КМ-16
Registration CertificatePlasma with certified values of coagulation, anticoagulation, and fibrinolytic system parameters (Multicalibrator) according to TU 9398-051-05595541-2014
Multicalibrator is a plasma calibrator designed for building calibration curves on automatic and semi-automatic coagulometers, biochemical analyzers, and aggregometers when determining hemostasis parameters:
• Prothrombin in % according to Quick; • International Normalized Ratio (INR); • Fibrinogen content according to Clauss, in g/L; • Activity of internal coagulation pathway factors VIII, IX, XI, and XII in %; • Activity of external coagulation pathway factors II, VII, X, %; • Factor XIII activity, in %; • von Willebrand factor activity (ristocetin co-factor activity), in %; • Antithrombin III activity, in %; • Protein C activity, in %; • Plasminogen activity, in %; • Plasmin inhibitor activity, in %.
Principle of action: The Multicalibrator is diluted with a buffer solution to obtain several solutions with known activity of hemostasis parameters. In all solutions, the corresponding hemostasis parameter is determined, and a calibration graph is constructed showing the clotting time (clotting methods) or optical density (chromogenic methods) depending on the activity of the investigated hemostasis parameter. The calibration graph is used to determine the activity of the investigated hemostasis parameter in the patient's plasma."
Note: The translation is provided for informational purposes and may require review by a subject matter expert for specific terminology and context.
Kit composition:
• Multicalibrator, lyophilized pooled plasma obtained from no less than 20 donors aged 20-40 years, stabilized with HEPES-citrate buffer (1 ml/vial) — 3 vials.
One vial of Multicalibrator is intended for conducting 20 analyses with a consumption of 0.05 ml of reagent solution per analysis.
