The purpose of this test method is to assist in the determination of the thrombus formation potential of medical materials exposed to human whole blood. Through the evaluation of surface-induced activation, the subsequent adherence to a material, and depletion of platelets and leukocytes (WBC's) from blood, a material's thrombus formation potential can be assessed. If a significant decrease in platelets is observed in whole blood when compared to a blank control, it is implied that the tested material has the potential to induce an in vivo thrombogenic response [1].

Although positive controls are outlined in the current guidance document: ASTM F2888-13 (Standard test method for platelet leukocyte count—An in vitro measure for hemocompatibility assessment of cardiovascular materials [1]), such as latex, black rubber, and glass. A simple and more reproducible positive control material is needed. Overall, the identified positive controls have...

Reference

Reference
1.
ASTM
,
2013
, “
Standard Test Method for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials (Active Standard)
,” ASTM International, West Conshohocken, PA, Standard No. ASTM F2888.
You do not currently have access to this content.