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.
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 these have severe
limitations. Newer tests, such as PCR-DNA amplification or
interferon-gamma 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.
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. The Tuberculosis Rapid Test
Cassette is a rapid test to qualitatively detect the presence of anti-TB (M.
tuberculosis, M. bovis and M. africanum) antibodies (all isotypes: IgG, IgM,
IgA, etc.) in human whole blood, serum or plasma. The test utilizes a
combination of recombinant antigens to selectively detect elevated levels of
anti-TB antibodies in human whole blood, serum or plasma.