Tuberculosis (TB) Rapid Test Cassette, 25t/ki

A rapid test for the qualitative detection of anti-TB antibodies (Isotypes IgG, IgM, and IgA) in whole blood, serum, or plasma specimens. For professional in vitro diagnostic use only.

INTENDED USE

 The Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of anti-TB antibodies (Isotypes IgG, IgM, and IgA) in whole blood, serum, or plasma specimens.

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 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 tests, sputum smears, and sputum culture,s and chest x-ray. But all these methods have some 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.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 the detection of mycobacteria.4,5,6 The Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test for the qualitative detection of anti-TB antibodies (Isotypes IgG, IgM, and IgA) in whole blood, serum, or plasma specimens. The test utilizes a combination of recombinant antigens to detect elevated levels of anti-TB antibodies in whole blood, serum, or plasma specimens.

PRINCIPLE

The Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, solid phase, two-site sandwich immunoassay for the detection of anti-TB antibodies in whole blood, serum, or plasma specimens. The membrane is pre-coated with TB recombinant antigen on the test line region of the Cassette. During testing, the anti-TB antibodies, if present in whole blood, serum, or plasma specimen react with the particles 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.

REAGENTS

The test cassette contains TB recombinant antigen-coated particles and TB recombinant antigen coated on the membrane.