The Calbiotech Anthrax protective antigen (PA) IgG ELISA Kit is intended for use in the detection of Anthrax IgG in human serum.

SUMMARY AND EXPLANATION

Bacillus anthracis, the etiologic agent of anthrax, is a large, gram-positive, nonmotile, spore-forming bacterial rod. The three virulence factors of B. anthracis are edema toxin, lethal toxin and a capsular antigen. Human anthrax has three major clinical forms: cutaneous, inhalation, and gastrointestinal. Cutaneous anthrax is a result of introduction of the spore through the skin; inhalation anthrax, through the respiratory tract; and gastrointestinal anthrax, by ingestion. In the United States, incidence of naturally acquired anthrax is extremely low. Gastrointestinal anthrax is rare but may occur as explosive outbreaks associated with ingestion of infected animals. Worldwide, the incidence is unknown, though B. anthracis is present in most of the world. If untreated, anthrax in all forms can lead to septicemia and death. Early treatment of cutaneous anthrax is usually curative, and early treatment of all forms is important for recovery. Patients with gastrointestinal anthrax have reported case- fatality rates ranging from 25% to 75%. Case-fatality rates for inhalational anthrax are thought to approach 90 to 100%. Because B. anthracis has a high probability for use as an agent in biologic terrorism, many centers are involved in studying the epidemiological and laboratory diagnostic of this bacterium. ELISA test for the detection of IgG antibody to Anthrax Protective Antigen (PA) can be used to study the efficacy of experimental anthrax vaccine and the exposure to this antigen. PA recombinant antigen

PRINCIPLE OF THE TEST

Diluted patient serum is added to wells coated with purified antigen. IgG specific antibody, if present, binds to the antigen. All unbound materials are washed away and the enzyme conjugate is added to bind to the antibodyantigen complex, if present. Excess enzyme conjugate is washed off and substrate is added. The plate is incubated to allow the hydrolysis of the substrate by the enzyme. The intensity of the color generated is proportional to the amount of IgG specific antibody in the sample.