Ordering Recommendation

Beckman Coulter phi is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA {>=}4.0 to {<=}10.0 ng/mL, and digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.

Mnemonic
PROST INDX
Methodology

Quantitative Chemiluminescent Immunoassay

Performed

Mon

Reported

Within 24 hours

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation

Specimens for testing must be drawn prior to prostate manipulations such as digital rectal examination (DRE), prostatic massage, transrectal ultrasound (TRUS), and prostatic biopsy.

Collect

Serum Separator Tube (SST) or Plain Red

Specimen Preparation

Separate serum from cells within 3 hours of collection. Allow serum specimen to clot completely at room temperature. Transfer 1.5 mL serum to an ARUP Standard Transport Tube (Min: 1.0 mL)

Storage/Transport Temperature

Critical Frozen

Unacceptable Conditions

Plasma

Remarks
Stability

After separation from cells: Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 5 Months

Reference Interval

By Report

Interpretive Data

The Prostate Health Index (P Score) is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL, and with digital rectal examination findings that are not suspicious for cancer. The P Score may also be used to determine the probability of prostate cancer on biopsy for an individual patient. Higher P Scores are associated with higher probability of prostate cancer. Prostatic biopsy is required for diagnosis of cancer.

Testing is performed with Beckman Coulter UniCel DxI 800 Access PSA, free PSA, and p2PSA assays using Hybritech calibration. Results obtained with different assay methods or kits cannot be used interchangeably. Results cannot be interpreted as absolute evidence of the presence or absence of malignant disease.


Probability of prostate cancer on biopsy based on P Score in patients with PSA between 4 and 10 ng/mL
Prostate Health Index (P Score) Probability of Cancer (percent) 95 percent 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 and greater 50.1 39.8-61.0
When total PSA is 10 ng/mL, free PSA and p2PSA assays are not performed. P Scores are therefore not available in that scenario.

When PSA is between 4 and 10 ng/mL, percent free PSA is also calculated.
The probability of prostate cancer for men with non-suspicious digital rectal exam (DRE) results and PSA between 4 and 10 ng/ml by patient age based on percent free PSA
Percent free PSA Probability of Cancer for Ages 50-64 years Probability of Cancer for Ages 65-75 years
0-10 56 55
11-15 24 35
16-20 17 23
21-25 10 20
Greater than 25 5 9

No compliance statements are in use for this test.

Note

If the Total PSA result is in the range of 4 to 10 ng/mL, then free PSA and p2PSA along with calculation of the free PSA percent and a P Score will be added. Additional charges will apply.

Hotline History
N/A
CPT Codes

84153, if reflexed add 84154; 86316

Components
Component Test Code* Component Chart Name LOINC
3000518 Total PSA
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Phi
Prostate Health Index