PSA Standardization

CAP Proficiency Testing

October 2009

Evaluation of CAP proficiency testing results from 2008 and 2009 also demonstrates the variability between manufacturers.  The percent bias calculated is the absolute percent bias which deviates from the Access/Hybritech method, chosen as the predicate or gold standard method. The variation ranges from less than 5% up to 40%.  It is clear that further efforts need to be made to produce results which have greater harmonization.

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• Introduction
• Elevated PSA Result on Screening
• Reasons for Ordering PSA¹
• PSA Screening in the News
• Recommendations for Screening
• Arguments for Screening for Prostate Cancer
• Recommendations for Not Screening
• Arguments Against Screening for Prostate Cancer
• PSA Sensitivity and Specificity
• High-Grade Prostate Cancer is Not Rare When PSA =4.0 ng/mL⁶
• Increase Specificity Using PSA Velocity⁸
• Optimizing Clinical Sensitivity and Specificity: Age/Ethnic Reference Intervals^9,10
• Utilization of Free/Total PSA Ratio¹¹
• Why Aren't PSA Results Interchangeable?
• Development of PSA Standards
• Development of PSA Standards
• Effect of Analytical Bias on Classification Based on Fixed Criteria
• Analytical Difference: Results per 1000 Patients Tested¹³
• Hybritech vs. WHO Standardized Assays^12,14
• Analytical Differences¹⁵
• CAP Proficiency Testing
• WHO 96/670 Total PSA Preparations¹⁶
• WHO Calibration/Concordance at 3.1 ng/mL Cutoff⁵
• WHO Calibration/Concordance at 3.1 ng/mL Cutoff⁵
• WHO Calibration/Concordance at 4.0 ng/mL Cutoff⁵
• Clinical Differences in PSA Screening¹⁴
• The Clinical Difference
• Fixed Thresholds Produce Problems for Biopsy Recommendations
• Effect on "Watchful Waiting"
• Effect on "Watchful Waiting"
• Adding Biological Variability into the Mix
• Futures in Prostate Cancer Testing?
• PSA Testing at Mayo
• Conclusions
• References
• References
• Questions?