Rheumatoid Factor, Human, BioAssay(TM) ELISA Kit (RF)

Intended Use:\nRheumatoid Factor, Human, BioAssay(TM) ELISA Kit (RF) is intended for the detection of IgM antibodies in serum to RF antigen.\n\nRheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology. Rheumatoid arthritis is a systemic disease characterized by chronic proliferation and inflammation of joint cartilage and supporting structures. RA is mainly defined by clinical criteria, in which systematic pathogenetic studies have been hampered by doubts about the presence of common pathogenetic mechanisms and the relative lack of unique laboratory findings. IgG rheumatoid factor has been reported to be present in sera of patients with rheumatoid arthritis both with and without IgM rheumatoid factor activity.\n\nRFs are immunoglobulins of any isotype with antibody activity directed against antigenic sites on the Fc portion of IgG molecules. Because of its pentavalent structure and ability to cross-link immunoglobulin G antigen, IgM-RF is the main isotype identified by clinically available diagnostic assays for RF detection. Rheumatoid factors may exist as the mu, gamma, alpha, and epsilon isotypes.\n\nRheumatoid factors are found in 1 to 4% of the general population. RFs are present in 75% of adult patients with the highest incidence of rheumatoid factors occurring in persons over 65 years of age and nearly all patients with Felty and Sjogren syndrome. The clinical correlation of an elevated rheumatoid factor should be interpreted cautiously. Increased titers may accompany a variety of acute immune responses, particularly viral infections and a number of other diseases (e.g., infectious mononucleosis, tuberculosis, leprosy, various parasitic diseases, liver disease, sarcoidosis, and lymphoproliferative syndromes). The earliest tests and those still most widely used rely on the agglutinating properties of the IgM class of rheumatoid factors. Sensitized sheep red blood cell and latex agglutination tests have been developed and routinely employed. These assays are most sensitive for the detection of RF that is of the IgM isotype because of its multivalent structure. These tests provide a dilution which is difficult to standardize and have laborious processing and poor reproducibility. Enzyme immunoassays are more sensitive than agglutination and very specific due to use of purified antigen.\n\nKit Components:\nR1997-05J1: Microtiter Strips, 1x96 wells\nR1997-05J2: Sample Diluent, 1x30ml, 0.1% Proclin\nR1997-05J3: Positive Control, 1.6-3.9, 1x400ul, <0.1% sodium azide\nR1997-05J4: Calibrator CF:0.55, 1x400ul, <0.1% sodium azide\nR1997-05J5: Negative Control, 0.0-0.8, 1x400ul <0.1% sodium azide\nR1997-05J6: IgG (HRP) Goat anti-human, 1x16ml, 0.1% Proclin\nR1997-05J7: Wash Buffer, 20X, 1x50ml, 0.1% Proclin\nR1997-05J8: Substrate (TMB), 1x15ml\nR1997-05J9: Stop Solution, 1N H2SO4, 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

R1997-05J

Size

1Kit

Applications

ELISA

Reactivities

Hum

References

1. Harris, E.A, N. Engl. J. Med. 322: 1277-1289 (1990). 2. Klareskog, L., et al., Current Opinion in Immunology. 3: 912-916 (1991). 3. Carson, D. A. 1985. Rheumatoid factor. In: Textbook of Rheumatology. W. N. Kelley, E. D. Harris, R. S. Sledge, eds. Philadelphia: W.B. Saunders. pp 664-679. 4. Mannik, M. & Nardella, F.A., Clin. Rheum. Dis. 11: 551-572 (1985). 5. Sager, D., et al., Laboratory Medicine. 23(1): 15-18 (1992). 6. Linker, J. B. III, et al., Man. Clin. Lab. Immunol, 3rd Edition. N. R. Rose, H. Friedman, and J. L. Fahey. eds. ASM, Wash., DC. pp 759-761. 7. CDC/NIH Guidelines: Biosafety in Microbiological and Biomedical Laboratories, 3rd Edition, 1993. 8. National Committee for Clinical Laboratory Standards. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. Approved Standard NCCLS Publication, H3- A National Committee for Clinical Laboratory Standards. Villanova, PA. 9. Engvall, E. and Perlman, P., Immunochemistry. 8: 871-874 (1971). 10. Engvall, E. and P. Perlman. 1971. Enzyme-Linked Immunosorbent Assay, ELISA. Peeters. H., ed. In: Protides of the Biological Fluids. Proceedings of the Nineteenth Colloquium, Brugge, Oxford. Pergamon Press. pp 553-556. 11. Engvall, E., et al., Biochem. Biophys. Acta. 251: 427-434 (1971). 12. Van Weeman, B.K. and Schuurs, A.H.W.M., FEBS Letter. 15: 232-235 (1971). 13. National Committee for Clinical Laboratory Standards. 1990. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture Approved Standard. NCCLS Publication H18-A. 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.