Kyowa Medex Co., Ltd. (President: Tetsuo Oka) is pleased to announce that in April 2000, the Company will launch "Determiner TBGL Antibody", an in vitro diagnostic reagent for tuberculosis and atypical mycobacteriosis¹⁾, which detects anti-TBGL antibodies in blood (plasma or serum) specimens through antigen-antibody reaction.
  Tuberculosis has been prevalent again for several years. In 1993, the WHO issued a declaration of worldwide tuberculosis emergency. According to that, tuberculosis affects more than eight million people every year in the whole world; particularly, the appearance of microorganisms resistant to multiple antitubercular agents has recently caused a great medical problem. The deaths due to tuberculosis reach about 3,000 per year in Japan, and hospital infection as well as mass infection among young people are attracting public attention.
  Granted a license to use the patented technique originally developed by the collaboration between Sawai Seiyaku Co., Ltd. and Professor Yano (an emeritus professor of the Osaka City University Medical School), Kyowa Medex has put the invention to practical use as a commercially available product, "Determiner TBGL Antibody". TBGL is one of glycolipid components that are present in the cell membrane surface of tubercle bacilli. The antibodies against TBGL are produced in the body of persons infected with tubercle bacilli or atypical mycobacteria. If the anti-TBGL antibodies are detected by the determination through antigen-antibody reaction (enzyme-linked immunosorbent assay), it suggests the infection with tubercle bacilli or atypical mycobacteria.
  The current diagnosis of tuberculosis is mainly based on "smear test" to microscopically search for tubercle bacilli in the sputum and "culture test" to detect the microorganisms by culturing the sputum; however, both of the tests are unsatisfactory in terms of detection rate and also are much time-consuming to yield results (two weeks or more for culture test). "Determiner TBGL Antibody" can detect the antibodies, if present, even in those tuberculosis patients who have no excretion of tubercle bacilli in the sputum, and the positive rate is as high as 81.0% in patients with tuberculosis. The combination of "Determiner TBGL Antibody" and sputum smear/culture tests would enable an accurate diagnosis. Another advantage of this new technique is that it requires much less time, only two hours and a half , thereby allowing a rapid diagnosis.