来自欧洲生物学变异研究的前列腺特异性抗原的生物学变异估计值；对前列腺癌诊断和监测的影响。

Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer.

机构信息

Laboratory Medicine, Ospedale San Raffaele, Milan, Italy; Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Belgium.

Laboratory Medicine, Ospedale San Raffaele, Milan, Italy.

出版信息

Clin Chim Acta. 2018 Nov;486:185-191. doi: 10.1016/j.cca.2018.07.043. Epub 2018 Jul 29.

DOI:10.1016/j.cca.2018.07.043

PMID:30063887

Abstract

BACKGROUND

Prostate-specific antigen (PSA) is central in the diagnosis of prostate cancer. However, high-quality biological variation (BV) estimates for PSA are scarce. Here BV estimates from the European Biological Variation Study (EuBIVAS) for total (tPSA), free (fPSA), conjugated PSA (cPSA), and percent free PSA (%fPSA) are provided.

METHOD

EuBIVAS samples were collected weekly from thirty-seven healthy males (22-59 years) for 10 weeks. All samples, stored at -80 °C, were measured in duplicate with a Roche Cobas e801. Outlier and homogeneity analysis were performed followed by CV-ANOVA to determine BV, analytical variation, analytical performance specifications (APS), reference change values (RCV) and the number of samples required to estimate the homeostatic set points.

RESULTS

Within-subject BV estimates were for tPSA 6.8% (6.1-7.4); fPSA 7.1% (6.5-7.7) cPSA: 8.8% (8.0-9.7) and %fPSA 5.3% (4.8-5.8), delivering RCV for increase of 15-20% and indicating that one sample is sufficient to estimate the homeostatic set points within ±15%. BV estimates for tPSA were lower than previously published estimates. Estimates for fPSA, cPSA and %fPSA have not previously been reported in healthy subjects.

CONCLUSIONS

Highly powered EuBIVAS BV estimates of tPSA, fPSA, cPSA and %fPSA provide updated APS and RCV for monitoring for prostate cancer.

摘要

背景

前列腺特异性抗原（PSA）是前列腺癌诊断的核心。然而，高质量的 PSA 生物学变异（BV）估计值却很少。本文提供了欧洲生物学变异研究（EuBIVAS）中总（tPSA）、游离（fPSA）、结合 PSA（cPSA）和游离 PSA 百分比（%fPSA）的 BV 估计值。

方法

EuBIVAS 从 37 名健康男性（22-59 岁）中每周采集一次样本，共采集 10 周。所有样本均储存在-80°C，用罗氏 Cobas e801 进行双份测量。对离群值和同质性进行分析，然后进行 CV-ANOVA 以确定 BV、分析变异、分析性能规格（APS）、参考变化值（RCV）和估计内稳态设定点所需的样本数量。

结果

个体内的 tPSA、fPSA、cPSA 和 %fPSA 的 BV 估计值分别为 6.8%（6.1-7.4）、7.1%（6.5-7.7）、8.8%（8.0-9.7）和 5.3%（4.8-5.8），RCV 增加 15-20%，表明只需一个样本即可估计内稳态设定点的±15%范围内。tPSA 的 BV 估计值低于之前发表的估计值。fPSA、cPSA 和 %fPSA 的估计值以前在健康受试者中没有报道过。