Alpha-Fetoprotein (AFP) With AFP-L3%, Serum
Alpha-Fetoprotein (AFP) With AFP-L3%, Serum
    
Number
141300
CPT
82107
Related Information
  • Alpha-Fetoprotein (AFP), Serum, Tumor Marker
    • Synonyms
    AFP With AFP-L3%, Serum
    Special InstructionsSpecial Instructions - Updated May 22 2008
    This procedure does not provide serial monitoring; it is intended for one-time use only. If serial monitoring is required, please use the serial monitoring number 480300 to order. Values obtained with different assay methods should not be used interchangeably in serial testing. It is recommended that only one assay method be used consistently to monitor each patient's course of therapy.
    Specimen
    Serum
    Volume
    0.5 mL
    Minimum Volume
    0.2 mL (Note: This volume does not allow for repeat testing.)
    Container
    Red-top tube or gel-barrier tube
    Collection
    If a red-top tube is used, transfer separated serum to a plastic transport tube.
    Storage Instructions
    Refrigerate
    Causes for Rejection
    Nonserum specimen received
    Use
    The AFP-L3% assay is intended for use in the assessment of risk for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases.1
    LimitationsLimitations - Updated May 22 2008
    Samples from patients with acute hepatitis or fulminant hepatitis can show high values of AFP-L3% and AFP. Pregnancy can cause high values of AFP-L3% and AFP. AFP producing tumors other than HCC can show high values of AFP-L3% and AFP. Bilirubin at a concentration of >20 mg/dL can cause a negative influence on the AFP-L3% and AFP values. Glucose at a concentration of >600 mg/dL can cause a negative influence on the AFP-L3% values. With regard to the AFP, normal values apply only to males and nonpregnant females. Normal infants less the 18 months of age may have higher values.

    Results for this test should not be used as absolute evidence of presence or absence of malignant disease without confirmation of the diagnosis by another medically established diagnostic product or procedure. Values obtained with different assay methods or kits cannot be used interchangeably.

    Methodology
    Liquid-phase binding assay
    Additional InformationAdditional Information - Updated October 5 2007
    Serum AFP levels are markedly elevated in the neonate because AFP is synthesized in large quantities during embryonic development by the fetal yolk sac and by the fetal liver.2 Serum AFP concentrations decrease gradually after birth until they reach adult levels by 12-18 months of age.2 Due to fetal production, AFP becomes elevated in maternal serum during pregnancy.2 Pathologically, increased AFP levels have been associated with both acute and chronic liver disease as well as hepatocellular carcinoma (HCC).2,3 AFP can also be elevated in a number of other malignancies including gastric, lung, pancreatic, biliary tract, and testicular carcinomas.2 Patients with chronic liver disease are at a greatly increased risk for developing HCC.2,3 Early detection of HCC is important, especially in high-risk populations.3 Unfortunately, increased AFP is often observed in patients with chronic liver disease that has not progressed to HCC.2,3 This serves to limit the utility of AFP measurements as an early indicator of progression to HCC in these patients.2,3

    AFP is a glycoprotein with a single glycosylation site at a specific argininne residue.2 Three glycosylation variants occur in serum reflecting different carbohydrate chains linked at this single position.2 These variants can be differentiated based on their relative binding to a lectin (carbohydrate binding protein) isolated from lentil seeds.4 This lectin, referred to as Lens culinaris agglutinin (LCA), binds to variants AFP-L1, AFP-L2, and AFP-L3 with increasing affinity. AFP-L1, which has the weakest binding to LCA, is the predominant fraction in patients with nonmalignant liver diseases, such as chronic hepatitis and liver cirrhosis.2

    A number of clinical studies have shown that the AFP-L3 fraction (the glycosylation variant that binds strongest to LCA) is produced predominantly by malignant cells.2,5 Liver cancer cells that express AFP-L3 have been shown to have an increased tendency for early vascular invasion and development of intrahepatic metastasis.3,5 Studies suggest that the measurement of AFP-L3% can allow earlier detection of HCC than imaging techniques.5,6,7 Elevated AFP-L3% has been associated with poorer prognosis for patients with HCC.8,9,10,11,12,13,14,15,16,17 In a recent multisite clinical trial, elevated AFP-L3% (≥10%) has been shown to be associated with a sevenfold increase in the risk of developing HCC within the next 21 months.1 This study concluded that patients with elevated serum AFP-L3% should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.1

    Footnotes
    1. LBA APF-L3 Manufacturer's Package Insert, Rev.#1/0505 DDD00K, Wako Pure Chemical Industries, Ltd., 1/05/05.
    2. Li D, Mallory T, and Satomura S, “AFP-L3: A New Generation of Tumor Marker for Hepatocellular Carcinoma,” Clin Chim Acta, 2001, 313(1-2):15-9.
    3. Khien VV, Mao HV, Chinh TT, et al, “Clinical Evaluation of Lentil Lectin-Reactive Alpha-Fetoprotein-L3 in Histology-Proven Hepatocellular Carcinoma,” Int J Biol Markers, 2001, 16(2):105-11.
    4. Yamagata Y, Shimizu K, Nakamura K, et al, “Simultaneous Determination of Percentage of Lens culinaris Agglutinin-Reactive Alpha-Fetoprotein and Alpha-Fetoprotein Concentration Using the LiBASys Clinical Auto-Analyzer,” Clin Chim Acta, 2003, 327(1-2):59-67.
    5. Oka H, Saito A, Ito K, et al, “Multicenter Prospective Analysis of Newly Diagnosed Hepatocellular Carcinoma With Respect to the Percentage of Lens culinaris Agglutinin-Reactive Alpha-Fetoprotein,” J Gastroenterol Hepatol, 2001, 16(12):1378-83.
    6. Taketa K, Endo Y, Sekiya C, et al, “A Collaborative Study for the Evaluation of Lectin-Reactive Alpha-Fetoproteins in Early Detection of Hepatocellular Carcinoma,” Cancer Res, 1993, 53(22):5419-23.
    7. Kumada T, Nakano S, Takeda I, et al, “Clinical Utility of Lens culinaris Agglutinin-Reactive Alpha Fetoprotein in Small Hepatocellular Carcinoma: Special Reference to Imaging Diagnosis,” J Hepatol, 1999, 30(1):125-30.
    8. Yamashita F, Tanaka M, Satomura S, et al, “Prognostic Significance of Lens culinaris Agglutinin A-Reactive Alpha-Fetoprotein in Small Hepatocellular Carcinomas,” Gastroenterology, 1996, 111(4):996-1001.
    9. Hayashi K, Kumada T, Nakano S, et al, “Usefulness of Measurement of Lens culinaris Agglutinin-Reactive Fraction of Alpha-Fetoprotein as a Marker of Prognosis and Recurrence of Small Hepatocellular Carcinoma,” Am J Gastroenterol, 1999, 94(10):3028-33.
    10. Aoyagi Y, Isokawa O, Suda T, et al, “The Fucosylation Index of Alpha-Fetoprotein as a Possible Prognostic Indicator for Patients With Hepatocellular Carcinoma,” Cancer, 1998, 83(10):2076-82.
    11. Yamashiki N, Seki T, Wakabayashi M, et al, “Usefulness of Lens culinaris Agglutinin, A- Reactive Fraction of Alpha-Fetoprotein (AFP-L3) as a Marker of Distant Metastasis From Hepatocellular Carcinoma,” Oncol Rep, 1999, 6(6):1229-32.
    12. Okuda K, Tanaka M, Kanazawa N, et al, “Evaluation of Curability and Prediction of Prognosis After Surgical Treatment for Hepatocellular Carcinoma by Lens culinaris Agglutinin-Reactive Alpha- Fetoprotein,” Int J Oncol, 1999, 14(2):265-71
    13. Leerapun A, Suravarapu SV, Bida JP et al. The utility of Lens culinaris agglutinin-reactive alpha-fetoprotein in the diagnosis of hepatocellular carcinoma: evaluation in a United States referral population. Clin Gastroenterol Hepatol, 2007 Mar;5(3):394-402.
    14. Sterling RK, Jeffers L, Gordon F et al. Clinical utility of AFP-L3% measurement in North American patients with HCV-related cirrhosis. Am J Gastroenterol, 2007 Oct; 102(10):2196-2205.
    15. Toyoda H, Kumada T, Kiriyama S et al. Prognostic significance of simultaneous measurement of three tumor markers in patients with hepatocellular carcinoma. Clinical Gastroenterology and Hepatology, 2006, 4:111-117.
    16. Carr Bl, Kanke F, Wise M et al. Clinical evaluation of lens culinaris agglutinin-reactive alpha-fetoprotein and des-gamma-carboxy prothrombin in histologically proven hepatocellular carcinoma in the United States. Dig Dis Sci. 2007 Mar;52(3):776-782
    17. Volk ML, Hernandez JC, Su GL et al. Risk factors for hepatocellular carcinoma may impair the performance of biomarkers: a comparison of AFP, DCP, and AFP-L3. Cancer Biomark. 2007;3(2):79-87.

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