WuXi AppTec Offers PTT Testing with BFT II Analysis

Posted by Jean Kringstad, Director In Vitro Services on May 22, 2018

Recently, the FDA has questioned partial thromboplastin time (PTT) that has been run on a Cascade M-4 analyzer. The FDA has concerns about the equipment’s accuracy and sensitivity, and has indicated a preference for results from a BFT II analyzer. A backlog of PTT testing has resulted since many labs do not offer BFT II analysis.

WuXi AppTec, however, offers a validated method for PTT assay using a BFT II analyzer exclusively and is ready to help customers meet this FDA expectation.
Additionally, WuXi complies with the FDA’s expectation of using pooled plasma from at least three donors.

The PTT assay is a general screening test for the detection of coagulation abnormalities in the intrinsic coagulation pathway. The test determines the time that citrated plasma takes to form a clot when exposed to medical materials and mixed with a suspension of phospholipid particles and calcium chloride. The PTT indirectly measures the formation of thrombin by its action on fibrinogen, forming the fibrin clot through a method compliant with the recommendations specified in ASTM F2382-17.  Materials that show a shortened PTT are considered activators of the intrinsic coagulation pathway.

For more information on PTT testing using BFT II analysis or to discuss your other testing needs, please contact us at (888)794-0077.

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Topics: Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, FDA, biocompatibility, hemocompatibility