PROSTATE CANCER GENE 3 (PCA3)

Message
"Before collection, the patient should undergo an attentive digital rectal exam (three strokes per lobe).

1. Collect a first-catch (approximately 20 to 30 mL of the initial stream) urine sample in a urine collection cup after DRE has been performed. Urine sample should be processed immediately following steps 2 and 3.

2. Invert the sample five times to resuspend the cells. Transfer 2.5 mL of urine (fill until the fluid level is between the black lines) into the urine specimen transport tube using the disposable pipette provided.

3. Recap the urine specimen transport tube tightly and invert five times to mix.
"


Test Code
489160


CPT Codes
81479

Preferred Specimen
urine


Minimum Volume
2ml


Instructions
"Please direct any questions regarding this test to customer service at 800-345-4363.
"


Transport Container
"Gen-Probe® PROGENSA® Urine Specimen Transport Kit (LabCorp PeopleSoft N° 97836, PK=10)
"


Transport Temperature
frozen


Specimen Stability
frozen-3 months


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
"Specimen volume <2 mL; incorrect collection kit; unfrozen specimen received after five days
"


Methodology
"Target capture, transcription-mediated amplification (TMA), and hybrid protection assay (HPA) "

Limitations
"The PROGENSA® PCA3 assay has the following performance characteristics using the PCA3 score cut-off value of 25 for this patient population: 77.5% sensitivity, 57.1% specificity, 90% negative predictive value and 33.6% positive predictive value.
"




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.