Hemocompatibility: Trombogenicity – Partial Tromboplastin Time test (PTT). ASTM F2382-04: 2010 - Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT).
Test Accredited by ENAC (National Accreditation Entity).
Test with the Certificate of Good Laboratory Practices (GLPs).
Thromboembolic complications are one of the main problems that can occur with artificial organs and other medical devices that come into contact with blood. The evaluation of thromboembolic capacity is more complex than other hemocompatibility tests such as the hemolysis or pyrogenicity test, due to the complexity of the blood coagulation system. This test is one of those considered within the set of tests indicated to determine the hemocompatibility of a medical device that comes into contact with blood.
The partial thromboplastin time test (PTT: Partial Thrombopastin Time) is a general screening method to determine the ability of a medical device to activate the intrinsic pathway of coagulation. Medical devices that activate the intrinsic pathway of coagulation will shorten the partial thromboplastin time (PTT). The test determines the time in which a citrated plasma exposed to a medical device takes a long time to form a clot when exposed to phospholipid particles and calcium chloride. The product (medical device) would be the activator. Medical devices that show a reduction in partial thromboplastin time are activators of the intrinsic pathway of coagulation. The product under evaluation, and the positive and negative controls, are exposed to citrated human plasma. Each test, and their respective controls must be evaluated in triplicate. Each sample is evaluated in the proportion of 4 square centimeters to 1 mL of plasma placed in polypropylene tubes. The results are expressed as percentages with respect to the negative control.