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


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: Centrifuge, aliquot serum into plastic vial, and refrigerate serum within 3 hours of collection.


Useful For

Aids in distinguishing prostate cancer from benign prostate conditions in men 50 years of age and older with prostate-specific antigen (PSA) results in the 4 to 10 ng/mL range and digital rectal examination (DRE) findings that are not suspicious for cancer

Highlights

Prostate health index (phi) may be used to determine the probability of prostate cancer on biopsy in men with prostate-specific antigen (PSA) in the 4.0 to 10.0 ng/mL range.

 

This test will generate results for PSA, free PSA and [-2]ProPSA regardless of PSA concentration.

 

Percent free PSA and phi calculations will only be reported when the initial PSA value is between 4.0 and 10.0 ng/mL.

Method Name

Immunoenzymatic Assay

Reporting Name

p2PSA with Prostate Health Index, S

Specimen Type

Serum Red

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Red Frozen 150 days

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

 

% 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%

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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 In Process

 

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

NY State Approved

Yes