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, Jeffrey E. Tam

Research output: Contribution to journalArticle

11 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1279-1283
Number of pages5
JournalClinica Chimica Acta
Volume413
Issue number15-16
DOIs
StatePublished - Aug 16 2012

Keywords

  • Evaluation
  • PSA
  • ProPSA
  • Prostate cancer
  • [-2]proPSA

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

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    Sokoll, L. J., Chan, D. W., Klee, G. G., Roberts, W. L., van Schaik, R. H. N., Arockiasamy, D. A., Broyles, D. L., Carlson, C. M., Mizrahi, I. A., Pierson, T. B., & Tam, J. E. (2012). Multi-center analytical performance evaluation of the Access Hybritech® p2PSA immunoassay. Clinica Chimica Acta, 413(15-16), 1279-1283. https://doi.org/10.1016/j.cca.2012.04.015