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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 Hemophilia A and B patients 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.

The ConcizuTrace ELISA is a manual assay performed by qualified healthcare professionals on the microplate reader qualified by Randox.

For prescription use only.

The ConcizuTrace ELISA is based on a standard sandwich enzyme-linked immunosorbent assay (ELISA) method in a classic 96-well plate format used for detection of concizumab in human plasma.

The assay contains the following components:

• Microtiter Plate – a 96-well plate coated with Tissue Factor Pathway Inhibitor (TFPI)
• ELISA Diluent/Wash Buffer Concentrate – buffer contains detergent and preservatives
• Assay Buffer – buffer containing detergent, blockers, and preservatives
• Acidification/ Neutralization Plate – blank microtiter plate
• Acetic Acid – 12% acetic acid
• Neutralizing Solution – buffer containing detergent, blockers, and preservatives
• Conjugate – labeled with horse radish peroxide (HRP) in stabilizing solution
• TMB Substrate – tetramethylbenzidine substrate supplied ready to use
• ELISA Stop Solution – acidic solution
• ConcizuTrace Calibrators – eight vials containing lyophilized plasma each with a different concizumab concentration
• ConcizuTrace QC – three vials containing lyophilized plasma (low, medium or high concizumab concentration)

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