Interassay Variability and Clinical Implications of Five Different Prostate-specific Antigen Assays
Background and objective: Prostate-specific antigen (PSA) remains a critical marker for prostate cancer (PCa) detection and monitoring. Recognising historical variability in PSA assays and the evolution of assay technology and calibration, this study aims to reassess interassay variability using the...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-05-01
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| Series: | European Urology Open Science |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666168324003343 |
| _version_ | 1827262668591857664 |
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| author | Basil Kaufmann Paloma Pellegrino Laura Zuluaga Reuben Ben-David Michael Müntener Etienne X. Keller Katharina Spanaus Arnold von Eckardstein Michael A. Gorin Cédric Poyet |
| author_facet | Basil Kaufmann Paloma Pellegrino Laura Zuluaga Reuben Ben-David Michael Müntener Etienne X. Keller Katharina Spanaus Arnold von Eckardstein Michael A. Gorin Cédric Poyet |
| author_sort | Basil Kaufmann |
| collection | DOAJ |
| description | Background and objective: Prostate-specific antigen (PSA) remains a critical marker for prostate cancer (PCa) detection and monitoring. Recognising historical variability in PSA assays and the evolution of assay technology and calibration, this study aims to reassess interassay variability using the latest generation of five assays in a contemporary cohort of men undergoing prostate biopsy. Methods: Five different commercially available PSA assays were tested in a blood sample of 76 men before undergoing a prostate biopsy. Total PSA (tPSA) and free-to-total PSA ratio (%fPSA) were compared across assays, using Roche (Basel, Switzerland) as the benchmark, and correlated with biopsy outcome to analyse the impact on PCa diagnosis. The statistical analysis included Passing-Bablok regression and Bland-Altman plots, with a p value threshold of <0.05 for significance. Key findings and limitations: Among the 76 men, 28 (36.8%) were diagnosed with significant PCa (defined as International Society of Urological Pathology grade ≥2). A high correlation was observed between tPSA and %fPSA values among the different PSA assays tested (r2 ≥ 0.9). The Passing-Bablok analysis showed that tPSA results varied substantially among the assays, with slopes ranging between 0.78 and 1.04. Compared with the tPSA of Roche, tPSA values were on average 20.7% lower by Beckman (Oststeinbeck, Germany), 15.2% lower by Abbott (Chicago, IL, USA), 6.1% lower by Diasorin (Saluggia, Italy), and 9.6% higher by Brahms (Hennigsdorf, Germany; p < 0.001 for all). The %fPSA values by Abbott and Brahms were higher at 15.7% and 10.6%, respectively (p < 0.001), while the Beckman and Diasorin values had minimal differences of -0.3% and 2.3%, respectively (p > 0.05). The variability across assays would have resulted in discrepancies in both the sensitivity and the specificity for tPSA and %fPSA by at least 14%, depending on the cut-offs applied. Conclusions and clinical implications: Despite the use of the latest PSA assays, relevant variability of tPSA and %fPSA results can be observed among different assays. There is an urgent need for standardised calibration methods and greater awareness among practitioners concerning interassay variability. Clinicians should acknowledge that clinically relevant thresholds may depend on the specific PSA assay and that ideally the same assay is applied over time for better clinical decision-making. Patient summary: Prostate-specific antigen (PSA) is a critical marker for prostate cancer (PCa) detection and monitoring. However, significant variations were observed in the results of the latest PSA assays. Thus, standardised calibration methods and greater awareness among practitioners concerning interassay variability are needed. |
| first_indexed | 2024-04-24T20:12:14Z |
| format | Article |
| id | doaj.art-9c1a8beaeea54b86ae6d6351724fa1c4 |
| institution | Directory Open Access Journal |
| issn | 2666-1683 |
| language | English |
| last_indexed | 2025-03-22T03:17:56Z |
| publishDate | 2024-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | European Urology Open Science |
| spelling | doaj.art-9c1a8beaeea54b86ae6d6351724fa1c42024-04-30T04:02:21ZengElsevierEuropean Urology Open Science2666-16832024-05-0163412Interassay Variability and Clinical Implications of Five Different Prostate-specific Antigen AssaysBasil Kaufmann0Paloma Pellegrino1Laura Zuluaga2Reuben Ben-David3Michael Müntener4Etienne X. Keller5Katharina Spanaus6Arnold von Eckardstein7Michael A. Gorin8Cédric Poyet9Department of Urology, University Hospital Zurich, University of Zurich, Zurich, Switzerland; Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Corresponding author. Department of Urology, University Hospital Zurich, Frauenklinikstrasse 10, CH-8091 Zurich, Switzerland. Tel. +41 44 255 54 40.Department of Urology, University Hospital Zurich, University of Zurich, Zurich, SwitzerlandDepartment of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USADepartment of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USADepartment of Urology, Municipal Hospital of Zurich, Zurich, SwitzerlandDepartment of Urology, University Hospital Zurich, University of Zurich, Zurich, SwitzerlandInstitute for Clinical Chemistry, University Hospital of Zurich, University of Zurich, Zurich, SwitzerlandInstitute for Clinical Chemistry, University Hospital of Zurich, University of Zurich, Zurich, SwitzerlandDepartment of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USADepartment of Urology, University Hospital Zurich, University of Zurich, Zurich, SwitzerlandBackground and objective: Prostate-specific antigen (PSA) remains a critical marker for prostate cancer (PCa) detection and monitoring. Recognising historical variability in PSA assays and the evolution of assay technology and calibration, this study aims to reassess interassay variability using the latest generation of five assays in a contemporary cohort of men undergoing prostate biopsy. Methods: Five different commercially available PSA assays were tested in a blood sample of 76 men before undergoing a prostate biopsy. Total PSA (tPSA) and free-to-total PSA ratio (%fPSA) were compared across assays, using Roche (Basel, Switzerland) as the benchmark, and correlated with biopsy outcome to analyse the impact on PCa diagnosis. The statistical analysis included Passing-Bablok regression and Bland-Altman plots, with a p value threshold of <0.05 for significance. Key findings and limitations: Among the 76 men, 28 (36.8%) were diagnosed with significant PCa (defined as International Society of Urological Pathology grade ≥2). A high correlation was observed between tPSA and %fPSA values among the different PSA assays tested (r2 ≥ 0.9). The Passing-Bablok analysis showed that tPSA results varied substantially among the assays, with slopes ranging between 0.78 and 1.04. Compared with the tPSA of Roche, tPSA values were on average 20.7% lower by Beckman (Oststeinbeck, Germany), 15.2% lower by Abbott (Chicago, IL, USA), 6.1% lower by Diasorin (Saluggia, Italy), and 9.6% higher by Brahms (Hennigsdorf, Germany; p < 0.001 for all). The %fPSA values by Abbott and Brahms were higher at 15.7% and 10.6%, respectively (p < 0.001), while the Beckman and Diasorin values had minimal differences of -0.3% and 2.3%, respectively (p > 0.05). The variability across assays would have resulted in discrepancies in both the sensitivity and the specificity for tPSA and %fPSA by at least 14%, depending on the cut-offs applied. Conclusions and clinical implications: Despite the use of the latest PSA assays, relevant variability of tPSA and %fPSA results can be observed among different assays. There is an urgent need for standardised calibration methods and greater awareness among practitioners concerning interassay variability. Clinicians should acknowledge that clinically relevant thresholds may depend on the specific PSA assay and that ideally the same assay is applied over time for better clinical decision-making. Patient summary: Prostate-specific antigen (PSA) is a critical marker for prostate cancer (PCa) detection and monitoring. However, significant variations were observed in the results of the latest PSA assays. Thus, standardised calibration methods and greater awareness among practitioners concerning interassay variability are needed.http://www.sciencedirect.com/science/article/pii/S2666168324003343Prostate-specific antigen assayScreeningProstate cancerBiomarker |
| spellingShingle | Basil Kaufmann Paloma Pellegrino Laura Zuluaga Reuben Ben-David Michael Müntener Etienne X. Keller Katharina Spanaus Arnold von Eckardstein Michael A. Gorin Cédric Poyet Interassay Variability and Clinical Implications of Five Different Prostate-specific Antigen Assays European Urology Open Science Prostate-specific antigen assay Screening Prostate cancer Biomarker |
| title | Interassay Variability and Clinical Implications of Five Different Prostate-specific Antigen Assays |
| title_full | Interassay Variability and Clinical Implications of Five Different Prostate-specific Antigen Assays |
| title_fullStr | Interassay Variability and Clinical Implications of Five Different Prostate-specific Antigen Assays |
| title_full_unstemmed | Interassay Variability and Clinical Implications of Five Different Prostate-specific Antigen Assays |
| title_short | Interassay Variability and Clinical Implications of Five Different Prostate-specific Antigen Assays |
| title_sort | interassay variability and clinical implications of five different prostate specific antigen assays |
| topic | Prostate-specific antigen assay Screening Prostate cancer Biomarker |
| url | http://www.sciencedirect.com/science/article/pii/S2666168324003343 |
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