The MycoDot test is based on the detection of anti-mycobacterial antibodies in the serum samples of patients by employing plastic combs coated with lipoarabinomannan (LAM) antigen which is a highly immunogenic lipopolysaccharide presenting in the cell wall of all species of mycobacteria.
Intended Use
The TB IgG/IgM Rapid Test is a sandwich 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 or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with M. TB. Any reactive specimen with the TB IgG/IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
Storage
Store the unused and unopened test kit at room temperature (2-30°C).
Each device may be used until the expiration date printed on the label if it remains sealed in the foil pouch containing desiccant.
Do not freeze the kit and or expose the kit t
Sensitivity
Clinical Performance for IgM Test: Relative Sensitivity: 93.3%
Clinical Performance For IgG Test: Relative Sensitivity: 94.6%
