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  • Title: [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].
    Author: Kano S, Ishibashi M, Itoh Y, PSA ad hoc Committee of Japanese Urological Association.
    Journal: Rinsho Byori; 2001 Oct; 49(10):967-73. PubMed ID: 11769473.
    Abstract:
    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.
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