ED-FDNA100

The DIASTAT™ anti-dsDNA test is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for double-stranded DNA (dsDNA) in human serum or plasma. It is intended to aid in the diagnosis of systemic lupus erythematosus, and to monitor dsDNA antibody levels during treatment and remission and is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.

References:

Tan, E.M. 1982. Autoantibodies to nuclear antigens (ANA): Their immunobiology and medicine. Adv. Immunol. 33: 167-240.
Morrow, J. and Isenberg, D. 1987. In “Autoimmune Rheumatic Diseases,” Blackwell.
Tan, E.M. 1989. Antinuclear antibodies: Diagnostic markers for autoimmune diseases and probes for cell biology. Ad. Immunol.44: 93-151.
Tan, E.M., et al. 1982. The 1982 revised criteria for the classification of systemic lupus erythematosus. Arth. Rheum 25: 1271-1277.
Swaak, A.J.G., et al. 1982. Prognostic value of anti-dsDNA in SLE. Ann. Rheum. Dis. 41: 388-395.
Smeenk, R., et al. 1990. Antibodies to DNA in patients with systemic lupus erythematosus. Their role in the diagnosis, the followup and the pathogenesis of the disease. Clin. Rheum. 9: 100-110.
Borg, E.J., et al. 1990. Measurement of increases in anti-dsDNA antibody levels as a predictor of disease exacerbation in SLE. Arth. Rheum. 33: 634-643.
Halbert, S.P., Karsh, J., Anken, M. 1981. Studies on autoantibodies to deoxyribonucleic acid and deoxyribonucleoprotein with enzymeimmunoassay (ELISA). J. Lab. Clin. Med. 97: 97-111.
Feltkamp, T.E.W., Kirkwood, T.B.L., Maini, R.N., Aarden, L.A. 1988. The first international standard for antibodies to double stranded DNA. Ann. Rheum. Dis. 47: 740-746.
Data on file and available on request.
Isenberg, D.A., Schoenfeld, Y., Schwartz, R.S. 1984. Multiple serologic reactions and their relationship to clinical activity in systemic lupus erythematosus, Sjögren’s Syndrome and rheumatoid arthritis. Arthritis Rheum. 27: 132-138.
HHS Publication No. 93-8395, 3rd ed. May 1993. Biosafety in Microbiological and Biomedical Laboratories. Washington, DC: US Department of Health and Human Services.
Manual Guide – Safety Management No. CDC-22 Decontamination of Laboratory Sink Drains to Remove Azide Salts. April 30, 1976. Atlanta, GA: Centers for Disease Control.