Chromogenic assays

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510k cleared for in vitro medical diagnostic testing

Clotting, Deficient Plasmas, & Chromogenic Assays products are available worldwide

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.

Assay characteristics

Kit components

Applications

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 <1.25mg/mL.

R1: 4 vials of 15 mg of chromogenic substrate specific for factor Xa (SXa-11).

R2: 4 vials of about 15 µg of bovine Factor Xa.

Measuring the heparin concentration in patients’ plasma for monitoring the therapy and adjusting drug dosage.