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Wako Pure Chemical Industries, Ltd.

1-2, Doshomachi 3-Chome, Chuo-Ku, Osaka 540-8605, Japan
Tel: +81-6-203-3741, Fax: +81-6-233-3810
Contact: Mr. Toshihiko Oda, International Business Development, Diagnostics
E-mail: oda.toshihiko@wako-chem.co.jp, Web: http://www.wako-chem.co.jp

1. Lens culinaris agglutinin-reactive alpha-fetoprotein ratio (AFP-L3%)

  1. Product: LBA AFP-L3
  2. Principle of the method:
    When a sample is mixed with Reagent 1, Lens culinaris agglutinin (LCA) reacts only with alpha-fetoprotein (AFP) having an additional fucose residue (AFP-L3). When reagent 2 is added, peroxidase (POD) labeled anti-AFP monoclonal antibody binds to all the AFP molecule present in the sample. The reaction mixture is introduced to an anion-exchange column, and by means of stepwise gradient, immune complex fractions are eluted into the reaction cup. Then, the POD activity of each complex is measured as the increase of fluorescence intensity. The total fluorescence intensity represents AFP concentration. The ratio, (complex 1)/(complex 1 + complex 2) represents AFP-L3%. By comparing the fluorescence intensity to that of the standard of a known value, AFP-L3% and AFP concentration in the sample are obtained.
  3. Reagents

    Reagent1 1 x 10 mL contains LCA and anion 1 conjugated anti-AFP monoclonal antibody
    Reagent2 1 x 1 mL contains POD-labeled anti-AFP monoclonal antibody and anion 2 conjugated anti-AFP monoclonal antibody
    Substrate1 2 x 1.3 mL contains 4-acetoamidophenol and 2-propanol
    Substrate2 2 x 15 mL contains hydrogen peroxide
    Shelf life 9 months after production.

  4. Features:
    LBA AFP-L3 is a reagent for the determination of both AFP-L3% and AFP concentration in serum with high specificity and high sensitivity, based on a new technology, liquid-phase biding assay (LBA). The LBA method uses a liquid-phase binding reaction between antigen and antibody and, thus, the antibody concentration and the reaction conditions can be set freely. The LBA method allows stoichiometric reaction between antigen and antibody and gives high sensitivity and a wide range of measurement. By the LBA method, bound and free forms are separated by column chromatography and, thus, AFP concentration and AFP-L3% can be obtained simultaneously. AFP-L3% is a highly specific tumor marker for hepatocellular carcinoma (HCC), and it is reported that in many cases, AFP-L3% shows positive results earlier than diagnosis of HCC made by imaging modalities. Furthermore, there are reports that describe its usefulness in prognosis after therapies of HCC, ant it reveals a biological malignancy of HCC.
Notice: This product has not been approved for use in diagnostic procedures by the United States FDA and can be used for research use only in the USA.
  1. References
    (1) Taketa, K., Endo, Y., et al.: Cancer Res., 53, 5419-5423 (1993).
    (2) Yamashita, F., Tanaka, M., et al.: Gastroenterology, 111, 996-1001 (1996).
    (3) Katoh, H., Nakamura, K., et al.: Anal. Chem., 70, 2110-2114 (1998).

2. (13)-beta-D-Gluca

  1. Product: beta-Glucan Test
  2. Principle of the method:
    The Limulus reagent (LAL: Limulus amebocyte lysate), made from extract of blood cells of horseshoe crabs, has drawn attention as an in vitro diagnostic reagent for deep mycosis since it was recently discovered that LAL reacts with (13)-beta-D-glucan as well as endotoxin. When a pretreated sample is mixed with the LAL solution, (13)-beta-D-glucan in the sample activates Factor G, which initiates the cascade reactions, and causes gelation. Since the concentration of (13)-beta-D-glucan in the sample is inversely proportional to the time for gel formation, the concentration can be determined by measuring the time required for the transmittance of the reaction mixture to reach the threshold value.
  3. Reagents
    LAL, lyophilized 50 x for 0.2 mL
    Shelf life: 1 year after production.
  4. Features:
    Clinical diagnosis of deep mycosis is difficult in many cases. LAL reacts with (13)-beta-D-glucan, a component of fungal cell walls. In cases of deep mycosis, infecting fungi release (13)-beta-D-glucan in the blood stream. Diagnosis of deep mycosis utilizing (13)-beta-D-glucan as a diagnosing parameter has been explored. Wako beta-Glucan Test specifically and accurately measures (13)-beta-D-glucan by the kinetic turbidimetric assay. This method is useful for early diagnosis and prognosis of patients of suspected deep mycosis.
Notice: This product has not been approved for use in diagnostic procedures by the United States FDA and can be used for research use only in the USA.
  1. References
    (1) 1. Mori, T., Ikemoto, H., Matsuura, M., et al.: E. J. Clin. Chem. Clin. Biochem. 35, 553-560 (1997).
    (2) Kakinuma, T., Asano, T., et al.: Biochem. Biophys. Res. Commun., 101, 434-439 (1981).
    (3) Morita, T., Tanaka, S., Nakamura, T. and Iwanaga, S.: FEBS Lett., 129, 318-321 (1981).

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