Special Precautions/Comments:

Method: Fluorescence enzyme immunoassay (FEIA). Calibration: WHO WO/80. EQA scheme: UK NEQAS scheme for Nuclear Antibodies. IQC: Commercial preparation

Interferences: None known

Interpretation: A NORMAL result is < 10 IU/mL (NEGATIVE). An EQUIVOCAL result is 10 – 15 IU/mL. A POSITIVE result is > 15 IU/mL The results obtained by this method should serve as an aid to diagnosis and should not be interpreted as diagnostic in itself. Low levels of anti-native double stranded DNA antibodies do occur in other autoimmune diseases and in patients with early, treated or inactive lupus. Also, low levels of anti-native double stranded DNA antibodies have been reported in normal, apparently healthy individuals in the absence of the disease. Not all patients with SLE have antibodies to DNA. [3] Anti-dsDNA testing should be reserved for those patients who have a positive anti-nuclear antibody test.

Additional Information:

Indication:  Autoimmune disease, including SLE

Background Information: Serum auto-antibodies directed against antigens present in cell nuclei are a frequent finding across the spectrum of connective tissue diseases. Frequently involved autoantigens include DNA (single and double stranded), histones, deoxyribonucleoprotein and ribonucleoproteins (such as U1-RNP, SM, SS-A/Ro and SS-B/La). Identification of the antinuclear antibody (ANA) specificity can be extremely useful in the differential diagnosis and management of these diseases and may also have prognostic significance. Antibodies to native dsDNA are characteristic of the autoimmune disease, systemic lupus erythematosus (SLE). There is a body of evidence which suggests that circulating DNA/anti-DNA immune complexes play a role in the pathogenesis of SLE (particularly renal disease) [1]. In general, native DNA antibodies are not found in other rheumatic diseases, but if present, their titre is usually lower than those in SLE patients. They may be seen in autoimmune chronic active hepatitis (AICAH) and in rheumatoid arthritis (RA) treated with sulphasalazine. [2] In some cases, an increase in dsDNA antibody levels will precede SLE reactivation. The presence of dsDNA antibodies may precede the onset of SLE clinical symptoms by several weeks and may also indicate remission or control of SLE.

References: Isenberg DA, et al. Fifty years of anti-dsDNA antibodies: are we approaching journey’s end? Rheumatology. 2007. 46(7):1052-1056. Deshmukh US, Bagavant H, Fu SM. Role of anti-DNA antibodies in the pathogenesis of lupus nephritis. Autoimmunity Reviews. 2006. 5(6):414-418. [Ref 1] Rouquette AM, Desgruelles C. Detection of antibodies to dsDNA:an overview of laboratory assays. Lupus. 2006. 15(7):403-407. Riboldi P, et al. Anti-DNA antibodies:a diagnostic and prognostic tool for systemic lupus erythematosus? Autoimmunity. 2005. 38(1):39-45. [Ref 2] Kavanagh AF, Solomon DH. Guidelines for immunologic laboratory testing in the rheumatic diseases:anti-DNA antibody tests. Arthritis and Rheumatism. 2002. 47(5):546-555. [Ref 3] Egner W. The use of laboratory tests in the diagnosis of SLE. Journal of Clinical Pathology. 2000. 53:424-432. Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum. 1997. 40:1725.

See Also: ANA, dsDNA Crithidia

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