This company has received FDA clearance for three new Immunosimplicity test kits: anti-Cardiolipin Screen, anti-Cardiolipin IgG/IgM, and anti-Cardiolipin IgA. The kits can be used either manually or as part of the MAGO Plus Automated EIA system, using a simple, standard EIA methodology.
These tests can assist physicians in assessing the risk of thrombosis in patients with systemic lupus erythematosus (SLE) or SLE-like disorders. Autoantibodies directed against phospholipids, and anti-cardiolipin in particular, have been associated with venous thrombosis, arterial thrombosis and spontaneous abortions. Anti-cardiolipin antibodies have also been associated with pregnancy-induced hypertension, pre-eclampsia and gestational diabetes. The term anti-phospholipid syndrome is often used to describe these conditions.
The three 96-test kits feature color-coded ready-to-use reagents, room temperature incubations, convenient 96-well breakaway plates and a 12-month shelf life. Results are available in less than two hours.
Keywords: autoimmune, test kit, thrombosis, pregnancy