Prothrombin Control

КМ-17

Registration Certificate

Description Instruction Manual Registration Certificate

Plasma Controls for Monitoring the Accuracy of INR Determination during Oral Anticoagulant Therapy (3 levels) (Prothrombin Control) according to TU 9398-056-05595541-2015

The set of Prothrombin Controls is intended for monitoring the accuracy and reproducibility of International Normalized Ratio (INR) determination and prothrombin as a percentage of the norm in blood plasma, both manually and on automatic analyzers.

The determination of prothrombin time is a highly sensitive screening test that detects abnormalities in the external blood coagulation pathway factors (Factors II, V, VII, and X) and is recommended for:

Monitoring therapy with indirect anticoagulants;
Diagnosing inherited and acquired coagulopathies;
Diagnosing liver diseases.

Prothrombin Control is a pool of plasma obtained from no fewer than 20 donors aged 20-40 years, with artificially reduced levels of prothrombin complex factors.

Method principle: Prothrombin Controls are analyzed simultaneously with the test plasma when performing the prothrombin time (PT) test using various thromboplastins certified according to the International Sensitivity Index (ISI). The investigated control material should fall within the range of values specified in the passport for this reagent batch.

Composition of the set:

Prothrombin Control Level 1 (1 ml/vial) – 1 vial;
Prothrombin Control Level 2 (1 ml/vial) – 1 vial;
Prothrombin Control Level 3 (1 ml/vial) – 1 vial.

One vial of plasma is intended for conducting 10 macro-analyses or 20 micro-analyses, with a consumption of 0.1 ml or 0.05 ml of plasma per analysis, respectively.