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Accreditation and Quality Assurance

, Volume 6, Issue 9–10, pp 424–426 | Cite as

Standardized method comparison for ACS:180 plus and Immulite sensitive PSA (sPSA) measurement methods

  • Yusuf Kurtulmus
  • T. Tanyalçın
  • Giray Bozkaya
  • Ogˇuzhan Gündüz
  • Ömür Çerçi
  • Fatma Z. Kutay
  • Biltan Ersöz
Practitioner’s Report

Abstract 

The aim of this study was to compare two immunoassay measurement methods, the ACS:180 Plus (Chiron Diagnostics) kit and the Immulite sPSA (DPC) kit. Method comparison analysis was performed according to EP9-A; approved guideline of NCCLS 51. Serum samples having a wide range of total prostate-specific antigen (PSA) concentrations were evaluated in split-sample analysis. F-test, t-test analysis and regression statistics were performed. In Deming regression analysis the coefficients were as follows; the slope=0.967; y-intercept=-0.148, r=0.989. An acceptable bias was seen since the systematical error was calculated to have a value less than the total allowable error calculated from biological variations. Non-parametric evaluation of the area under ROC curves for ACS:180 Plus and Immulite sPSA were 0.997 and 0.987, respectively. Diagnostic accuracy was at the level of p= 0.000 and no statistical difference was found between the two assay methods.

Keywords Standardized method comparison PSA ROC curve analysis 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2001

Authors and Affiliations

  • Yusuf Kurtulmus
    • 1
  • T. Tanyalçın
    • 1
  • Giray Bozkaya
    • 2
  • Ogˇuzhan Gündüz
    • 3
  • Ömür Çerçi
    • 4
  • Fatma Z. Kutay
    • 1
  • Biltan Ersöz
    • 1
  1. 1.Ege University Faculty of Medicine, Department of Biochemistry Bornova 35100 Izmir Turkey e-mail: tanyalci@med.ege.edu.tr Tel: +90-232-388 10 96 Fax: +90-232-373 94 77TR
  2. 2.SSK Bozyaka Hospital, Department of Biochemistry, Izmir, TurkeyTR
  3. 3.Ege University Faculty of Medicine, Department of Urology, Izmir, TurkeyTR
  4. 4.Atatürk State Hospital, Izmir, TurkeyTR

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