PSA Standardization

Optimizing Clinical Sensitivity and Specificity: Age/Ethnic Reference Intervals^9,10

October 2009

Use of age and ethnic specific reference intervals was also suggested to improve the specificity and sensitivity of PSA.  Many studies have noted that men without prostate cancer will have higher PSA values as they age.  Use of age adjusted cutoffs could improve sensitivity in younger males, allowing their cancer to be detected earlier, and improve specificity in older males so the false-positive rate is reduced and less biopsies are performed.  This approach has not been uniformly accepted and the most recent National Academy of Clinical Biochemistry guidelines in 2008 do not recommend age-specific reference ranges.

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Optimizing Sensitivity

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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?