- Patient Preparation
- Collection must follow Digital Rectal Exam (DRE).
- 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 Progensa PCA3 Urine Specimen Transport Tube (ARUP Supply #45682). Liquid level must be between black lines on transport tube. Cap transport tube and invert 5 times to mix. Transport tubes are available online through eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787.
- Storage/Transport Temperature
- Unacceptable Conditions
- Urine in original collection cup. Specimens in APTIMA Combo 2 Urine Specimen transport media (ARUP Supply #28908).
- Ambient: 5 days; Refrigerated: 5 days; Frozen: 3 months
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.
|Component Test Code*||Component Chart Name|
|2010103||PCA3 by TMA - Score|
|2010104||PCA3 by TMA - Result|
- PCA3 score
- PCA3/PSA ratio