PRODUCT DESCRIPTION

For In Vitro Diagnostic Use. In EU: This Product is CE Marked. Health Canada Licensed. Chromogenic anti-Xa method for measuring homogeneously heparin (UFH) and Low Molecular Weight Heparin (LMWH), using the same calibration curve (kinetics method, one stage). The assay can also be used for testing heparin analogues, such as Sodium Danaparoid (Orgaran®), or Pentasaccharide (Fondaparinux). Automatic or Manual method.

For measuring the heparin concentration in patients’ plasma for monitoring the therapy and adjusting drug dosage. Available online.

PRODUCT CHARACTERISTICS

Total Assay Time: < 3 min Detection Threshold: 0.05 IU/mL Dynamic Range: 0 to 2 IU/mL Intra-Assay CV: < 3% Inter-Assay CV: < 5% No significant interference observed for Bilirubin concentrations < 0.1 mg/mL, hemoglobin concentrations < 2 mg/mL and triglycerides concentrations < 1.25 mg/mL added to plasma.

PRODUCT COMPONENTS

R1: 3 x 3 mL of chromogenic substrate specific for Factor Xa (SXa-11), lyophilized.

R2: 3 x 3 mL of bovine Factor Xa, lyophilized.

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PRODUCT APPLICATION