Prostate Specific Antigen, Free, and %Free (calculated)

Cleveland HeartLab Cancer, P, Test

NEW YORK DOH APPROVED: YES
CPT Code: 84154
Order Code: Panel code: C556
ABN Requirement:  No
Synonyms: FPSA; PSA-free; % FPSA
Specimen: Serum
Volume: 0.5 mL
Minimum Volume: 0.2 mL
Container: Gel-barrier tube (SST, Tiger Top)

Collection:

  1. Collect and label sample according to standard protocols.
  2. Gently invert tube 5 times immediately after draw. DO NOT SHAKE.
  3. Allow blood to clot 30 minutes.
  4. Centrifuge for 10 minutes.

Special Instructions: Samples should not be taken from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last dose. Samples should be collected prior to a patient receiving a digital rectal exam.

Transport: Store serum at 2°C to 8°C after collection and ship the same day per packaging instructions provided with the Cleveland HeartLab shipping box.

Stability:

Ambient (15-25°C): not acceptable
Refrigerated (2-8°C): 5 days
Frozen (-20°C): 3 months
Deep Frozen (-70°C): 3 months

Causes for Rejection: Specimens other than serum; improper labeling; samples not stored properly; samples older than stability limits

Methodology: Electrochemiluminescence Immunoassay (ECLIA)

Turn Around Time: 1 to 5 days

Reference Range: The reference range listed is in terms of %Free PSA is attached to each result as an interpretive comment:

FPSA

Test Method: Roche Chemiluminescent Immunoassay for Total PSA 4.0-10.0 ng/mL:

>25% Free PSA – 8% Risk for Prostate Cancer

20-25% Free PSA – 16% Risk for Prostate Cancer

15-20% Free PSA – 20% Risk for Prostate Cancer

10-15% Free PSA – 28% Risk for Prostate Cancer

0-10% Free PSA – 56% Risk for Prostate Cancer

Catalona et al. JAMA. 1998; 279:1542.

Use: A free PSA test, in conjunction with total PSA, is used as an aid in distinguishing prostate cancer from a benign prostate condition and to monitor the efficacy of treatment for prostate cancer.

Limitations: Flutamide at therapeutic dosage levels resulted in slightly decreased fPSA results. In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur. A digital rectal exam can cause a temporary increase in PSA levels. Vigorous exercise that affects the prostate, such as bike riding, and ejaculation may also lead to a temporary rise in PSA levels. Chemotherapeutic drugs may affect PSA levels.

Additional Information: If the PSA test result is high, it should be repeated 6 weeks and 3 months later, as other prostate conditions can cause a transient increase in PSA levels.

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.