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

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.

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.

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.

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

Clinica chimica acta; international journal of clinical chemistry. 2018 Jul 28 [Epub ahead of print]

Anna Carobene, Elena Guerra, Massimo Locatelli, Vito Cucchiara, Alberto Briganti, Aasne K Aarsand, Abdurrahman Coşkun, Jorge Díaz-Garzón, Pilar Fernandez-Calle, Thomas Røraas, Sverre Sandberg, Niels Jonker, Ferruccio Ceriotti, European Federation of Clinical Chemistry , Laboratory Medicine Working Group on Biological Variation

Laboratory Medicine, Ospedale San Raffaele, Milan, Italy; Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Belgium. Electronic address: ., Laboratory Medicine, Ospedale San Raffaele, Milan, Italy., Division of Oncology, Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy., Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Belgium; Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway; Norwegian Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway., Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Belgium; Acibadem Mehmet Ali Aydinlar University, School of Medicine, Atasehir, Istanbul, Turkey., Hospital Universitario La Paz, Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC), Spain., Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Belgium; Hospital Universitario La Paz, Quality Analytical Commission of Spanish Society of Clinical Chemistry (SEQC), Spain., Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Belgium; Norwegian Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway., Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Belgium; Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway; Norwegian Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway; Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway., Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine, Belgium; Certe, Wilhelmina Ziekenhuis Assen, Europaweg-Zuid 1, 9401 RK Assen, the Netherlands., Central Laboratory, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.

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