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

Reporting Name

Prostate-Specific Ag Diagnostic, S

Useful 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

 

To aid in the prognosis and management of individuals diagnosed with prostate cancer

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 (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 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.

Report Available

1 to 3 days

Day(s) Performed

Monday through Saturday

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.

Method Name

Electrochemiluminescent Immunoassay (ECLIA)

Specimen Type

Serum


Necessary 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

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.

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

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, 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

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

Mayo Clinic Laboratories | Neurology Catalog Additional Information:

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