Tuberculosis (TB) Rapid Test Cassette

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 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 detection of mycobacteria. The Tuberculosis Rapid Test Cassette (Whole Blood/Serum/Plasma is a rapid test for 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.

【DIRECTIONS FOR USE】
Allow the test cassette, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface.
For Serum or Plasma Specimens:
Hold the dropper vertically, transfer 3 drops of serum or plasma (approximately 75 μL) to the specimen well (S) of test cassette and then start the timer. See illustration below.
For Venipuncture Whole Blood Specimens:
Hold the dropper vertically and transfer 3 drops of venipuncture whole blood (approximately 75μL) to the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
For Fingerstick Whole Blood Specimens:
Allow 3 hanging drops of fingerstick whole blood (approximately 75 μL) to fall into the center of the specimen well (S) of test cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 30 minutes.