Tuberculosis (IgG&IgM&IgA) Test

Tuberculosis (IgG&IgM&IgA) W/P/S Test Card is a rapid chromatographic immunoassay for the qualitative detection of anti-TB (M.tuberculosis, M. bovis and M. africanum) antibodies (all isotypes: IgG, IgM, IgA, etc.) in human whole blood, serum or plasma.

SUMMARY

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. 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, 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. Because of the requirement of laboratory equipments and skilled personnel, these new methods are not cost effective and may not be practical in rural area or developing countries.

Serological methods constitute an attractive alternative as it is simple, inexpensive and non-invasive. The Rapid Tuberculosis (TB) Test 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 specimen. The test utilizes a combination of recombinant antigens to selectively detect elevated levels of anti-TB antibodies in whole blood, serum or plasma.

Tuberculosis (IgG&IgM&IgA) W/P/S Test Card IS a qualitative, solid phase, two-site sandwich immunoassay for the detection of anti-TB antibodies in whole blood, serum or plasma. The membrane is pre-coated with TB recombinant antigen on the test line region of the Device. During testing, Serum or plasma specimen reacts with the particle coated with TB recombinant antigen. The mixture migrates upward on the membrane chromatographically by capillary action to react with TB recombinant antigen on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.