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

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

BACKGROUND

Anti double stranded DNA (anti-dsDNA) have been vital in the diagnosis of systemic lupus erythematosus (SLE) and they are produced by the immune system when it fails to differentiate self from non-self. Majority of patient with SLE are found to display antibodies against dsDNA for IgG, IgA and IgM class within their sera, these autoantibodies are usually associated with lupus nephritis.

Also, many studies have demonstrated the link of these subclass with certain parameters of the disease activity for example consumption of complement component C3, elevated erythrocyte sedimentation rate, acral necrosis, erythema, cutaneous vasculitis.

INTENDED USE

Human anti-dsDNA screen ELISA kit can be used for analysing in vitro quantitative levels of anti IgA, IgG and IgM autoantibodies to anti double stranded DNA (anti ds-DNA, anti-dsDNA) screen in human serum or plasma samples. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

CONTENT

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 (ds DNA screen) is bound to microwells.
Calibrator A-F: Concentration 0, 12.5, 25, 50, 100, 200 U/ml, made up from human anti-dsDNA screen.
Control Positive and Control Negative: Containing anti dsDNA screen antibodies in a serum/buffer matrix.
Sample Buffer (5x).
Enzyme Conjugate: Contains anti-human IgG, IgA and IgM antibodies, HRP labelled.
TMB Substrate.
Stop Solution.
Wash Buffer (50x).
Instruction for Use.
Certificate of Analysis.

SENSITIVITY

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

ASSAY CHARACTERISTICS

– Limit Of Detection (LOD): Functional sensitivity is 1 IU/ml.
– Measuring Range: 0 – 200 IU/ml.
– Results Interpretation: Negative: < 25 IU/ml, Positive: ≥ 25 IU/ml.
– Expected Values: Cut-off 25 IU/ml for samples from healthy blood donors.
– Linearity: 93 – 101%
– Intra Assay: 3.0 – 6.8%
– Inter Assay: 7.7 – 8.6%
– Interfering Substances: None
– Clinical Diagnosis: Sensitivity (83.2%), Specificity (98.0%), Overall agreement (89.4%).

REFERENCES

A recombinant topoisomerase I ELISA: screening for IgG, IgM and IgA anti-topo I autoantibodies in human sera. Clin Exp Immunol. (1992) 89 (3): 456-60. Verheijen R., et al.
Significance of levels of specific immunoglobulins to DNA in SLE patients’ sera detected by solid phase radioimmunoassay. J Invest Dermatol. (1979) 72 (2): 55-8. Heinzerling R.H., et al.
Analyzing pathogenic (double-stranded (ds) DNA-specific) plasma cells via immunofluorescence microscopy. Arthritis Res Ther. (2015) 17: 293. Winter O., et al.
Vomitoxin-induced dysregulation of serum IgA, IgM and IgG reactive with gut bacterial and self antigens. Food Chem Toxicol. (1992) 30 (6): 499-504. Rasooly L. and Pestka J.J.

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