BIOPHEN™ Dabigatran Control Low
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BIOPHEN™ Dabigatran Control Low (225001) is a Dabigatran quality control plasma set, low range. Manufactured by HYPHEN BioMed.
Intended Use
The BIOPHEN™ Dabigatran Control kits consist of lyophilized human plasmas, spiked with Dabigatran at various concentrations, for the quality control of Dabigatran assays.
They are titrated and optimized for the assay of Dabigatran by anti-IIa method.
Summary and Explanation
Technical These controls are proposed for the quality control of anti-IIa clotting and chromogenic assays of Dabigatran in plasma (HEOCLOT™ Thrombin Inhibitors and BIOPHEN™ DTI, low range / standard range).
Clinical Dabigatran is the active moiety of the oral direct anticoagulant anti-thrombin pro-drug, Dabigatran etexilate (Pradaxa®), used for both curative and preventive purposes. Though monitoring is not needed in treated patients, measurement in human plasma may be of use in certain cases, particularly in the event of emergency surgery or of suspected overdosage (bleeding risk).
Reagents
CI Control I: Lyophilized human plasma containing a titrated quantity of Dabigatran of approximately 25 ng/mL. CII Control II: Lyophilized human plasma containing a titrated quantity of Dabigatran of approximately 75 ng/mL.
C1 Control 1: Lyophilized human plasma containing a titrated quantity of Dabigatran of approximately 100 ng/mL. C2 Control 2: Lyophilized human plasma containing a titrated quantity of Dabigatran of approximately 300 ng/mL.
The control plasmas contain 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.
BIOPHEN™ Dabigatran Control Low REF 225001 ➔ CI 6 vials of 1 mL, CII 6 vials of 1 mL
UKCA
