Important COVID-19 Update from HemoSonics

Consistent with our company’s mission to deliver clinical tools that provide actionable information in the critical care setting resulting in better care for patients, HemoSonics is closely monitoring the COVID-19 pandemic and evaluating how the Quantra® System may help in the effort to conserve valuable blood supplies, support protection of healthcare providers, and improve patient outcomes.

Recent clinical reports have shown that patients with severe COVID-19 infection can develop a coagulopathy that is likely triggered by the acute inflammatory response. This is reflected as abnormal values of laboratory coagulation parameters consistent with disseminated intravascular coagulation (DIC). These include prolonged clotting times, high D-dimer levels, thrombocytopenia and low fibrinogen levels. DIC is a rapidly evolving condition that, if not properly recognized and addressed, can quickly lead to the formation of microvascular thrombi and/or hemorrhage.

“While we are very early in this work, we are committed to doing our part in the fight against this global pandemic,” said Bob Roda, President and CEO of HemoSonics.

HemoSonics has responded to requests from several clinical sites in Europe and is supporting their investigations to understand the potential utility of the Quantra System for the evaluation of blood coagulation status in COVID-19 patients at the point-of-care. The Quantra Hemostasis Analyzer and its closed system cartridges (QPlus® and QStat® Cartridges) require no blood manipulation after collection which minimizes potential biological exposure to healthcare professionals.
Quantra COVID19

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This communication contains information on products which is targeted to a wide range of audiences and could contain product details or information not otherwise accessible or valid in your country. Please refer to the applicable approved instructions for use.*

*Indications for Use:
The Quantra QPlus System is composed of the Quantra Hemostasis Analyzer, QPlus Cartridge, and Quantra Quality Controls Level 1 and 2. The Quantra QPlus System is intended for in vitro diagnostic use. The Quantra Hemostasis Analyzer 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 3.2% citrated venous whole blood sample. The QPlus Cartridge includes tests to assess coagulation characteristics via the intrinsic pathway, via the 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).The Quantra QPlus System is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure.
Results obtained with the Quantra QPlus System should not be the sole basis for patient diagnosis.
Rx Only. The Quantra QPlus System has not been evaluated to guide blood product use or use of medication.
Please consult the Quantra User Manual and/or cartridge Instructions for Use for complete information.
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