001, respectively). Both tests demonstrated significant correlation of sensitivities and tumor stage/grade for the overall cancer cohort and for patients with primary BC. Both tests had specificity values of 100% in healthy individuals. Specificity was 93% for BladderChek® and 99% for ELISA in patients with benign diseases (p=0.048).

CONCLUSION

BladderChek® may be clinically more useful for BC detection. Due to high specificity, BladderChek® could be used for high-risk screening. However, due to its low sensitivity, BladderChek® cannot replace but only complement cystoscopy for BC detection.

摘要

目的

比较核基质蛋白 22 （NMP22）表达的 BladderChek® 和 ELISA 检测方法，作为膀胱癌（BC）的尿液检测方法。

患者与方法

分析了 100 例 BC 患者和 100 例对照者的尿液样本。基于敏感性和特异性进行了对比统计学评价。

结果

71 例患者为初发性膀胱癌，29 例为复发性膀胱癌。与 ELISA 相比，BladderChek®在整体癌症队列和初发性膀胱癌患者中的敏感性显著更高（p<0.0001 和 p=0.0001）。两种检测方法在整体癌症队列和初发性膀胱癌患者中均显示敏感性与肿瘤分期/分级显著相关。在健康个体中，两种检测方法的特异性均为 100%。在良性疾病患者中，BladderChek®的特异性为 93%，ELISA 的特异性为 99%（p=0.048）。