Improving the comparability of immunoassays for prostate-specific antigen (PSA): progress and problems

Area of Science:

• Laboratory medicine
• Clinical chemistry
• Biomarker standardization

Background:

• Commutability of immunoassay results is a key goal in laboratory medicine.
• Standardization efforts for prostate-specific antigen (PSA) have improved method comparability.
• However, PSA assay results remain non-interchangeable across different methods.

Purpose of the Study:

• To highlight the importance of PSA assay commutability.
• To discuss the progress and challenges in achieving PSA assay interchangeability.
• To propose a path forward for improving PSA testing consistency.

Main Methods:

• Review of national and international initiatives for PSA assay standardization.
• Analysis of factors influencing method comparability in PSA testing.
• Focus on antibody selection and assay design principles.

Main Results:

• Significant progress has been made in improving PSA method comparability.
• Interchangeability of PSA results across different assays has not yet been fully achieved.
• Recommendations for antibody combinations are needed to advance standardization.

Conclusions:

• Universal adoption of recommendations on antibody combinations can substantially improve between-method agreement.
• Careful attention to assay design is essential for successful implementation.
• Ensuring the use of pure secondary standards is critical for accurate PSA measurements.