TB Test Kits

TB IgG/IgM Combo Rapid Test

OnSite TB IgG/IgM Combo Rapid Test, Intended Use:

The OnSite TB IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay for
the simultaneous detection and differentiation of anti-Mycobacterium tuberculosis (M. TB) IgM and IgG in human serum, plasma, or whole blood. It is intended to be used by professionals as a preliminary test result to aid in diagnosis of infection with M. TB.

The test detects anti-M. TB IgM and IgG in serum, plasma, or whole blood in 15 minutes. An IgM positive result indicates a fresh M. TB infection, while an IgG positive result suggests a previous or chronic infection. Since the test uses M. TB specific antigens7-9, it can still detect IgM antibodies in individuals who were recently exposed to M. TB but were vaccinated with BCG. In addition, the test can be performed by minimally skilled personnel without cumbersome laboratory equipment.

TB Test Kits

Screen for TB on any patient, anywhere.
 

• Easy to use with results in 10-15 minutes

• Simultaneously detects and differentiates anti-TB IgG and IgM

• Uses blood specimen instead of sputum for easier specimen collection

• Aids in diagnosis of pulmonary and extrapulmonary TB

The test cassette consists of a coloured conjugate pad containing M. TB antigens conjugated with colloidal gold (M. TB conjugates) and a control antibody conjugated with colloidal gold. A nitrocellulose membrane strip containing two test lines (M and G lines) and a control line (C line). The M line is pre-coated with monoclonal anti-human IgM for the detection of anti-M. TB IgM, the G line is pre-coated with reagents for the detection of anti- M. TB IgG, and the C line is pre-coated with a control line antibody.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, if anti-M. TB IgM is present in the specimen, it will bind to the M. TB conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody forming a coloured M line, indicating an IgM positive test result.

If anti-M. TB IgG is present in the specimen, it will bind to the M. TB conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane forming a coloured G line, indicating an IgG positive test result.

Absence of any test lines (M and G) suggests a negative result. The test contains an internal control (C line) which should exhibit a coloured line of the immunocomplex of the control antibodies regardless of colour development on any of the T lines. Otherwise, the test result is invalid, and the specimen must be retested with another device.

Performance Characteristics:
Relative Sensitivity: 87.2%
Relative Specificity: 94.6%
Relative agreement: 93.2%

For more information about this product and to see the instructions of use, click here.

Simple procedure:

• 1 drop of specimen

• 1 drop of sample diluent

• Results in 15 minutes