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HelpTest Code PSAU Prostate-Specific Antigen (PSA) Ultrasensitive, Serum
Useful For
As an aid in the detection of prostate cancer when used in conjunction with a digital rectal exam in men ages 50 years and older
To aid in the prognosis and management of individuals diagnosed with prostate cancer
Monitoring disease after radical prostatectomy
This test should not be used for initial prostate cancer screening.
Method Name
Electrochemiluminescent Immunoassay (ECLIA)
Reporting Name
PSA, Ultrasensitive, SSpecimen Type
SerumOrdering Guidance
Free prostate-specific antigen (PSA) can be added on within 72 hours of performing this test. Specimen must have been shipped frozen.
If both free and total PSA results are desired, order PSAFT / Prostate-Specific Antigen (PSA), Total and Free, Serum.
Additional Testing Requirements
Necessary Information
Include patient's age.
Specimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions:
1. Serum gel tubes should be centrifuged within 2 hours of collection.
2. Red-top tubes should be centrifuged, and the serum aliquoted into a plastic vial within 2 hours of collection.
Specimen Minimum Volume
0.75 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 180 days | |
| Refrigerated | 14 days | ||
| Ambient | 7 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Clinical Information
Prostate-specific antigen (PSA) is the most widely used method to detect prostate cancer recurrence after radical prostatectomy (RP). Approximately 20% to 35% of patients develop a rising PSA following RP for clinically localized prostate cancer. Biochemical recurrence (BCR) is defined as an increase in PSA after curative therapy without clinical or radiological evidence of disease. The median time to BCR could vary between 2 to 3 years. A standard PSA cutpoint to indicate BCR has yet to be established. For example, the American Urological Association and the American Society for Radiation Oncology defined BCR after surgery as initial and confirmatory PSA concentrations of 0.2 ng/mL or greater. However, a BCR definition of 0.4 ng/mL PSA has also been proposed.
Assays that measure PSA to concentrations below 0.1 ng/mL are denoted ultrasensitive PSA (USPSA). The use of USPSA cutpoints below currently recommended PSA thresholds may be helpful in identifying cases of early biochemical recurrence and for selecting patients with adverse clinicopathologic risk factors for secondary therapy. However, some authors believe that USPSA assays offers minimal advantages and could lead to increased anxiety in patients who have clinically meaningless rises of PSA and might lead to overtreatment.
Reference Values
Males:
|
Age (years) |
PSA upper limit (ng/mL) |
|
<40 |
≤2.0 |
|
40-49 |
≤2.5 |
|
50-59 |
≤3.5 |
|
60-69 |
≤4.5 |
|
70-79 |
≤6.5 |
|
≥80 |
≤7.2 |
Females: Not applicable
Interpretation
An undetectable (<0.01 ng/mL) ultrasensitive prostate-specific antigen (USPSA) concentration after radical prostatectomy is reassuring and may aid in postoperative risk stratification of patients.
A detectable USPSA concentration (≥0.01 ng/mL) after radical prostatectomy (RP) does not necessarily translate into disease progression or recurrence. Interpretation of a detectable USPSA needs to be made in conjunction with other clinicopathologic risk factors. The cutpoint for interpretation of USPSA assays remains controversial and has ranged from 0.01 to 0.05 ng/mL. For example, in a study that included 754 men after RP, a cutpoint of 0.01 ng/mL was an independent predictor of biochemical recurrence (BCR). BCR-free survival at 5 years was 92.4% for patients with an USPSA post-RP of less than 0.01 ng/mL and 56.8% for patients with an USPSA post-RP of 0.01 ng/mL or higher.(1) In the same study a cutoff of 0.03 ng/ml also predicted BCR independent of clinicopathological factors and BCR-free survival at 5 yrs was 90.8% for patients with an USPSA post-RP of less than 0.03 ng/mL and 26.9% for patients with a PSA post-RP of greater or equal to 0.03 ng/mL.(1)
Cautions
Serum markers are not specific for malignancy, and values may vary by method.
When age is not supplied, the results cannot be flagged as high or low.
Digital rectal examination generally does not increase normal prostate-specific antigen (PSA) values. However, cystoscopy, urethral instrumentation, and prostate biopsy may increase PSA levels.
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. The presence of antibodies to streptavidin or ruthenium can also rarely occur and may interfere in this assay. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.
No interference was observed from rheumatoid factors up to a concentration of 1500 IU/mL.
There is no high-dose hook effect at total PSA concentrations up to 17,000 ng/mL.
Serum biotin concentrations up to 1200 ng/mL do not interfere with this assay. Concentrations up to 1200 ng/mL may be present in specimens collected from patients taking extremely high doses of biotin up to 300 mg per day.(2) In a study among 54 healthy volunteers, supplementation with 20 mg/day biotin resulted in a maximum serum biotin concentration of 355 ng/mL 1 hour post-dose.(3)
Method Description
The Roche Elecsys total PSA (prostate-specific antigen) assay is a sandwich electrochemiluminescence immunoassay that employs a biotinylated monoclonal PSA-specific antibody and a monoclonal PSA-specific antibody labeled with ruthenium complex. PSA in the specimen reacts with both the biotinylated monoclonal PSA-specific antibody (mouse) and the monoclonal PSA-specific antibody (mouse) labeled with a ruthenium, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured against a calibration curve to determine the amount of PSA in the patient specimen. This method has been standardized against the Reference Standard/WHO 96/670.(Package insert: Elecsys total PSA. Roche Diagnostics; V 2.0, 06/2023)
Day(s) Performed
Monday through Saturday
Report Available
1 to 3 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
84153
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| PSAU | PSA, Ultrasensitive, S | 35741-8 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| PSAU | PSA, Ultrasensitive, S | 35741-8 |