PSA Standardization

Introduction

October 2009

Welcome to Mayo Medical Laboratories Video Hot Topics. These presentations provide short discussion of current topics and may be helpful to you in your practice.

Our presenter for this program is Amy K. Saenger, PhD, Director of the Central Clinical Laboratory in the Department of Laboratory Medicine & Pathology at Mayo Clinic in Rochester, Minnesota. Dr. Saenger will provide an overview of the methods available for evaluating prostate-specific antigen levels and discuss the clinical implications of standardizing PSA methods.

Today I will be discussing issues related to prostate specific antigen testing and touch on the controversial topic of screening for prostate cancer. This is a subject that has received much attention in both the clinical and laboratory realm due to several large clinical trials recently published and the fact that there are major implications for measuring an accurate and precise PSA.

Introduction

Next Slide >

 

Jump to section:

• 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?