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

Fingerprint

Neoplasm Genes
Prostatic Neoplasms
Genes
Assays
Urine
Messenger RNA
Prostate-Specific Antigen
Prostate
Biopsy
Digital Rectal Examination
Research
ROC Curve
Recovery
Area Under Curve

Keywords

  • Molecular urine test
  • PCA3
  • Prostate cancer
  • PSA

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry

Cite this

A multicenter evaluation of the PCA3 molecular urine test : Pre-analytical effects, analytical performance, and diagnostic accuracy. / Sokoll, Lori J; Ellis, William; Lange, Paul; Noteboom, Jennifer; Elliott, Debra J.; Deras, Ina L.; Blase, Amy; Koo, Seongjoon; Sarno, Mark; Rittenhouse, Harry; Groskopf, Jack; Vessella, Robert L.

In: Clinica Chimica Acta, Vol. 389, No. 1-2, 03.2008, p. 1-6.

Research output: Contribution to journalArticle

Sokoll, LJ, Ellis, W, Lange, P, Noteboom, J, Elliott, DJ, Deras, IL, Blase, A, Koo, S, Sarno, M, Rittenhouse, H, Groskopf, J & Vessella, RL 2008, 'A multicenter evaluation of the PCA3 molecular urine test: Pre-analytical effects, analytical performance, and diagnostic accuracy', Clinica Chimica Acta, vol. 389, no. 1-2, pp. 1-6. https://doi.org/10.1016/j.cca.2007.11.003
Sokoll, Lori J ; Ellis, William ; Lange, Paul ; Noteboom, Jennifer ; Elliott, Debra J. ; Deras, Ina L. ; Blase, Amy ; Koo, Seongjoon ; Sarno, Mark ; Rittenhouse, Harry ; Groskopf, Jack ; Vessella, Robert L. / A multicenter evaluation of the PCA3 molecular urine test : Pre-analytical effects, analytical performance, and diagnostic accuracy. In: Clinica Chimica Acta. 2008 ; Vol. 389, No. 1-2. pp. 1-6.
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