Reagent Kit for Determination of Blood Coagulation Factor IX Activity (Factor IX Test) according to TU 9398-021-05595541-2009
Intended for the determination of blood coagulation factor IX (f. IX) activity in the plasma of patients and in factor IX preparations using a one-stage clotting method for the diagnosis of hemophilia B, thrombophilia, and the assessment of the quality of factor IX preparations.
The Factor IX Test is designed to be used manually, as well as on automatic and semi-automatic coagulometers capable of registering clot formation in the presence of kaolin.
Deficiency of factor IX causes hemophilia B. Hemophilia B, like hemophilia A, is a severe hereditary disease characterized by spontaneous, often fatal bleeding, hemorrhages into joints leading to early disability. Even with a decrease in the deficient factor to 30% (normal range 50-150%), the disease manifests in a latent form and is detected after surgical interventions as profuse bleeding. These patients require lifelong replacement therapy with plasma products.
Method Principle: Upon adding substrate-deficient plasma to diluted test plasma, correction of all coagulation factors occurs except for f.IX. Therefore, the clotting time in the APTT test of the mixture of diluted test and substrate-deficient plasma for f.IX depends solely on the activity of f.IX in the test plasma.
Factor IX activity is determined using a calibration graph of dilutions of the calibrator plasma with a known f.IX activity. The values of f.IX activity are plotted on the X-axis. On the Y-axis, the clotting time values of each diluted sample of calibrator plasma in seconds are plotted. A calibration graph is drawn through the obtained points, which in semi-logarithmic coordinates should represent a straight line.
