How Sensitive Is a Prostate-Specific Antigen Measurements? How Sensitive Does It Need to Be?

Jay L. Bock, George G. Klee

Research output: Contribution to journalReview articlepeer-review

16 Scopus citations


Assays are now available that can measure very low concentrations of prostate-]specific antigen (PSA), but their analytic performance and clinical utility are not well defined. This brief article highlights some of the clinical issues related to the limited prognostic significance of small changes in PSA concentrations in men with prostate cancer who have been treated with prostate ablation therapy. College of American Pathologists proficiency survey data are presented, illustrating the performance of commercial PSA assays with low PSA concentration survey samples tested between 1998 and 2002. The performance of the assays appears to be improving, but many of the currently used assays have intralaboratory coefficients of variation greater than 20% for PSA concentrations less than 0.4 ng/mL. Also, there are major differences in the level of PSA reported by various assays in these low concentration samples. These level differences (if they are also seen in clinical samples) may cause clinical problems when fixed serum PSA thresholds (eg, 0.2 ng/mL) are used to make clinical decisions related to prostate tumor recurrence.

Original languageEnglish (US)
Pages (from-to)341-343
Number of pages3
JournalArchives of Pathology and Laboratory Medicine
Issue number3
StatePublished - Mar 2004

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology


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