Prostate-Specific Antigen (PSA), Total
Label Mnemonic: PSA
Epic code: LAB116
Order form: Laboratory Requisition
Supply order: Supply Order Form
Billing: Billing Policies
CPT code: 84153
Specimen(s):
Plasma
Collection Medium:
Plasma Separator Tube 4.5 mL
Alternate Collection Media:
Call laboratory for additional acceptable specimen collection containers.
Minimum:
3 mL whole blood in light green top tube or TWO Microtainer® devices.
Testing Schedule:
24 hrs/day, 7 days a week, including holidays.
Turn Around Time:
1 hour (upon receipt in laboratory)
Reference Range:
   Age     Reference Range
Up to 50   0.00-2.50 ng/mL
50 - 59    0.00-3.50 ng/mL
60 - 69    0.00-4.50 ng/mL
> 70       0.00-6.50 ng/mL

Age specific normal values from the literature for PSA are provided as 
a guide only.  No one decision level is appropriate when utilizing PSA 
in screening situation.  Age, family history, previous values, and 
other factors should be used in decisions involving PSA values.
Comments:
Assay updated with increased tolerance to biotin on 11/9/21.

Prostate-Specific Antigen (PSA) measurement used in conjunction with Digital Rectal Exam (DRE) is indicated as an aid for the detection of prostate cancer in men aged 50 years or older. It is also useful in monitoring patients with known prostate cancer. PSA is specific to the prostate gland and is present in normal, hyperplastic and neoplastic prostatic epithelium. Serum elevations are detected in not only prostate carcinoma, but also in benign prostatic hypertrophy and inflammatory conditions of the prostate and adjacent genitourinary tissues. Diagnosis of prostate cancer requires biopsy and histopathologic examination.

Please print, complete and submit the Advance Beneficiary Notice (ABN) along with the Laboratory Requisition before shipping the specimen.
Test Limitations:
The assay is unaffected by icterus (bilirubin < 65 mg/dL), 
hemolysis (Hb is less than 2200 mg/dL), lipemia (Intralipid is less 
than 1500 mg/dL) and biotin is less than 1200 ng/mL (criterion: recovery within plus or minus 10% of initial value).

No interference was observed from rheumatoid factor (up to 1,500 
IU/mL).

There is no high-dose hook effect at tPSA concentrations up to 17,000 
ng/mL.

In vitro tests were performed on 28 commonly used pharmaceuticals. No 
interference with the assay was found.

As with all tests containing monoclonal mouse antibodies, erroneous 
findings may be obtained from samples taken from patients who have 
been treated with monoclonal mouse antibodies or have received them 
for diagnostic purposes. Elecsys total PSA contains additives which 
minimize these effects.

In rare cases, interference due to extremely high titers of antibodies 
to streptavidin can occur.

It is known that in rare cases PSA isoforms do exist which may be 
measured differently by different PSA tests. Findings of this kind 
have occasionally been reported for PSA tests from various 
manufacturers.(1-3)

For diagnostic purposes, the total PSA findings should always be 
assessed in conjunction with the patient's medical history, clinical 
examination and other findings.

(1) Van Duijnhoven HLP, Perqueriauz NCV, van Zon JPHM, Blankenstein MA.
    Large discrepancy between prostate specific antigen results from
    different assays during longitudinal followup of a prostate cancer
    patient. Clin Chem 1996;42:637-641.

(2) Wians FH. The "Correct" PSA Concentration. Clin Chem
    1996;42:1882-1885

(3) Cohen RJ, Haffejee Z, Steele GS, Nayler SJ. Advanced Prostate
    Cancer With Normal Serum Prostate-Specific Antigen Values. Arch
    Pathol Lab Med 1994;118:1123-1126.
Methodology:
Electrochemiluminescence Immunoassay
Sample Processing:
Centrifuge at a speed and time necessary to get barrier separation of plasma/serum and cells.
Each sample must be labeled with at least TWO full patient identifiers (First/Last Name & DOB are sufficient for non-UIHC affiliated clients) to avoid sample rejection/delays.
Sample Storage:
Refrigerate.
All sample storage requirements are intended for delivery to UIHC within 24 hours of collection for testing. If samples won't arrive in this time period, please call the UIHC Core Lab for alternative storage/shipping instructions (319-356-3527).
Transport Instructions:
Place labeled specimen into zip-lock type biohazard bag; seal bag.
Place completed requisition into outside pocket of bag.
Transport in cooler with refrigerated coolant packs.
CPT Code:
84153