Do not use for initial prostate cancer screening. Preferred test is Prostate Specific Antigen, Total (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 negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care.
Qualitative Transcription-Mediated Amplification
Collection must follow Digital Rectal Exam (DRE).
20-30 mL first catch urine following DRE in preservative-free urine collection cup.
Invert urine container 5 times to mix. Transfer 2.5 mL urine ASAP or within 4 hours of collection into two (2) Progensa PCA3 Urine Specimen Transport Tubes (ARUP Supply #45682) available online through eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787. (Min: 2.5 mL per tube) Liquid level must be between black lines on transport tubes. Cap transport tubes and invert 5 times to mix.
Urine in original collection cup. Specimens in APTIMA Urine Specimen Transport Tube (ARUP Supply #28908).
Ambient: 5 days; Refrigerated: 5 days; Frozen: 3 months
Effective August 18, 2014
|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.|
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.
No compliance statements are in use for this test.
|Component Test Code*||Component Chart Name||LOINC|
|2010103||PCA3 by TMA - Score||69361-4|
|2010104||PCA3 by TMA - Result||69362-2|
- PCA3 score
- PCA3/PSA ratio