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Rapid test for the qualitative detection of anti-TB antibodies (IgG, IgM and IgA isotypes) in whole blood, serum or plasma samples. The Rapid Tuberculosis Test (Whole Blood/Serum/Plasma) is a qualitative, solid phase, direct, two-site immunoassay for the detection of anti-TB antibodies in whole blood, serum or plasma samples. The membrane is pre-coated with recombinant TB antigen on the line in the test region of the media. During the test, anti-TB antibodies, if present in the whole blood, serum or plasma sample, react with the particles coated with recombinant TB antigen. The compound migrates upwards on the membrane chromatographically by capillary action reacting with the recombinant TB antigen on the membrane and generates a colored line. The presence of this colored line in the test area indicates a positive result, while its absence indicates a negative result. As a procedural control, a line will always appear in the test control zone, indicating that the correct volume of specimen has been used and that the membrane has been soaked. Tuberculosis (TB) is mainly spread by airborne transmission of aerosolized droplets emitted by coughing, sneezing and talking. Poorly ventilated areas present the greatest risk of exposure to infection. TB is the leading cause of morbidity and mortality worldwide, causing the largest number of deaths from a single infectious agent. The World Health Organization reports the diagnosis of over 8 million new cases of active tuberculosis every year. About 3 million deaths per year are also attributed to TB1,2. Timely diagnosis is crucial for TB control, as it allows for a rapid start of therapy and limits further spread of the infection. Over the years, various methods have been used to detect TB, including skin tests, sputum smears, sputum culture and chest X-rays. But all of these methods have limitations. Newer tests, such as DNA amplification by PCR or the interferon-gamma test, have recently been introduced. However, the lead times for these tests are long, require laboratory equipment and trained personnel, and some are neither convenient nor easy to use. These tests are also expensive and impractical for developing countries. Serological methods are a valid alternative, since the serodiagnosis of TB is easy, inexpensive, relatively non-invasive and does not depend on the detection of mycobacteria. The Rapid Tuberculosis Test (Whole Blood/Serum/Plasma) is a rapid test for the qualitative detection of anti-TB antibodies (IgG, IgM and IgA Isotypes) in whole blood, serum or plasma samples. The test uses a combination of recombinant antigens to detect elevated levels of anti-TB antibodies in whole blood, serum or plasma samples.
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