Anti-dsDNA IgM ELISA Kit (Anti-Double Stranded DNA)


Human anti-dsDNA IgM ELISA kit is a method designed for determining in vitro quantitative concentrations of anti IgM autoantibodies to anti double stranded DNA (anti-dsDNA IgM, anti ds-DNA IgM) using human plasma and serum. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.


Anti double stranded DNA (anti-dsDNA) is vital in diagnosing lupus (systemic lupus erythematosus, SLE). These are a group of autoantibodies which are known as antinuclear antibodies (ANA). They are produced by the immune system when the body fails to distinguish self and non-self. The antibodies targeted against dsDNA tend to present in the active phase of SLE and for majority of cases the levels of the serum concentrations positively correlate with the severity of the disease.

IgM class anti dsDNA antibodies have been identified in approx. 50 % of the sera from patients with SLE, however, in contrast to IgA and IgG autoantibodies, the subclass IgM antibodies display no correlation with disease activity. There is a highly significant negative correlation lupus nephritis and IgM anti-dsDNA antibodies, indicating this may be a subset of lupus patients that is being protected against the risk of developing nephritis.


All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Divisible Microplate: Consisting of 12 modules of 8 wells each, human recombinant anti double stranded DNA (dsDNA IgM) is bound to microwells.
  • Calibrator A-F: Concentration 0, 12.5, 25, 50, 100, 200 U/ml,  made up from human anti-dsDNA IgM.
  • Control Positive and Control Negative: Containing anti dsDNA IgM antibodies in a serum/buffer matrix.
  • Sample Buffer (5x).
  • Enzyme Conjugate: Contains anti-human IgM antibodies, HRP labelled.
  • TMB Substrate.
  • Stop Solution: Contains acid.
  • Wash Buffer (50x).
  • Instruction for Use.
  • Certificate of Analysis.


The minimum detection sensitivity level of IgG antibodies to anti-dsDNA IgM (anti double stranded DNA antibodies, anti dsDNA IgM, anti ds-DNA IgM) using current human anti dsDNA IgM ELISA kit was 1.0 U/ml. The dynamic range for this assay is 12.5 – 200.0 U/ml.


– Results Interpretation: Serum from healthy blood donors display a Cut-Off: 20 U/ml.
– Intra Assay: 3.1 – 6.4%
– Inter Assay: 5.2 – 12.4%
– Sensitivity: 1.0 U/ml
– Specificity: Recognizes only autoantibodies specific for double-stranded DNA.
– Interfering Substances: None


  1. IgM antibodies against dsDNA in SLE. Clin Rev Allergy Immunol. (2008) 34 (3): 345-7. Review. Witte T.
  2. Initiation of systemic autoimmunity and sequence specific anti-DNA autoantibodies. Crit Rev Immunol. (1999) 19 (2): 117-26. Review. Radic M.Z., et al.
  3. IgM peak independently predicts treatment-free survival in chronic lymphocytic leukemia and correlates with accumulation of adverse oncogenetic events. Leukemia. (2015) 29 (2): 337-45. Rizzo D., et al.
  4. Quantitative analyses of C3b capture and immune adherence of IgM antibody/dsDNA immune complexes. J Immunol. (1989) 143 (11): 3626-31. Taylor R.P., et al.
  5. IgG and IgM autoantibody differences in discoid and systemic lupus patients. J Invest Dermatol. (2012) 132 (12): 2770-9. Chong B.F., et al.


  • Full Name: Anti-dsDNA IgM ELISA kit (Anti-Double Stranded DNA)
  • Reactivity: Human
  • Sample Type: Serum, Plasma
  • Sensitivity: 1.0 U/ml


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