AFP-L3 Test

Enhance Liver Cancer Surveillance
using AFP-L3 and DCP tests

Lectin-reactive fraction of alpha-fetoprotein (AFP-L3) is a serum biomarker for hepatocellular carcinoma (HCC). Adding AFP-L3 to your current surveillance practice for HCC could increase your chances of detecting early HCC.

Clinical Significance

Elevated AFP-L3 values (>=10%) have been shown to be associated with a 10.6-fold increased risk of HCC development within the next 21 months, for chronic liver disease patients (“μTASWako AFP-L3 Package Insert” (PDF)).
The American Association for the Study of Liver Disease (AASLD) recommends surveillance using ultrasound every 6 months for patients in high-risk groups [1]. High risk groups for HCC development are defined as patients with the chronic liver disease conditions of cirrhosis and certain patient groups with hepatitis B infection (even if without cirrhosis) [1].
AFP-L3 could alert about the early development of HCC before it can be detected by imaging modalities and is useful for identifying patients at an increased risk for HCC [2-5].
An elevation in AFP-L3 has been shown to correlate to various phases of HCC development. Increased AFP-L3 values have been reported to correlate with a greater malignant potential of HCC, to shorter doubling time of tumor volume and increased hepatic arterial supply [6].
AFP-L3 values are also correlated to pathologic features of HCC such as infiltrative tumor growth pattern, capsule infiltration, and vascular invasion [7].
The Japan Society of Hepatology recommends the use of ultrasound and biomarkers, including AFP-L3, AFP and des-gamma-carboxy prothrombin (DCP), for HCC surveillance practice. Patients who have an elevation in any of the HCC risk biomarkers should be closely monitored by enhanced imaging modalities [8].
FUJIFILM Wako’s fully automated immunoassay system, μTASWako i30, with improved analytical sensitivity for measurement of serum AFP-L3 has also demonstrated increased clinical sensitivity in patients with early stage HCC [5,9].
The μTASWako i30 is for in vitro diagnostic use and provides parallel measurements for both AFP-L3 and DCP.

LEARN DCP Test

Intended Use

The μTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the μTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (>= 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.

AFP-L3 and DCP Tests Are Available
in the United States and Canada

Both AFP-L3 and DCP tests are available at major reference laboratories in the United States and are CMS reimbursed. Please contact Wako Diagnostics for more information on how to order the tests in Canada.

CPT code
AFP-L3	82107
DCP	83951

Characteristics

AFP is a glycoprotein with a single asparagine-linked complex-type carbohydrate chain on each molecule. Different glycoform types of this protein have been identified.
Lens culinaris agglutinin (LCA), which is isolated from Lens culinaris (lentil) seeds, interacts with glycoform AFP-L3 but not AFP-L1. Therefore, total AFP can be separated based on the reactivity to LCA on affinity electrophoresis.
The glycoform AFP-L3 has an additional alpha1-6 fucose residue attached at the reducing terminus of N-acetylglucosamine. The AFP-L3 protein has been shown to be elevated in patients with HCC [10].
AFP-L3% is the ratio of AFP-L3 to total AFP (AFP-L1 and L3) as a percentage. The AFP-L3 (%) has been reported to be highly specific for HCC compared to AFP concentration in clinical practice [11].

References

Bruix J, Sherman M. Management of Hepatocellular Carcinoma: An Update. Hepatology. 2011;53:1020-2.
Taketa K, et al. A collaborative study for the evaluation of lectin-reactive a-fetoproteins in early detection of hepatocellular carcinoma. Cancer Res 1993;53:5419-23.
Shiraki K, et al. A clinical study of lectin-reactive alpha-fetoprotein as an early indicator of hepatocellular carcinoma in the follow-up of cirrhotic patients. Hepatology 1995;22:802-7.
Shimauchi Y, et al. A simultaneous monitoring of Lens culinaris agglutinin A-reactive alpha-fetoprotein and des-gamma-carboxy prothrombin as an early diagnosis of hepatocellular carcinoma in the follow-up of cirrhotic patients. Oncol Rep 2000;7:249-56.
Oda K, et al. Highly sensitive lens culinaris agglutinin-reactive a-fetoprotein is useful for early detection of hepatocellular carcinoma in patients with chronic liver disease. Oncol Rep 2011;26:1227-33.
Kumada T, et al. Clinical utility of Lens culinaris agglutinin-reactive alpha-fetoprotein in small hepatocellular carcinoma: special reference to imaging diagnosis. J Hepatol 1999;30:125-30.
Tada T, et al. Relationship between Lens culinaris agglutinin-reactive alpha-fetoprotein and pathologic features of hepatocellular carcinoma. Liver Int 2005;25:848-53.
Makuuchi M, et al. Development of evidence-based clinical guidelines for the diagnosis and treatment of hepatocellular carcinoma in Japan. Hepatol Res. 2008;38:37-51.
Choi JY, et al. Diagnostic value of AFP-L3 and PIVKA-II in hepatocellular carcinoma according to total-AFP. World J Gastroenterol. 2013;19:339-46.
Sato Y, et al. Early recognition of hepatocellular carcinoma based on altered profiles of alpha-fetoprotein. N Engl J Med. 1993;328:1802-6.
Oka H, 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; 16:1378-83.