Human Tuberculosis(TB) Rapid Test

For the qualitative detection of Antibody against Tuberculosis in serum and plasma

INTENDED USE

The TB Rapid Test is a chromatographic immunoassay for direct qualitative detection of Tuberculosis antibody in human serum or plasma.

PRINCIPLE

Tuberculosis remains an important socio-economical and medical problem throughout the world. According to the Centers for Disease Control, the incidence of TB is expected to increase from 7.5 million cases per year in 1995 to 11.9 million in 2005. The case fatality rate is estimated at 55% for untreated people and 15% for the treated patients.

The commonly used diagnostic tests for the tuberculosis such as sputum examination of acid fast bascilli, culture of sputum or other fluids, the tuberculin skin test and radiological investigations do not achieve the required diagnostic sensitivity.

TB is a chromatographic immunoassay test 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. The chasing buffer mixed with specific Mouse anti human antibody, which is conjugated with colloidal gold, will flow up the membrane. If TB antibody is present, a pink colored band will develop on the test region 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 C region will always appear regardless of the presence or absence of TB antibody.

REAGENTS AND MATERIALS PROVIDED

1.　One pouched cassette with desiccant.

2.　Blood diluent in a dropper bottle, stored at 2-8°C.

3.  One piece of operating instruction

WARNING AND PRECAUTIONS

• For in vitro diagnostic use only.

• All patient samples should be treated as if capable of transmitting diseases.

• Do not interchange reagents from different lots or use the test kit beyond expiration date.