Prostate-specific antigen: Bias and molarity of commercial assays for PSA in use in England

Annals of Clinical Biochemistry

Volumn 43, Issue 1, 2006, Pages 35-48

  Roddam, Andrew W ^a   Rimmer, Janet ^b   Nickerson, Claire ^b   Ward, Anthony Milford ^b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b NATIONAL HEALTH SERVICE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

ANALYTIC METHOD; ARTICLE; CALIBRATION; CONCENTRATION (PARAMETERS); EXPERIMENTATION; IMMUNOASSAY; INTERNATIONAL STANDARD UNIT; LABORATORY; PRIORITY JOURNAL; QUALITY CONTROL; SAMPLE; UNITED KINGDOM; WORLD HEALTH ORGANIZATION;

BIAS (EPIDEMIOLOGY); CALIBRATION; CLINICAL CHEMISTRY TESTS; DIAGNOSTIC TESTS, ROUTINE; ENGLAND; HUMANS; MALE; PROSTATE-SPECIFIC ANTIGEN; REPRODUCIBILITY OF RESULTS; WORLD HEALTH ORGANIZATION;

EID: 30844455114     PISSN: 00045632     EISSN: 00045632     Source Type: Journal    
DOI: 10.1258/000456306775141731     Document Type: Article

References (22)

1. Chan DW, Sokall LJ. WHO First International Standard for prostate-specific antigen: the beginning of the end for assay discrepancies? Clin Chem 2000; 46: 1291-2
2. National Screening Committee. Prostate Cancer Risk Management Programme (2005). http://www.cancerscreening.nhs.uk/prostate/
3. Donovan JL, Frankel SJ, Neal DE, Hamdy FE. Screening for prostate cancer in the UK. BMJ 2001; 323: 763-4
4. Price CP, Allard J, Davies G, et al. Pre- and postanalytical factors that may influence use of serum prostate specific antigen and its isoforms in a screening programme for prostate cancer. Ann Clin Biochem 2001; 38: 188-216
5. 1- antichymotrypsin is the major form of prostatespecific antigen in serum of patients with prostate cancer: assay of the complex improves clinical sensitivity for cancer. Cancer Res 1991; 51: 222-6
6. Richards M. Prostate Cancer Risk Management Programme. DH Executive Letter, 23 September, 2002
7. Rafferty B, Rigsby P, Rose M, Stamey T, Gaines Das R. 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
8. Cleveland WS, Grosse E, Shyu WM. Local regression models In: Chambers JM, Hastie TJ, eds. Statistical Models. New York: Chapman & Hall, 1992: 301-74
9. R Development Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, 2004; http://www.R-project.org
10. Zhou AM, Tewari PC, Bluestein BI, Caldwell GW, Larsen FL. Multiple forms of prostate speci.c antigen in serum: differences in immunorecognition by monoclonal and polyclonal assays. Clin Chem 1993; 39: 2483-91
11. Wener MH, Daum PR, Brawer MK. Variation in measurement of prostate-specific antigen: Importance of method and lot variability. Clin Chem 1995; 41: 1730-7
12. Ward AM. Pitfalls of PSA estimation. In: Bowsher WG, Gingell JC, Badenoch DF, Peeling WB, eds. Technical Aspects of Prostate Cancer Treatment. Oxford: Oxford Clinical Communications, 1994; 10-1
13. Tillyer CR, Konings M, Gobin PJ, Iqbal J. Disagreement between Roche Cobas Core and Hybritech TANDEM-E PSA assays when measuring free, complexed and total prostate specific antigen. Ann Clin Biochem 1994; 31: 501-5
14. Ward AM, White PAE. How long is a PSA string? Proceedings of the ACB National Meeting 1997, p 94-5
15. Stamey TA, Chen Z, Prestigiacomo AF. Reference material for PSA: the IFCC standardization study. Clin. Biochem 1998; 31: 475-81
16. National Committee for Clinical Laboratory Standards. Primary reference preparations used to standardise calibration of the immunochemical assays for serum prostate-specific antigen (PSA); approved guidelines. NCCLS Document I/LA 19-A. Villanova, PA, USA, 1997
17. Chan DW. Prostate-specific antigen: update 1997. J IFCC 1997; 9: 120-5
18. Semjonow A, Oberpenning F, Weining C, et al. Do modifications of nonequimolar assays for total prostate-specific antigen improve detection of prostate cancer? Clin Chem 2001; 47: 1472-5
19. Roddam AW, Price CP, Allen NE, Ward AM. Assessing the clinical impact of prostate-speci.c antigen assay variability and nonequimolarity: a simulation study based on the population of the United Kingdom. Clin Chem 2004; 50: 1012-6
20. Oberpenning F, Weining C, Brandt B, et al. A new modification of the chiron ACS assay for total prostate- specific antigen achieves equimolar response characteristics and improves the detection of prostate cancer. Clin Chem Lab Med 2003; 41: 90-4
21. Onur R, Ilhan N, Orhan I. Increased discrimination between benign prostatic hyperplasia and prostate cancer with equimolar total prostate specific antigen measurement. World J Urol 2003; 21: 43-7
22. Jung K, Brux B, Lein M, et al. Molecular forms of prostate-specific antigen in malignant and benign prostatic tissue: biochemical and diagnostic implications. Clin Chem 2000; 46: 47-54