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Beaumont Laboratory

Total Prostate Specific Antigen (tPSA)

PSA (Total), Prostate Specific Antigen, Total (tPSA), Screening: EPIC: LAB5106, SOFT: PSAS, Diagnostic: EPIC: LAB5105, SOFT: PSAD

Instructions

  • Prostate Specific Antigen, Screening, is restricted to one order per patient every 365 days.
  • Prostate Specific Antigen, Diagnostic, can be ordered as medically necessary.

Specimen Collection Criteria

Collect: One Gold-top SST tube.

Contact the Laboratory for acceptability of other tube types.

Physician Office/Drawsite Specimen Preparation

Let SST specimens clot 30-60 minutes then immediately centrifuge to separate serum from cells. Refrigerate (2-8°C or 36-46°F) the centrifuged SST tube within two hours of collection. (Min: 1.0 mL)

Preparation for Courier Transport

Transport: Centrifuged SST tube, refrigerated (2-8°C or 36-46°F). (Min: 1.0 mL)

Rejection Criteria

  • Plasma specimens.
  • Hemolyzed specimens.
  • Severely lipemic specimens.
  • Red-top tubes with serum not separated from cells within two hours of collection.

Storage

Specimen Stability for Testing:

Centrifuged SST Tubes and Microtainers® with Separator Gel
Room Temperature (20-26°C or 68-78.8°F): 8 hours
Refrigerated (2-8°C or 36-46°F): 5 days
Frozen (-20°C/-4°F or below): Unacceptable

Red-top Tubes and Microtainers® without Separator Gel
Room Temperature (20-25°C or 68-77°F): 2-4 hours
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Serum Specimens (Pour-Overs)
Room Temperature (20-26°C or 68-78.8°F): 8 hours
Refrigerated (2-8°C or 36-46°F): 5 days
Frozen (-20°C/-4°F or below): 7 days

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Farmington Hills Chemistry Laboratory.
Grosse Pointe Chemistry Laboratory.
Royal Oak Automated Chemistry Laboratory.
Troy Chemistry Laboratory.

Performed

Sunday - Satuday, 24 hours a day.
Results available within 24 hours of receipt in the Laboratory.

Reference Range

Less than or equal to 2.50 ng/mL.

Test Methodology

Chemiluminescence Immunoassay.

Interpretation

  • Using a tPSA cut-off value of 4.00 ng/mL, one achieves a sensitivity of 78% and a specificity of 60% for cancer detection. Lowering the PSA threshold to 2.50 ng/mL may increase the rate of cancer detection in men younger than 60 years of age with little loss in specificity.
  • The Percent Complexed PSA (%cPSA) is the most recent of five different approaches being used to improve the ability of PSA to detect early prostate cancer:
    1. Age-Specific Reference Ranges: The lab has not established age related cut-offs for our tPSA assay.
    2. tPSA Density: TPSA Serum value is divided by the prostatic volume determined by transrectal ultrasonography (TRUS). Patients with tPSA values between 4.00-10.00 ng/mL, negative digital rectal examination (DRE), and tPSA density greater than 0.15 have increased risk of prostate cancer.
    3. tPSA Velocity: A baseline tPSA value is established and the rate of increase of tPSA calculated. An average rate of 0.75 ng/mL/yr increased the specificity of tPSA to differentiate prostate cancer from BPH to 90%.
    4. Percent Free PSA: The %fPSA test order, which included a tPSA, was performed only when the tPSA was between 4.00 and 10.00 ng/mL. Our research data suggests Beaumont patients with %fPSA values above 24% had a 1 in 10 chance of having a positive biopsy. Percent free PSA is now calculated (100 - %cPSA).
    5. Percent Complexed PSA (%cPSA): Recent studies suggest:
      • For patients with a tPSA of 2.50-10.00 ng/mL, the %cPSA (greater than 76%) may improve the sensitivity of tPSA for prostate cancer detection and eliminate unnecessary biopsies.
      • For patients with a tPSA of 2.50-4.00 ng/mL, a cPSA cut-off of 2.20 ng/mL results in 92% sensitivity and 42% specificity for prostate cancer detection.

Clinical Utility

  • PSA is a serine protease (Kalikrein family) produced by epithelial cells of the acini and ducts of prostate gland. Normally, very little PSA is secreted into the blood. Increased PSA levels may be due to increases in glandular size and tissue damage caused by benign prostatic hypertrophy, prostatitits, and/or prostate cancer. The tPSA assay is used to monitor patients with a history of prostate cancer, both as an indicator of tumor recurrence and response to therapy.
  • The American Cancer Society recommends annual examination with digital rectal examination (DRE) and serum tPSA beginning at age 50 for men with a life expectancy of at least 10 years after detection, Men in a high risk group (African Americans) or those with strong familial predisposition, testing may begin at a younger age.

CPT Code

Screening: G0103, Diagnostic: 84153.

Test Codes

Screening: EPIC: LAB5106, SOFT: PSAS, Diagnostic: EPIC: LAB5105, SOFT: PSAD

Last Updated

12/06/2017

Microtainer® and Vacutainer® are registered trademarks of Becton, Dickinson and Company.
UroVysion® is a registered trademark of Abbott Laboratories. ThinPrep® is a registered trademark of Hologic, Incorporated.

This directory currently reflects information only for specimens collected and/or processed at the Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.