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Test ID: PSA Prostate-Specific Antigen (PSA) Diagnostic, Serum

Reporting Name

Prostate-Specific Ag Diagnostic, S

Useful For

Evaluating patients with documented prostate problems in whom multiple prostate-specific antigen tests may be necessary per year

 

Monitoring patients with a history of prostate cancer as an early indicator of recurrence and response to treatment

Clinical Information

Prostate-specific antigen (PSA) is a glycoprotein that is 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 also for those 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 (PSA) 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.

 

PSA values exceeding the age-specific limits are suspicious for prostate disease, but further 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.

Analytic Time

Same day/1 day

Day(s) and Time(s) Performed

Monday through Friday; 5 a.m.-12 a.m.

Saturday; 6 a.m.-6 p.m.

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 Aug 18;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;52:8-22

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 June 15;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 January;165(1):119-1255. Netto GJ and Epstein JI. Ch 16: Immunohistology of the Prostate. In Diagnostic Immnuohistochemistry. Fifth Edition. Edited by DJ Dabbs. Elsevier. 2019. pp 588-623

Method Name

Electrochemiluminescent Immunoassay (ECLIA)

Specimen Type

Serum


Necessary Information


Include patient's age.



Specimen Required


Patient Preparation: For 12 hours before this test do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.6 mL

Collection Instructions:

1. Serum gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.

Additional Information: Free prostate-specific antigen (PSA) can only be added on within 12 hours of performing total PSA. Specimen must have been shipped frozen.


Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 180 days
  Refrigerated  5 days

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

Test Classification

This test has been cleared or approved by the U.S. 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
Mayo Clinic Laboratories | Neurology Catalog Additional Information:

mml-Neuroimmunology, mml-Neuro-oncology, mml-Pediatric