Sign in →

Test Code PSAU Prostate-Specific Antigen (PSA) Ultrasensitive, Serum

Useful For

As an aid in the detection of prostate cancer when used in conjunction with a digital rectal exam in men ages 50 years and older

 

To aid in the prognosis and management of individuals diagnosed with prostate cancer

 

Monitoring disease after radical prostatectomy

 

This test should not be used for initial prostate cancer screening.

Method Name

Electrochemiluminescent Immunoassay (ECLIA)

Reporting Name

PSA, Ultrasensitive, S

Specimen Type

Serum
Beebe Healthcare Laboratory Services Note:

Collect in an SST


Ordering Guidance


Free prostate-specific antigen (PSA) can be added on within 72 hours of performing this test. Specimen must have been shipped frozen.

 

If both free and total PSA results are desired, order PSAFT / Prostate-Specific Antigen (PSA), Total and Free, Serum.



Additional Testing Requirements


 



Necessary Information


Include patient's age.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

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

2. Red-top tubes should be centrifuged, and the serum aliquoted into a plastic vial within 2 hours of collection.


Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 180 days
  Refrigerated  14 days
  Ambient  7 days

Reference Values

Males:

Age (years)

PSA upper limit (ng/mL)

<40

≤2.0

40-49

≤2.5

50-59

≤3.5

60-69

≤4.5

70-79

≤6.5

≥80

≤7.2

 

Females: Not applicable

Interpretation

An undetectable (<0.01 ng/mL) ultrasensitive prostate-specific antigen (USPSA) concentration after radical prostatectomy is reassuring and may aid in postoperative risk stratification of patients.

 

A detectable USPSA concentration (≥0.01 ng/mL) after radical prostatectomy (RP) does not necessarily translate into disease progression or recurrence. Interpretation of a detectable USPSA needs to be made in conjunction with other clinicopathologic risk factors. The cutpoint for interpretation of USPSA assays remains controversial and has ranged from 0.01 to 0.05 ng/mL. For example, in a study that included 754 men after RP, a cutpoint of 0.01 ng/mL was an independent predictor of biochemical recurrence (BCR). BCR-free survival at 5 years was 92.4% for patients with an USPSA post-RP of less than 0.01 ng/mL and 56.8% for patients with an USPSA post-RP of 0.01 ng/mL or higher.(1) In the same study a cutoff of 0.03 ng/ml also predicted BCR independent of clinicopathological factors and BCR-free survival at 5 yrs was 90.8% for patients with an USPSA post-RP of less than 0.03 ng/mL and 26.9% for patients with a PSA post-RP of greater or equal to 0.03 ng/mL.(1)

Clinical Reference

1. Sokoll LJ, Zhang Z, Chan DW, et al. Do ultrasensitive prostate specific antigen measurements have a role in predicting long-term biochemical recurrence-free survival in men after radical prostatectomy? J Urol. 2016;195(2):330-336. doi:10.1016/j.juro.2015.08.080

2. Saint Paul LP, Debruyne D, Bernard D, Mock DM, Defer GL. Pharmacokinetics and pharmacodynamics of MD1003 (high-dose biotin) in the treatment of progressive multiple sclerosis. Expert Opin Drug Metab Toxicol. 2016;12(3):324-344. doi:10.1517/17425255.2016.1136288

3. Grimsey P, Frey N, Bendig G, et al. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. J Pharmacokinet Pharmacodyn. 2017 Sept;2(4):247-256. doi:10.4155/ipk-2017-0013

4. Thompson IM, Valicenti RK, Albertsen P, et al. Adjuvant and salvage radiotherapy after prostatectomy: AUA/ASTRO guideline. J Urol. 2013;190(2):441-449. doi:10.1016/j.juro.2013.05.032

5. Mir MC, Li J, Klink JC, Kattan Mw, Klein EA, Stephenson A. Optimal definition of biochemical recurrence after radical prostatectomy depends on pathologic risk factors: Identifying candidates for early salvage therapy. Eur Urol. 2014;66(2):204-210. doi:10.1016/j.eururo.2013.08.022

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

84153

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PSAU PSA, Ultrasensitive, S 35741-8

 

Result ID Test Result Name Result LOINC Value
PSAU PSA, Ultrasensitive, S 35741-8