[The present status of standardization in serum total PSA measurement--a result of "Survey 2000" conducted by PSA ad hoc Committee of Japanese Urological Association].
Immunoassays for serum total PSA are classified into two categories; equimolar and skewed, according to their response to free PSA and ACT-PSA. The analytical survey conducted in 1997 ("Survey 1997") revealed that more than a half of the kits displayed a skewed response which caused inter-assay variability as a major factor. PSA ad hoc committee of Japanese Urological Association chaired by Prof. H. Yamanaka carried out a survey in 2000 ("Survey 2000") in which 26 kits were participated from 18 manufacturers. Comparing with 1997, the inter-kit variability, on the whole, was remarkably reduced in 2000. The dilution tests using purified samples of free PSA and ACT-PSA elucidated that five sixths of the kits were counted to be equimolar (12; completely equimolar, 10; nearly equimolar or slightly skewed, 4; skewed). Immunological behavior of the assays to free PSA and ACT-PSA in serum samples was also markedly improved, in which free PSA content ranged to 50%. Conversion of data measured by each kit to those of Tandem-R was capable in 19 kits. The remaining 7 kits were out of interchangeability, however, a measure of improvement or withdrawal of these kits would be in progress by the corresponding manufacturers. Total PSA assay is certainly going on toward standardization.
Kano
S
S
Clinical Laboratory, Tokyo Teishin Hospital, Chiyoda-ku, Tokyo 102-8798.
Ishibashi
M
M
Itoh
Y
Y
D014408:Biomarkers, Tumor / Q000097:blood*; D005163:Factor Analysis, Statistical; D006801:Humans; D007118:Immunoassay; D008297:Male; D017430:Prostate-Specific Antigen / Q000097:blood* / Q000592:standards*; D011471:Prostatic Neoplasms; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012015:Reference Standards
D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic; D017430:Prostate-Specific Antigen