Details for Mycobacterium Tuberculosis ELISA IgG, IgM, IgA Assay (Serum/Plasma) Instruction for use
|Product Name||Mycobacterium Tuberculosis ELISA IgG, IgM, IgA Assay (Serum/Plasma).|
|# of Samples||1 x 96 well.|
|Intended Use||The GenWay Biotech, Inc. Mycobacterium tuberculosis (TB) ELISA IgG, IgM, IgA Assay system is an enzyme-linked immunosorbent assay (ELISA) designed for the presumptive qualitative detection of IgG, IgM and IgA antibodies to TB in human serum and for the presumptive diagnosis of acute, recent, or reactive TB infection. To adequately assess the patient's serological status, testing must be performed in conjunction with any of the other traditional TB diagnostic technologies.|
|Background||The Mycobacterium tuberculosis belongs to the genus Mycobacterium, which are aerobic, non-motile, and rod-shaped bacteria with two distinguishing characteristics: acid-fastness and slow growth.
Mycobacterium tuberculosis is one of most successful pathogens of mankind, infecting one-third of the global population and claiming two million lives every year. The ability of the bacteria to persist in the form of a long-term asymptomatic infection, referred to as latent tuberculosis, is central to the biology of the disease.
Approximately eight million people develop active tuberculosis (TB) every year, with two million dying from the disease. In addition to this already huge burden of disease, it is estimated that up to two billion people have been infected with the causative agent, Mycobacterium tuberculosis. Most people control the initial infection by mounting a cell-mediated immune response that prevents disease but can leave a residual population of viable mycobacteria. Between 5 - 10% of individuals who become infected subsequently develop clinical disease. Primary TB develops within 1 or 2 years after an initial infection and, particularly in children, is often associated with disseminated disease. Post-primary TB develops later in life, and can be caused either by reactivation of bacteria remaining from the initial infection or by failure to control a subsequent reinfection. Post-primary TB is predominantly a pulmonary disease, involving extensive damage to the lungs and efficient aerosol transmission of bacteria. The risk of disease is highly dependent on the immune status of the host; coinfection with HIV markedly increases the incidence of both forms of disease.
Currently, latent infection is diagnosed in a non-immunized person by a tuberculin skin test, which yields a delayed hypersensitivity type response to an extract made from M. tuberculosis. Those immunized for TB or with past-cleared infection will respond with delayed hypersensitivity parallel to those currently in a state of infection, so the test must be used with caution, particularly with regard to persons from countries where TB immunization is common. Tuberculin tests have the disadvantage in that they may produce false negatives, especially when the patient is co-morbid with sarcoidosis, Hodgkins lymphoma, malnutrition, or most notably active tuberculosis disease. New TB tests are being developed that offer the hope of a less expensive, fast and more
accurate TB testing. These use polymerase chain reaction detection of bacterial DNA and antibody assays to detect the release of interferon gamma in response to mycobacteria. These tests are not affected by immunization, so generate fewer false positive results.
Unlike the Tuberculin skin test, the GenWay Biotech, Inc. Mycobacterium Tuberculosis ELISA IgG, IgM, IgA Assay (Serum/Plasma) will dectect HIV/TB coinfection and has no detectable cross reactivity with BCG vaccinations.
|Principles of the assay||The GenWay Bio ELISA test system is designed to detect IgG, IgM, and IgA class antibodies to TB in human sera. Wells of plastic microwell strips are sensitized by passive absorption with TB composite antigen. The antigen composite is a combination of recombinant proteins and fractionated Mycobacterium components.The test procedure involves three incubation steps
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Additional Info for Mycobacterium Tuberculosis ELISA IgG, IgM, IgA Assay (Serum/Plasma) Instruction for use
|Name||Mycobacterium Tuberculosis ELISA IgG, IgM, IgA Assay (Serum/Plasma) Instruction for use|
|Related Product Names||Mycobacterium Tuberculosis ELISA IgG, IgM, IgA Assay (Serum/Plasma)|