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* For research use only, not for use in diagnostic procedures.
Intended Use
Product Introduction
General Description
The Legionella Antibody Rapid Test detects IgM and IgG antibodies specific to 7 types of Legionella pneumophila(type 1,3,4,5,6,8,10) through visual interpretation of color development on the internal strip. Legionella antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with Legionella antigen conjugated to colored particles and precoated onto the conjugate pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are sufficient antibodies to Legionella in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Principle
L. pneumophila was identified as the causative agent for Legionellosis (Legionella pneumonia, or Legionnaire's Disease) in 1977. Presently, there are more than 25 species and 33 serogroups in the family Legionellaceae, with at least 18 species associated with pneumonia, accounting for roughly 1-5% of all cases of pneumonia. L. pneumophila displays a multitude of morphologies including the bacillus, coccobacillus, and elongated fusiform. Although often difficult to perform, the Gram stain will be Gram-negative.
Reagents And Materials Provided
1. Individually packed test devices: Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions.
2. Buffer: 0.1 M Phosphate buffered saline (PBS) and 0.02% sodium azide.
3. Disposable pipettes: For adding specimens
4. Package insert: For operating instructions
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