What Is Mycodot Test?
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
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Store the unused and unopened test kit at room temperature (2-30°C).
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Each device may be used until the expiration date printed on the label if it remains sealed in the foil pouch containing desiccant.
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Do not freeze the kit and or expose the kit t
Sensitivity
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Clinical Performance for IgM Test: Relative Sensitivity: 93.3%
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Clinical Performance For IgG Test: Relative Sensitivity: 94.6%