(TB) Tuberculosis Test Serum/Plasma (Cassette)
The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative detection of tuberculosis antibody in human whole blood, serum or plasma.
Instruction for use, pipette,buffer,sterile lancet
Principle of Test:
INTENDED USE: The TB Test Device is a chromatographic immunoassay (CIA) for direct qualitative detection of tuberculosis antibody in human whole blood, serum or plasma.
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 whole blood 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.
INTERPRETATION OF RESULTS
Two pink lines appear in the result window. This indicates that the specimen contains detectable amount of TB antibody.
Only one pink line appears in test region of the result window. This indicates that there is no detectable TB antibody in the specimen.
No line appears in the control region regardless of the presence or absence of the line in the test region.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.