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

A Carobene, E Guerra, M Locatelli, V Cucchiara, A Briganti, AK Aarsand, A Coşkun, J Díaz-Garzón, P Fernandez-Calle, T Røraas, S Sandberg, N Jonker, F Ceriotti, Laboratory Medicine Working Group on Biological Variation on behalf of the European Federation of Clinical Chemistry

Research output: Contribution to journalArticle

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. © 2018 Elsevier B.V.
Original languageEnglish
Pages (from-to)185-191
Number of pages7
JournalClinica Chimica Acta
Volume486
DOIs
Publication statusPublished - 2018

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Prostate-Specific Antigen
Prostatic Neoplasms
Reference Values
Monitoring
Specifications
Analysis of variance (ANOVA)
Analysis of Variance
Healthy Volunteers

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Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer. / Carobene, A; Guerra, E; Locatelli, M; Cucchiara, V; Briganti, A; Aarsand, AK; Coşkun, A; Díaz-Garzón, J; Fernandez-Calle, P; Røraas, T; Sandberg, S; Jonker, N; Ceriotti, F; on behalf of the European Federation of Clinical Chemistry, Laboratory Medicine Working Group on Biological Variation.

In: Clinica Chimica Acta, Vol. 486, 2018, p. 185-191.

Research output: Contribution to journalArticle

Carobene, A, Guerra, E, Locatelli, M, Cucchiara, V, Briganti, A, Aarsand, AK, Coşkun, A, Díaz-Garzón, J, Fernandez-Calle, P, Røraas, T, Sandberg, S, Jonker, N, Ceriotti, F & on behalf of the European Federation of Clinical Chemistry, LMWGOBV 2018, 'Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer', Clinica Chimica Acta, vol. 486, pp. 185-191. https://doi.org/10.1016/j.cca.2018.07.043
Carobene, A ; Guerra, E ; Locatelli, M ; Cucchiara, V ; Briganti, A ; Aarsand, AK ; Coşkun, A ; Díaz-Garzón, J ; Fernandez-Calle, P ; Røraas, T ; Sandberg, S ; Jonker, N ; Ceriotti, F ; on behalf of the European Federation of Clinical Chemistry, Laboratory Medicine Working Group on Biological Variation. / Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer. In: Clinica Chimica Acta. 2018 ; Vol. 486. pp. 185-191.
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title = "Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer",
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. {\circledC} 2018 Elsevier B.V.",
author = "A Carobene and E Guerra and M Locatelli and V Cucchiara and A Briganti and AK Aarsand and A Coşkun and J D{\'i}az-Garz{\'o}n and P Fernandez-Calle and T R{\o}raas and S Sandberg and N Jonker and F Ceriotti and {on behalf of the European Federation of Clinical Chemistry}, {Laboratory Medicine Working Group on Biological Variation}",
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TY - JOUR

T1 - Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer

AU - Carobene, A

AU - Guerra, E

AU - Locatelli, M

AU - Cucchiara, V

AU - Briganti, A

AU - Aarsand, AK

AU - Coşkun, A

AU - Díaz-Garzón, J

AU - Fernandez-Calle, P

AU - Røraas, T

AU - Sandberg, S

AU - Jonker, N

AU - Ceriotti, F

AU - on behalf of the European Federation of Clinical Chemistry, Laboratory Medicine Working Group on Biological Variation

PY - 2018

Y1 - 2018

N2 - 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. © 2018 Elsevier B.V.

AB - 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. © 2018 Elsevier B.V.

U2 - 10.1016/j.cca.2018.07.043

DO - 10.1016/j.cca.2018.07.043

M3 - Article

VL - 486

SP - 185

EP - 191

JO - Clinica Chimica Acta

JF - Clinica Chimica Acta

SN - 0009-8981

ER -