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Related Experiment Videos

How sensitive is a prostate-specific antigen measurement? How sensitive does it need to be?

Jay L Bock1, George G Klee

  • 1Department of Pathology, Stony Brook University, Stony Brook, NY, USA.

Archives of Pathology & Laboratory Medicine
|February 28, 2004
PubMed
Summary

New prostate-specific antigen (PSA) assays offer improved sensitivity but show significant variability at low concentrations. This variability complicates clinical decisions regarding prostate cancer recurrence after treatment.

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Area of Science:

  • Clinical Chemistry
  • Oncology Diagnostics
  • Prostate Cancer Biomarkers

Background:

  • Highly sensitive prostate-specific antigen (PSA) assays are available for detecting low concentrations.
  • The analytical performance and clinical utility of these sensitive PSA assays remain incompletely defined.
  • Small changes in PSA levels have limited prognostic significance in treated prostate cancer patients.

Purpose of the Study:

  • To highlight clinical issues associated with the prognostic significance of minor PSA concentration changes.
  • To evaluate the performance of commercial PSA assays using low-concentration proficiency survey samples.
  • To assess the impact of assay variability on clinical decision-making for prostate cancer recurrence.

Main Methods:

  • Analysis of College of American Pathologists proficiency survey data from 1998-2002.

Related Experiment Videos

  • Evaluation of commercial PSA assay performance on low-concentration samples (<0.4 ng/mL).
  • Assessment of intralaboratory coefficients of variation and inter-assay level differences.

    • Main Results:

    • Assay performance for low PSA concentrations shows improvement over time.
    • Many assays exhibit intralaboratory coefficients of variation exceeding 20% for PSA <0.4 ng/mL.
    • Significant differences exist in PSA levels reported by various assays for low-concentration samples.

    Conclusions:

    • Inter-assay variability in low PSA measurements poses challenges for clinical interpretation.
    • Fixed serum PSA thresholds (e.g., 0.2 ng/mL) may lead to clinical problems due to assay differences.
    • Further standardization and validation are needed for reliable clinical utility of sensitive PSA assays.