Prostate-Specific Antigen, Total

Cleveland HeartLab Cancer, P, Test

NEW YORK DOH APPROVED: YES
CPT Code: 84153
Order Code: C154, C556, C512
ABN Requirement:  No
Synonyms: PSA; TPSA
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 at 1300 rcf 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, Inc. shipping box.

Stability:

Ambient (15-25°C): not acceptable
Refrigerated (2-8°C): 5 days
Frozen (-20°C): 6 months
Deep Frozen (-70°C): 6 months

Causes for Rejection: Samples which are heat-inactivated; specimens other than serum; improper labeling; samples not stored properly; samples older than stability limits

Methodology: Electrochemiluminescence Immunoassay (ECLIA)

Turn Around Time: 1 to 3 days

Reference Range:

Age ng/mL
All Ages ≤4.000

An interpretive comment is also attached to each result:

TPSA

Test Method: Roche Chemiluminescent Immunoassay:

<1.0 ng/mL TPSA: 8.8% Risk for Prostate Cancer

1.1-2.0 ng/mL TPSA: 17.8% Risk for Prostate Cancer

2.1-3.0 ng/mL TPSA: 23.9% Risk for Prostate Cancer

3.1-4.0 ng/mL TPSA: 26.9% Risk for Prostate Cancer

4.1-10.0 ng/mL TPSA: >27% Risk for Prostate Cancer

>10.0 ng/mL TPSA: >50% Risk for Prostate Cancer

Thompson et al. New Engl J Med. 2004;350:2239

Presti et al. J Urol. 2003;169:125

Use: The total PSA test is used for the evaluation and monitoring of patients with prostatic carcinoma.

Limitations: In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.