APTIMA PCA3 Molecular Urine Test: Development of a Method to Aid in the Diagnosis of Prostate Cancer
Open Access
- 1 June 2006
- journal article
- Published by Oxford University Press (OUP) in Clinical Chemistry
- Vol. 52 (6), 1089-1095
- https://doi.org/10.1373/clinchem.2005.063289
Abstract
Background: Prostate cancer gene 3 (PCA3) encodes a prostate-specific mRNA that has shown promise as a prostate cancer diagnostic tool. This report describes the characterization of a prototype quantitative PCA3-based test for whole urine. Methods: Whole-urine specimens were collected after digital rectal examination from 3 groups: men scheduled for prostate biopsy (n = 70), healthy men (<45 years of age with no known prostate cancer risk factors; n = 52), and men who had undergone radical prostatectomy (n = 21). PCA3 and prostate-specific antigen (PSA) mRNAs were isolated, amplified, and quantified by use of Gen-Probe DTS400® Systems. Prostate biopsy results were correlated with the PCA3/PSA mRNA ratio, and PSA mRNA concentrations were used to normalize PCA3 signals and confirm the yield of prostate-specific RNA. Assay precision, specimen stability, and mRNA yield were also evaluated. Results: The specimen informative rate (fraction of specimens yielding sufficient RNA for analysis) was 98.2%. In this clinical research study, ROC curve analysis of prebiopsy specimens yielded an area under the curve of 0.746; sensitivity was 69% and specificity 79%. Serum PSA assay specificity was 28% for this same group. PCA3 and PSA mRNAs were undetectable in postprostatectomy specimens except for one man with recurrent prostate cancer. Assay interrun CVs were ≤12%. Both mRNAs were stable in processed urine up to 5 days at 4 °C and after 5 freeze–thaw cycles. Conclusion: The APTIMA® PCA3 assay combines simple specimen processing with precise assays and existing instruments and could add specificity to the current algorithm for prostate cancer diagnosis.Keywords
This publication has 12 references indexed in Scilit:
- Innovations in Serum and Urine Markers in Prostate Cancer: Current European Research in the P-Mark ProjectEuropean Urology, 2005
- uPM3, a new molecular urine test for the detection of prostate cancerUrology, 2004
- Prevalence of Prostate Cancer among Men with a Prostate-Specific Antigen Level ≤4.0 ng per MilliliterThe New England Journal of Medicine, 2004
- DD3PCA3-based Molecular Urine Analysis for the Diagnosis of Prostate CancerEuropean Urology, 2003
- Highly Sensitive Multiplex Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNAJournal of Clinical Microbiology, 2002
- Molecular diagnostic testing for infectious diseases using TMA technologyExpert Review of Molecular Diagnostics, 2001
- DNA-based detection of prostate cancer in urine after prostatic massageUrology, 2001
- THE USE OF TELOMERASE ACTIVITY FOR THE DETECTION OF PROSTATIC CANCER CELLS AFTER PROSTATIC MASSAGEJournal of Urology, 2001
- The role of prostate needle biopsy in evaluation of chemopreventive agentsUrology, 2001
- Decreased concentrations of prostate-specific antigen and human glandular kallikrein 2 in malignant versus nonmalignant prostatic tissueUrology, 2000