DIASTAT® anti-dsDNA - Discontinued
FDNA100
The DIASTAT® anti-dsDNA test is a quantitative/qualitative ELISA for the detection of IgG and IgM autoantibodies specific for double-stranded DNA (dsDNA) in human serum or plasma.
It is intended to aid in the diagnosis of systemic lupus erythematosus, and to monitor dsDNA antibody levels during treatment and remission. Autoantibody levels represent one parameter in a multicriterion diagnostic process and the detection of dsDNA autoantibodies by the ELISA technique is a simple, sensitive and reproducible method that can be standardised by reference to the World Health Organisation anti-dsDNA standard, Wo/80.
Antibodies against dsDNA are characteristic for systemic lupus erythematosus (SLE) and are one of the criteria for disease classification by the American College of Rheumatology. The presence of these antibodies has high diagnostic specificity for SLE (90%) and can be used to monitor the treatment effect in patients.
At a glance
| Product code | FDNA100 |
| Assay target | dsDNA antibodies |
| Size | 96 wells |
| Technology | ELISA |
| Read-out of results | Qualitative, Quantitative, |
| Range | 0-300 IU/mL |
| Assay time | 2h |
| Detection system | ALP/PMP read at 550 nm |
| Regulatory status | IVD, CE labeled, 510(k) FDA |
What's in the box?
- dsDNA-Coated Wells and Strip Holder, 12 × 8 well microtitre strips.
- 1 × 15mL Conjugate
- 1 × 15mL Substrate
- 1 × 15mL Stop Solution
- 2 × 25mL Wash Buffer Concentrate (16X)
- 1 × 25mL Sample Diluent 2, Concentrate (5X)
- 5 × 1.0mL Anti-dsDNA Standards, Human plasma
- 1 × 1.5mL Anti-dsDNA Reference Control, Human plasma
- 1 × 0.2mL Positive Control, Human plasma
- 1 × 0.2mL Negative Control, Human plasma
All reagents in the kit are ready for use except wash buffer concentrate, sample diluent concentrate, positive and negative control. All reagents should be stored at 2-8° C.
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