IB10 sphingotest® D-Dimer
IB10 sphingotest® D-Dimer, is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of cross-linked fibrin degradation products containing D-dimer, in human whole blood or plasma, using lithium heparin or sodium citrate as the anticoagulant. The D-Dimer Test is intended for use in conjunction with the Nexus IB10 Analyzer and provides quantitative results in 20 minutes.
This Test is designed for professional use only and may be used in hospital central laboratories and in alternate care settings such as emergency departments, critical care units, and other sites where near patient testing is practiced. D-dimer determinations aid in the quantitative assessment and evaluation of patients presenting with clinical symptoms of Venous Thromboembolism (VTE) including severely evolving Disseminated Intravascular Coagulation (DIC), pulmonary embolism (PE) and deep vein thrombosis (DVT). Values at or below the upper limit of a healthy reference population are highly predictive of exclusion of VTE as a cause of symptoms.
Products based on the Nexus IB10 technology (Nexus Dx, Inc., San Diego, CA, USA) described are CE-IVD-marked and hence certified and approved for use in the European Economic Area (EEA) only. Human diagnostic use of such products may be subject to local regulations.
Caution – The information contained in this communication does not constitute nor imply an offer to sell or transfer any product based on the Nexus IB10 technology as in vitro diagnostic (IVD) product in the United States of America or Canada. No product based on the Nexus IB10 technology is currently available for sale as an IVD product in the United States of America or Canada. The analytical and clinical performance characteristics in compliance with U.S. FDA medical device regulations of any Nexus IB10 product may be sold at some future point in time in the U.S., have not yet been established.