ConcizuTrace™ ELISA (CZM) - Clinical chemistry therapeutic drug monitoring IVDs

Intended purpose

For in vitro diagnostic use. The ConcizuTrace™ ELISA (Enzyme Linked Immunosorbent Assay) is intended for the quantitative measurement of concizumab concentration in human 3.2% citrated plasma samples from Haemophilia A and B patients (with and without inhibitors) after 4 weeks from the initiation of treatment with concizumab. The measurement of concizumab concentration is used for dose adjustment decision in accordance with the drug label. Concizumab concentration (X) at clinical cutoff: Adjusted concizumab dose: X < 200 ng/mL: Dose adjustment to 0.25 mg/kg 200 ng/ml ≤ X ≤ 4000 ng/mL: No dose adjustment (dose kept at 0.20 mg/kg) X > 4000 ng/mL: Dose adjustment to 0.15 mg/kg X = Concentration level in patient sample The ConcizuTrace™ ELISA is a manual assay intended for use by trained laboratory professionals.

Functional description

The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals.