Prostate Health Index Reflex, Serum


Abbrev Code:MMMISC   
Order Code:LAB4909Order Name:Laboratory Miscellaneous Order
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, approved or is exempt 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. A 6 week waiting period between needle biopsy and specimen collection is recommended.
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: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 Less than or equal to 2.0 ng/mL
40-49 years Less than or equal to 2.5 ng/mL
50-59 years Less than or equal to 3.5 ng/mL
60-69 years Less than or equal to 4.5 ng/mL
70-79 years Less than or equal to 6.5 ng/mL
Greater than or equal to 80 years Less 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
Less 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 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%
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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