Substrate Plasma, Deficient in Factor VIII (Substrate Plasma VIII) according to TU 9398-060-05595541-2016
The kit is designed for determining the activity of blood coagulation Factor VIII (FVIII) in the plasma of patients, fresh-frozen donor plasma (FFDP), and cryoprecipitate using a one-stage clotting method. It aims to diagnose hemophilia A and thrombophilia, as well as assess the quality of FFDP and cryoprecipitate. It can be used for manual methods as well as on all types of automatic and semi-automatic coagulometers.
Principle of the Method: Upon adding diluted test plasma to substrate-deficient plasma, correction of all coagulation factors occurs except for Factor VIII. Therefore, the activated partial thromboplastin time (APTT) of the mixture of diluted test and substrate plasma, deficient in Factor VIII, depends solely on the activity of FVIII in the test plasma. FVIII activity is determined using a calibration curve with dilutions of a calibrator plasma with a known FVIII activity.
Composition of Kits: KM-6:
Substrate Plasma VIII (1 ml/vial) — 3 vials; KM-6/1:
Substrate Plasma VIII (1 ml/vial) — 6 vials; KM-6/2:
Substrate Plasma VIII (1 ml/vial) — 1 vial.
One vial is intended for conducting 20 analyses with an expenditure of 0.05 ml of the reagent per analysis. Interpretation of Results: In the normal plasma of healthy individuals, the activity of Factor VIII is 50 — 150%. Levels of Factor VIII Activity in Normal and Pathological Conditions:
Factor VIII Activity, % Condition Greater than 150 Renal insufficiency
Diabetes Thrombophilic condition
Use of hormonal contraceptives
50 to 150 Normal
25 to 49 Hemophilia A,
mild form 5 to 24 Hemophilia A,
moderate form 1 to 5 Hemophilia A,
severe form Less than 1 Hemophilia A, very severe form Normal and pathological values of Factor VIII activity should be monitored using Control Plasma, code KM-2, and Pathoplasma VIII, code KM-8/9.
