Third-generation PSA: ultrasensitive or ultraprecise assay?

Int J Biol Markers. 1995 Oct-Dec;10(4):229-33. doi: 10.1177/172460089501000408.

Abstract

The ultrasensitive PSA assay has been recently acknowledged as a useful tool for the monitoring of patients prostatectomized for prostatic cancer. We have evaluated a commercially available ultrasensitive PSA assay (Immulite Third Generation PSA-DPC-Los Angeles CA) in comparison with the routinely used PSA (Immulite PSA-DPC-Los Angeles CA). When evaluated with different approaches, the analytical sensitivity of ultrasensitive PSA ranged between 0.0029 and 0.0038 ng/ml. The biological detection limit was 0.0098 ng/ml. Dilution of samples with low PSA levels showed a good recovery (from 88 to 113%) up to 1:128 dilution factor (final PSA levels ranging from 0.004 to 0.016 ng/ml in different samples). The assay precision was excellent in the low dose range, the highest interassay interadjustment CV among replicates being 5.84% when assaying serum samples with PSA lower than 1.0 ng/ml. Besides its role in the follow-up of prostatectomized patients, the evaluated ultrasensitive PSA could be reliably used for the detection of clinically meaningful PSA variations in the low dose range, and it could therefore be a candidate for the assessment of PSA velocity.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Humans
  • Male
  • Monitoring, Physiologic
  • Prostate-Specific Antigen / blood*
  • Prostatectomy
  • Prostatic Neoplasms / blood
  • Prostatic Neoplasms / diagnosis*
  • Prostatic Neoplasms / surgery
  • Reagent Kits, Diagnostic
  • Regression Analysis
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Reagent Kits, Diagnostic
  • Prostate-Specific Antigen