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Test Code LAB116 Prostate-Specific Antigen (PSA) Screen, Plasma or Serum

Reporting Title

PSA Screen

Methodology

Roche Diagnostics, Chemiluminescence Sandwich IA (ECLIA)- RMH, OBH, MGH and DMH, MH

Useful as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination in men ≥50 years.

Results from assays produced by different manufacturers may not be comparable

Useful For

Monitor is useful in evaluating patients with documented prostate problems in whom multiple prostate-specific antigen tests may be necessary per year Monitoring patients with a history of prostate cancer as an early indicator of recurrence and response to treatment

Performing Laboratory

OhioHealth Laboratory Services-RMH, MGH, MH Core Laboratories

Specimen Requirements

Due to interference, patients receiving high doses of biotin (>5 mg/day) should wait at least 8 hours after dose before having blood drawn.

 

Collection Instructions:

1. Serum and Plasma gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.

 

 

Submit only 1 of the following specimens:

 

Preferred:

Serum

Draw blood in a gold-top serum gel tube(s). Spin down and send 1 mL of serum refrigerated.
Note:

1. A speckled-top serum gel tube (s) or a plain, red-top tube(s) is also acceptable.

2. Draw specimen before biopsy, prostatectomy, or prostate massage since manipulation of prostate may lead to elevated PSA levels persisting up to 3 weeks.

3. Patients receiving therapy with mouse monoclonal antibodies may have erroneous results.

4. Indicate serum on request form.

5. Label specimen appropriately (serum).

 

Alternate: Preferred for Siemens Users

Plasma

Draw blood in a mint green-top (lithium heparin) gel tube(s) or a lavender-top (EDTA) tube(s). Spin down and send 1 mL of heparinized or EDTA plasma refrigerated.

Note:  1. Draw specimen before biopsy, prostatectomy, or prostate massage since manipulation of prostate may lead to elevated PSA levels persisting up to 3 weeks.

2. Patients receiving therapy with mouse monoclonal antibodies may have erroneous results.

3. Indicate plasma on request form.

4. Label specimen appropriately (plasma).

Specimen Stability Information

Specimen Type Temperature Time
Serum or plasma Refrigerated 5 days
  Ambient   
  Frozen  6 months

 

Specimen Transport Temperature

Ambient/Refrigerate/Frozen

Reference Values

TOTAL PSA- Recommended guidlines from the National Cancer Comprehensive Network (NCCN), 2016

PSA 0.00-0.99  ng/mL for ages ≤  75

PSA 0.00-3.00  ng/mL for ages >75

All PSA results will flag as high in men age 75 and younger with an interpretive comment based on age and PSA value. The comment will list the recommendation of the NCCN.

The new recommendations put forth by the NCCN are to obtain a baseline PSA level for men age 45-75. The frequency of subsequent screening is dictated by the baseline result.  If the result is <1.0 ng/mL, repeat testing every 2-4 years.  If the result is between 1.00-3.00 ng/mL, repeat testing every 1-2 years.  PSA values >3.00 ng/mL are considered positive regardless of age.  PSA testing in men over 75 should only be considered in very select patient.  Very few men in this age group benefit from PSA screening.

 

Serum concentrations should not be interpreted as absolute evidence for presence or absence of malignant disease, nor should PSA be used alone as a screening test for malignant disease. Elevated PSA can also be found in benign prostatic hyperplasia, inflammatory conditions of adjacent genitourinary tissue, and non-prostate carcinoma. Values may vary by method.

Note:  Specimen from patients who have had treatment with mouse monoclonal antibodies may show erroneous results.

Day(s) Test Set Up

Monday through Sunday

Test Classification and CPT Coding

84153 - PSA

G0103 - Medicare