Shaheen R M, Miseljic S, Wiehle R D, Wittliff J L
Department of Biochemistry, University of Louisville, KY 40292, USA.
Clin Chem. 1995 Nov;41(11):1585-91.
We evaluated cathepsin D concentrations in 318 breast carcinoma specimens with a standardized IRMA and established distribution values of 5.9-217.8 nmol/g (median 51.8). Concentrations of cathepsin D did not correlate with age or with concentrations of HER-2/neu oncoprotein, estrogen receptor, or epidermal growth factor receptors. A significant correlation was observed between cathepsin D and progestin receptor (P = 0.009), but only in postmenopausal patients. In our role as a National Reference Laboratory for conducting interlaboratory comparisons of tumor markers, we evaluated cathepsin D assay proficiency by using control samples with intra- and interassay CVs of 2-8% and 10-13%, respectively. Human reference specimens containing known quantities of cathepsin D were developed to facilitate standardized testing. The IRMA procedure and the use of quality-assurance samples permits evaluation of the clinical significance of cathepsin D in human breast cancer trials.
我们使用标准化免疫放射分析（IRMA）评估了318份乳腺癌标本中的组织蛋白酶D浓度，并确定了其分布值为5.9 - 217.8 nmol/g（中位数为51.8）。组织蛋白酶D的浓度与年龄、HER-2/neu癌蛋白、雌激素受体或表皮生长因子受体的浓度均无相关性。组织蛋白酶D与孕激素受体之间存在显著相关性（P = 0.009），但仅在绝经后患者中如此。作为进行肿瘤标志物实验室间比对的国家参考实验室，我们使用批内和批间变异系数分别为2 - 8%和10 - 13%的对照样本评估了组织蛋白酶D检测的熟练度。开发了含有已知量组织蛋白酶D的人类参考标本以促进标准化检测。免疫放射分析程序和质量保证样本的使用使得在人类乳腺癌试验中能够评估组织蛋白酶D的临床意义。
