Intended Use
The Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma).
Storage
When stored at 2 °C to 8 °C unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date. Opened reagents must be stored at 2 °C to 8 °C. Microtiter wells must be stored at 2 °C to 8 °C. Once the foil bag has been opened, care should be taken to close it tightly again. Opened kits retain activity for two months if stored as described above.
Sensitivity
The diagnostic sensitivity is defined as the probability of the assay of scoring positive in the presence of the specific analyte. It is 95.49 %.
General Description
Bordetella species are non-spore-forming encapsulated bipolar, coccoid (pale-staining) Gram-negative bacilli (about 0.3 - 0.5 μm thick and 1 μm long). The genus consists of the human parasites B. pertussis and B. parapertussis, and B. bronchiseptica which cause enzootic infections in various wild and domestic animal species.
Bordetella pertussis produces a single-disease syndrome in man known as pertussis or whooping cough. It is a highly contagious childhood disease (approx. 80% of cases occur before the age of 5 years) which is transmitted by respiratory contact and is associated with a high mortality rate (about 1-2% in the first year of life, later on about 1%).
In the absence of immunization, essentially no one escapes pertussis. Clinical pertussis is followed by natural acquired immunity which is long-lasting but not permanent. The distribution of the disease is worldwide, though clearly modified by immunization and other poorly defined social, economic, and nutritional factors. In most countries an active vaccination is recommended. Usually the immunization preparation is combined with diphtheria and tetanus toxoids.
Citations
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