4K Prostate Score (Serum)

Test Code

37941

CPT Codes
81539<br>Limited Access Code

Preferred Specimen

3 mL frozen serum collected in a red-top serum separator tube (SST)

Minimum Volume

3 mL

Other Acceptable Specimens

Serum received spun

Instructions

**Specimen must be shipped within 24 hours of collection**

Note: The 4K Score test is limited to patients age 45 and over.

Fill tube, invert gently 5 times, let stand for minimum of 30 minutes, maximum of 1 hour, spin for 10-15 minutes. Pour the serum off into an aliquot tube and, label with patient name. Freeze immediately.

Transport Container

Plastic aliquot tube

Transport Temperature

Aliquot tube: Frozen
Spun (SST): Refrigerated

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 72 hours
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Frozen serum separator tube

Methodology
Electrochemiluminescent Immunoassay

FDA Status
This test was evaluated and its performance characteristics determined by BioReference Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such a clearance or approval is not necessary. The results reported for this procedure are for research use only. BioReference Laboratories is certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) as qualified to perform high-complexity clinical testing.

Setup Schedule

Set up: Mon-Sat; Report available: 3-4 days

Reference Range

See Laboratory Report

Clinical Significance

High Grade (Gleason 7+) Prostate Cancer Risk Evaluation.

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.