PCA3 - Prostate Cancer Biomarker by Transcription-Mediated Amplification
2010102
Ordering Recommendation
Do not use for initial prostate cancer screening. Preferred test is total prostate specific antigen (PSA) (0070121) in conjunction with digital rectal exam. The PCA3 test may be useful, in conjunction with other patient information, to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care.
Mnemonic
PCA3 TMA
Methodology
Qualitative Transcription-Mediated Amplification
Performed
Tue, Fri
Reported
3-6 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
- Patient Preparation
- Collection must follow Digital Rectal Exam (DRE).
- Collect
- 20-30 mL first catch urine following DRE in preservative-free urine collection cup.
- Specimen Preparation
- Invert urine container 5 times to mix, then transfer 2.5 mL urine to each Progensa PCA3 Urine Specimen Transport Tube (ARUP Supply #45682). Available online through eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787. Liquid level must be between black lines on transport tubes. Cap transport tubes and invert 5 times to mix.
- Storage/Transport Temperature
- Frozen.
- Unacceptable Conditions
- Urine in original collection cup. Specimens in APTIMA Urine Specimen Transport Tube (ARUP Supply #28908).
- Remarks
- Stability
- Ambient: 5 days; Refrigerated: 5 days; Frozen: 3 months
Reference Interval
Effective August 18, 2014
| PCA3 Ratio | Interpretation |
| 0-17 | Negative - Result associated with decreased likelihood of a positive biopsy for prostate cancer. |
| 18-24 | Negative - Result should be interpreted with caution. Due to normal test variability, specimens with PCA3 scores near the cut-off may yield a different overall interpretation upon repeat testing. |
| 25-31 | Positive - Result should be interpreted with caution. Due to normal test variability, specimens with PCA3 scores near the cut-off may yield a different overall interpretation upon repeat testing. |
| >31 | Positive - Result associated with increased probability of a positive biopsy for prostate cancer. |
Interpretive Data
The Progensa PCA3 assay is an in vitro nucleic acid amplification test utilizing target capture, transcription-mediated amplification, and a hybridization-protection assay for amplicon detection. PCA3 Score is calculated as the ratio of PCA3 RNA copies to PSA RNA copies, multiplied by 1000.
Sensitivity and Specificity: 77.5 percent and 57.1 percent respectively (relative to prostate biopsy outcome), based on a PCA3 score cutoff value of 25.
Limitations: This test should not be used for men with a result of Atypical Small Acinar Proliferation (ASAP) on their most recent biopsy. Performance has not been established in men who undergo a repeat biopsy less than 3 months or more than 7 years after their most recent negative biopsy. The effect of medications known to influence serum PSA levels or therapeutic and/or diagnostic procedures such as prostatectomy, radiation, or prostate biopsy that may impact the viability of prostatic tissue and PCA3 Score have not been evaluated.
Values obtained with different assay methods or kits cannot be used interchangeably. Results should be interpreted in correlation with clinical history and other relevant data.
Sensitivity and Specificity: 77.5 percent and 57.1 percent respectively (relative to prostate biopsy outcome), based on a PCA3 score cutoff value of 25.
Limitations: This test should not be used for men with a result of Atypical Small Acinar Proliferation (ASAP) on their most recent biopsy. Performance has not been established in men who undergo a repeat biopsy less than 3 months or more than 7 years after their most recent negative biopsy. The effect of medications known to influence serum PSA levels or therapeutic and/or diagnostic procedures such as prostatectomy, radiation, or prostate biopsy that may impact the viability of prostatic tissue and PCA3 Score have not been evaluated.
Values obtained with different assay methods or kits cannot be used interchangeably. Results should be interpreted in correlation with clinical history and other relevant data.
Note
CPT Code(s)
81313
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2010103 | PCA3 by TMA - Score | 69361-4 |
| 2010104 | PCA3 by TMA - Result | 69362-2 |
Aliases
- PCA3 score
- PCA3/PSA ratio