IsoPSA®
Test Code
12061
0359U
In-home collection is not available in your area through Quest Mobile.
Clinical Significance
IsoPSA® - 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.
Test Resources
None found for this test
Please visit our Clinical Education Center to stay informed on any future publications, webinars, or other education opportunities.
Please visit our Clinical Education Center to stay informed on any future publications, webinars, or other education opportunities.
Test Details
IsoPSA and Total PSA
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.
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.
Methodology
Immunoassay (IA)
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 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 strongly recommended that these 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.
This test is not available for New York patient testing.
This test is not available for New York patient testing.
Reference Range(s)
See Laboratory Report
Preferred Specimen(s)
1 mL frozen plasma collected in a lithium heparin (green-top) tube
Minimum Volume
0.5 mL
Collection 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
Gross hemolysis • Received thawed
Setup Schedule
1 mL frozen plasma collected in a lithium heparin (green-top) tube
0.5 mL
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.
Note: Only collect from male patients ≥50 years of age with an established total PSA level of ≥4 ng/mL.
Transport tube
Frozen
Room temperature: Unacceptable
Refrigerated: 24 hours
Frozen: 14 days
Refrigerated: 24 hours
Frozen: 14 days
Gross hemolysis • Received thawed