Loeb Stacy, Chan Daniel W, Sokoll Lori, Kan Donghui, Maggiore Jack, Mikolajczyk Stephen D, Mondo Dana M, Griffin Chris R, Catalona William J
Department of Urology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
J Urol. 2008 Nov;180(5):1959-62; discussion 1962-3. doi: 10.1016/j.juro.2008.07.036. Epub 2008 Sep 17.
Although prostate specific antigen is widely used to detect and manage prostate cancer, many patients and physicians are unaware of which prostate specific antigen assay is being used. Most commercial prostate specific antigen assays are standardized to the WHO 90:10 standard or aligned with the original Hybritech assay with potentially disparate results.
A total of 1,916 men participated in a prostate cancer screening study in 2007. On the day of collection prostate specific antigen was tested from the same serum sample using the Access (Hybritech standard) and ADVIA Centaur (WHO 90:10 prostate specific antigen standard) assays. We examined the differences between the 2 assays and the effect that this might have on clinical decisions.
Median prostate specific antigen was 0.9 and 1.05 ng/ml for the Centaur and Access assays, respectively, representing a 17% difference. Mean prostate specific antigen was 3.45 and 4.79 ng/ml, respectively, representing a 38% difference. Using a prostate specific antigen threshold of 2.5 ng/ml 5% of men would have been recommended to undergo biopsy using the Access but not the Centaur assay. Furthermore, prostate specific antigen differed by greater than 0.4 ng/ml in 26%, greater than 0.75 ng/ml in 14.5% and greater than 2 ng/ml in 4.5% of men in the same sample simply by using the different assays.
In our prospective screening population median prostate specific antigen was 17% lower using WHO vs Hybritech based assay standardization. As such, if these assays were instead used on a serial basis in the same patient, this could lead to false acceleration or false deceleration in prostate specific antigen velocity. Thus, the assay may influence the likelihood of prostate biopsy and, thereby, prostate cancer detection.
尽管前列腺特异性抗原被广泛用于检测和管理前列腺癌，但许多患者和医生并不清楚所使用的是哪种前列腺特异性抗原检测方法。大多数商业化的前列腺特异性抗原检测方法是按照世界卫生组织90:10标准进行标准化的，或者与最初的Hybritech检测方法一致，结果可能存在差异。
2007年共有1916名男性参与了一项前列腺癌筛查研究。在采集样本当天，使用Access（Hybritech标准）和ADVIA Centaur（世界卫生组织90:10前列腺特异性抗原标准）检测方法对同一血清样本进行前列腺特异性抗原检测。我们研究了这两种检测方法之间的差异以及这可能对临床决策产生的影响。
Centaur和Access检测方法的前列腺特异性抗原中位数分别为0.9和1.05 ng/ml，相差17%。平均前列腺特异性抗原分别为3.45和4.79 ng/ml，相差38%。使用2.5 ng/ml的前列腺特异性抗原阈值时，5%的男性使用Access检测方法会被建议进行活检，而使用Centaur检测方法则不会。此外，仅因使用不同检测方法，同一样本中26%的男性前列腺特异性抗原差异大于0.4 ng/ml，14.5%的男性差异大于0.75 ng/ml，4.5%的男性差异大于2 ng/ml。
在我们的前瞻性筛查人群中，使用基于世界卫生组织标准与基于Hybritech标准的检测方法进行标准化时，前列腺特异性抗原中位数低17%。因此，如果在同一患者中连续使用这些检测方法，可能会导致前列腺特异性抗原速度出现假性加快或假性减慢。因此，检测方法可能会影响前列腺活检的可能性，进而影响前列腺癌的检测。
