BIOPHEN™ Normal Control Plasma
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BIOPHEN™ Normal Control Plasma (223201) is a Normal Control Plasma for coagulation assay quality control. Manufactured by HYPHEN BioMed.
Intended Use
The BIOPHEN™ Normal Control Plasma kit is a set of normal citrated human plasma, lyophilized, intended for the quality control of some coagulation factors assays.
Summary and Explanation
Technical The following table shows the various parameters, which are measured using assays from HYPHEN BioMed or other manufacturers, and according to the package inserts:
| Parameter | Method |
| PT/INR/% and aPTT | Activity |
| Fibrinogen (Fbg) | Activity / Antigen |
| Thrombin Time (TT) | Activity |
| Lupus Anticoagulant (LA) | Activity |
| α2 – Antiplasmin (α2-AP) | Activity |
| Antithrombin (AT) | Activity / Antigen |
| Prothrombin (FII) | Activity |
| Factor V (FV) | Activity |
| Factor VII (FVII) | Activity |
| Factor VII + X (FVII + X) | Activity |
| Factor VIII:C (FVIII) | Activity |
| Factor IX (FIX) | Activity |
| Factor X (FX) | Activity |
| Factor XI (FXI) | Activity |
| Factor XII (FXII) | Activity |
| Factor XIII (FXIII) | Activity |
| Plasminogen (Plg) | Activity |
| Protein C (PC) | Clotting activity |
| Protein C (PC) | Chromogenic activity |
| Protein C (PC) | Antigen |
| Protein S (PS) | Clotting activity |
| Free Protein S (Free PS) | Antigen |
| von Willebrand Factor Antigen (vWF: Ag) | Antigen |
| ActPCr (% FVL) | Clotting (Quantitative) |
The BIOPHEN™ Normal Control Plasma is tested for the absence of Lupus Anticoagulant. It can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-r).
When the aPTT is performed with or without Activated Protein C (APC) the ratio obtained (aPTT + APC/aPTT) is ≥ 2.00. When tested with HEMOCLOT™ Quanti VL kit (CK065K) from HYPHEN BioMed, the expected value is <10% FVL.
Reagents
C1 Normal citrated human plasma, lyophilized.
12 vials of 1mL.
Control plasma contains stabilizing agents.
The control concentrations may vary slightly from one batch to another. For the assay, see the exact values indicated on the flyer provided with the kit used.
Antithrombin (AT)
Factor II (FII)
Factor IX (FIX)
Factor V (FV)
Factor VII (FVII)
Factor VII + X (FVII + X)
Factor VIII:C (FVIII:C)
Factor X (FX)
Factor XI (FXI)
Factor XII (FXII)
Factor XIII (FXIII)
Fibrinogen (FIB)
Lupus Anticoagulant (LA)
Plasminogen (PLG)
Protein C (PC)
Protein S (PS)
Prothrombin (FII)
PT/INR/aPTT
Thrombin Time (TT)
von Willebrand Factor Antigen (vWF: Ag)
α2-Antiplasmin (α2-AP)
CE-Mark - Professional Use
UKCA
