[Progress in standardization of total PSA immunoassays].
The standardization of the total PSA assay was considered internationally after 1992, when the first Stanford Conference was organized by Prof. Dr. T. Stamey (Stanford University). In Japan, an analytical survey was carried out three times in the past six years by the committee of PSA standardization. The discrepancy in PSA values among each assay system was determined and the cause of discrepancy was studied. As a result, the principal cause of each discrepancy between kits was revealed, and 34% of all kits in the 1997 survey, 73% in the 2000 survey and 84% in 2003 were classified as equimolar response kits. The inter-kit variability of total PSA assay value was improved drastically. The standardization of the PSA assay has made great progress based on the establishment of purification of PSA from the seminal fluid pool and the guideline of value assignment approved by the NCCLS. In Japan, the special committee of PSA standardization was formed by the JCCLA in 2002. In this committee, we are considering the establishment of a reference measurement system including serum-based reference material, which is inactivated protease inhibitor, due to the traceability of the PSA concentration from the primary reference material that was certified by the WHO for patient serum.
Ishibashi
Midori
M
Department of Laboratory Medicine, Keio University Hospital, Shinjuku-ku, Tokyo 160-8582.
D014408:Biomarkers, Tumor / Q000097:blood / Q000592:standards*; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000592:standards*; D007391:International Cooperation; D007564:Japan; D008297:Male; D017430:Prostate-Specific Antigen / Q000097:blood / Q000592:standards*; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012015:Reference Standards
D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic; D017430:Prostate-Specific Antigen