TB (Tuberculosis) Rapid Test Kit

For the Qualitative Detection of Antibody against Tuberculosis in serum and plasma

Intended Use
The TB (Tuberculosis) Rapid Test is a chromatographic immunoassay (CIA) for direct qualitative detection of Tuberculosis antibody in human serum or plasma

Principle
TB RDT is a chromatographic immunoassay (CIA) for the detection of TB antibody in human serum or plasma. Specific antigens are pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the antigens firstly. And then chasing buffer mixed with specific Mouse anti human antibody, which conjugated with colloidal gold, will flow onto the membrane. If TB antibody present, a pink colored band will develop on the area of membrane. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the B region will always appear regardless the presence of TB antibody.

Assay Procedure
Serum/Plasma

1. Open a pouch containing a cassette and lay the cassette on a flat surface.

2. Carefully apply sample onto the light blue line (sample indicating line) printed on the center area of membrane as illustrated in figure 1.

Note: Do not scratch the membrane.

3. Wait one minute and let sample solution absorb on the membrane.

4. Add two drops (40-80ul) of chasing buffer into the sample well(s).

5. Read the result in 15 minute.

Interpretation of Results

Negative:

No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no TB antibody has been detected.

Positive:

In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains TB.

Invalid:

If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).