General Information on Tuberculosis:

Tuberculosis is caused by infection with Mycobacterium tuberculosis (M. tuberculosis) and remains the single most important fatal infection of human beings, causing around 3 million deaths and 8 million cases annually.

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 method is very time consuming, it takes 4 ~ 6 weeks to obtain the results, and sensitivity is only 75%. 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 past 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.

Product Design:

Subtractive DNA hybridization of pathogenic M. bovis and M. bovis BCG have identified three regions of difference designated RD1 ~ RD3. These region encoeds some secreted protein. The advantages of these proteins are existed at low levels in M. tuberculosis and M. bovis culture supernatant and act as potent T-cell antigens which are recognized by over 70% of tuberculosis patients.

In Formosa Biomedical Technology Corporation, two proteins in RD have been cloned and expressed, and their monoclonal and polyclonal antibodies were also prepared. The MeDiPro M. tuberculosis Antigen ELISA shows superior performance for differentiating active TB patients from normal population.

Advantages:

* Convenience: Grapid and simple procedures.
* Efficiency: time saving, only need 2 hours.
* Safety: in vitro testing, and no risk for the medical staffs.
* Specificity: no cross-reaction with other Mycobacterium and BCG strains.
* Application: can be used for diagnosis of extrapulmonary tuberculosis