IB10 sphingotest® bio-ADM®
IB10 sphingotest® bio-ADM®, is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of bioactive adrenomedullin (bio-ADM® ), a hormone controlling the endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM® indicate loss of endothelial function and predict blood pressure break down and leaky vessels resulting in edema. Imbalanced endothelial function is the major cause of shock ultimately resulting in organ dysfunction and death. Early identification of loss of endothelial function may allow guidance of vasopressor, fluid and diuretic therapy in critically ill patients to improve outcomes.
The IB10 sphingotest® bio-ADM® 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.
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.