Test Catalog

Test Id : PSAU

Prostate-Specific Antigen (PSA) Ultrasensitive, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring disease after radical prostatectomy

 

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

Method Name
A short description of the method used to perform the test

Electrochemiluminescent Immunoassay (ECLIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

PSA, Ultrasensitive, S

Aliases
Lists additional common names for a test, as an aid in searching

Post Prostatectomy

PSA, Third Generation

Ultrasensitive PSA

Specimen Type
Describes the specimen type validated for testing

Serum

Additional Testing Requirements

Free prostate-specific antigen (PSA) can be added on within 12 hours of performing this test. Specimen must have been shipped frozen. Call 800-533-1710 if wanting to order PSAFT / Prostate-Specific Antigen (PSA), Total and Free, Serum instead.

Necessary Information

Include patient's age.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring disease after radical prostatectomy

 

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Prostate-specific antigen (PSA) is the most widely used method to detect prostate cancer recurrence after radical prostatectomy (RP). Approximately 20% to 35% of patients develop a rising PSA following RP for clinically localized prostate cancer. Biochemical recurrence (BCR) is defined as an increase in PSA after curative therapy without clinical or radiological evidence of disease. The median time to BCR could vary between 2 to 3 years. A standard PSA cutpoint to indicate BCR has yet to be established. For example, the American Urological Association and the American Society for Radiation Oncology defined BCR after surgery as initial and confirmatory PSA concentrations of 0.2 ng/mL or greater. However, a BCR definition of 0.4 ng/mL PSA has also been proposed.

 

Assays that measure PSA to concentrations below 0.1 ng/mL are denoted ultrasensitive PSA (USPSA). The use of USPSA cutpoints below currently recommended PSA thresholds may be helpful in identifying cases of early biochemical recurrence and for selecting patients with adverse clinicopathologic risk factors for secondary therapy. However, some authors believe that USPSA assays offers minimal advantages and could lead to increased anxiety in patients who have clinically meaningless rises of PSA and might lead to overtreatment.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Males:

Age (years)

PSA upper limit (ng/mL)

<40

< or =2.0

40-49

< or =2.5

50-59

< or =3.5

60-69

< or =4.5

70-79

< or =6.5

> or =80

< or =7.2

 

Females: Not applicable

Interpretation
Provides information to assist in interpretation of the test results

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 (> or =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)

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Serum markers are not specific for malignancy, and values may vary by method.

 

When age is not supplied, the results cannot be flagged as high or low.

 

Digital rectal examination generally does not increase normal prostate-specific antigen (PSA) values. However, cystoscopy, urethral instrumentation, and prostate biopsy may increase PSA levels.

 

Some patients who have been exposed to animal antigens, either in the environment or as part of treatment or imaging procedure, may have circulating anti-animal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results.

 

No interference was observed from rheumatoid factors up to a concentration of 1500 IU/mL.

 

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

 

Serum biotin concentrations up to 1200 ng/mL do not interfere with this assay. Concentrations up to 1200 ng/mL may be present in specimens collected from patients taking extremely high doses of biotin up to 300 mg per day.(2) In a study among 54 healthy volunteers, supplementation with 20 mg/day biotin resulted in a maximum serum biotin concentration of 355 ng/mL 1 hour post-dose.(3)

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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 Feb;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 Aug;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 Aug;66(2):204-210. doi: 10.1016/j.eururo.2013.08.022

Method Description
Describes how the test is performed and provides a method-specific reference

The Roche Elecsys total PSA (prostate-specific antigen) assay is a sandwich electrochemiluminescence immunoassay that employs a biotinylated monoclonal PSA-specific antibody and a monoclonal PSA-specific antibody labeled with ruthenium complex. PSA in the specimen reacts with both the biotinylated monoclonal PSA-specific antibody (mouse) and the monoclonal PSA-specific antibody (mouse) labeled with a ruthenium, forming a sandwich complex. Streptavidin-coated microparticles are added and the mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured against a calibration curve to determine the amount of PSA in the patient specimen. This method has been standardized against the Reference Standard/WHO 96/670.(Package insert: Elecsys total PSA reagent. Roche Diagnostics; V 3.0 English, 02/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

12 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

84153

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
PSAU PSA, Ultrasensitive, S 35741-8
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
PSAU PSA, Ultrasensitive, S 35741-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports