



BIOPHEN™ V-L Plasma Calibrator
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BIOPHEN™ V-L Plasma Calibrator (222401) is a kit of Human Plasmas for the calibration of Factor V-Leiden assays by clotting method. Manufactured by HYPHEN BioMed.
Intended Use
The BIOPHEN™ V-L Plasma Calibrator kit consists of undiluted lyophilized human plasmas, titrated at various concentrations of Factor V-Leiden (FV-L), for the calibration of FV-L assay.
It is titrated and optimized for the assay of FV-L by clotting method.
Summary and Explanation
Technical Activated Protein C plays a role of regulator in the coagulation process by specifically inactivating activated Factors V (Va) and VIII (VIIIa), in the presence of co-factors. The resistance phenomenon to activated Protein C (APC) is due in more than 90% of cases to the R506Q mutation of Factor V called “Factor V Leiden”. This mutation in Factor V exon 10 (1691 G → A) substitutes arginine at position 506 by glutamine, prevents this site cleavage by APC.
These calibrators are used to establish the calibration curve for clotting assay of FV-L in plasma (HEMOCLOT™ Quanti. VL).
Clinical FV-L mutation is the most common hereditary thrombophilia risk factor. Its prevalence is about 5% in Caucasian populations. Patients carrying FV-L mutation have an increased risk of venous thrombosis, 3 to 7 fold in heterozygotes and up to 80 fold in homozygotes.
This genetic anomaly can be evidenced by clotting assay in the presence or absence of APC.
Reagents
CAL1 Calibrator 1: Undiluted lyophilized human plasma, containing a titrated quantity of FV-L of approximately 10% (plasma presenting APC resistance) (level 1). CAL2 Calibrator 2: Undiluted lyophilized human plasma, containing a titrated quantity of FV-L of approximately 25% (plasma presenting APC resistance) (level 2). CAL3 Calibrator 3: Undiluted lyophilized human plasma, containing a titrated quantity of FV-L of approximately 50% (plasma presenting APC resistance) (level 3).
Each kit contains 3 vials of 0.5 mL for each calibrator (CAL1, CAL2, and CAL3).
Calibrator plasmas contain stabilizing agents.
The calibrator 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.
Note: The 1:10 dilution of CAL3 in Imidazole buffer allows obtaining the first point of the calibration curve, at about 100% of FV-L (the exact concentration is twice the concentration “C” indicated on the corresponding flyer).
CE-Mark - Professional Use
UKCA