Prostate Health Index (phi), Serum - LG 3


Sunquest Code:MMMISC  
Epic Code:LAB4909Epic Name:Send Outs Misc Test
Synonyms:PHI; P2PSA; Pro-2-PSA
Methodology:Immunoenzymatic Assay
CPT Code:84153, 84154, 86316
Turnaround Time:Specimens are sent to the reference laboratory Mon-Fri; results are reported within 2-4 days.
Compliance:

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.



Collection Instructions

Specimen:Blood
Optimal Volume:2 mL
Minimum\Peds Volume:1.7 mL
Patient Preparation:Specimens for testing should be drawn prior to prostate manipulations such as digital rectal examination (DRE), prostatic massage, transrectal ultrasound (TRUS) and prostatic biopsy.
Specimens should not be collected from patients receiving therapy with high biotin (vitamin B7) doses (i.e., >5 mg/day) until at least 8 hours following the last biotin administration.
Causes for Rejection:Grossly hemolyzed or lipemic specimens. Collection in a serum separator tube.


Processing and Shipping

Specimen Processing:Centirufge and aliquot within 3 hours of collection 1 mL; 0.75 mL minimum. Store frozen.
Shipping Instructions:Ship frozen.
Test Performed at or Referral Lab Lab Sendouts  (Mayo Medical Laboratories)
Referral Lab number:PHI11


Interpretive

Reference Range:Females: Not applicable.     Total PSA Males:
Age Reference Range
Less than 40 years Greater than or equal to 2.0 ng/mL
40-49 years Greater than or equal to 2.5 ng/mL
50-59 years Greater than or equal to 3.5 ng/mL
60-69 years Greater than or equal to 4.5 ng/mL
70-79 years Greater than or equal to 6.5 ng/mL
Greater than or equal to 80 years Greater than or equal to 7.2 ng/mL
    % Free PSA Males, when total PSA is in the range of 4-10 ng/mL
% Free PSA Probability of Cancer
Greater than or equal to 10% 56%
11-15% 28%
16-20% 20%
21-25% 16%
Greater than 25% 8%
    Prostate Health Index (phi) Males, when total PSA is inthe 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%
Greater than or equal to 55.0 50.1% 39.8-61.0%
 
Use:Aids in distinguishing prostate cancer from benign prostate conditions in men with total PSA results inthe 4-10 ng/mL range and digital rectal examination (DRE) findings that are not suspicious for cancer.


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