Groskopf Jack, Aubin Sheila M J, Deras Ina Lim, Blase Amy, Bodrug Sharon, Clark Craig, Brentano Steven, Mathis Jeannette, Pham Jimmykim, Meyer Troels, Cass Michelle, Hodge Petrea, Macairan Maria Luz, Marks Leonard S, Rittenhouse Harry
Gen-Probe Incorporated, San Diego, CA 92121, USA.
Clin Chem. 2006 Jun;52(6):1089-95. doi: 10.1373/clinchem.2005.063289. Epub 2006 Apr 20.
Prostate cancer gene 3 (PCA3) encodes a prostate-specific mRNA that has shown promise as a prostate cancer diagnostic tool. This report describes the characterization of a prototype quantitative PCA3-based test for whole urine.
Whole-urine specimens were collected after digital rectal examination from 3 groups: men scheduled for prostate biopsy (n = 70), healthy men (<45 years of age with no known prostate cancer risk factors; n = 52), and men who had undergone radical prostatectomy (n = 21). PCA3 and prostate-specific antigen (PSA) mRNAs were isolated, amplified, and quantified by use of Gen-Probe DTS400 Systems. Prostate biopsy results were correlated with the PCA3/PSA mRNA ratio, and PSA mRNA concentrations were used to normalize PCA3 signals and confirm the yield of prostate-specific RNA. Assay precision, specimen stability, and mRNA yield were also evaluated.
The specimen informative rate (fraction of specimens yielding sufficient RNA for analysis) was 98.2%. In this clinical research study, ROC curve analysis of prebiopsy specimens yielded an area under the curve of 0.746; sensitivity was 69% and specificity 79%. Serum PSA assay specificity was 28% for this same group. PCA3 and PSA mRNAs were undetectable in postprostatectomy specimens except for one man with recurrent prostate cancer. Assay interrun CVs were < or =12%. Both mRNAs were stable in processed urine up to 5 days at 4 degrees C and after 5 freeze-thaw cycles.
The APTIMA PCA3 assay combines simple specimen processing with precise assays and existing instruments and could add specificity to the current algorithm for prostate cancer diagnosis.
前列腺癌基因3（PCA3）编码一种前列腺特异性mRNA，已显示出作为前列腺癌诊断工具的潜力。本报告描述了一种基于PCA3的全尿定量检测原型的特性。
在直肠指检后，从3组人群中收集全尿标本：计划进行前列腺活检的男性（n = 70）、健康男性（年龄<45岁，无已知前列腺癌风险因素；n = 52）以及接受过前列腺根治术的男性（n = 21）。使用Gen-Probe DTS400系统分离、扩增并定量PCA3和前列腺特异性抗原（PSA）mRNA。将前列腺活检结果与PCA3/PSA mRNA比值相关联，并使用PSA mRNA浓度对PCA3信号进行标准化，以确认前列腺特异性RNA的产量。还评估了检测精密度（分析精密度）、样本稳定性和mRNA产量。
样本信息率（产生足够RNA用于分析的样本比例）为98.2%。在这项临床研究中，活检前标本的ROC曲线分析得出曲线下面积为0.746；敏感性为69%，特异性为79%。同一组的血清PSA检测特异性为28%。除一名复发性前列腺癌患者外，前列腺切除术后标本中未检测到PCA3和PSA mRNA。批间变异系数（CV）≤12%。两种mRNA在4℃下处理过的尿液中长达5天以及经过5次冻融循环后均稳定。
APTIMA PCA3检测将简单的样本处理与精确的检测及现有仪器相结合，可为当前前列腺癌诊断算法增加特异性。
