Home
HelpTest ID BLOD1553 Prostate Health Index Reflex, Serum
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
Specimen Type
Serum RedSpecimen Required
Patient Preparation:
1. Specimens for testing should be collected prior to prostate manipulations such as digital rectal examination, prostatic massage, transrectal ultrasound, 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.
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
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 Minimum Volume
0.75 mL
Reject Due To
| Gross hemolysis | Reject |
| Gross icterus | Reject |
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum Red | Frozen (preferred) | 150 days |
| Ambient | 24 hours | |
| Refrigerated | 24 hours |
Day(s) Performed
Monday through Saturday
Report Available
1 to 3 daysMethod Name
Immunoenzymatic Assay
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
84153 - Total PSA
84154 - Free PSA (if appropriate)
86316 - [-2]ProPSA (if appropriate)
Secondary ID
113000Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| PHI13 | Prostate Health Index (phi) Reflex | No | No |
Testing Algorithm
This test begins with the analysis of prostate-specific antigen (PSA). If the PSA concentration is between 2.0 and 10.0 ng/mL, then the reflex test will be performed at an additional charge.
If the initial PSA concentration is between 2.0 and 10.0 ng/mL, then free PSA and [-2]pro-PSA isoform results will be reported.
If the initial PSA concentration is between 4.0 and 10.0 ng/mL, then the percent free PSA result and prostate health index (phi) will be calculated and reported.
If the initial PSA concentration is between 2.0 and 4.0 ng/mL, then the percent free PSA result and prostate health index (phi) will not be calculated or reported.
Reporting Name
Prostate Health Index Reflex, SReference 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 PSA is in the range of 4.0-10.0 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 4.0-10.0 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% |
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.Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
SANFORD INTERFACE BUILD INFORMATION
| Result Code | Result Code Description |
|---|---|
| 22655 | Prostate Specific Antigen, S |