CLIA Cardiolipin IgG
The chemiluminescence assay is intended for use as an aid in the diagnosis of antiphospholipid syndrome (APS) and other autoimmune diseases using IgG antibodies to cardiolipin in human serum or plasma.
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The chemiluminescence assay is intended for use as an aid in the diagnosis of antiphospholipid syndrome (APS) and other autoimmune diseases using IgG antibodies to cardiolipin in human serum or plasma.
| Catalog Number: | CL-CLG100 |
|---|---|
| Size: | 100 tests |
| Regulatory status: | CE IVD |
| Clinical topic: | Immunology & Autoimmune Diseases |
| Diagnostic panel: | Antiphospholipid Syndrome |
| Producer: | TestLine Clinical Diagnostics s.r.o. |
Support for the Diagnosis of Antiphospholipid Syndrome (APS) and Other Autoimmune Diseases
Cardiolipin, a phospholipid, is a major structural component of the inner mitochondrial membrane and is also present in the plasma membrane of certain prokaryotes. Because antibodies directed against cardiolipin alone commonly occur in infectious diseases, diagnostic assays therefore utilize a complex epitope composed of cardiolipin and β2-glycoprotein I.
The diagnosis of APS is based on a combination of clinical manifestations (such as a history of thrombosis, spontaneous miscarriage, thrombocytopenia, or stroke) and laboratory findings (including the presence of IgM/IgG autoantibodies against cardiolipin and β2-glycoprotein I, detection of lupus anticoagulant antibodies, and abnormalities in coagulation testing).
| Assay time | 30 min |
| Assay stability | 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C |
| Sample matrix | Plasma, Serum |
| Sample volume | 10 µL |
| Measuring range | 0–300 GPL/ml |
| Assay/kit content | Reagent Cartridge with specific reagents for the assay, magnetic beads, calibrators |
| Complementary products | Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer |
| Note | The kits are CE-IVD certified and intended for professional use. |