μTASWako AFP-L3For In Vitro Diagnostic Use
μTASWako AFP-L3 is an immunofluorescence assay to be used with μTASWako i30 analyzer for the quantitative determination of the ratio of lectin-reactive alpha-fetoprotein (AFP-L3%) and alpha-fetoprotein (AFP) in human serum as aid in the diagnosis of malignant tumor. This product is intended for professional use.
Liquid-phase Binding Assay (LBA) method
- 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 .
- 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 .
Principle of the Method
- Elevated AFP-L3 values (>=10%) have been shown to be associated with an increased risk of HCC development for chronic liver disease patients [Package insert].
- 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 [3-6].
- 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 . AFP-L3 values are also correlated to pathologic features of HCC such as infiltrative tumor growth pattern, capsule infiltration, and vascular invasion .
- International authorities and organizations for liver diseases identify patients with cirrhosis and patients with chronic hepatitis B and C infection as being at high risk for HCC development [9-11]. They recommend at-risk patients be enrolled in HCC surveillance programs for early detection of HCC. The Japan Society of Hepatology recommends the use of ultrasound and biomarkers, including AFP-L3, AFP and PIVKA-II, for HCC surveillance practice. Patients who have an elevation in any of the HCC biomarkers should be closely monitored by enhanced imaging modalities .
- Newly developed 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 [6,12-14].
- HCC is known as a cancer with high incidence of recurrence even after curative treatment. Patients who have high levels of the AFP-L3 are likely to develop recurrent HCC [15,16].
- Elevated AFP-L3 values indicate tumors with increased malignant potential and it is associated with poor prognosis of HCC patients.
- The JSH recommends continuous surveillance in conjunction with ultrasound and HCC biomarkers for patients after the treatment to predict recurrent HCC early .
- 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.
- 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 desgamma-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.
- Heimbach JK, et al. AASLD Guidelines for the Treatment of Hepatocellular Carcinoma: Hepatology. 2018 Jan; 67 (1): 358-380
- EASL Clinical Practice Guideline: Management of hepatocellular carcinoma: J. Hepatol. 69 (2018) 182-236
- Kokuno N, et al. Evidence-based Clinical Practice Guidelines for Hepatocellular Carcinoma: The Japan Society of Hepatology 2013 update (3rd JSH-HCC Guidelines). Hepatol. Res. 2015 Jan 45 (2)
- 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.
- Hann HW, et al. Usefulness of highly sensitive AFP-L3 and DCP in surveillance for hepatocellular carcinoma in patients with a normal alpha-fetoprotein. J. Med. Microb. Diagn. 2014, 3:1
- Choi J, et al. Longitudinal Assessment of Three Serum Biomarkers to Detect Very Early-Stage Hepatocellular Carcinoma. Hepatology. 2018 Aug. 28
- Toyoda H, et al. Clinical utility of highly sensitive Lens culinaris agglutinin-reactive alpha-fetoprotein in hepatocellular carcinoma patients with alpha-fetoprotein > 20 ng/mL. Cancer 2011 May; 102 (5) 1025-31
- Toyoda H, et al. Prognostic significance of a combination of pre- and post-treatment tumor markers for hepatocellular carcinoma curatively treated with hepatectomy. J. Hepatol. 2012 Dec; 57(6): 1251-7
- Kobayashi M, et al. Highly sensitive AFP-L3% assay is useful for predicting recurrence of hepatocellular carcinoma after curative treatment pre- and postoperatively. Hepatol. Res. 2011 Nov; 41(11): 1036-45
- 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.
|Product||Storage Condition||Shelf Life|
|μTASWako AFP-L3||2-10°C||14 months|
|μTASWako AFP-L3 Calibrator Set
|μTASWako AFP-L3 Control L||2-10°C||14 months|
|μTASWako AFP-L3 Control H||2-10°C||14 months|
|μTASWako Chip Cassette||Room temperature||24 months|
|μTASWako Sample Dilution Buffer||2-10°C||12 months|
|μTASWako Wash Solution||2-36℃||18 months|
|Sample Cup S||Room temperature|