Tuberculosis IgM/IgG Rapid Test (DTS514)

Regulatory status: For research use only, not for use in diagnostic procedures.

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


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