CLSI EP17-A protocol: A useful tool for better understanding the low end performance of total prostate-specific antigen assays

Clinica Chimica Acta

Volumn 412, Issue 11-12, 2011, Pages 1143-1145

  Moretti, Marco ^a   Sisti, Davide ^b   Rocchi, Marco B ^b   Delprete, Ernesto ^a  

^a Laboratory of Clinical Pathology   (Italy)

^b UNIVERSITY OF URBINO   (Italy)

Author keywords

EP17 A; Low end; Methods correlation; Prostate specific antigen; Standardization

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

ANTIGEN DETECTION; ARTICLE; BLOOD ANALYSIS; CALIBRATION; CHEMOLUMINESCENCE; CLINICAL PROTOCOL; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; HUMAN; IMMUNOASSAY; INTERMETHOD COMPARISON; LIMIT OF BLANK; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MALE; PARAMETERS OF MEASUREMENT AND ANALYSIS; PRIORITY JOURNAL;

BLOOD CHEMICAL ANALYSIS; CALIBRATION; DATA INTERPRETATION, STATISTICAL; HUMANS; LIMIT OF DETECTION; LINEAR MODELS; MALE; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; RECURRENCE;

EID: 79955002697     PISSN: 00098981     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cca.2011.03.002     Document Type: Article

References (13)

1. Ekins R.P. The precision profile: its use in assay design, assessment and quality control. Immunoassays for clinical chemistry 1983, 76-105. Churchill Livingstone, Edinburgh. W.M. Hunter, J.E.T. Come (Eds.).
2. Apple F.S., Jesse R.L., Newby L.K., Wu A.H., Christenson R.H. National Academy of Clinical Biochemistry and IFCC Committee for standardization of markers of cardiac damage laboratory medicine practice guidelines: analytical issues for biochemical markers of acute coronary syndromes. Clin Chem 2007, 53:547-551.
3. Tholen D.W., Linnet K., Kondratovich M., et al. Protocols for determination of limits of detection and limits of quantitation; approved guideline 2004, Vol. 24, n° 34. NCCLS, Wayne, PA, USA, NCCLS publication EP17-A. 2nd ed.
4. Jansen F.H., Roobol M., Bangma C.H., van Schaik R.H. Clinical impact of new prostate-specific antigen WHO standardization on biopsy rates and cancer detection. Clin Chem 2008, 54:1999-2006.
5. Fillée C., Tombal B., Philippe M. Prostate cancer screening: clinical impact of WHO calibration of Beckman Coulter Access prostate-specific antigen assays. Clin Chem Lab Med 2010, 48:285-288.
6. Studnicka G.M. Hyperbolic regression analysis for kinetics, electrophoresis, ELISA, RIA, Bradford, Lowry, and other applications. Comput Appl Biosci 1987, 3:9-16.
7. 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.
8. Stephan C., Kahrs A.M., 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, 46:623-629.
9. Stephan C., Bangma C., Vignati G., et al. 20-25% of lower concentration 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. Int J Biol Markers 2009, 24:65-69.
10. Schroder F.H., Hugosson J., Roobol M.J., et al. Screening and prostate cancer mortality in a randomized European study. N Engl J Med 2009, 360:1320-1328.
11. Andriole G.L., Grubb R.L., Buys S.S., et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 2009, 360:1310-1319.
12. Lippi G., Montagnana M., Guidi G.C., Plebani M. Prostate-specific antigen-based screening for prostate cancer in the third millennium: useful or hype?. Ann Med 2009, 4:1-10.
13. Diamandis E.P. Prostate cancer screening with prostate-specific antigen testing: more answers or more confusions?. Clin Chem 2010, 56:345-351.