50401 – DotDiver Anti-Phospholipid IgG

Intended Purpose

The DotDiver Anti-Phospholipid IgG is a qualitative line immunoassay for the determination of IgG antibodies against phospholipids and serum proteins in human serum. The DotDiver Anti-Phospholipid IgG is intended as an aid in the diagnosis of anti-phospholipid antibody syndrome (APAS) in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

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. 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.

Product Specifications

Title DotDiver Anti-Phospholipid IgG
Product code 50401
Indication Anti-phospholipid antibody syndrome
Description Line immunoassay for the qualitative determination of IgG antibodies against phospholipids and serum proteins in human serum
Format Test strips coated with cardiolipin, phosphatidic acid, phosphatidylethanolamine, phosphatidylglycerol, phosphatidylinositol, phosphatidylserine, annexin V, ß2-glycoprotein I and prothrombin
Total incubation time 67 min.
Sample volume 30 µL serum
No. of determinations 24 x 9

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.