Thrombin generation test

Quantitative determination of activated coagulation factor XI as an impurity in therapeutic immunoglobulins from Chinese blood fractionation companies

L. Ma, Sun, P., Lin, F. Z., Diao, G., and Li, C. Q., Quantitative determination of activated coagulation factor XI as an impurity in therapeutic immunoglobulins from Chinese blood fractionation companies, vol. 12, pp. 2556-2561, 2013.

Residual activated coagulation factor XI (FXIa) has been suggested to play an important role in thromboembolic events associated with the use of intravenous immunoglobulin (IVIG) lots. This study investigated the predominant plasma proteases in 42 IVIG lots from 4 Chinese manufacturers. In one-stage clotting assays, the procoagulant activities of factors II, VII, IX, X, XI, and XII were quantified. Non-activated partial thromboplastin time and a modified thrombin generation test served as global and FXIa-specific clotting assays, respectively.

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