CLIA dsDNA
Chemiluminescence kit for the detection of dsDNA antibodies in human serum or plasma.
Available
Chemiluminescence kit for the detection of dsDNA antibodies in human serum or plasma.
| Catalog Number: | CL-DNA050 |
|---|---|
| Size: | 50 tests |
| Regulatory status: | CE IVD |
| Clinical topic: | Immunology & Autoimmune Diseases |
| Diagnostic panel: | Rheumatic Diseases |
Antibodies to double-stranded DNA (anti-dsDNA) fall in the group of antinuclear antibodies. Anti-dsDNA is included in the Systemic Lupus International Collaborating Clinics classification criteria (SLICC) for SLE and is also outlined in the classification criteria for SLE of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR). The antibodies are considered highly specific for systemic lupus erythematosus (SLE). Antibodies to dsDNA are present during the active phase of the disease and are associated with lupus nephritis.
Testing for IgG antibodies to dsDNA is indicated in patients positive for a homogeneous structure of anti-cell antibodies (i.e., Antinuclear Antibodies: ANA) using the HEp-2 substrate by indirect immunofluorescence assay (IFA) along with SLE-compatible clinical features. The serum concentrations of anti-dsDNA may fluctuate with SLE disease activity. An increase in antibody levels may be associated with flares while decline or negative results may indicate response to treatment or disease remission.
Lower titres and low-affinity anti-dsDNA may be present in patients with other systemic diseases / immunopathological conditions (e.g. viral infections), very rarely also in healthy individuals.
Antigen Used: Purified native human dsDNA.
| Assay stability | 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C |
| Sample matrix | Serum, Plasma |
| Sample volume | 10 µL |
| Measuring range | 5-500 IU/ml |
| Assay/kit content | Reagent Cartridge with specific reagents for the assay, magnetic particles, calibrators |
| Complementary products | Wash buffer, Anchor® Tips, Stackable cuvettes, Trigger solutions |
| Note | The kits are CE-IVD certified and intended for professional use. |