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 Citations (Scopus)

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

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Immunoassay
Assays
Protein Isoforms
Serum
Monoclonal Antibodies
varespladib methyl
Alkaline Phosphatase
Prostatic Neoplasms
Hooks

Keywords

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

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Sokoll, L. J., Chan, D. W., Klee, G. G., Roberts, W. L., van Schaik, R. H. N., Arockiasamy, D. A., ... 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

Multi-center analytical performance evaluation of the Access Hybritech® p2PSA immunoassay. / Sokoll, Lori J.; Chan, Daniel W.; Klee, George G.; Roberts, William L.; van Schaik, Ron H N; Arockiasamy, Dorothy A.; Broyles, Dennis L.; Carlson, Corey M.; Mizrahi, Isaac A.; Pierson, Tina B.; Tam, Jeffrey E.

In: Clinica Chimica Acta, Vol. 413, No. 15-16, 16.08.2012, p. 1279-1283.

Research output: Contribution to journalArticle

Sokoll, LJ, Chan, DW, Klee, GG, Roberts, WL, van Schaik, RHN, Arockiasamy, DA, Broyles, DL, Carlson, CM, Mizrahi, IA, Pierson, TB & Tam, JE 2012, 'Multi-center analytical performance evaluation of the Access Hybritech® p2PSA immunoassay', Clinica Chimica Acta, vol. 413, no. 15-16, pp. 1279-1283. https://doi.org/10.1016/j.cca.2012.04.015
Sokoll LJ, Chan DW, Klee GG, Roberts WL, van Schaik RHN, Arockiasamy DA et al. Multi-center analytical performance evaluation of the Access Hybritech® p2PSA immunoassay. Clinica Chimica Acta. 2012 Aug 16;413(15-16):1279-1283. https://doi.org/10.1016/j.cca.2012.04.015
Sokoll, Lori J. ; Chan, Daniel W. ; Klee, George G. ; Roberts, William L. ; van Schaik, Ron H N ; Arockiasamy, Dorothy A. ; Broyles, Dennis L. ; Carlson, Corey M. ; Mizrahi, Isaac A. ; Pierson, Tina B. ; Tam, Jeffrey E. / Multi-center analytical performance evaluation of the Access Hybritech® p2PSA immunoassay. In: Clinica Chimica Acta. 2012 ; Vol. 413, No. 15-16. pp. 1279-1283.
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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.",
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AU - Klee, George G.

AU - Roberts, William L.

AU - van Schaik, Ron H N

AU - Arockiasamy, Dorothy A.

AU - Broyles, Dennis L.

AU - Carlson, Corey M.

AU - Mizrahi, Isaac A.

AU - Pierson, Tina B.

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KW - Prostate cancer

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