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The Immunetics® QuickELISA™ Anthrax-PA Kit is intended for use in the qualitative detection of antibodies to the Protective Antigen (PA) protein of B. anthracis in human serum. The assay should be used only on serum samples from individuals with a clinical history, signs or symptoms consistent with anthrax infection as an aid in the diagnosis of anthrax, or from recipients of anthrax vaccine. - The diagnosis of anthrax infection must be made based on history, signs, symptoms, Exposure likelihood, and when possible other laborative rooults in addition to the presence of antiation from other evidence to exclude anthrax. - The assay has not been evaluated in individuals without clinical signs on symptoms who were probamou oxposures on information available to interpret cutaneous of innulation antinentive test result for such individuals - the meaning of a positive of negativens from patients infected by the The assay fluo not boon orded results with such infections are unknown. - The minimum level of anti-PA antibodies that confers protection following the vaccination is not known. This galue and protective immunity has not been established. - The affinity and/or avidity of anti-PA IgG and IgM for the rPA antigen have not been determined with this assay.

The Immunetics® QuickELISA Anthrax-PA Kit allows qualitative detection in human serum of total antibodies to the Protective Antigen (PA) protein of B. anthracis, in a non-subtype specific, non-species specific microwell ELISA format. The PA toxin component of B. anthracis has been shown to elicit a detectable IgG response in naturally infected individuals and vaccine recipients. The assay is based on a single binding step, in which serum antibodies are incubated with a mixture of two rPA conjugates: Streptavidin-rPA and rPA-horseradish peroxidase (rPA-HRP). PA-specific, multivalent antibodies are able to form ternary complexes in which streptavidin-TPA and rPA-HRP are bound to different antigen combining sites on a single antibody molecule. The complexes are bound to the biotin-coated microplate via the streptavidin conjugate and detected via the HRP conjugate. In the assay procedure Sample Diluent, serum samples and Conjugate mixture are added to wells and incubated. Unbound antibodies and Conjugate are removed by wash steps, and bound anti-PA antibodies and HRP Conjugate are detected by adding a chromogenic peroxidase substrate containing tetramethylbenzidine (TMB). A blue product is produced in wells where antibody has been bound to the solid phase. The color development reaction is quenched by addition of an acidic Stop Solution, which causes a change in color from blue to yellow, after which optical Absorbance at 450nm corrected by 620-650mm background subtraction is measured in each well using an ELISA microplate reader. Turn-around time for the test is approximately 35 minutes if agitation is used, or 70 minutes without agitation. While the assay provides a qualitative result when undiluted samples are tested, it may also be used to obtain semi-quantitative anti-PA IgG titer results when serial dilution data are collected for the scrum sample, in similar fashion to that described by U.S. Centers for Disease Control (CDC) Quinn, C.P. et al. Emerging Infectious Diseases 2002; 8(10):1103-1110.