-1739993209.png){kind=logo}
Home
HelpTest Code PSA Prostate-Specific Antigen (PSA) Diagnostic, Serum
Reporting Name
Prostate-Specific Ag Diagnostic, SUseful For
As an aid in the detection of prostate cancer when used in conjunction with a digital rectal exam in men 50 years and older
As an aid in the prognosis and management of individuals diagnosed with prostate cancer
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumNecessary Information
Include patient's age.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.6 mL serum
Collection Instructions:
1. For serum gel tubes, centrifuge within 2 hours of collection.
2. For red top tubes, centrifuge and aliquot serum into a plastic vial within 2 hours of collection.
Additional Information: Free prostate-specific antigen (PSA) can only be added on within 72 hours of performing total PSA. Specimen must have been shipped frozen.
Specimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Frozen (preferred) | 180 days |
| Refrigerated | 5 days |
Day(s) Performed
Monday through Saturday
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 |
|---|---|---|
| PSA | Prostate-Specific Ag Diagnostic, S | 83112-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| PSA | Prostate-Specific Ag Diagnostic, S | 83112-3 |
Clinical Information
Prostate-specific antigen (PSA) is a glycoprotein produced by the prostate gland, the lining of the urethra, and the bulbourethral gland. Normally, very little PSA is secreted in the blood. Increases in glandular size and tissue damage caused by benign prostatic hypertrophy, prostatitis, or prostate cancer may increase circulating PSA levels.
In patients with previously diagnosed prostate cancer, PSA testing is advocated as an early indicator of tumor recurrence and as an indicator of response to therapy. The role of PSA in early detection of prostate cancer is controversial. The American Cancer Society recommends annual examination with digital rectal examination and serum PSA beginning at age 50 and for men with a life expectancy of at least 10 years after detection of prostate cancer. For men in high-risk groups, such as African Americans or men with a first-degree relative diagnosed at a younger age, testing should begin at a younger age. It is generally recommended that information be provided to patients about the benefits and limitations of testing and treatment so they can make informed decisions.
Interpretation
Prostate-specific antigen values are reported with the 95th percentile limits by decade of age. These reference limits include men with benign prostatic hyperplasia. They exclude all cases with proven cancer.
Prostate-specific antigen values exceeding the age-specific limits are suspicious for prostate disease, but additional testing, such as prostate biopsy, is needed to diagnose prostate pathology.
The minimal reporting value is 0.1 ng/mL. Values above 0.2 ng/mL are considered evidence of biochemical recurrence of cancer in men after prostatectomy.
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 also 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.
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. In a study among 54 healthy volunteers, supplementation with 20 mg/day biotin resulted in a maximum serum biotin concentration of 355 ng/mL one hour post-dose.
Clinical Reference
1. Oesterling JE, Jacobsen SJ, Chute CG, et al. Serum prostate-specific antigen in a community-based population of healthy men. JAMA. 1993;270:860-864
2. Smith RA, Cokkinides V, von Eschenbach A, et al. American Cancer Society guidelines for the early detection of cancer. CA Cancer J Clin. 2002;52(1):8-22
3. Barry MJ, Albertsen PC, Bagshaw MA, et al. Outcomes for men with clinically nonmetastatic prostate carcinoma managed with radical prostatectomy, external beam radiotherapy, or expectant management: a retrospective analysis. Cancer. 2001;91(12):2302-2314
4. Blute ML, Bergstralh EJ, Scherer BG, et al. Use of Gleason score, prostate specific antigen, seminal vesicle and margin status to predict biochemical failure after radical prostatectomy. J Urol. 2001;165(1):119-125
5. Netto GJ, Epstein JI: Immunohistology of the prostate. In: Dabbs DJ, ed. Diagnostic Immunohistochemistry. 5th ed. Elsevier; 2019:588-623
6. Peyro Saint Paul L, Debruyne D, Bernard D, Mock DM, Defer GL. Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis. Expert Opin Drug Metab Toxicol. 2016;12:(3):327-344
7. Grimsey P, Frey N, Bendig, et al. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. J Pharmacokinet Pharmacodyn. 2017; 2(4), 247-256
Report Available
1 to 3 daysSpecimen Retention Time
14 daysReject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Method Name
Electrochemiluminescent Immunoassay (ECLIA)
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.