Normal Reference (Factor Assay Control) Plasma

FRNCP0105 – VisuCon-F Frozen Normal Control Plasma – 5 x 1ml Box (IVD)
FRNCP0125 – VisuCon-F Frozen Normal Control Plasma – 25 x 1ml Box (IVD)

Description

Normal Reference (Factor Assay Control) Plasma

The VisuCon-F Frozen Normal Plasma is a Normal Reference (Factor Assay Control) Plasma for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated partial thromboplastin time (APTT) and fibrinogen, in the normal range. Good laboratory practice requires that assays be calibrated over the relevant range and that controls be performed regularly to confirm assay calibration. The VisuCon-F Frozen Normal Control plasma is a pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.02M HEPES buffer, dispensed and rapidly frozen. This Normal Reference (Factor Assay Control) Plasma may be used to monitor the performance of coagulation assays for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX, X, XI, XII, antithrombin, Protein C, and Protein S.

This product is cleared for in vitro Diagnostic use by FDA, Health Canada and CE marked. Available for sale in the United States, Canada and select European countries.

Box containing 5 x 1 mL vials of frozen plasma, Prod. # FCSN0105
Box containing 25 x 1 mL vials of frozen plasma, Prod. # FCSN0125

Each box of VisuCon-F Frozen Normal Control Plasma contains a lot-specific Certificate of Analysis with the assigned reference ranges for each parameter. The reported reference ranges were determined against, where available, the SSC/ISTH secondary coagulation standard that is traceable to current WHO International Standards.

Preparation/Handling:

Thaw each vial at 37°C (+/- 1°C) in a water bath for 5 minutes. Invert gently before use.

Storage and Stability:

Once thawed, the plasma is stable for 8 hours at 2-8°C in original vial. Thawed material should be discarded after use and not be refrozen.

Assay Procedure:

After thawing the Control Plasma, use on coagulation instrument or assay system with corresponding reagents in accordance with established assay procedures for the quantitative determination of coagulation parameters. Refer to the lot specific Certificate of Analysis for the assigned range for each parameter. The results obtained for the control plasma will depend on various factors including types of reagents, factor deficient substrates and instrumentation therefore it is recommended that each laboratory establish its own mean values and expected reference ranges for quality control purposes using their particular instrument-reagent system.

Product Datasheet: VisuCon-F Normal Control Plasma