IsoPSA® Index

Test Code

12061

CPT Codes
⁠⁠⁠⁠⁠⁠⁠0359U<br>This test is not available for New York patient testing.

Includes

IsoPSA and Total PSA

Preferred Specimen

1 mL plasma collected in a lithium heparin (green-top) tube

Patient Preparation
Do not collect specimens:
Within 72 hours after prostate manipulation, including DRE.
Within 2 weeks after UTI and/or prostatitis.
Within 30 days after prostate surgery including prostate biopsy, urinary catheterization, prostate infarction, or endoscopic evaluation; or other urinary tract malignancy after a transrectal biopsy.

Minimum Volume

0.5 mL

Instructions

Draw blood into a lithium heparin tube. Invert sample 5-10 times and let sit for 15 minutes. Centrifuge sample within 1 hour of collection. Transfer plasma into a transport/pour off plastic tube. Freeze plasma.

Note: Only collect from male patients ≥ 50 years of age with an established total PSA level of ≥ 4 ng/mL.

Transport Container

Transport tube

Transport Temperature

Frozen

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 24 hours
Frozen: 14 days

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

Gross hemolysis • Received thawed

Methodology
Immunoassay (IA)

FDA Status
The IsoPSA test was developed and its performance characteristics determined by Cleveland Diagnostics, Inc. The laboratory performing the IsoPSA test is regulated under Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). IsoPSA should not be used for screening purposes. It is recommended that IsoPSA test results be communicated to the patient in a setting that includes appropriate counseling. All total PSA tests are performed by Cleveland Diagnostics using a Roche cobas® instrument and are performed in accordance with the manufacturer's test specifications.

Setup Schedule

Set up: Mon-Sat; Report available: 1-3 days

Reference Range

See Laboratory Report

Clinical Significance

IsoPSA is a structure-based (rather than concentration- based) assay that interrogates the entire spectrum of structural changes to PSA (or isoforms), and can effectively differentiate between high-grade prostate cancer and lowgrade prostate cancer/benign.

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.