INOVA Diagnostics, Inc. | 708200 NOVA Lite™ dsDNA Crithidia luciliae

NOVA Lite™ dsDNA Crithidia luciliae

708200

For In Vitro Diagnostic Use
CLIA Complexity: High

Intended Use:
NOVA Lite™ dsDNA Crithidia luciliae is an indirect immunofluorescent assay for the screening and semi quantitative determination of anti-double stranded DNA (dsDNA) in human serum. The presence of anti-double stranded DNA can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus (SLE).

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Overview: Systemic Lupus Erythematosus (SLE)
While the commonly used Anti-Nuclear Antibody (ANA) tests are sensitive screening assays for SLE and other connective tissue diseases, they are by no means specific for SLE. Because of this, all positive ANA samples should be tested for specific autoantibodies to double stranded DNA (dsDNA). The presence of autoantibodies to dsDNA strongly indicates SLE; however, absence of these antibodies does not rule out SLE in all cases.

Autoantibodies to dsDNA occur almost exclusively in patients with systemic lupus erythematosus and as such are considered marker antibodies. Autoantibodies to dsDNA have been included in the 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus by an Arthritis and Rheumatism Association sub committee.¹

A variety of methods have been employed over the years to detect autoantibodies to dsDNA. These methods include complement fixation², passive agglutination³ and RIA.^{4 6} The current gold standard for dsDNA testing uses the hemoflagellate, Crithidia luciliae. This single-cell organism possesses a giant mitochondrion containing a highly condensed mass of circular dsDNA.⁷ This mass of dsDNA, known as the kinetoplast, appears to be free of histones or other mammalian nuclear antigens.^7,8 It serves as a sensitive and specific substrate for detecting autoantibodies to dsDNA.

Want to learn more about the Crithida luciliae assay? http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=272167

Want to learn and understand more about SLE? http://www.medicinenet.com/systemic_lupus/article.htm

Tan EM, et al.: The 1982 Revised Criteria for the Classification of Systemic Lupus Erythematosus. Arthritis and Rheumatism 25: 1271 1277, 1982.
Arana R, Seligmann M: Antibodies to native and denatured deoxyribonucleic acid in systemic lupus erythematosus. J. Clin. Invest. 46: 1867 1882, 1967.
Inami YH, Nakamura RM, Tan EM: Microhemagglutination test for the detection of native and single stranded DNA antibodies and circulating DNA antigen. J. Immunol. Methods 3: 287 300, 1973.
Aarden LA, Lakmaker F, de Groot ER, et al.: Detection of antibodies to DNA by radioimmunoassay and immunofluorescence. Scand. J. Rheu. Suppl. 11: 12 19, 1975.
Fish F, Ziff M: A sensitive solid phase microradioimmunoassay for anti double stranded DNA antibodies. Arthritis and Rheumatism 24: 534 543, 1981.
Pincus T, Schur P, Rose JA, et al.: Measurement of serum DNA binding activity in systemic lupus erythematosus. The New England J. of Medicine 281: 701 705, 1969.
Aarden LA, de Groot ER, Feltkamp TE: Immunology of DNA. III. Crithidia luciliae, a simple substrate for the detection of anti dsDNA with immunofluorescence techniques. Ann. NY Acad. Sci. 254: 505 515, 1975.
Crowe W, Kusher I: An immunofluorescent method using Crithidia luciliae to detect antibodies to double stranded DNA. Arthritis and Rheumatism 20: 811 814, 1977.