Alpha-Fetoprotein (AFP) L3% and Total, Hepatocellular Carcinoma Tumor Marker, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Distinguishing between hepatocellular carcinoma and chronic liver disease
Monitoring individuals with hepatic cirrhosis from any etiology for progression to hepatocellular carcinoma
Surveillance for development of hepatocellular carcinoma in individuals with a positive family history of hepatic cancer
Surveillance for development of hepatocellular carcinoma in individuals within specific ethnic and gender groups who do not have hepatic cirrhosis, but have a confirmed diagnosis of chronic infection by hepatitis B acquired early in life including:
-African males above the age of 20
-Asian males above the age of 40
-Asian females above the age of 50
Isotachophoresis with Laser-Induced Fluorescence
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
AFP-L3% and Total AFP, S
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: 0.5 mL
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)||90 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Worldwide, hepatocellular carcinoma is the third leading cause of death from cancer.(1) While hepatocellular carcinoma can be treated effectively in its early stages, most patients are not diagnosed until they are symptomatic and at higher grades and stages, which are less responsive to therapies. Alpha-fetoprotein (AFP) is the standard serum tumor marker utilized in the evaluation of suspected hepatocellular carcinoma. However, increased serum concentrations of AFP might be found in chronic hepatitis and liver cirrhosis, as well as in other tumor types (eg, germ cell tumors), decreasing the specificity of AFP testing for hepatocellular carcinoma. Furthermore, AFP is not expressed at high levels in all hepatocellular carcinoma patients, resulting in decreased sensitivity, especially in potentially curable small tumors.
AFP is differentially glycosylated in several hepatic diseases. For example, UDP-alpha-1-->6-fucosyltransferase is differentially expressed in hepatocytes following malignant transformation.(3) This enzyme incorporates fucose residues on the carbohydrate chains of AFP. Different glycosylated forms of AFP can be recognized following electrophoresis by reaction with different carbohydrate-binding plant lectins. The fucosylated form of serum AFP that is most closely associated with hepatocellular carcinoma is recognized by a lectin from the common lentil (Lens culinaris). This is designated as AFP-L3 (third electrophoretic form of lentil lectin-reactive AFP). AFP-L3 is most useful in the differential diagnosis of individuals with total serum AFP < or =200 ng/mL, which may result from a variety of benign pathologies, such as chronic liver diseases.
AFP-L3 should be utilized as an adjunct to high-resolution ultrasound for surveillance of individuals at significant risk for developing hepatic lesions, as described below.
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.
Alpha-fetoprotein (AFP)-L3 > or =10% is associated with a 7-fold increased risk of developing hepatocellular carcinoma. Patients with AFP-L3 > or =10% should be monitored more intensely for evidence of hepatocellular carcinoma according to current practice guidelines.
Total serum AFP >200 ng/mL is highly suggestive of a diagnosis of hepatocellular carcinoma. In patients with liver disease, a total serum AFP of >200 ng/mL is near 100% predictive of hepatocellular carcinoma. With decreasing total AFP levels, there is an increased likelihood that chronic liver disease, rather than hepatocellular carcinoma, is responsible for the AFP elevation.
Based on a retrospective study at the Mayo Clinic, for patients with total AFP levels < or =200 ng/mL, AFP-L3 specificity approaches 100% for hepatocellular carcinoma when its percentage exceeds 35% of the total AFP.(4)
AFP concentrations over 100,000 ng/mL have been reported in normal newborns, and the values rapidly decline in the first 6 years of life.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Tumor marker tests are not specific for diagnosis of malignancy. Some hepatocellular tumors do not synthesize alpha-fetoprotein (AFP). AFP or AFP-L3 should, therefore, not be relied upon alone. Concomitant clinical assessment or imaging is recommended in hepatocellular carcinoma surveillance of high-risk patients and for hepatocellular carcinoma diagnosis.
Test results for AFP are not interpretable if the patient is pregnant.
Values obtained with different assay methods or kits cannot be used interchangeably. The total AFP test value must be obtained using this method (uTASWako i30 AFP-L3 kit) in order to determine the percent AFP-L3. Mayo Medical Laboratories’ other AFP tumor marker test, AFP / Alpha-Fetoprotein (AFP) Tumor Marker, Serum; is not suitable for use with AFP-L3 values.
Heterophilic antibodies may be present in the serum of some individuals, which may falsely lower or increase the apparent concentration of AFP or AFP-L3.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Okuda K: Hepatocellular carcinoma. J Hepatol 2000;32(Suppl 1):225-237
2. Kawai K, Kojima T, Miyanaga N, et al: Lectin-reactive alpha-fetoprotein as a marker for testicular tumor activity. Int J Urol 2005;12:284-289
3. Noda K, Miyoshi E, Kitada T, et al: The enzymatic basis for the conversion of nonfucosylated to fucosylated alpha-fetoprotein by acyclic retinoid treatment in human hepatoma cells: Activation of alpha 1-6 fucosyltransferase. Tumor Biol 2002;23:202-211
4. Leerapun A, Suravarapu S, Bida JP, et al: The utility of serum AFP-L3 in the diagnosis of hepatocellular carcinoma: Evaluation in a U.S. referral population. Clin Gastroenterol Hepatol 2007;5(3):394-402
5. Package insert: LBA AFP-L3, Wako Diagnostics, Richmond, VA. 06.1.24K02
6. Wako Pure Chemical Industries, Ltd. Specimen Stability Bulletin, March 22, 2006
Method Description Describes how the test is performed and provides a method-specific reference
Total alpha-fetoprotein (AFP) is measured by laser-induced fluorescence, with separation of the lentil lectin-reactive AFP-L3 and lectin nonreactive forms of AFP by isotachophoresis of their immune-complexes. Results are expressed as the percent ratio of AFP-L3 to total AFP.(Package insert: uTASWako i30 AFP-L3, Wako Diagnostics, Richmond, VA)
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, Wednesday, Friday; 10 a.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
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|
|TAFP||Total AFP, S||1834-1|