Rapid Diagnostic Tests > TB Ab
TB Diagnosis

Tuberculosis (TB) is caused by repeated exposure to airborne droplets contaminated with a rod-shape bacterium, Mycobacterium tuberculosis. The TB bacterium is also known as the tubercle bacillus. A person with active pulmonary tuberculosis can spread the disease by coughing and sneezing. Once the person is infected with Mycobacterium tuberculosis, the infection will slowly progress to disease. More than 8 million new cases of Tuberculosis (TB) have been diagnosed each year and are responsible for more than three million deaths per year. Almost two and three quarter billion people (2.75 billion) or 33% of population are latently infected with TB.
Among screening infectious diseases, a rapid and accurate diagnostic method of tuberculosis is very important for human health maintain and the disease control. At present, the clinical check (X-ray) coupling with the microscope examination and specimen bacterial culture is the major diagnostic method for the tuberculosis. However, this often takes 4-6 weeks, and the results sometime inaccurate. In the early days, the antibody detection in the blood test was regarded as a convenient method. However, its sensitivity and specificity appeared very poor. For the last 50 years, the successful program for screening tuberculosis is based on the tuberculin skin test (TST) by using the purified protein derivates (PPD) to stimulate the T cells. However, the major drawback of TST with PPD is its cross-reaction with BCG immunized persons.
To improve the tuberculosis diagnosis we search for the specific antigens and produce their antibodies, then, prepare diagnostic kits for the detection of antibodies and antigens in body fluid. By using techniques of biotechnology, Mahairas et al. have identified some M. tuberculosis specific antigens. They employed subtractive genomic hybridization analysis to identify genetic differences between virulent M. bovis and M. tuberculosis and attenuated/avirulent BCG. Three distinct genomic regions of difference, designated RD1, RD2, and RD3, were found deleted in BCG. The specific proteins encoded from the regions of difference (RDs) gene clusters in M. tuberculosis have been chosen as the specific antigens for the diagnosis of tuberculosis, and some proteins have been cloned and expressed, and their antibodies were also prepared both as monoclonal and polyclonal forms. In our invention, various devices of immunoassays such as radio-immunoassay, enzyme immunoassay, immunochromatographic assay device, fluorescence immunoassays, immunoblotting and dot immunobinging, luminescence immunoassay, immuno-agglutination, biological chips can be used to develop an in vitro tuberculosis diagnostic kit by comprising these antigens and antibodies.


Antibody Detection:

Selection of appropriate antigens for use in serology tests is important in order to increase sensitivity without losing specificity. For this reason, we have elected to use the highly specific antigens that have consistently been shown to produce results with the highest sensitivity when compared to other antigens.
The novelty and new functions of the antibodies detection kit in our invention are: (1) no cross-reaction with other Mycobacterium and BCG strains, showing negative response for the BCG immunized subjects and non tuberculosis patients; (2) in vitro testing, and no risk for the medical personnel, and the patients no need to return for clinical reexamination; (3) rapid and simple procedures; (4) both high sensitivity and specificity; (5) can be used for diagnosis of extrapulmonary tuberculosis diagnosis; (6) can be used for monitoring response to therapy.


Antigen detection:

The novelty and new functions of the antigens detection kit in our invention are: (1) the first kit in the world to detect the M. tuberculosis antigens in biological fluids; (2) differentiate between active and latent tuberculosis;(3) no cross-reaction with other Mycobacterium and BCG strains, showing negative response for the BCG immunized subjects and non tuberculosis patients; (4) in vitro testing, and no risk for the medical personnel, and the patients no need to return for clinical reexamination; (5) rapid and simple procedures; (6) both high sensitivity and specificity; (7) can be used for diagnosis of extrapulmonary tuberculosis diagnosis; (8) can be used for substituting the traditional diagnosis in tuberculosis screening.

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