Human Anti-dsDNA ELISA (IgG) Kit
Kit Size: 96 wells/kit
Typical results
(Example only, not for calculation of actual results)
Calibrator* | Concentration (IU/mL) | OD450 (Blanked) |
1 | 600 | 1.149 |
2 | 400 | 0.809 |
3 | 200 | 0.594 |
4 | 100 | 0.350 |
5 | 80 | 0.265 |
6 | 30 | 0.180 |
7 | 20 | 0.163 |
Negative Control | 0 | 0.049 |
Positive Control | 210 | 0.538 |
*Calibrator standardised against International Standard WHO Wo/80.
Cut-off | IU/mL |
Negative | < 25 IU/mL |
Positive | ≧ 25 IU/mL |
*This cut off has been validated at ImmunoDiagnostics. However, we recommend each laboratory establish its own reference ranges of anti-dsDNA levels to distinguish healthy and pathological subjects, as well as include its own internal control samples in the assay.
INTRODUCTION
The dsDNA-specific autoantibodies (anti-dsDNA) are considered a specific marker for systemic lupus erythematosus (SLE), due to the high clinical associations.
The presence of anti-dsDNA autoantibodies in other pathological conditions and in healthy subjects is very rare (< 0.5%). In contrast, they may be present in SLE patients even before they develop clinical symptoms.
Therefore, regular measurement of anti-dsDNA autoantibodies in blood is important for early diagnosis, as well as monitoring the progression of SLE.
ASSAY CHARACTERISTICS
Clinical Evaluation
Sensitivity
79.69% (n=64)
Specificity
96.77% (n=40)
Inter-Assay Precision
Sample
IU/mL (n=20)
CV
1
394
2.6%
2
144
8.4%
3
81
9.4%
Intra-Assay Precision
Sample
IU/mL (n=20)
CV
1
375
2.5%
2
120
8.4%
3
73
9.3%
Sample Type: Serum and plasma
Storage : 4°C
References:
1.D. A. Isenberg, et al. Fifty Years Of Anti-ds Dna Antibodies: Are We Approaching Journey's End? Rheumatology, Vol. 46, No. 7, Pp. 1052–1056, 2007.
2.G. C. Tsokos. Systemic Lupus Erythematosus. The New England Journal Of Medicine, Vol. 365, No. 22, Pp. 2110–2121, 2011.
3.E. Cozzani, et al. Serology Of Lupus Erythematosus: Correlation Between Immunopathological Features And Clinical Aspects,” Autoimmune Diseases, Vol. 2014, Article Id 321359, 13 Pages, 2014.
DATA SHEET