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Proteinase-3, Human, BioAssay(TM) ELISA Kit (cANCA, PR3)

Cat no: P9099-05

Proteinase-3, Human, BioAssay(TM) ELISA Kit (cANCA, PR3)

The United States Biological Proteinase-3, Human, BioAssay(TM) ELISA Kit is intended for the detection and semi-quantitative determination of antibodies to PR-3 in human serum. The assay is to be used to detect antibodies in a single serum specimen. \n \nProteinase-3 is a lysosomal enzyme that can be found in human neutrophils. There are two subsets of autoantibodies to sample neutrophils, c- ANCA and p-ANCA. The first subtype, c-ANCA, shows cytoplasmic staining by IFA and is diagnostic for Wegener's granulomatosis. The major antigen responsible for the c-ANCA staining is Proteinase-3. The second subtype, p- ANCA, shows perinuclear staining by IFA. The major antigen responsible for the p-ANCA response has been shown to be myeloperoxidase. The ANCA staining patterns are obtained using ethanol-fixed sample neutrophils. Anti- PR-3 autoantibodies have been associated with Wegener's granulomatosis but less often with microscopic polyangiitis. Other antigen specificity's (CAP 57) can be responsible for the c-ANCA pattern. These antigens are generally not diagnostic for PR-3 associated vaculitus diseases.\n \nKit Components:\nEach kit contains the following components in sufficient quantities to perform the number of tests indicated on the package label.\n1. Microtiter Plate: 1x96 wells\n2. Sample Diluent: 1x30ml\n3. Positive Control, High: 1x400ul\n4. Calibrator: 1x400ul\n5. Negative Control: 1x400ul\n6. Positive Control, Low: 1x400ul\n7. IgG, IgA, IgM (HRP) Goat x human: 1x15ml\n8. Wash Buffer, 20X: 1x50ml\n9. Tetramethylbenzidine (TMB): 1x15ml\n10. Stop Solution: 1x15ml\n \nStorage and Stability:\nStore all components at 4 degrees C. Stable for 6 months. For maximum recovery of product, centrifuge the original vial prior to removing the cap.

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SPECIFICATIONS

Catalog Number

P9099-05

Size

1Kit

Applications

ELISA

Reactivities

Hum

References

1. Falk, R.J., et al., New Engl. J. Med. 318:1651-7. 2. Kallenberg, C.G.M., et al. 1991. Autoimmunity to lysosomal enzymes: new clues to vasculitis and glomerulonephritis. Immunol. Today.12:61-4. 3. Falk, R.J., et al. 1990. Clinical Course of Anti-Neutrophil Cytoplasmic Autoantibody - associated Glomerolonephritis and Systemic Vasculitis. Am. Intern. Med. 113:656-63. 4. Nolle, B., et al. 1989. Anticytoplasmic Autoantibodies: Their Immunodiagnostic Value in Wegener's Granulomatosis. Am. Intern. Med. 111:28-40.. 5. Niles, J.L, et al. 1989. Wegener's Granulomatosis Autoantigen is a Novel Neutrophil Serine Proteinase. Blood. 74:1888-93. 6. Gallicchio, M.C. and J.S. Savige. 1991. Detection of Antimyeloperoxidase and anti-elastase antibodies in vasculitides and infections. Clin. Exp. Immunol. 84:232-7. 7. Hagen, E.C., et al. 1993. Antineutrophil Cytoplasmic Autoantibodies: A Review of the Antigens Involved, the Assays, and the Clinical and Possible Pathogenetic Consequences. Blood. 81: 1996-2002. 8. CDC-NIH Manual. 1993. In: Biosafety in Microbiological and Biomedical Laboratories, 3rd Edition. U. S. Dept. of Health and Human Services, Public Health Service. pp 9-12. 9. National Committee for Clinical Laboratory Standards. 1990. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture Approved Standard. NCCLS Publication H18-A. 10. Engvall, E., and P. Perlman. 1971. Enzyme-Linked Immunosorbent Assay, (ELISA) Quantitative Assay of Immunoglobulin G. Immunochemistry. 8: 871-874. 11. Engvall, E.,et al., Proceedings of the Nineteenth Colloquium, Brugge, Oxford. Pergamon Press. pp 553-556. 12. Engvall, E., K. Jonsson, and P. Perlman. 1971. Enzyme- Linked Immunosorbent Assay. II. Quantitative Assay of Protein Antigen, Immunoglobulin-G, By Means of Enzyme- Labelled Antigen and Antibody-Coated tubes. Biochem. Biophys. Acta. 251: 427-434. 13. Van Weeman, B. K. and A.H.W.M. Schuurs. 1971. Immunoassay Using Antigen-Enzyme Conjugates. FEBS Letter. 15: 232-235. 14. NCCLS. 1991. National Committee for Clinical Laboratory Standard. Internal Quality Control Testing: Principles & Definition. NCCLS Publication C24- A. 15. http://www.cap.org/html/ftpdirectory/ checklistftp.html. 1998. Laboratory General - CAP (College of American Pathology) Checklist (April 1998). pp 28-32. 16. NCCLS. 1997. National Committee for Clinical Laboratory Standard. Preparation and Testing of Reagent Water in the Clinical Laboratory. NCCLS Publication C3- A3.

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