Authors: Shogik Abramyan, MD; Luca Milone, MD
HemoSonics received FDA notification in March 12, 2019 regarding the Quantra Hemostasis Analyzer platform, and its initial QPlus cartridge being granted de novo marketing.
The Quantra Hemostasis Analyzer platform is a viscoelastic point‐of‐care device designed for automated and rapid noncontact assessment of hemostasis. It uses Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry, an ultrasound-based technology, to measure the shear modulus of whole blood during coagulation.
The QPlus Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation state of a venous whole blood sample. The Quantra QPlus System utilizes a fully sealed consumable cartridge to run a panel of viscoelastic blood coagulation tests and it is commercially available in the U.S. and Europe. It can evaluate the function of the intrinsic pathway and extrinsic pathway, and includes tests with a heparin neutralizer.
The system is intended to be used by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time (CT), Clot Time with Heparinase (CTH), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS) and Clot Time Ratio (CTR). Validation studies were performed using plasma-based control material and whole blood samples (obtained in 3.2%sodium citrate) from healthy subjects. Comparative studies were performed with the TEG 5000 and the STart4 systems.
The Quantra QPlus System is indicated for the evaluation of blood coagulation during the perioperative period in patients 18 years and older. It may be used to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedures.
Results obtained with the Quantra QPlus System should not be the sole basis for patient diagnosis.