Manuel M Garrido1,2, José C Marta3, Ruy M Ribeiro4, Luís C Pinheiro5,6, Stefan Holdenrieder7, João T Guimarães8,9,10. 1. Department of Clinical Pathology, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal; manuel.agarrido@chlc.minsaude.pt. 2. Department of Laboratory Medicine, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal. 3. Department of Clinical Pathology, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal. 4. Biomathematics Laboratory, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal. 5. Department of Urology, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal. 6. Department of Urology, Faculdade de Ciências Médicas da Universidade Nova de Lisboa, Lisbon, Portugal. 7. Institute of Laboratory Medicine, Munich Biomarker Research Center, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 8. Department of Clinical Pathology, Centro Hospitalar Universitário de São João, Porto, Portugal. 9. Department of Biomedicine, Faculdade de Medicina, Universidade do Porto, Porto, Portugal. 10. EPIUnit, Instituto de Saúde Pública, Universidade do Porto, Porto, Portugal.
Abstract
BACKGROUND/AIM: Lack of interchangeability between prostate-specific antigen (PSA) assays could have a clinical impact. We compared PSA assays from different manufacturers and calibrations. PATIENTS AND METHODS: A total of 233 men who underwent prostate biopsy (PSA: 2-10 ng/ml; Beckman Coulter Access® Hybritech® as reference) were enrolled. Total (tPSA) and free PSA (fPSA) were also measured using the Roche cobas® and the Abbott Architect® methods. RESULTS: Roche tPSA values were ≈1% higher than Beckman, while Abbott values were ≈5% lower. Roche had the highest diagnostic sensitivity (92%) compared to Beckman Coulter (87%) and Abbott (85%). Roche fPSA was ≈3% lower and Abbott ≈17% higher than that of Beckman. For the percentage of fPSA, Roche had the highest sensitivity (98%). CONCLUSION: Roche cobas® and Beckman Coulter Access® Hybritech® tPSA were almost interchangeable. While the agreement was acceptable for tPSA, this did not happen with fPSA and greater efforts for harmonization are required.
BACKGROUND/AIM: Lack of interchangeability between prostate-specific antigen (PSA) assays could have a clinical impact. We compared PSA assays from different manufacturers and calibrations. PATIENTS AND METHODS: A total of 233 men who underwent prostate biopsy (PSA: 2-10 ng/ml; Beckman Coulter Access® Hybritech® as reference) were enrolled. Total (tPSA) and free PSA (fPSA) were also measured using the Roche cobas® and the Abbott Architect® methods. RESULTS: Roche tPSA values were ≈1% higher than Beckman, while Abbott values were ≈5% lower. Roche had the highest diagnostic sensitivity (92%) compared to Beckman Coulter (87%) and Abbott (85%). Roche fPSA was ≈3% lower and Abbott ≈17% higher than that of Beckman. For the percentage of fPSA, Roche had the highest sensitivity (98%). CONCLUSION: Roche cobas® and Beckman Coulter Access® Hybritech® tPSA were almost interchangeable. While the agreement was acceptable for tPSA, this did not happen with fPSA and greater efforts for harmonization are required.
Authors: William J Catalona; Jerome P Richie; Frederick R Ahmann; M'Liss A Hudson; Peter T Scardino; Robert C Flanigan; Jean B DeKernion; Timothy L Ratliff; Louis R Kavoussi; Bruce L Dalkin; W Bedford Waters; Michael T MacFarlane; Paula C Southwick Journal: J Urol Date: 2016-12-22 Impact factor: 7.450
Authors: Sheila A R Kort; Frans Martens; Hilde Vanpoucke; Hans L van Duijnhoven; Marinus A Blankenstein Journal: Clin Chem Date: 2006-06-08 Impact factor: 8.327