TB is a contagious disease that is transmitted from person to person through coughing and breathing in airborne droplets that contain bacteria. TB primarily affects the lungs but can affect any part of the body. As one of the most common infections in the world, TB remains a major problem in many countries and among vulnerable populations.
The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative detection of tuberculosis antibody in human serum or plasma.
Human TB has become a global disease with its reemergence in the Western countries in the last decades. According to WHO, more than 30 % of the world's population is estimated to be infected with the TB bacterium, M. tuberculosis. TB is predominantly a disease of the respiratory tract, but can also affect other organs. People who are suffering from active pulmonary tuberculosis are highly infectious. The spread of TB takes place by coughing and sneezing. TB kills yearly about 2 million people.
Although the TB bacterium was identified more than 100 years ago, the diagnostic methods, which are currently available, suffer from high price, poor sensitivity and specificity and are mostly time consuming. The diagnosis of TB is usually made based on a combination of several laboratory tests.
1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of serum/plasma to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
Caution: The above interpreting time is based on room temperature range of 15 - 30° C. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.