5012 – Anti-Phospholipid 10 Dot

Intended Purpose

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. 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 fetal 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., beta-2-glycoprotein-I (β2GPI), 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 β2GPI, 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.


Product Specifications

Title Anti-Phospholipid 10 Dot
Product code 5012
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

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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.