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INNOVANCE® Heparin Assay In vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFI) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS® XP System in the clinical laboratory. For use with plasma from patients undergoing heparin anticoagulant therapy with either UFH or LMWH. The performance of this device has not been established in neonate and pediatric patient populations. INNOVANCE® Heparin Calibrator For calibration of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma. INNOVANCE® Heparin UF and LMW Controls For quality control of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.

The INNOVANCE® Heparin assay is a one stage chromogenic assay. The reagent kit consists of two components. One component (INNOVANCE Heparin Reagent) contains Coagulation Factor Xa (Xa), the other (INNOVANCE Heparin Substrate) a chromogenic substrate specific for Xa. Upon mixing of INNOVANCE Heparin Reagent and INNOVANCE Heparin Substrate, Xa converts the chromogenic substrate into two products, one of them is paranitroaniline. The formation of paranitroaniline can be quantified by the coaqulation analyzer employing light absorption at a specific wavelength (405 nm). In the presence of a heparin containing sample the formation of paranitroaniline will be reduced in a time dependent manner. This is due to inhibition of Xa by the heparin/antithrombin (AT) complex. This complex is formed in the patient's plasma and competes with the substrate conversion by Xa. The concentration of the complex is not only dependent on the concentration of heparin but also on the availability of the patient's endogenous antithrombin. By comparison to a reference curve the heparin activity of the sample can be quantified. To reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture. The INNOVANCE® Heparin Calibrator consists of 5 calibrator levels. INNOVANCE® Heparin Calibrator 1 represents plasma containing no heparin. INNOVANCE® Heparin Calibrator 2, 3, 4 and 5 contain defined activities of LMWH and are calibrated against the World Health Orqanization (WHO) International Standards for UFH and LMWH. The calibrator levels are used to establish a reference curve (calibration curve) which then can be employed to quantify the heparin activity of UFH and LMWH containing plasmas. The INNOVANCE® Heparin Controls consist of plasmas containing defined activities of either UFH or LMWH. Recovery of these controls within their assigned ranges indicates proper functionality of the assay system.