Publication Detail

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Multi-center analytical performance evaluation of the Access Hybritech® p2PSA immunoassay.

Lori J Sokoll; Daniel W Chan; George G Klee; William L Roberts; Ron H N van Schaik; Dorothy A Arockiasamy; Dennis L Broyles; Corey M Carlson; Isaac A Mizrahi; Tina B Pierson; et al. (Profiled Authors: Daniel Chan; Lori Sokoll)

Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD 21287, United States.
Clinica chimica acta; international journal of clinical chemistry 2012;413(15-16):1279-83.

BACKGROUND: Total 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. METHODS: The 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. RESULTS: The Access Hybritech p2PSA assay for [-2]proPSA had a dynamic range of 0.5 to 5000 pg/ml. The total CV of the assay was <7% for [-2]proPSA concentrations between 20 and 1000 pg/ml. The LOB was 0.50 pg/ml, LOD 0.69 pg/ml, and LOQ 3.23 pg/ml (20% CV). There was no hook effect up to 15,000 pg/ml. There was a <5% difference between calibrator and reagent lots and no interference from normal serum constituents. CONCLUSIONS: The Access Hybritech p2PSA assay is a robust immunoassay for the measurement of serum [-2]proPSA.

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