Tuberculosis Antibody Test Kit (Colloidal Gold) TB Rapid Test Cassette (Whole Blood/Serum/Plasma)

【INTENDED USE】
The Tuberculosis (TB) Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of anti-TB antibodies (Isotypes IgG, IgM and IgA) in whole blood, serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of Tuberculosis.
 
【INTRODUCTION】
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 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. 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.
 
【MAIN CONTENTS】
• Rapid test cassette with desiccant.
• Disposable pipettes
• Buffer
• Package insert
 
【DIRECTION OF USE】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Transfer 1 drop of whole blood/serum/plasma into the sample well (S), then add 1 drop of Buffer, and start the timer. Avoid trapping air bubbles in the specimen well, and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Donot interpret after 20 minutes

 
【INTERPRETATION OF RESULTS】
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result. INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
 
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