Leukocytes Activation

Adverse interactions between blood and blood-contacting medical device can cause activation and destruction of blood components, which results in decrease of blood cells and formation of thrombus. Therefore, hemocompatibility is one of the most important criteria for the successful in vivo applicability of blood-contacting medical device. According to ISO 10993-4, analysis of leukocytes activation before and after the incubation of medical device extract with fresh human blood can be used to evaluate the hemocompatibility of medical device.

STEMart provides in vitro leucocytes activation test 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

Leukocyte Activation Test Service

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

• External communicating devices in contact with circulating blood
• Atherectomy devices
• Blood monitors
• Blood storage and administration equipment, blood collection devices, extension sets
• Extracorporeal membrane oxygenator system
• Hemodialysis/hemofiltration equipment
• Percutaneous circulatory support devices
• Catheters, guidewires, intravascular endoscopes, intravascular ultrasound, laser systems, retrograde coronary perfusion catheters
• Cell savers
• Devices for absorption of specific substances from blood
• Donor and therapeutic apheresis equipment
• Implant devices placed largely or entirely within the vascular system
• Annuloplasty rings, mechanical heart valves
• Intra-aortic balloon pumps
• Total artificial hearts, ventricular-assist devices
• Embolization devices
• Endovascular grafts
• Implantable defibrillators and cardioverters
• Pacemaker leads
• Leukocyte removal filter
• Prosthetic (synthetic) vascular grafts and patches
• Stents
• Tissue heart valves
• Tissue vascular grafts and patches
• Vena cava filters

Test Markers for Leukocytes Activation

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

• Reactive oxygen species (ROS) by chemiluminescence
• Release of elastase from PMN granulocytes by ELISA
• Expression of CD 11B on the surface of leukocytes with fluorescence-activated cell sorting (FACS)

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

Reference

• Weber, M., et al. "Blood-contacting biomaterials: in vitro evaluation of the hemocompatibility." Frontiers in bioengineering and biotechnology 6: 99 (2018).
• International Organization for Standardization. Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood. ISO 10993-4; (2002).