Modified Thrombin Generation Assay: Application To The Analysis Of Immunoglobulin Concentrates
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چکیده
Intravenous immunoglobulins cause thromboembolic events at a frequency of 2-3%. Complications of this nature can be life threatening. Nevertheless, a test for thrombogenicity such as non activated partial thromboplastin time is not mandatory for these drugs. As a result of recent incidents we have performed experiments to evaluate a modified thrombin generation test for its ability to detect minute amounts of thrombogenic impurit ies in intravenous immunoglobulin preparations. We were able to show that this modified thrombin generation test is more sensitive than the Ph. Eur. assay for activated coagulation factors.
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