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AFP-L3

μTASWako AFP-L3For In Vitro Diagnostic Use

Intended 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.

Method

Liquid-phase Binding Assay (LBA) method

Special 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 [1].
  • 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 [2].

Special Characteristics

Principle of the Method

Principle of the Method

Principle of the Method

Principle of the Method

Principle of the Method

Principle of the Method

Principle of the Method

Principle of the Method

Principle of the Method

Clinical Significance

  • 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 [7]. AFP-L3 values are also correlated to pathologic features of HCC such as infiltrative tumor growth pattern, capsule infiltration, and vascular invasion [8].
  • 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 [11].
  • 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 [17].

References

  1. Sato Y, et al. Early recognition of hepatocellular carcinoma based on altered profiles of alpha-fetoprotein. N. Engl. J. Med. 1993; 328: 1802-6.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Tada T, et al. Relationship between Lens culinaris agglutinin-reactive alpha-fetoprotein and pathologic features of hepatocellular carcinoma. Liver Int. 2005; 25: 848-53.
  9. Heimbach JK, et al. AASLD Guidelines for the Treatment of Hepatocellular Carcinoma: Hepatology. 2018 Jan; 67 (1): 358-380
  10. EASL Clinical Practice Guideline: Management of hepatocellular carcinoma: J. Hepatol. 69 (2018) 182-236
  11. 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)
  12. 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.
  13. 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
  14. Choi J, et al. Longitudinal Assessment of Three Serum Biomarkers to Detect Very Early-Stage Hepatocellular Carcinoma. Hepatology. 2018 Aug. 28
  15. 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
  16. 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
  17. 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
  18. Sato Y, et al. Early recognition of hepatocellular carcinoma based on altered profiles of alpha-fetoprotein. N. Engl. J. Med. 1993; 328:1802-6.
  19. 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.

Ordering Information

Product Storage Condition Shelf Life
μTASWako AFP-L3 2-10°C 14 months
μTASWako AFP-L3 Calibrator Set
Blank
Calibrator 1
Calibrator 2
2-10°C 14 months
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

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