OnSite TB IgG/IgM Combo Rapid Test
The OnSite TB IgG/IgM Combo Rapid Test is a lateral flow rapid 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. and detect anti-M. TB IgM and IgG in serum, plasma, or whole blood rapidly within 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 antigens 7-9, 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 with a simple procedure of:
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1 drop of specimen
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1 drop of sample diluent
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Results in 15 minutes
What's included?
Within the box, the following is included:
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30 Individually packed cassette devices
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30 Plastic droppers
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1 Sample Diluent (5mL/bottle)
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1 Package Insert
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1 Instructions for use (IFU)
Performance Characteristics
Relative Sensitivity 87.2%
Relative Specificity 94.6%
Relative Agreement 93.2%
Features
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Easy to use
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Results in 10-15 minutes
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Minimal training needed and no equipment required
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Simultaneously detects and differentiates anti-TB IgG and IgM
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Uses blood specimens instead of sputum for easier specimen collection
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Aids in diagnosis of pulmonary and extrapulmonary TB
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