The 5-PLASMA Bivalirudin AMR Verification Kit is an in vitro diagnostic reagent kit intended for the verification of the Analytical Measurement Range (AMR) of assays used to quantify bivalirudin activity or concentration in human plasma. The kit consists of five levels of plasma-based materials containing defined concentrations of bivalirudin, covering the clinically relevant measurement range of the associated assay.The kit is designed for laboratory use to verify that a coagulation analyzer or assay method performs accurately and linearly across its claimed analytical measuring range for bivalirudin. It is not intended for direct diagnostic use or patient result reporting.
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and/or therapeutic monitoring of a direct thrombin inhibitor oral anticoagulant (e.g., dabigatran, argatroban, hirudin) in a clinical specimen, by determining its ability to inhibit the activity of activated coagulation factor IIa, also referred to as thrombin.
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