IB10 sphingotest® beta-hCG
IB10 sphingotest® beta-hCG, is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of human chorionic gonadotropin (hCG) in lithium heparin whole blood and plasma. The IB10 sphingotest® beta-hCG is intended for use in conjunction with the Nexus IB10 Analyzer and provides quantitative results in 20 minutes.
This test detects total hCG, measuring both the intact hCG molecule and its free beta subunit. The quantitative measurement of hCG aids in the early detection of pregnancy. 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.