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Test Code P2PHI [-2]Pro Prostate-Specific Antigen with Prostate Health Index, Serum

Reporting Name

p2PSA with Prostate Health Index, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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 and digital rectal examination findings that are not suspicious for cancer.

Method Name

Immunoenzymatic Assay


Specimen Required


Patient Preparation:

1. Specimens for testing should be collected prior to prostate manipulations such as digital rectal examination (DRE), prostatic massage, transrectal ultrasound (TRUS), and prostatic biopsy.

2. A 6-week waiting period between needle biopsy and specimen collection is recommended.

3. Specimens should not be collected from patients receiving therapy with high biotin (vitamin B7) doses (ie, >5 mg/day) until at least 8 hours following the last biotin administration.

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Within 3 hours of collection, centrifuge, aliquot serum into a plastic vial, and refrigerate. Freeze sample within 24 hours of collection and send frozen.


Specimen Type

Serum Red

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Red Frozen (preferred) 150 days
  Ambient  24 hours
  Refrigerated  24 hours

Reject Due To

Gross hemolysis Reject
Gross icterus Reject

Reference Values

Females: Not applicable

 

PROSTATE-SPECIFIC ANTIGEN (PSA) MALES:

Age

Reference range

<40 Years

≤2.0 ng/mL

40-49 Years

≤2.5 ng/mL

50-59 Years

≤3.5 ng/mL

60-69 Years

≤4.5 ng/mL

70-79 Years

≤6.5 ng/mL

≥80 Years

≤7.2 ng/mL

 

PERCENT FREE PSA MALES:

When total PSA is in the range of 4-10 ng/mL

% Free PSA

Probability of cancer

≤10%

56%

11-15%

28%

16-20%

20%

21-25%

16%

>25%

8%

 

PROSTATE HEALTH INDEX (phi) MALES:

When PSA is in the range of 4-10 ng/mL

phi range

Probability of cancer

95% Confidence interval

0-26.9

9.8%

5.2-15.4%

27.0-35.9

16.8%

11.3-22.2%

36.0-54.9

33.3%

26.8-39.9%

≥55.0

50.1%

39.8-61.0%

Interpretation

The prostate health index (phi) may be used to determine the probability of prostate cancer on biopsy in men 50 years of age and older with total prostate-specific antigen (PSA) in the 4.0 to 10.0 ng/mL range. Low phi scores are associated with a lower probability of finding prostate cancer on biopsy, and higher phi scores are associated with an increased probability of finding prostate cancer on biopsy. The choice of an appropriate phi score to be used in guiding clinical decision making may vary for each patient and may depend on other clinical factors or family history. The table below indicates the probability of finding prostate cancer on biopsy when total PSA is in the range of 4.0 to 10.0 ng/mL and may be used as guidance for interpreting the phi score.

 

phi range

Probability of cancer

95% Confidence interval

0-26.9

9.8%

5.2%-15.4%

27.0-35.9

16.8%

11.3%-22.2%

36.0-54.9

33.3%

26.8%-39.9%

55.0+

50.1%

39.8%-61.0%

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

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-Total PSA

84154-Free PSA

86316-[-2]ProPSA

LOINC Code Information

Test ID Test Order Name Order LOINC Value
P2PHI p2PSA with Prostate Health Index, S 53764-7

 

Result ID Test Result Name Result LOINC Value
PSAT Prostate Specific Antigen, S 83112-3
PSAF Free PSA, S 83113-1
PSAP2 [-2]ProPSA, S 97149-9
PSAP3 % Free PSA 12841-3
PSAP4 Prostate Health Index 97150-7