Expected use
The one-step rapid tuberculosis test is a chromatographic immunoassay for the qualitative detection of antibodies against M. tuberculosis in human serum. This test is intended for professional use as an aid in the detection of antibodies to M. tuberculosis in human serum, whole blood, or plasma.
Three specially selected recombinant TB proteins are used in the test band as capture materials and gold conjugates. These allow the rapid tuberculosis test to identify anti-tuberculosis antibodies in human serum, whole blood or plasma with a high degree of precision.
Summary and explanation
Tuberculosis is a highly infectious disease caused by Mycobacterium tuberculosis and a life-threatening human disease. It is transmitted almost exclusively by aerosol transmission of respiratory secretions from sick patients to their contacts. Tuberculosis especially affects the lungs and more than 80% of all tuberculosis cases were confined to the lungs. The morbidity of tuberculosis has decreased, but recently HIV-associated tuberculosis and multidrug-resistant tuberculosis are increasing.
It is not easy to detect TB disease early in the infection, as there are few symptoms. The tuberculin skin test or chest X-ray can be used to detect tuberculosis. However, these methods require complex procedures or may not confirm that a person has TB disease. Serological testing can overcome these disadvantages with its simple and rapid method.
