Intended Use:

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

Sample:

Serum/Plasma/Whole Blood

Operation Process:

Performance:

For IgM Test

Relative Sensitivity: 85.7%, Relative Specificity: 96.5%, Overall Agreement: 94.9%

For IgG Test

Relative Sensitivity: 88.6%, Relative Specificity: 96.5%, Overall Agreement: 95.3%

Infectious Disease Rapid Test Catalogue: