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PSA Standardization


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Development of PSA Standards

Slide 15

October 2009

Perhaps it may help to examine the evolution of PSA testing even further.  The first PSA assay was a dual monoclonal radioimmunoassay manufactured by Hybritech and referred to as Tandem-R assays.  The concentration of the purified PSA used to standardize the Hybritech assay back in 1984 was determined based on Lowry protein methods, which were what was available at that time.  In 1991, the Hybritech assay became an automated immunoassay on the Beckman Access and first used in prostate cancer screening after further FDA approval in 1994. Efforts to standardize PSA assays were initiated in 1992 by Dr. Thomas Stamey at the First Stanford Conference. At the Second Stanford Conference on International Standardization of Prostate-Specific Antigen in 1994, Dr. Stamey and colleagues proposed use of a primary calibrator consisting of 90% purified PSA-complexed to alpha1-antichymotrypsin and 10% free PSA (later termed the 90:10 standard) on a molar basis.

Development of PSA Standards


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