AFSSAPS market survey of total PSA, free PSA and complexed PSA assay kits.

assays for prostate cancer screening, Afssaps has conducted, in the context of its mission, a market survey of devices indicating quantitative results. The objective of this survey was to evaluate the analytical performances of these assays, particularly to verify the accuracy of total PSA, free PSA and complexed PSA assay kits and to study the equimolarity of total PSA reagents in the analogous recognition of the various forms of serum PSA (free PSA/bound PSA) by measuring 2 ng/ml, 4 ng/ml and 10 ng/ml samples of total PSA containing 0%, 25%, 50%, 75% or 100% of free PSA, prepared from Stanford University standard solutions (Stamey). Package leaflets were also examined to verify compliance with the essential requirements defined in Directive 98/79/EC.