Test Id : PSAFT
Prostate-Specific Antigen (PSA), Total and Free, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
As an aid in distinguishing prostate cancer from benign prostatic conditions in men aged 50 years and older with total PSA between 4.0 and 10.0 ng/mL with digital rectal examination findings that are not suspicious for cancer
Highlights
In individuals with a total prostate-specific antigen (PSA) concentration between 4.0 and 10.0 ng/mL, free PSA:total PSA ratio could help determine the relative risk of prostate cancer. The lower the free PSA:total PSA ratio, the higher the risk of prostate cancer.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Total prostate-specific antigen (PSA) and free PSA are performed and reported on every specimen.
If the initial total PSA concentration is between 4.0 and 10.0 ng/mL, then the percent free PSA result will be calculated and reported.
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Free PSA
PSA (Prostate-Specific Antigen)
PSA Free/Total Ratio
PSA Total and Free
PSA Ratio
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Total prostate-specific antigen (PSA) and free PSA are performed and reported on every specimen.
If the initial total PSA concentration is between 4.0 and 10.0 ng/mL, then the percent free PSA result will be calculated and reported.
Specimen Type
Describes the specimen type validated for testing
Serum
Ordering Guidance
This test may be ordered for patients undergoing evaluation of suspicion of prostate cancer, or for assessing the risk of prostate cancer in patients with borderline or moderately increased total prostate-specific antigen (4.0-10.0 ng/mL).
Necessary Information
Include patient's age.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial within 3 hours of collection.
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-General Request (T239)
-Oncology Test Request (T729)
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
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 | Reject |
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) | 90 days | |
| Refrigerated | 72 hours |
Useful For
Suggests clinical disorders or settings where the test may be helpful
As an aid in distinguishing prostate cancer from benign prostatic conditions in men aged 50 years and older with total PSA between 4.0 and 10.0 ng/mL with digital rectal examination findings that are not suspicious for cancer
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Total prostate-specific antigen (PSA) and free PSA are performed and reported on every specimen.
If the initial total PSA concentration is between 4.0 and 10.0 ng/mL, then the percent free PSA result will be calculated and reported.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Prostate-specific antigen (PSA) is a glycoprotein 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.
PSA exists in serum in multiple forms: complexed to alpha-1-anti-chymotrypsin (PSA-ACT complex), unbound (free PSA), and enveloped by alpha-2-macroglobulin (not detected by immunoassays).
Higher total PSA levels and lower percentages of free PSA are associated with higher risks of prostate cancer.
Most prostate cancers are slow growing, so the utility of prostate cancer screening is marginal in most men with a life expectancy of less than 10 years.
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.
TOTAL PROSTATE-SPECIFIC ANTIGEN (PSA)
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
FREE PSA:TOTAL PSA
Males:
When Total PSA concentration is in the range of 4.0-10.0 ng/mL:
| Probability of cancer | |||
| Free PSA/total PSA ratio | 50-59 years | 60-69 years | > or =70 years |
| < or =0.10 | 49% | 58% | 65% |
| 0.11-0.18 | 27% | 34% | 41% |
| 0.19-0.25 | 18% | 24% | 30% |
| >0.25 | 9% | 12% | 16% |
Females: Not applicable
Interpretation
Provides information to assist in interpretation of the test results
When total prostate-specific antigen (PSA) concentration is below 2.0 ng/mL, the probability of prostate cancer in asymptomatic men is low, further testing and free PSA may provide little additional information. When total PSA concentration is above 10.0 ng/mL, the probability of cancer is high and prostate biopsy is generally recommended.
The total PSA range of 4.0 to 10.0 ng/mL has been described as a diagnostic "gray zone," in which the free PSA:total PSA ratio helps to determine the relative risk of prostate cancer (see table). Therefore, some urologists recommend using the free PSA:total ratio to help select which men should undergo biopsy. However, even a negative result of prostate biopsy does not rule-out prostate cancer. Up to 20% of men with negative biopsy results have subsequently been found to have cancer.
Based on free PSA:total PSA ratio: the percent probability of finding prostate cancer on a needle biopsy by age in years:
| Free PSA:total PSA ratio | 50-59 years | 60-69 years | 70 years and older |
| < or =0.10 | 49% | 58% | 65% |
| 0.11-0.18 | 27% | 34% | 41% |
| 0.19-0.25 | 18% | 24% | 30% |
| >0.25 | 9% | 12% | 16% |
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Normal results do not eliminate the possibility of prostate cancer.
Values obtained with different assay methods or kits may be different and cannot be used interchangeably.
Tumor markers are not specific for malignancy. Test results cannot be interpreted as absolute evidence for the presence or absence of malignant disease.
Specimens collected from patients undergoing prostate manipulation, especially needle biopsy and transurethral resection, may show erroneously high prostate-specific antigen (PSA) results. Care should be taken that specimens are obtained before these procedures are performed.
Prostate cancer patients receiving treatment with antiandrogens and luteinizing hormone-releasing factor agonists may exhibit markedly decreased levels of PSA. Also, men treated for benign prostatic hyperplasia with inhibitors of 5-alpha-reductase (finasteride) may demonstrate a significant reduction in PSA levels compared to values before treatment. Care should be taken in interpreting values for these individuals.
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.(1) 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.(2)
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. The presence of antibodies to streptavidin or ruthenium can also rarely occur and may interfere in this assay. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. 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):327-344. doi:10.1517/17425255.2016.1136288
2. 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. Int J Pharmacokinet. 2017 Sept;2(4):247-256. doi:10.4155/ipk-2017-00131.
3. Catalona WJ, Smith DS, Wolfert RL, et al. Evaluation of percentage of free serum prostate-specific antigen to improve specificity of prostate cancer screening. JAMA. Oct:274(15);214-1220
4. Oesterling JE, Jacobsen SJ, Klee GG, et al. Free, complexed and total serum prostate specific antigen: the establishment of appropriate reference ranges for their concentrations and ratios. J Urol. 1995 Sep;154(3):1090-1095. doi:10.1016/s0022-5347(01)66984-2
5. Duffy MJ. Biomarkers for prostate cancer: prostate-specific antigen and beyond. Clin Chem Lab Med. 2020 Feb 25;58(3):326-339. doi: 10.1515/cclm-2019-0693
6. Catalona WJ: Prostate cancer screening. Med Clin North Am. 2018 Mar;102(2):199-214. doi:10.1016/j.mcna.2017.11.001
7. Catalona WJ, Smith DS, Wolfert RL, et al. Evaluation of percentage of free serum prostate-specific antigen to improve specificity of prostate cancer screening. JAMA. 1995:274(15);214-1220
8. Ilic D, Djulbegovic M, Jung JH, et al. Prostate cancer screening with prostate-specific antigen (PSA) test: a systematic review and meta-analysis. BMJ. 2018;362:k3519. doi:10.1136/bmj.k3519
Method Description
Describes how the test is performed and provides a method-specific reference
Total prostate-specific antigen:
The Roche Elecsys total prostate-specific antigen (PSA) assay is a sandwich electrochemiluminescent 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 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., Roche Diagnostics; V 2.0, 06/2023)
Free PSA:
The Roche Elecsys free PSA assay is a sandwich electrochemiluminescent immunoassay that employs a biotinylated monoclonal PSA-specific antibody and a monoclonal PSA-specific antibody labeled with ruthenium complex. Free 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 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 free PSA in the patient specimen. This method has been standardized against the Reference Standard/WHO 96/668.(Package insert: Elecsys Free PSA reagent, Roche Diagnostics; V 2.0, 06/2023)
Free PSA:Total PSA Ratio:
The free PSA concentration is divided by the total PSA to derive the free:total ratio. The PSA, total and free test provides a free PSA measurement on every specimen, however, because very high or low total PSA measurements are predictive in themselves, a ratio is provided only when the total PSA is in the range of 4.0 to 10.0 ng/mL.
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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 Saturday
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.
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
Indicates the location of the laboratory that performs the test
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 account representative. 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.
CPT codes are provided by the performing laboratory.
84153
84154
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 |
|---|---|---|
| PSAFT | PSA Total and Free, S | 53764-7 |
| 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.
|
|---|---|---|
| TPSA | Total PSA | 83112-3 |
| FPSA | Free PSA | 83113-1 |
| PSA_R | Free PSA/PSA Ratio | 12841-3 |