20-25% lower concentrations of total and free prostate-specific antigen (PSA) after calibration of PSA assays to the WHO reference materials - Analysis of 1098 patients in four centers

International Journal of Biological Markers

Volumn 24, Issue 2, 2009, Pages 65-69

  Stephan, Carsten ^a   Bangma, Chris ^b   Vignati, Giulio ^c   Bartsch, Georg ^d   Lein, Michael ^a,e   Jung, Klaus ^a,e   Philippe, Marianne ^f   Semjonow, Axel ^g   Catalona, William J ^h  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b INTERUNIVERSITY CARDIOLOGY INSTITUTE OF THE NETHERLANDS   (Netherlands)

^c Ospedale G Fornaroli   (Italy)

^d INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^e Berlin Institute of Urologic Research   (Germany)

^f CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

^g UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^h NORTHWESTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FREE PROSTATE SPECIFIC ANTIGEN; PROSTATE SPECIFIC ANTIGEN; UNCLASSIFIED DRUG;

ANTIGEN DETECTION; ANTIGEN SPECIFICITY; ARTICLE; CALIBRATION; COHORT ANALYSIS; CONTROLLED STUDY; HUMAN; HUMAN TISSUE; IMMUNOASSAY; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; PROSTATE BIOPSY; PROSTATE CANCER; WORLD HEALTH ORGANIZATION; BIOSYNTHESIS; BLOOD; CANCER DIAGNOSIS; CLINICAL CHEMISTRY; DIAGNOSIS, MEASUREMENT AND ANALYSIS; METABOLISM; METHODOLOGY; PROSTATE TUMOR; REFERENCE VALUE; REPRODUCIBILITY; STANDARD;

CALIBRATION; CHEMISTRY, CLINICAL; COHORT STUDIES; EARLY DETECTION OF CANCER; HUMANS; LABORATORY TECHNIQUES AND PROCEDURES; MALE; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; REFERENCE STANDARDS; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; WORLD HEALTH ORGANIZATION;

EID: 70349775143     PISSN: 03936155     EISSN: None     Source Type: Journal    
DOI: 10.5301/JBM.2009.1349     Document Type: Article

References (27)

1. Catalona WJ, Richie JP, Ahmann FR, et al. Comparison of digital rectal examination and serum prostate specific antigen in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men. J Urol 1994; 151: 1283-90.
2. Semjonow A, Brandt B, Oberpenning F, Roth S, Hertle L. Discordance of assay methods creates pitfalls for the interpretation of prostate-specific antigen values. Prostate 1996; 7: 3-16.
3. Stamey TA. Second Stanford Conference on International Standardization of Prostate-Specific Antigen Immunoassays: September 1 and 2, 1994. Urology 1995; 45: 173-84.
4. Rafferty B, Rigsby P, Rose M, Stamey T, Gaines DR. Reference reagents for prostate-specific antigen (PSA): establishment of the first international standards for free PSA and PSA (90:10). Clin Chem 2000; 46: 1310-7.
5. Panteghini M. Traceability, reference systems and result comparability. Clin Biochem Rev 2007; 28: 97-104.
6. Sotelo RJ, Mora KE, Perez LH, et al. Assay standardization bias: different prostate cancer detection rates and clinical outcomes resulting from different assays for free and total prostate-specific antigen. Urology 2007; 69: 1143-6.
7. Sturgeon CM, Ellis AR. Improving the comparability of immunoassays for prostate-specific antigen (PSA): progress and problems. Clin Chim Acta 2007; 381: 85-92.
8. Semjonow A, Oberpenning F, Brandt B, et al. Impact of free prostate-specific antigen on discordant measuremen results of assays for total prostate-specific antigen. Urology 1996; 48: 10-5.
9. Semjonow A, Oberpenning F, Weining C, et al. Do modifications of nonequimolar assays for total prostatespecific antigen improve detection of prostate cancer? Clin Chem 2001; 47: 1472-5.
10. Meany DL, Chan DW. Comparability of tumor marker immunoassays: still an important issue for clinical diagnostics? Clin Chem Lab Med 2008; 46: 575-6.
11. Blijenberg BG, yurdakul G, Van Zelst BD, et al. Discordant performance of assays for free and total prostate-specific antigen in relation to the early detection of prostate cancer. BJU Int 2001; 88: 545-50.
12. Kort SA, Martens F, Vanpoucke H, van Duijnhoven HL, Blankenstein MA. Comparison of 6 automated assays for total and free prostate-specific antigen with special reference to their reactivity toward the WHO 96/670 reference preparation. Clin Chem 2006; 52: 1568-74.
13. Leewansangtong S, Goktas S, Lepoff R, Holthaus K, Crawford ED. Comparability of serum prostate-specific antigen measurement between the hybritech Tandem-R and Abbott AxSyM assays. Urology 1998; 52: 467-9.
14. Link RE, Shariat SF, Nguyen CV, et al. Variation in prostate specific antigen results from 2 different assay platforms: clinical impact on 2304 patients undergoing prostate cancer screening. J Urol 2004; 171: 2234-8.
15. Nixon RG, Meyer GE, Blase AB, Gold MH, Brawer MK. Comparison of 3 investigational assays for the free form of prostate specific antigen. J Urol 1998; 160: 420-5.
16. Patel D, White PA, Milford WA. A comparison of six commercial assays for total and free prostate specific antigen (PSA): the predictive value of the ratio of free to total PSA. BJU Int 2000; 85: 686-9.
17. Semjonow A, De Angelis G, Oberpenning F, et al. The clinical impact of different assays for prostate specific antigen. BJU Int 2000; 86: 590-7.
18. Stephan C, Klaas M, Müller C, Schnorr D, Loening SA, Jung K. Interchangeability of measurements of total and free prostatespecific antigen in serum with 5 frequently used assay combinations: an update. Clin Chem 2006; 52: 59-64.
19. Slev PR, La'ulu SL, Roberts WL. Intermethod differences in results for total PSA, free PSA, and percentage of free PSA. Am J Clin Pathol 2008; 129: 952-8.
20. Roddam AW, Rimmer J, Nickerson C, Ward AM. Prostates-pecific antigen: bias and molarity of commercial assays for PSA in use in England. Ann Clin Biochem 2006; 43: 35-48.
21. Stephan C, Semjonow A. Accuracy assessment of PSA methods must be based on clinical instead of artificial samples - a response to AW Roddam et al., Ann Clin Biochem 2006; 43: 35-48. Ann Clin Biochem 2006; 43: 421-2.
22. Stephan C, Kramer J, Meyer HA, et al. Different prostate-specific antigen assays give different results on the same blood sample: an obstacle to recommending uniform limits for prostate biopsies. BJU Int 2007; 99: 1427-31.
23. Fillée C, Tombal B, Philippe M. Total and free PSA WHO calibration: impact on decision point. In revision, 2009.
24. Jansen FH, Roobol M, Bangma CH, van Schaik RH. Clinical impact of new prostate-specific antigen WHO standardization on biopsy rates and cancer detection. Clin Chem 2008; 54: 1999-2006.
25. Stephan C, Kahrs AM, Klotzek S, et al. Toward metrological traceability in the determination of prostate-specific antigen (PSA): calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards. Clin Chem Lab Med 2008; 46: 623-9.
26. Vignati G, Giovanelli L. Standardization of PSA measures: a reappraisal and an experience with WHO calibration of Beckman Coulter Access Hybritech total and free PSA. Int J Biol Markers 2007; 22: 295-301.
27. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999; 8: 135-60.