Distinguishing between hepatocellular carcinoma and chronic liver
Monitoring individuals with hepatic cirrhosis from any etiology for
Surveillance for development of hepatocellular carcinoma in
Surveillance for development of hepatocellular carcinoma in
-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
Serum
Collection Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
-Oncology Test Request (T729)
0.2 mL
Gross hemolysis | Reject |
Gross lipemia | OK |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum | Frozen (preferred) | 90 days | |
Refrigerated | 5 days |
Distinguishing between hepatocellular carcinoma and chronic liver
Monitoring individuals with hepatic cirrhosis from any etiology for
Surveillance for development of hepatocellular carcinoma in
Surveillance for development of hepatocellular carcinoma in
-African males above the age of 20
-Asian males above the age of 40
-Asian females above the age of 50
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),(2) 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, uridine diphosphate (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, which 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 of 200 ng/mL or below, 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.
TOTAL AFP:
<4.7 ng/mL
%L3:
<10%
Alpha-fetoprotein (AFP)-L3 results of 10% or above are associated with a 7-fold increased risk of developing hepatocellular carcinoma. Patients with AFP-L3 at this level should be monitored more intensely for evidence of hepatocellular carcinoma according to current practice guidelines.
A total serum AFP above 200 ng/mL is highly suggestive of a diagnosis of hepatocellular carcinoma. In patients with liver disease, a total serum AFP at this level 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.
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.
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 Clinic 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.
1. Kawai K, Kojima T, Miyanaga N, et al: Lectin-reactive alpha-fetoprotein as a marker for testicular tumor activity. Int J Urol 2005 Mar;12(3):284-289
2. 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 Jul-Aug;23(4):202-211
3. 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 Mar;5(3):394-402
4. Chaiteerakij R, Addissie BD, Roberts LR: Update on biomarkers of hepatocellular carcinoma. Clin Gastroenterol Hepatol 2015 Feb;13(2):237-245. doi: 10.1016/j.cgh.2013.10.038
5. Johnson P, Pirrie S, Cox T, et al: The detection of hepatocellular carcinoma using a prospectively developed and validated model based on serological biomarkers. Cancer Epidemiol Biomarkers Prev 2014 Jan;23(1):144-153. doi: 10.1158/1055-9965.EPI-13-0870
6. Yang JD, Addissie BD, Mara KC, et al: GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score. Cancer Epidemiol Biomarkers Prev 2019 Mar;28(3):531-538. doi: 10.1158/1055-9965
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 18.07.18K13. Wako Diagnostics 07/2018)
Monday, Wednesday, Friday
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.
82107
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
L3AFP | AFP-L3% and Total AFP, S | 96451-0 |
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.
|
---|---|---|
TAFP | Total AFP, S | 1834-1 |
L3 | %L3 | 42332-7 |
INT67 | Interpretation | 69048-7 |