DRG® Tuberculosis IgG Sensitive ELISA (EIA-4508)Intended Use
The DRG Tuberculosis Sensitive ELISA has been designed for the detection and the quantification of specific IgG / IgM / IgA antibodies respectively against Mycobacterium tuberculosis in serum and plasma. Further applications in other body fluids are possible and can be provided on request.INTRODUCTION
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 acidresistant
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. Convergences 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 unsatisfying and did not allow the differentiation of 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 civilisations 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. In the ELISA kits for the determination of IgG / IgM / IgA antibodies purified PPD proteins are used 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.