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HelpTest Code P2PHI Prostate-Specific Antigen (PSA) and [-2]ProPSA with Prostate Health Index (PHI), 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: Within 3 hours of collection, centrifuge, aliquot serum into a plastic vial, and refrigerate. Freeze sample within 24 hours of collection and send frozen.
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.
Testing Algorithm
This test begins with the analysis of prostate specific antigen (PSA), free PSA, and [-2]proPSA. If the initial PSA is between 4.0 and 10.0 ng/mL, then the percent free PSA and the prostate health index (phi) will be calculated and reported.
Reporting Name
p2PSA with Prostate Health Index, SSpecimen Type
Serum RedSpecimen Minimum Volume
0.75 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum Red | Frozen (preferred) | 150 days |
| Ambient | 24 hours | |
| Refrigerated | 24 hours |
Reject Due To
| Gross hemolysis | Reject |
| Gross icterus | Reject |
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 |
PERCENT 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% |
Method Description
Prostate-specific antigen:
The Access Hybritech PSA (prostate-specific antigen) assay is a 2-site immunoenzymatic ("sandwich") assay. A sample is added to mouse monoclonal anti-PSA alkaline phosphatase conjugate and paramagnetic particles coated with a second mouse monoclonal anti-PSA antibody. The PSA in the sample binds to the immobilized monoclonal anti-PSA on the solid phase, while the monoclonal anti-PSA alkaline phosphatase conjugate reacts with a different antigenic site on the sample PSA. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The chemiluminescent substrate Lumi-Phos* 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of PSA in the sample and is determined from a stored, multipoint calibration curve.(Package insert: Access Hybritech PSA/Prostate-Specific Antigen Instructions for Use. Beckman Coulter Inc; 08/2023)
Free PSA:
The Access Hybritech free PSA assay is a 2-site immunoenzymatic ("sandwich") assay. A sample is added to mouse monoclonal anti-free PSA-alkaline phosphatase conjugate and paramagnetic particles coated with a second mouse monoclonal anti-PSA antibody. The free PSA in the sample binds to the immobilized monoclonal anti-PSA on the solid phase, while the monoclonal anti-free PSA-alkaline phosphatase conjugate reacts with different antigenic sites on the free PSA molecule. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The chemiluminescent substrate Lumi-Phos* 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of free PSA in the sample and is determined from a stored, multi-point calibration curve.(Package insert: Access Free PSA Instructions for Use. Beckman Coulter Inc; 06/2020)
[-2]ProPSA (p2PSA):
The Access Hybritech p2PSA is a 2-site immunoenzymatic ("sandwich") assay. A sample is added to mouse monoclonal anti-PSA-alkaline phosphatase conjugate, paramagnetic particles coated with a mouse monoclonal anti-[-2]proPSA antibody, and a blocking reagent. The [-2]proPSA in the sample binds to the immobilized monoclonal anti-[-2]proPSA on the solid phase, while the monoclonal anti-PSA-alkaline phosphatase conjugate reacts with different antigenic sites on the [-2]proPSA molecule. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The chemiluminescent substrate Lumi-Phos* 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of [-2]proPSA in the sample and is determined from a stored, multi-point calibration curve.(Package insert: Access p2PSA/[-2]proPSA Instructions for Use. Beckman Coulter Inc; 10/2023)
Percent free PSA:
The free PSA concentration is divided by the total PSA to derive the percent free PSA. The percentage is provided only when the total PSA is in the range of 4.0 to 10.0 ng/mL.
Prostate health index:
Prostate health index (phi) is calculated in the laboratory information system and provided only when the total PSA is in the range of 4.0 to 10.0 ng/mL.
Specimen Retention Time
2 weeksPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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 | 53764-7 |
| 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 |
Day(s) Performed
Monday through Saturday