Prostate Health Index (phi), Serum - LG 3


Abbrev Code:MMMISC   
Order Code:LAB4909Order Name:Send Outs Misc Test
Synonyms:PHI; P2PSA; Pro-2-PSA
Methodology:Immunoenzymatic Assay
CPT Codes: 84153 x1, 84154 x1, 86316 x1
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
Container:Red (no gel)
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:Centrifuge and aliquot within 3 hours of collection 1 mL; 0.75 mL minimum. Store frozen.
Shipping Instructions:Ship frozen.
Stability:Stability is 150 days 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 in the 4-10 ng/mL range and digital rectal examination (DRE) findings that are not suspicious for cancer.


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