5012 – Anti-Phospholipid 10 Dot
The Anti-Phospholipid 10 Dot is a qualitative line immunoassay for the determination of IgG or IgM antibodies against phospholipids and serum proteins in human serum. The Anti-Phospholipid 10 Dot is intended as an aid in the diagnosis of anti-phospholipid antibody syndrome (APAS) in conjunction with other clinical and laboratory findings.
Anti-phospholipid antibody syndrome (APAS), an autoimmune disorder evident by clinical symptoms such as thrombocytopenia, arterial (venous) thrombosis, and recurrent foetal loss, as well as systemic lupus erythematosus (SLE), is characterized by the presence of autoantibodies reactive to negatively charged phospholipids.
The detection of such autoantibodies is well established and plays an essential role in the diagnostics of systemic autoimmune diseases.
In autoimmune patients, phospholipid antibodies seem to recognize phospholipids associated with plasma protein cofactors, e.g. ß2 glycoprotein-I (ß2 GP-I), a serum protein with a molecular weight of ca. 50 kDa, that affects platelet aggregation and coagulation. Negatively charged phospholipids such as Cardiolipin interact with the positively charged fifth domain of ß2 GP-I, an interaction that leads to conformational changes of the protein and the creation of new epitopes recognized by autoimmune phospholipid autoantibodies. In other words, anti-cardiolipin antibodies are commonly used for the diagnosis of APAS. Antibodies to the other phospholipids are especially used for the differential diagnosis, if anti-cardiolipin antibodies are negative.
Line immunoassays are frequently used for the determination of specific antibodies directed against multiple antigens. The test strips are coated with various antigens in consistent intervals. If antibodies are present in the patient´s sample, they bind to the respective antigens. A secondary antibody conjugated with the enzyme horseradish peroxidase detects the generated immune complexes. A colorless substrate is converted into a colored, insoluble product. The signal intensity of the precipitated reaction product is proportional to the antibody activity in the sample.
The Anti-Phospholipid 10 Dot is designed for manual professional in vitro diagnostic use.
|Title||Anti-Phospholipid 10 Dot|
|Indication||Anti-phospholipid antibody syndrome|
|Description||Line immunoassay for the qualitative determination of IgG or IgM antibodies against phospholipids and serum proteins in human serum|
|Format||Test strips coated with cardiolipin, phosphatidic acid, phosphatidylcholine, -ethanolamine, -glycerol, -inositol, -serine, annexin V, β2-glycoprotein I and prothrombin|
|Total incubation time||55 min.|
|Sample volume||30 µL serum|
|No. of determinations||20 x 10|