One-Step TB Rapid Test
For the qualitative detection of Antibody against Tuberculosis in
serum and plasma
The TB Rapid Test is a chromatographic immunoassay for direct
qualitative detection of Tuberculosis antibody in human serum or
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
1. For in vitro diagnostic use only.
2. All patient samples should be treated as if capable of
3. Do not interchange reagents from different lots or use the test
kit beyond expiration date.
4. Icteric, lipemic, hemolysed, heat treated and contaminated sera
may give erroneous results.
The kits should be stored at temperature 4-30°C, the sealed pouch
for the duration of the shelf life (24 months).
SAMPLE COLLECTION AND PREPARATION
1. Have a certified phlebotomist collect whole blood into a purple,
blue or green top collection tube (containing EDTA, citrate or
heparin, respectively) by vein puncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing, or label and store it
at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up
to one year.
1. Have a certified phlebotomist collect whole blood into a red top
collection tube (containing no anticoagulants) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum for testing or label and store it
at 2-8°C for up o two weeks. Serum may be frozen at -20°C for up to
1. Bring all reagent to room temperature.
2. Open a pouch containing a cassette and lay the cassette on a
3. Carefully apply 3ml of sample Into the sample well(please the
4. Then add 2 drops (80ul) of buffer into the buffer well (B).
5. Read the result within or up to 15 minutes. Dispose of the
cassette after 20 minutes.
Contact Rebecca Yan