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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.

The QualiCode™ B. burgdorferi IgM Western Blot Kit is an in vitro qualitative assay for the detection of human IgM antibodies reactive with Borrelia burgdorferi antigens present on a membrane strip. The QualiCode™ B. burgdorferi IgM Western Blot Kit is intended for supplemental testing of human serum specimens which yield positive or equivocal results on B. burgdorferi ELISA or IFA screening assays. QualiCode test results can provide additional, more specific evidence of infection with B. burgdorferi which may be useful in the diagnosis of Lyme disease. The QualiCode™ B. burgdorferi IgM Western Blot Kit can be used to test human sera for IgM antibodies during the acute phase of disease, within one month of infection, in accordance with CDC/ASTPHLD guidelines. During this period, patients may not yet have developed a detectable IgG response. Beyond one month from infection, an IgG Western Blot test is recommended. Patients should not be tested solely for IgM antibodies at this stage due to the higher probability of false-positive results. Symptomatic patients showing IgM but not IgG antibodies at an early stage in infection should be re-tested for IgG antibodies 2-4 weeks later.

The device is a Western Blot assay. Proteins and other antigenic components of the Borrelia spirochete are fractionated by polyacrylamide gel electrophoresis in the presence of sodium dodecyl sulfate. The separated proteins are electrophoretically transferred from the gel to nitrocellulose membranes. which are subsequently blocked to minimize non-specific binding and cut into strips. These nitrocellulose strips with resolved Borrelia burgdorferi antigens are then reacted with diluted serum and controls (positive and negative sera of defined reactivity). During the incubation period, human antibodies specific to the B, burgdorferi antigens, if present in the sample or control, will bind to the antigen to which they have affinity. Unbound serum and non-specific antibodies are washed from the strip. Detection of bound IgM antibodies is accomplished by reacting and incubating the strips with a solution containing anti-human IgM antibodies conjugated with alkaline phosphatase. Unbound conjugate antibodies are removed by washing. The qualitative assessment of the detected IgM antibodies is then accomplished by the reaction of the alkaline phosphatase with a chemical substrate, which is cleaved into a colored, insoluble product that can be visualized. The determination of the reactivity of each unknown specimen is accomplished by comparison of the identified, visualized bands to the Band Identifying and Band Intensity Controls.

The QualiCode™ B. burgdorferi IgG Western Blot Kit is an in vitro qualitative assay for the detection of human IgG antibodies reactive with Borrelia burgdorferi antigens present on a membrane strip. The QualiCode™ B. burgdorferi IgG Western Blot Kit is intended for supplemental testing of human serum specimens which yield positive or equivocal results on B. burgdorferi ELISA or IFA screening assays: QualiCode test results can provide additional, specific evidence of infection with B. burgdorferi which may be useful in the diagnosis of Lyme disease. The OualiCode™ B, burgdorferi IgG Western Blot Kit can be used to test human sera at any time following onset of symptoms, and when (1) only IgM antibodies were originally detected: (2) IgG antibodies were detected previously, but were not considered significant by Western Blot; or (3) previously seronegative patients become positive by ELISA or IFA screening tests.

The device is a Western Blot assay. Proteins and other antigenic components of the Borrelia spirochete are fractionated by polyacrylamide gel electrophoresis in the presence of sodium dodecvl sulfate. The separated proteins are electrophoretically transferred from the gel to nitrocellulose membranes, which are subsequently blocked to minimize non-specific binding and cut into strips. These nitrocellulose strips with resolved Borrelia burgdorferi antigens are then reacted with diluted serum and controls (positive and negative sera of defined reactivity). During the incubation period, human antibodies specific to the B. burgdorferi antigens, if present in the sample or control, will bind to the antigen to which they have affinity. Unbound serum and non-specific antibodies are washed from the strip. Detection of bound IgG antibodies is accomplished by reacting and incubating the strips with a solution containing anti-human IgG antibodies conjugated with alkaline phosphatase. Unbound conjugate antibodies are removed by washing. The qualitative assessment of the detected IgG antibodies is then accomplished by the reaction of the alkaline phosphatase with a chemical substrate, which is cleaved into a colored, insoluble product that can be visualized. The determination of the reactivity of each unknown specimen is accomplished by comparison of the identified, visualized bands to the Band Identifying and Band Intensity Controls.