Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer
Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer
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DOI：
10.1016/j.cca.2018.07.043
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发表时间：
2018-11-01
影响因子：
5
通讯作者：
Ceriotti, Ferruccio
中科院分区：
文献类型：
--
作者：
Carobene, Anna;Guerra, Elena;Ceriotti, Ferruccio
背景：前列腺特异性抗原（PSA）是前列腺癌诊断的核心。然而，PSA的高质量生物变异（BV）估计是稀缺的。这里提供了来自欧洲生物变异研究（EuBIVAS）的总PSA（tPSA）、游离PSA（fPSA）、结合PSA（cPSA）和游离PSA百分比（%fPSA）的BV估计值。储存在-80 ℃下的所有样品用Roche Cobas e801一式两份测量。进行离群值和同质性分析，然后进行CV-ANOVA，以确定BV、分析变异、分析性能质量标准（APS）、参考变化值（RCV）和估计稳态设定点所需的样本数量。（6.1-7.4）; fPSA 7.1%（6.5-7.7）cPSA：8.8%（8.0-9.7）和%fPSA 5.3%（4.8-5.8），提供15-20%增加的RCV，并表明一个样本足以估计15%内的稳态设定点。tPSA的BV估计值低于先前公布的估计值。估计fPSA，cPSA和%fPSA以前没有在健康subjects.Conclusions：高功率EuBIVAS BV估计tPSA，fPSA，cPSA和%fPSA提供更新的APS和RCV监测前列腺癌。
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 degrees 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.