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Related Experiment Videos

Third-generation PSA: ultrasensitive or ultraprecise assay?

R Mione1, M Barichello, P Sartorello

  • 1Center for the Study of Biological Markers of Malignancy, National Center for the Application of Biotechnologies in Oncology, Venezia, Italy.

The International Journal of Biological Markers
|October 1, 1995
PubMed
Summary

An ultrasensitive prostate-specific antigen (PSA) assay shows excellent precision and sensitivity for monitoring prostate cancer patients post-surgery. This advanced assay can reliably detect subtle PSA variations, aiding in assessing PSA velocity.

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Area of Science:

  • Clinical Chemistry
  • Oncology
  • Biomarker Analysis

Background:

  • Prostate-specific antigen (PSA) assays are crucial for monitoring prostate cancer patients after prostatectomy.
  • Existing PSA assays may lack the sensitivity to detect minimal PSA variations in low-dose ranges.

Purpose of the Study:

  • To evaluate the performance of a commercially available ultrasensitive PSA assay.
  • To compare its analytical sensitivity, detection limits, recovery, and precision against a routine PSA assay.

Main Methods:

  • Evaluation of the Immulite Third Generation ultrasensitive PSA assay.
  • Comparison with the routine Immulite PSA assay.
  • Assessment of analytical sensitivity, biological detection limit, sample dilution recovery, and assay precision.

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Main Results:

  • Ultrasensitive PSA assay demonstrated analytical sensitivity between 0.0029-0.0038 ng/ml and a biological detection limit of 0.0098 ng/ml.
  • Excellent recovery (88-113%) observed up to a 1:128 dilution factor for low PSA levels.
  • High assay precision with interassay coefficient of variation (CV) below 5.84% for samples with PSA < 1.0 ng/ml.

Conclusions:

  • The ultrasensitive PSA assay is a valuable tool for monitoring prostatectomized patients.
  • It reliably detects clinically meaningful PSA variations in the low dose range.
  • The assay is a potential candidate for assessing PSA velocity in prostate cancer management.