Measurement of complement activation by biomaterials by...

C - Chemistry – Metallurgy – 12 – Q

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C12Q 1/37 (2006.01) C07K 5/083 (2006.01) C07K 5/093 (2006.01)

Patent

CA 2242012

A process for determining complement activation due to contact between a biomaterial and a complement system, by incubating in vitro the biomaterial with the complement system and determining the formation of a complement convertase by using a substrate of the complement convertase and detecting substrate cleavage. The biomaterial after said incubation with the complement system may be separated therefrom and formation of a complement convertase may be determined with the separated biomaterial, the separated complement system or both. The complement convertase may be Factor B convertase, C3 convertase or C5 convertase, and the substrate may be a labeled oligopeptide comprising an amino acid sequence corresponding to the cleavage site of the complement convertase. Suitable labels are dyes, fluorochromes, radioactive atoms or groups, and enzymes. Either classical or alternative pathway complement activation, or both, are determined. The complement system may be a non-clotting derivative of blood, blood plasma or blood serum, including fibrinogen depleted forms, anticoagulated forms, and derivatives containing thrombin inhibitor. Complement convertase substrates suitable for use in the process are also disclosed.

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