Test Id : AFP
Alpha-Fetoprotein (AFP) Tumor Marker, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
Follow-up management of patients undergoing cancer therapy, especially for testicular and ovarian tumors and for hepatocellular carcinoma
Often used in conjunction with human chorionic gonadotropin.(2)
This test is not recommended as a screening procedure for cancer detection in the general population.
This test is not intended for the detection of neural tube defects.
This test is not useful for patients with pure seminoma or dysgerminoma.
Method Name
A short description of the method used to perform the test
Immunoenzymatic Assay
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
AFP (Alpha-Fetoprotein)
Alpha Fetoprotein, Tumor Marker (AFP), Serum
Alpha-Fetoprotein (AFP)
Alpha-Fetoprotein Tumor Marker
Fetoprotein, Alpha
Tumor Marker, Alpha Fetoprotein, Serum
AFP Tumor Marker
Specimen Type
Describes the specimen type validated for testing
Serum
Ordering Guidance
This test is used as a tumor marker and is not intended for the detection of neural tube defects. For testing amniotic fluid specimens, order AFPA / Alpha-Fetoprotein, Amniotic Fluid.
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: 0.6 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Forms
If not ordering electronically, complete, print, and send Oncology Test Request (T729) with the specimen.
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.
0.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | 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 | Refrigerated (preferred) | 7 days | |
| Frozen | 90 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Follow-up management of patients undergoing cancer therapy, especially for testicular and ovarian tumors and for hepatocellular carcinoma
Often used in conjunction with human chorionic gonadotropin.(2)
This test is not recommended as a screening procedure for cancer detection in the general population.
This test is not intended for the detection of neural tube defects.
This test is not useful for patients with pure seminoma or dysgerminoma.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Alpha-fetoprotein (AFP) is a glycoprotein that is produced in early fetal life by the liver and by a variety of tumors including hepatocellular carcinoma, hepatoblastoma, and nonseminomatous germ cell tumors of the ovary and testis (eg, yolk sac and embryonal carcinoma). Most studies report elevated AFP concentrations in approximately 70% of patients with hepatocellular carcinoma. Elevated AFP concentrations are found in 50% to 70% of patients with nonseminomatous testicular tumors.(1)
Alpha-fetoprotein is elevated during pregnancy. Persistence of AFP in the mother following birth is a rare hereditary condition.(2) Neonates have markedly elevated AFP levels (>100,000 ng/mL) that rapidly fall to below 100 ng/mL by 150 days and gradually return to normal over their first year.(2)
Concentrations of AFP above the reference range also have been found in the serum of patients with benign liver disease (eg, viral hepatitis, cirrhosis), gastrointestinal tract tumors, and along with carcinoembryonic antigen, in ataxia telangiectasia.
The biological half-life of AFP is approximately 5 days.
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.
Reference values are for nonpregnant subjects only; fetal production of alpha-fetoprotein elevates values in pregnant women.
Range for newborns is not available, but concentrations over 100,000 ng/mL have been reported in normal newborns, and the values rapidly decline in the first 6 months of life.(See literature reference: Wu JT, Book L, Sudar K. Serum alpha fetoprotein (AFP) levels in normal infants. Pediatr Res. 1981;15(1):50-52) For further interpretive information, see Alpha-Fetoprotein (AFP).
Serum markers are not specific for malignancy, and values may vary by method.
Interpretation
Provides information to assist in interpretation of the test results
Alpha-fetoprotein (AFP) levels may be elevated in association with a variety of malignancies or benign diseases.
Failure of the AFP value to return to normal by approximately one month after surgery suggests the presence of residual tumor.
Elevation of AFP after remission suggests tumor recurrence; however, tumors originally producing AFP may recur without an increase in AFP.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This assay is intended only as an adjunct in the diagnosis and monitoring of alpha-fetoprotein (AFP)-producing tumors. The diagnosis should be confirmed by other tests or procedures.
Higher values are found in newborns and pregnant women.
In some immunoassays, the presence of unusually high concentrations of analyte may result in a high dose "hook" effect. This may result in a lower or even normal measured analyte concentration. If the reported result is inconsistent with the clinical presentation, the laboratory should be alerted for troubleshooting. For diagnostic purposes, these immunoassay results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings. For the Beckman Access AFP assay a hook effect is not expected up to 500,000 ng/mL. Concentrations greater than 500,000 ng/mL may result in a falsely low result.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Sturgeon CM, Duffy MJ, Stenman UH, et al. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers. Clin Chem. 2008;54(12):e11-e79
2. Blohm ME, Vesterling-Hörner D, Calaminus G, Göbel U. Alpha 1-fetoprotein (AFP) reference values in infants up to 2 years of age. Pediatr Hematol Oncol. 1998;15(2):135-142
3. Milose JC, Filson CP, Weizer AZ, Hafez KS, Montgomery JS. Role of biochemical markers in testicular cancer: diagnosis, staging, and surveillance. Open Access J Urol. 2011;4:1-8
4. Schefer H, Mattmann S, Joss RA. Hereditary persistence of alpha-fetoprotein. Case report and review of the literature. Ann Oncol. 1998;9(6):667-672
5. Adigun OO, Yarrarapu SNS, Zubair M, Khetarpal S. Alpha-Fetoprotein Analysis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; May 1, 2024.6. Glowska-Ciemny J, Szymanski M, Kuszerska A, Rzepka R, von Kaisenberg CS, Kocylowski R. Role of Alpha-Fetoprotein (AFP) in Diagnosing Childhood Cancers and Genetic-Related Chronic Diseases. Cancers (Basel). 2023;15(17):4302
Method Description
Describes how the test is performed and provides a method-specific reference
The test is performed on the Beckman Coulter UniCel DxI 800. The Beckman Coulter Access alpha-fetoprotein (AFP) immunoassay is a 2-site immunoenzymatic sandwich assay. A specimen is added to a reaction vessel with mouse monoclonal anti-AFP alkaline phosphatase conjugate, and paramagnetic particles coated with a second mouse monoclonal anti-AFP antibody. The AFP in the specimen binds to the immobilized monoclonal anti-AFP on the solid phase while, at the same time, the monoclonal anti-AFP-alkaline phosphatase conjugate reacts with different antigenic sites on the specimen AFP. After incubation in a reaction vessel, materials bound by the solid phase are held in a magnetic field while unbound materials are washed away. A chemiluminescent substrate is added to the reaction vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the amount of AFP in the specimen. The amount of analyte in the specimen is determined by means of a stored multipoint calibration curve.(Package insert: Access AFP. Beckman Coulter Inc.; 09/2024)
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 Friday, Sunday
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.
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- 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.
82105
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 |
|---|---|---|
| AFP | Alpha-Fetoprotein, Tumor Marker, S | 53962-7 |
| 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.
|
|---|---|---|
| AFP | Alpha-Fetoprotein, Tumor Marker, S | 53962-7 |