IVD Quantitative Assay for Factor VIII Activity - Vietnam Registration 2403237ĐKLH/BYT-HTTB

1. FACTOR VIII CHROMOGENIC is an in vitro diagnostic test to determine factor VIII (factor VIII) according to the WHO standard, to support the diagnosis and monitoring of factor VIII deficiency, whether congenital or acquired, in patients with bleeding disorders or at risk of factor VIII deficiency in human blood plasma, on automated, semi-automated and/or manual coagulation analyzers. In addition, factor VIII testing may be used to monitor factor VIII replacement therapy. ; 2. STANDARD PLASMA is used to calibrate the following tests: 1. Prothrombin time (PT) 2. Fibrinogen (Clauss method) 3. Factors of coagulation: II, V, VII, VIII, IX, X, XI, XII, XIII and vWF 4. Inhibitors: Antithrombin III, protein C, protein S, α2-antiplasmin, C1 inhibitor 5. Plasminogen Furthermore, STANDARD PLASMA is used as a diluent for some tests if specified in the application form of these tests. In addition, the sensitivity values mentioned for the ProC® test are provided to calculate the ProC® Global and ProC® Global/FV normalization ratios. ; 3. CONTROL N is a tested control material used to evaluate the accuracy and analytical variability of the following tests within the normal range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (APTT) 3. Thrombin time (TT) 4. Batroxobin time 5. Fibrinogen 6. Factors of coagulation: II, V, VII, VIII, IX, X, XI, XII, XIII and vWF 7. Inhibitors: Antithrombin III, protein C, protein S, α2-antiplasmin, C1 inhibitor 8. Plasminogen 9. ProC related analytes 10. Lupus anticoagulant. The values given were determined at Siemens Healthcare Diagnostics Products GmbH using the Siemens Healthineers test on mechanical and optical coagulation analyzers. ; 4. CONTROL P is a tested control material used to evaluate the accuracy and analytical variability of the following tests within the pathological range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (APTT) 3. Fibrinogen (Clauss method) 4. Factors of coagulation: II, V, VII, VIII, IX, X, XI, XII, XIII and vWF 5. Inhibitors: Antithrombin III, protein C, protein S, α2-antiplasmin, C1 inhibitor 6. Plasminogen 7. Thrombin time (a) The values were determined using the Siemens Healthineers test on mechanical and optical coagulation analyzers. (a) The application and reference values may differ in different countries.