A rapid test for the qualitative detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in serum or plasma specimens. For professional in vitro diagnostic use only.
Tuberculosis (TB) is spread primarily via airborne transmission of aerosolized droplets developed by coughing, sneezing and talking. Areas of poor ventilation pose the greatest risk of exposure to infection. TB is a major cause of morbidity and mortality worldwide, resulting in the greatest number of deaths due to a single infectious agent. The World Health Organization reports that more than 8 million new cases of active tuberculosis are diagnosed annually. Almost 3 million deaths are attributed to TB as well.1,2 Timely diagnosis is crucial to TB control, as it provides early initiation of therapy and limits further spread of infection. Several diagnostic methods for detecting TB have been used over the years including skin test, sputum smear, and sputum culture and chest x-ray. But all these methods have some limitations. Newer tests, such as PCR-DNA amplification or interferongamma assay, have been recently introduced. However, the turn-around time for these tests is long, they require laboratory equipment and skilled personnel, and some are neither cost effective nor easy to use.3 These tests are also expensive and not practical for developing countries. Serological methods constitute an attractive alternative, since TB serodiagnosis is simple, inexpensive, relatively non-invasive, and it does not depend on detection of mycobacteria.4,5,6 The Tuberculosis Rapid Test Cassette (Serum/Plasma) is a rapid test for qualitative detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in serum or plasma specimens. The test utilizes a combination of recombinant antigens to detect elevated levels of anti-TB antibodies in serum or plasma specimens.
Materials Provided