4036 – Anti-ß2-GP-I Screen

Intended Purpose

The Anti-ß2-GP-I Screen is a semi-quantitative immunoassay for the determination of IgG, IgM and IgA antibodies against β2-glycoprotein I (β2-GP I) in human serum. The Anti-ß2-GP-I Screen 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 manual professional in vitro diagnostic use.

Diagnostic Relevance

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) are 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. b2 glycoprotein-I (β2GP-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 Anti-ß2-GP-I Screen
Product code 4036
Indication Anti-phospholipid antibody syndrome (APAS)
Description Enzyme immunoassay for the semi-quantitative determination of IgG, IgM and IgA antibodies against β2-glycoprotein I in human serum
Format Microtiter plate coated with human β2-glycoprotein I
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (93 x 1) + 1 x Calibrator + 2 x Controls

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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.