Prostate-Specific Antigen (PSA) Screen, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Monitoring patients with a history of prostate cancer as an early indicator of recurrence and response to treatment
Prostate cancer screening
Electrochemiluminescent Immunoassay (ECLIA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Prostate-Specific Ag Screen, S
Screen for Prostate Specific Ag
PSA (Prostate-Specific Antigen)
PSA (Prostate-Specific Antigen)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.6 mL
1. Free PSA can only be added on within 12 hours of performing total PSA. Specimen must have been shipped frozen.
2. Include patient's age.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Frozen (preferred)||180 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Prostate-specific antigen (PSA) is a glycoprotein that is produced by the prostate gland, the lining of the urethra, and the bulbourethral gland. Normally, very little PSA is secreted in the blood. Increases in glandular size and tissue damage caused by benign prostatic hypertrophy, prostatitis, or prostate cancer may increase circulating PSA levels.
In patients with previously diagnosed prostate cancer, PSA testing is advocated as an early indicator of tumor recurrence and as an indicator of response to therapy. The role of PSA in early detection of prostate cancer is controversial. The American Cancer Society recommends annual examination with digital rectal examination and serum PSA beginning at age 50, and also for those men with a life expectancy of at least 10 years after detection of prostate cancer. For men in high-risk groups, such as African Americans or men with a first-degree relative diagnosed at a younger age, testing should begin at a younger age. It is generally recommended that information be provided to patients about the benefits and limitations of testing and treatment so they can make informed decisions.
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.
PSA Upper Limit (ng/mL)
< or =2.0
< or =2.5
< or =3.5
< or =4.5
< or =6.5
> or =80
< or =7.2
Females: not applicable
Prostate-specific antigen (PSA) values are reported with the 95th percentile limits by decade of age. These reference limits include men with benign prostatic hyperplasia. They exclude all cases with proven cancer.
PSA values exceeding the age-specific limits are suspicious for prostate disease, but further testing, such as prostate biopsy, is needed to diagnose prostate pathology.
The minimal reporting value is 0.1 ng/mL. Values >0.2 ng/mL are considered evidence of biochemical recurrence of cancer in men after prostatectomy.
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.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Oesterling JE, Jacobsen SJ, Chute CG, et al: Serum Prostate-Specific Antigen in a Community-Based Population of Healthy Men. JAMA 1993 Aug 18;270:860-864
2. Smith RA, Cokkinides V, von Eschenbach A, et al: American Cancer Society Guidelines for the Early Detection of Cancer. CA Cancer J Clin 2002;52:8-22
3. Barry MJ, Albertsen PC, Bagshaw MA, et al: Outcomes for men with clinically nonmetastatic prostate carcinoma managed with radical prostatectomy, external beam radiotherapy, or expectant management: a retrospective analysis. Cancer 2001 June 15;91(12):2302-2314
4. Blute ML, Bergstralh EJ, Scherer BG, et al: Use of Gleason score, prostate specific antigen, seminal vesicle and margin status to predict biochemical failure after radical prostatectomy. J Urol 2001 January;165(1):119-125
Method Description Describes how the test is performed and provides a method-specific reference
Instrument used is Roche Cobas 6000 e601. The Elecsys Cobas Total PSA (prostate-specific antigen) method 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: Roche total PSA reagent, 07-2010. Roche Diagnostic Corp., Indianapolis, IN)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 5 a.m.-12 a.m., Saturday; 6 a.m.- 6 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|SPSA||Prostate-Specific Ag Screen, S||2857-1|