IsoPSA®
Test code
CPT code(s)*
Test resources
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Details
Includes
IsoPSA and Total PSA
Methodology
Immunoassay (IA)
Assay category
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.
Specimen requirements | |
|---|---|
| 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. |
| 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 |
Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.
*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.
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