Complement Activation

The complement system consists of more than 20 small proteins which circulate in the blood and tissue fluids. Complement activation is a part of the innate immune system which attacks the cells plasma membrane to eliminate microorganisms and damaged cells.

Fig. 1 Complement activation pathways and assembly of the terminal pathway. (Tegla, Cosmin A., 2011)

Complement activation induced by a medical device can have harmful effects, such as tissue damage and inflammation.

STEMart provides in vitro screening of complement activating properties for medical device in contact with blood to help manufacturer demonstrate the regulatory compliance of product to blood/device interaction.

Standard

ISO 10993-4: 2002

Complement Activation Test Service

STEMart provides complement activation test for the medical device including but limited to:

• External communicating devices in contact with circulating blood
• Extracorporeal membrane oxygenator system
• Hemodialysis/hemofiltration equipment
• Percutaneous circulatory support devices
• Devices for absorption of specific substances from blood
• Donor and therapeutic apheresis equipment
• Implant devices placed largely or entirely within the vascular system
• Intra-aortic balloon pumps

Test Markers for Complement Activation

According to ISO 10993-4, the following items can be used as a marker for evaluation of complement activation.

• Complement split product from C3 (C3a)
• Complement split product from C5 (C5a)
• Terminal complement complex (TCC)
• Product of alternative pathway complement activation (Bb)
• Product of central C complement activation (iC3b)
• Product of classical pathway complement activation (C4d)
• Product of terminal pathway complement activation (SC5b-9)
• 50% total haemolytic complement (CH50)
• C3 convertase
• C5 convertase

Test Technology

ELISA

If you have additional questions about Complement Activation test service or would like to find out more about our services, please feel free to contact us.

References

• Tegla, Cosmin A., et al. "Membrane attack by complement: the assembly and biology of terminal complement complexes." Immunologic research 51.1: 45 (2011).
• International Organization for Standardization. Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood. ISO 10993-4; (2002).