Hemocompatibility

Hemocompatibility tests are in-vitro assays used to assess the possibility of a test article to cause adverse effects on red blood cells (hemolysis), thrombosis, coagulation, platelets and complement system.

Hemocompatibility Testing Services

Hemocompatibility tests are in-vitro assays used to assess the possibility of a test article to cause adverse effects on red blood cells (hemolysis), thrombosis, coagulation, platelets and complement system.  Test article devices are tested by exposure directly to the blood or plasma samples.

Testing Methods and Capabilities

  • Beta-thromboglobulin (BTG)
  • Complement Activation – C3a, SC5b-9
  • Hemolysis – rabbit, human, mechanical
  • In Vitro Hemocompatibility (IVH, Complete Blood Count)
  • Platelet Aggregation
  • Platelet and Leukocyte Binding
  • Prothrombin Time (PT)
  • Unactivated Partial Thromboplastin Time (UPTT)

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
BTG12 cm² <0.5 mm thick, 6 cm² ≥0.5 mm thick, or 0.4 g per unit and at least 3 units, or multiples of 33-4 weeks
Complement Activation Direct Contact12 cm² <0.5 mm thick, 6 cm² ≥0.5 mm thick, or 0.4 g per unit and at least 3 units, or multiples of 33-4 weeks
Complement Activation Indirect Contact60 cm² <0.5mm thick, 30 cm² ≥0.5 mm thick, or 2 g3-4 weeks
Hemolysis ASTM Method42 cm² <0.5 mm thick, 21 cm² ≥0.5 mm thick, or 1.4 g per unit and at least 6 units, or multiples of 6 if units are less than 21 cm2 , 42 cm2 or 1.4 g2-3 weeks
Hemolysis Autian Method
60 cm² <0.5mm thick, 30 cm² ≥0.5 mm thick, or 2 g2-3 weeks
In-vivo Thrombogenicity in Dog2 units, at least 15 cm in length, with predicate control5-6 weeks
IVH/Platelet Leukocyte Binding Direct Contact18 cm² <0.5 mm thick, 9 cm² ≥0.5 mm thick, or 0.6 g per unit and at least 3 units, or multiples of 32-3 weeks
IVH/Platelet Leukocyte Binding Indirect Contact60 cm² <0.5mm thick, 30 cm² ≥0.5 mm thick, or 2 g2-3 weeks
Platelet Aggregation Direct Contact12 cm² <0.5 mm thick, 6 cm² ≥0.5 mm thick, or 0.4 g per unit and at least 3 units, or multiples of 33-4 weeks
Platelet Aggregation Indirect Contact60 cm² <0.5mm thick, 30 cm² ≥0.5 mm thick, or 2 g3-4 weeks
UPTT/PT Direct Contact12 cm² <0.5 mm thick, 6 cm² ≥0.5 mm thick, or 0.4 g per unit and at least 3 units, or multiples of 32-3 weeks
UPTT/PT Indirect Contact60 cm² <0.5mm thick, 30 cm² ≥0.5 mm thick, or 2 g2-3 weeks