Mycobacterioses (tuberculosis, leprosy, atypical mycobacterioses, paratuberculosis, and perhaps
Crohn’s Disease) are the infectious diseases of men and animals with the largest diffusion on earth.
The infectious agents of tuberculosis are acid-resistant rod-like formed bacteria of the family
Mycobacteriaceae, genus Mycobacterium. The germ was detected by Robert Koch in 1882. Owing
to the very high infectious power of pathogenic mycobacteria, early diagnosis is essential to
prevent spreading of the disease. Convergence of various approaches are necessary to control the
mycobacterioses, immune reactions and bacterial shedding being variable during the diseases.
However, usual diagnostic procedures were up to now unsatisfactory and did not allow to
distinguish among different mycobacterial species. The illness is normally transferred by droplets
of saliva from infected persons. The target of the infection are mostly the lungs, but also other
organs like the brain, intestinal tract, bones, lymph nodes and kidneys can be afflicted.
Tuberculosis is not only found in developing countries with 8 million of new infections yearly, but
also in industrialized civilizations, as an actual disease with some thousands of cases yearly.
Without treatment, the disease leads in 50% of the cases to death within less than two years.
Clinical symptoms are fatigue, loss of weight, lack of appetite, light fever, nocturnal sweat and
pain in the chest. Especially patients with HIV are threatened by tuberculosis due to their impaired
immune system. A vaccination with living attenuated bacteria is possible (BCG = Bacille Calmette
Guérin). This is mostly done with newborn or young children. With older patients, before the
vaccination there is normally performed the tuberculin test (Pirquet or Mantoux), where a small
amount of tuberculin is injected under the skin. In a positive case, there exist antibodies against
Mycobacteria, and a vaccination is not necessary. Up to recently, there have not existed any
serological methods to detect tuberculosis antibodies in serum. The only available procedure was
besides the skin tuberculin test the direct microscopical identification of the dyed bacteria in
sputum. Meanwhile specific antigens have been prepared either by purification of natural material
or by recombinant methods. This ELISA test kit for the determination of IgG antibodies uses a
cocktail of highly pure proteins in order to determine an immune response against the bacteria in
human serum. A fresh or chronically active infection can be diagnosed by IgA and IgM tests,
which are also available.