Abstract
BackgroundTotal PSA assays measure both complexed and non-complexed forms of PSA while free PSA assays only measure non-complexed forms. Free PSA is a mixture of isoforms including immature PSA (proPSA) with retained portions of the leader sequence (e.g. [−7], [−4], and [−2]proPSA) and nicked forms (BPSA). ProPSA isoforms in male sera have been associated with prostate cancer. This study characterized the analytical performance of a chemiluminescent immunoassay for [−2]proPSA. MethodsThe Access Hybritech p2PSA assay is a sandwich immunoassay using an anti-[−2]proPSA monoclonal antibody attached to paramagnetic beads and an anti-PSA monoclonal antibody conjugated to alkaline phosphatase calibrated with recombinant [−2]proPSA. Analytical studies including sensitivity (CLSI EP17-A) and imprecision (CLSI EP5-A2) were performed. ResultsThe Access Hybritech p2PSA assay for [−2]proPSA had a dynamic range of 0.5 to 5000pg/ml. The total CV of the assay was <7% for [−2]proPSA concentrations between 20 and 1000pg/ml. The LOB was 0.50pg/ml, LOD 0.69pg/ml, and LOQ 3.23pg/ml (20% CV). There was no hook effect up to 15,000pg/ml. There was a <5% difference between calibrator and reagent lots and no interference from normal serum constituents. ConclusionsThe Access Hybritech p2PSA assay is a robust immunoassay for the measurement of serum [−2]proPSA.
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