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Test Code PSAFT Prostate-Specific Antigen (PSA), Total and Free, Serum

Reporting Name

PSA Total and Free, S

Useful For

As an aid in distinguishing prostate cancer from benign prostatic conditions in men aged 50 years and older with total PSA between 4.0 and 10.0 ng/mL with digital rectal examination findings that are not suspicious for cancer

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Ordering Guidance


This test may be ordered for patients undergoing evaluation of suspicion of prostate cancer, or for assessing the risk of prostate cancer in patients with borderline or moderately increased total prostate-specific antigen (4.0-10.0 ng/mL).



Necessary Information


Include patient's age.



Specimen Required


Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial within 3 hours of collection.


Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 90 days
  Refrigerated  72 hours

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

84154

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PSAFT PSA Total and Free, S 53764-7

 

Result ID Test Result Name Result LOINC Value
TPSA Total PSA 83112-3
FPSA Free PSA 83113-1
PSA_R Free PSA/PSA Ratio 12841-3

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.

 

PSA exists in serum in multiple forms: complexed to alpha-1-anti-chymotrypsin (PSA-ACT complex), unbound (free PSA), and enveloped by alpha-2-macroglobulin (not detected by immunoassays).

 

Higher total PSA levels and lower percentages of free PSA are associated with higher risks of prostate cancer.

 

Most prostate cancers are slow growing, so the utility of prostate cancer screening is marginal in most men with a life expectancy of less than 10 years.

Interpretation

When total prostate-specific antigen (PSA) concentration is below 2.0 ng/mL, the probability of prostate cancer in asymptomatic men is low, further testing and free PSA may provide little additional information. When total PSA concentration is above 10.0 ng/mL, the probability of cancer is high and prostate biopsy is generally recommended.

 

The total PSA range of 4.0 to 10.0 ng/mL has been described as a diagnostic "gray zone," in which the free PSA:total PSA ratio helps to determine the relative risk of prostate cancer (see table). Therefore, some urologists recommend using the free PSA:total ratio to help select which men should undergo biopsy. However, even a negative result of prostate biopsy does not rule-out prostate cancer. Up to 20% of men with negative biopsy results have subsequently been found to have cancer.

 

Based on free PSA:total PSA ratio: the percent probability of finding prostate cancer on a needle biopsy by age in years:

Free PSA:total PSA ratio

50-59 years

60-69 years

70 years and older

≤0.10

49%

58%

65%

0.11-0.18

27%

34%

41%

0.19-0.25

18%

24%

30%

>0.25

9%

12%

16%

Report Available

1 to 3 days

Specimen Retention Time

14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus Reject

Method Name

Electrochemiluminescent Immunoassay (ECLIA)

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Oncology Test Request (T729)

Secondary ID

81944

Testing Algorithm

Total prostate-specific antigen (PSA) and free PSA are performed and reported on every specimen.

 

If the initial total PSA concentration is between 4.0 and 10.0 ng/mL, then the percent free PSA result will be calculated and reported.