Prostate Health Index

Also known as: PROST INDX

Clinical Use

Use

The Prostate Health Index (PHI) serves as an aid in differentiating prostate cancer from benign prostatic conditions in men 50 years and older who have a total PSA level between 4 and 10 ng/mL and non-suspicious digital rectal examination (DRE) findings. It provides a probability score indicating the likelihood of prostate cancer, with higher scores correlating with higher probabilities. Although PHI is used in cancer detection, a prostate biopsy remains necessary for definitive cancer diagnosis.

Special Instructions

Not provided.

Limitations

Results obtained through different assay methods or kits should not be used interchangeably. Testing is carried out with Beckman Coulter UniCel DxI 800 Access PSA, free PSA, and p2PSA assays with Hybritech calibration. This test cannot provide absolute evidence of the presence or absence of malignant prostate disease. Additionally, results when PSA levels fall below 4 ng/mL or exceed 10 ng/mL are limited as P Scores are unavailable because free PSA and p2PSA assays are not conducted in such scenarios.

Test Details

FDA Approved

New York Approved

Methodology

Immunoassay (CLIA)

Biomarkers

Free PSA

Analyte

Free PSA

Concentration / Level • Quantitative (Continuous) (e.g., copies/mL, % expression)

p2PSA

Analyte

p2PSA

Concentration / Level • Quantitative (Continuous) (e.g., copies/mL, % expression)

Total PSA

Analyte

Total PSA

Concentration / Level • Quantitative (Continuous) (e.g., copies/mL, % expression)

Result Turnaround Time

1-7 days

Specimen

Serum

Volume

1.5 mL

Minimum Volume

1.0 mL

Container

Serum separator tube (SST) or plain red

Collection Instructions

Separate serum from cells within 3 hours of collection. Allow the serum specimen to clot completely at room temperature. Transfer to an ARUP standard transport tube.

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.