4041 – Anti-ß2 GP-I

Highlights

• Use of IgG and/or IgM antibodies against β2-glycoprotein I (β2-GP I)
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Short incubation times (60 min / 30 min / 15 min) at room temperature
• Quantitative determination of IgG and/or IgM antibodies
• Accurate diagnostic sensitivity and specificityfor anti-phospholipid antibody syndrome (APAS)
• High precision and linearity within the measurement range
• CE marked
• Automatable


Intended Purpose

The Anti-ß2-GP-I is a quantitative enzyme-linked immunoassay for the determination of IgG and / or IgM antibodies against β2-glycoprotein I (β2-GP I) in human serum. The Anti-ß2-GP-I 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

Patients with anti-phospholipid antibody syndrome (APAS) or systemic lupus erythematosus (SLE) produce autoantibodies that react to negatively charged phospholipids. Clinicians routinely detect these autoantibodies, which play an essential role in diagnosing systemic autoimmune diseases.

In autoimmune patients, phospholipid antibodies seem to recognize phospholipids associated with plasma protein cofactors, e.g. β2 glycoprotein-I (β2-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 β2-GP-I, an interaction that leads to conformational changes of the protein and the creation of new epitopes recognized by autoimmune phospholipid autoantibodies.

Publications

Product Specifications

Title Anti-ß2 GP-I
Product code 4041
Indication Anti-phospholipid antibody syndrome (APAS)
Description Enzyme immunoassay for the determination of IgG and / or IgM antibodies against β2-glycoprotein I (β2-GP I) in human serum
Format Microtiter plate coated with β2-glycoprotein I
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (89 x 1) + 5 x Calibrators + 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.