TB Tuberculosis Test

Intended Use
The Tuberculosis Rapid Test Kit is a rapid chromatographic immunoassay for the qualitative detection of anti-TB antibodies (isotypes IgG, IgM, and IgA) in human whole blood, serum, or plasma specimens. It is intended to assist in the diagnosis of tuberculosis infection as a screening tool.

Test Procedure

Testing

1. Preparation
   1.1 Bring the pouch containing the test device to room temperature before opening.
   1.2 Remove the test device from the sealed pouch and place it on a clean, flat surface. Use it as soon as possible.
2. Specimen Application
   • For serum or plasma specimens:
     2.1 Hold the dropper vertically and add 2 drops of serum or plasma (approximately 50 µl) into the specimen well (S) of the test device.
     2.2 Start the timer immediately.
   • For whole blood specimens:
     2.1 Hold the dropper vertically and add 1 drop of whole blood (approximately 15 µl) into the specimen well (S) of the test device.
     2.2 Add 2 drops of buffer solution (approximately 50 µl) to the same well.
     2.3 Start the timer immediately.
3. Result Interpretation
   • Wait for the colored line(s) to appear.
   • Read the results after 15 minutes. Do not interpret results after 30 minutes.