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Prostate-specific Antigen (PSA), Ultrasensitive

CPT: 84153
Updated on 01/29/2020
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Synonyms

  • PSA, Third Generation

Test Includes

Total PSA, ultrasensitive

Total PSA, ultrasensitive


Special Instructions

PSA sampling should not be performed for at least six weeks after prostatic biopsy. This test is intended for use as an aid in the management of patients following surgical or medical treatment for prostate cancer.

Values obtained with different assay methods should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor each patient's course of therapy. This procedure does not provide serial monitoring; it is intended for one-time use only. If serial monitoring is required, please use the serial monitoring number 140723 to order.

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.


Expected Turnaround Time

Within 1 day


Related Documents


Specimen Requirements


Specimen

Serum


Volume

0.8 mL


Minimum Volume

0.3 mL (Note: This volume does not allow for repeat testing.)


Container

Red-top tube or gel-barrier tube


Collection

If a red-top tube is used, transfer separated serum to a plastic transport tube.


Storage Instructions

Maintain specimen at room temperature.


Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

7 days

Frozen

14 days

Freeze/thaw cycles

Stable x3


Causes for Rejection

Citrate plasma specimen; improper labeling


Test Details


Use

Prostate-specific antigen (PSA) is a glycoprotein produced by the epithelial cells lining the prostatic ducts and acini. Normally, it is secreted into the prostatic ducts and is present only in prostate tissue, prostatic fluid, and seminal plasma. PSA is produced by normal, hyperplastic, and cancerous prostatic tissue. PSA is used as a tumor marker for the early detection of prostate cancer and in other areas of prostate disease management.1 The Prostate-Specific Antigen Best Practice Statement: 2009 Update1 published by the American Urologic Association describes the use of PSA testing for:

• The evaluation of men at risk for prostate cancer

• Assistance in pretreatment staging

• Risk assessment posttreatment monitoring

• Use as a guide in management of men who recur after primary or secondary therapy


Limitations

The measured PSA value of a patient's sample can vary depending on the testing procedure used.2 PSA values determined on patient samples by different test procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.2 Results cannot be interpreted as absolute evidence of the presence or absence of malignant disease.1 The PSA value should be used in conjunction with information from clinical evaluation and other diagnostic procedures.1

PSA levels can be elevated in patients with prostatitis.1 Treatment with antibiotics will decrease PSA by approximately 30% in men whose PSA elevation is due to prostatitis alone.1 PSA can also be increased in men with benign prostatic hyperplasia (BPH).1 PSA can be increased due to urethral or prostatic trauma.1 Prostate biopsy can cause substantial elevation of PSA levels.1 Cystoscopy may increase PSA levels immediately after testing.1 Ejaculation and DRE have been reported to increase PSA levels but studies have shown the effects to be variable or insignificant.1 PSA testing can be performed with reasonable accuracy after rectal examination.1

Surgical castration or medical castration (with LHRH-agonist or antiandrogen therapy) can lower PSA levels dramatically.1 Finasteride and dutasteride (5-α reductase inhibitors) can lower PSA levels by approximately 50% regardless of the dose.1 Prostatic intraepithelial neoplasia (PIN) does not increase PSA levels.1


Methodology

Electrochemiluminescence immunoassay (ECLIA)


Reference Interval

Male: 0.000−4.000 ng/mL (Note: This interval is not intended to be used as a reference for posttreatment follow-up and monitoring of patients.)

According to the American Urological Association (AUA), serum PSA should decrease and remain at undetectable levels after radical prostatectomy. The AUA defines biochemical recurrence as an initial PSA value ≥0.20 ng/mL followed by a subsequent confirmatory PSA value ≥0.20 ng/mL.


Footnotes

1. Prostate-Specific Antigen Best Practice Statement: 2009 Update, American Urologic Association. Available at:http://www.auanet.org/content/guideline-and-quality-care/clinical-guidelines/main-reports/psa09.pdf. Accessed March 3, 2011.7880240
2. Total PSA, 2007-09, V EN Elescys 1010/2010 and Modular Analytics E170, Indi package insert, Indianapolis, IN: Roche Diagnostics.10411025

References

Mohler J, Bahnson RR, Boston B, et al. NCCN clinical practice guidelines in oncology: Prostate cancer. J Natl Compr Canc Netw. 2010; 8(2):162-200.20141676

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
140731 PSA, Ultrasensitive W/O Serial 35741-8 140735 PSA, Ultrasensitive ng/mL 35741-8

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