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The T-TAS 01 Instrument is intended for use with T-TAS reagent chips in the clinical laboratory. The T-TAS 01 PL chip is intended for use in the clinical laboratory for the analysis of the platelet thrombus formation process (primary hemostatic function) in patients age 21 and older with a history of conditions associated with impaired primary hemostatic function or use of antiplatelet therapy. The test uses BAPA-anticoagulated whole blood specimens to measure platelet adhesion to a thrombogenic collagen-coated surface and aggregation, which causes an increase in flow pressure inside the PL chip. The test measures primary hemostatic function as the area under the pressure-time curve (AUC), with AUC < 260 suggesting abnormal primary hemostatic function. Additional testing may be necessary to identify the cause(s) of abnormal primary hemostatic function. The test has been evaluated in patients taking antiplatelet therapy, in patients with von Willebrand disease, and in patients with Glanzmann's thrombasthenia. Other primary hemostasis disorders have not been evaluated. The BAPA tube for T-TAS 01 is intended to be used for the collection, transport, and storage of blood specimens for use with the T-TAS 01 system.

The T-TAS 01 system is an in vitro diagnostic device that is comprised of tabletop instrument controlled by a dedicated PC and a disposable, single-use flow chamber. The PL Chip for T-TAS 01 is designed to specifically measure platelet thrombus formation (PTF) under physiological conditions on a collagen-coated analytical path consisting of 26 microcapillary channels. Platelet thrombus formation is a direct indicator of the patient's primary hemostatic function. The assay is performed under arterial flow conditions using benzylsulfonyl-D-Arg-Pro-4-amidinobenzylamide (BAPA)-anticoagulated whole blood samples. BAPA is an anticoagulant that inhibits thrombin and factor Xa, blocking the coagulation cascade and allowing the PL assay to specifically measure only the platelet thrombus formation process (primary hemostasis). During the assay, the blood sample is exposed to arterial shear stresses at 1,500 s-1 in the presence of a collagen-coated surface, which causes platelet attachment to collagen mediated by von Willebrand factor (vWF), and platelet activation. Platelet activation causes the release of endogenous factors contained within the platelets that recruit and activate other platelets and cause aggregation, and platelet thrombus formation. The growing platelet thrombus causes occlusion of the microcapillary channels, which increases the flow pressure within the assay chip. The process of platelet thrombus formation in the flow chamber is continuously monitored by a pressure sensor that tracks pressure changes in the flow path. Results are calculated automatically within 10 minutes or when the pressure a reading reaches 60 kPa above the baseline pressure, whichever occurs first. Results are displayed as AUC, which is the flow pressure curve over 10 minutes. AUC results less than 260 are associated with abnormal primary hemostatic function.