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[Progress in standardization of total PSA immunoassays]
1Department of Laboratory Medicine, Keio University Hospital, Shinjuku-ku, Tokyo 160-8582.
Summary
The standardization of prostate-specific antigen (PSA) assays has significantly improved accuracy. Japan
Area of Science:
- Clinical Chemistry
- Biomarker Standardization
Context:
- International efforts to standardize prostate-specific antigen (PSA) assays began after the 1992 Stanford Conference.
- PSA assay standardization is crucial for accurate prostate cancer diagnosis and monitoring.
Purpose:
- To assess and improve the accuracy of total PSA assays in Japan.
- To identify and address the causes of discrepancies in PSA values among different assay kits.
Summary:
- Analytical surveys in Japan from 1997 to 2003 revealed significant improvements in PSA assay standardization.
- The proportion of equimolar response kits increased from 34% to 84%, drastically reducing inter-kit variability.
- Progress is attributed to PSA purification, NCCLS guidelines, and the formation of a Japanese standardization committee.
Impact:
- Enhanced accuracy and reliability of total PSA testing in clinical practice.
- Facilitated more consistent patient monitoring and treatment decisions.
- Established a foundation for a robust reference measurement system in Japan.