Clinical impact of prostate specific antigen (PSA) inter-assay variability on management of prostate cancer

Clinical Biochemistry

Volumn 49, Issue 1, 2016, Pages 79-84

  Murthy, Vedang ^a   Rishi, Anupam ^a   Gupta, Sanjeev ^b   Kannan, Sadhana ^c   Mahantshetty, Umesh ^a   Tongaonkar, Hemant ^a   Bakshi, Ganesh ^a   Prabhash, Kumar ^a   Bhanushali, Paresh ^b   Shinde, Bhoopal ^a   Inamdar, Nitin ^a   Shrivastava, Shyamkishore ^a  

^a TATA MEMORIAL HOSPITAL   (India)

^b Yashraj Biotechnology Ltd   (India)

^c CANCER RESEARCH INSTITUTE   (India)

Author keywords

Clinical impact; Passing Bablok; Prostate specific antigen; PSA assays; Variability

Indexed keywords

PROSTATE SPECIFIC ANTIGEN;

ARTICLE; BIOCHEMICAL RECURRENCE; COMPARATIVE STUDY; CROSS-SECTIONAL STUDY; ELISA KIT; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; IMMUNOASSAY ANALYZER; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROSTATE CANCER; PROSTATE HYPERTROPHY; REGRESSION ANALYSIS; RISK FACTOR; AUTOMATION; BLOOD; IMMUNOLOGY; PROSTATIC NEOPLASMS; REPRODUCIBILITY;

AUTOMATION; CROSS-SECTIONAL STUDIES; HUMANS; MALE; PROSPECTIVE STUDIES; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; REPRODUCIBILITY OF RESULTS;

EID: 84953299411     PISSN: 00099120     EISSN: 18732933     Source Type: Journal    
DOI: 10.1016/j.clinbiochem.2015.10.013     Document Type: Article

References (21)

1. Balk S.P., Ko Y.J., Bubley G.J. Biology of prostate-specific antigen. J. Clin. Oncol. 2003, 21:383-391.
2. Mikolajczyk S.D., Marks L.S., Partin A.W., et al. Free prostate-specific antigen in serum is becoming more complex. Urology 2002, 59:797-802.
3. Mikolajczyk S.D., Catalona W.J., Evans C.L., et al. Proenzyme forms of prostate-specific antigen in serum improve the detection of prostate cancer. Clin. Chem. 2004, 50:1017-1025.
4. Semjonow A., De Angelis G., Oberpenning F., et al. The clinical impact of different assays for prostate specific antigen. BJU Int. 2000, 86:590-597.
5. Stamey T.A., Chen Z., Prestigiacomo A.F. Reference material for PSA: the IFCC standardization study. International Federation of Clinical Chemistry. Clin. Biochem. 1998, 31:475-481.
6. Rafferty B., Rigsby P., Rose M., et al. Reference reagents for prostate-specific antigen (PSA): establishment of the first international standards for free PSA and PSA (90:10). Clin. Chem. 2000, 46:1310-1317.
7. Semjonow A., Brandt B., Oberpenning F., et al. Discordance of assay methods creates pitfalls for the interpretation of prostate-specific antigen values. Prostate Suppl. 1996, 7:3-16.
8. Link R.E., Shariat S.F., Nguyen C.V., 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, 171:2234-2238.
9. Patel D., White P.A., Milford Ward A. 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, 85:686-689.
10. Oesterling J.E., Moyad M.A., Wright G.L., et al. An analytical comparison of the three most commonly used prostate-specific antigen assays: Tandem-R, Tandem-E, and IMx. Urology 1995, 46:524-532.
11. Kort S.A., Martens F., Vanpoucke H., et al. 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, 52:1568-1574.
12. Stephan C., Kramer J., Meyer H.A., 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, 99:1427-1431.
13. Bland J.M., Altman D.G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986, 1:307-310.
14. Zaki R., Bulgiba A., Ismail R., et al. Statistical methods used to test for agreement of medical instruments measuring continuous variables in method comparison studies: a systematic review. PLoS One 2012, 7.
15. Roddam A.W., Rimmer J., Nickerson C., et al. Prostate-specific antigen: bias and molarity of commercial assays for PSA in use in England. Ann. Clin. Biochem. 2006, 43:35-48.
16. Stephan C., Klaas M., Muller C., et al. Interchangeability of measurements of total and free prostate-specific antigen in serum with 5 frequently used assay combinations: an update. Clin. Chem. 2006, 52:59-64.
17. Nixon R.G., Meyer G.E., Blase A.B., et al. Comparison of 3 investigational assays for the free form of prostate specific antigen. J. Urol. 1998, 160:420-425.
18. Foj L., Filella X., Alcover J., et al. Variability of assay methods for total and free PSA after WHO standardization. Tumour Biol. 2014, 35:1867-1873.
19. Roddam A.W., Price C.P., Allen N.E., et al. Assessing the clinical impact of prostate-specific antigen assay variability and nonequimolarity: a simulation study based on the population of the United Kingdom. Clin. Chem. 2004, 50:1012-1016.
20. Mohler J.L. The 2010 NCCN clinical practice guidelines in oncology on prostate cancer. J. Natl. Compr. Cancer Netw. 2010, 8:145.
21. Roach M., Hanks G., Thames H., et al. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int. J. Radiat. Oncol. Biol. Phys. 2006, 65:965-974.