PCA3 - Prostate cancer biomarker by TMA-994

Test info

  
PCA3 - Prostate cancer biomarker by TMA
  
994
  
LAB994
  
MSO
  
Prostate cancer Ag 3
Prostate cancer antigen 3
  

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.

  

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.

Specimen

  

Collection must follow digital rectal exam (DRE)

  
Urine
  
  

Collect 20-30 mL first catch urine following DRE in preservative-free urine collection cup

  
  1. Invert the sample five times to resuspend the cells
  2. Using the disposable pipette provided in the kit, transfer 2.5 mL of urine (fill until the fluid level is between the black lines) into the two urine specimen transport tubes from the Gen-Probe Progensa PCA3 urine specimen transport vial/tube
  3. Recap the urine specimen transport tubes tightly and invert five times to mix
  4. Freeze
  

Frozen (preferred) – 3 months

Refrigerated – 5 days

Ambient – 5 days

  
  • Urine in original collection container
  • Specimens in APTIMA Urine Specimen Transport Tube
  • Specimen volume less than 2.5 mL

Performance

  
ARUP (2010102) via Labcorp (009985): R-NX
  
Th
  
7 - 8 days
  

Qualitative Transcription-Mediated Amplification (TMA)

Clinical and Interpretive info

  

Negative (0 - 17 ratio)

  

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.

Billing

  
81313
  
Yes
  

Tracking

  
02/23/2021
  
03/10/2021