A multicenter evaluation of the PCA3 molecular urine test: Pre-analytical effects, analytical performance, and diagnostic accuracy

Lori J. Sokoll, William Ellis, Paul Lange, Jennifer Noteboom, Debra J. Elliott, Ina L. Deras, Amy Blase, Seongjoon Koo, Mark Sarno, Harry Rittenhouse, Jack Groskopf, Robert L. Vessella

Research output: Contribution to journalArticle

Abstract

Background: Measurement of prostate cancer gene 3 (PCA3) mRNA normalized to prostate-specific antigen (PSA) mRNA in urine has been proposed as a marker for prostate cancer. Methods: We investigated pre-analytical effects, analytical performance, and diagnostic accuracy of a quantitative assay for PCA3. Results: Urine specimens collected without prostate manipulation demonstrated low informative rates. However, specimens collected following digital rectal examinations of 3 or 8 strokes per prostate lobe demonstrated informative rates > 94%. Across all urine specimen types, median PCA3 results did not show statistically significant differences (P > 0.8). Measurements of controls of known mRNA content demonstrated percent recoveries of 100 ± 15% for both PCA3 and PSA mRNAs. PCA3 mRNA total, intra-assay, inter-assay, and inter-site CVs were ≤ 17.1%, ≤ 14.0%, ≤ 9.9%, and ≤ 3.2%, respectively. Corresponding CVs for PSA mRNA assay were ≤ 11.5%, ≤ 8.6%, ≤ 7.9%, and ≤ 8.3%. Blinded assay of urines from 72 men with known prostate biopsy outcomes yielded areas under the curve from receiver-operating characteristic analysis of 0.7 at both research sites. Deming regression of individual PCA3 results between sites yielded slope = 0.94, intercept = 0.48, R = 0.9677 (P < 0.0001). Conclusions: The PCA3 assay is insensitive to pre-analytical factors, performs well analytically and correctly classifies a high percent of subjects with known prostate cancer status across research sites.

Original languageEnglish (US)
Pages (from-to)1-6
Number of pages6
JournalClinica Chimica Acta
Volume389
Issue number1-2
DOIs
StatePublished - Mar 2008

Keywords

  • Molecular urine test
  • PCA3
  • PSA
  • Prostate cancer

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

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