Nexus IB10 is a high quality, rapid point of care instrument that is easy to use for clinicians who need to make decisions in a high stress, complex environment, providing test results in 20 minutes. The IB10 has an innovative design making all steps easy for the end user.
Nexus IB10 Analyzer
The Nexus IB10 is an immunoanalyzer that quantitatively measures in-vitro antigens or antibodies in whole blood or plasma samples on a dedicated test disc. The Nexus IB10 system combines chemistry with microfluidics and centrifugal flow to separate cell free plasma from whole blood. The plasma then moves through a channel, mixes with immunoconjugates, and is quantitatively measured.
The automated testing process allows fast, accurate test results with minimal maintenance.
- ✔ Results reported in 20 minutes.
- ✔ An intuitive user interface with minimal interaction from the user.
- ✔ Small footprint for optimal space utilization
- ✔ Built in self-test feature minimizes hands on maintenance
- ✔ No sample preparation needed. Blood separation takes place in the Nexus IB10 instrument.
- ✔ Test discs stable at room temperature for 30 days
- ✔ Connects to Laboratory Information Management System (LIMS)
- ✔ Built-in thermal printer
- ✔ Wi-Fi and barcode reader capability
- ✔ An optional smart battery pack can be installed
The sphingotest® disc combines chemistry with centrifugal microfluidic flow to rapidly prepare cell free plasma from whole blood, which can then flow through a channel to rehydrate, solubilize and mix with freeze dried immunoconjugates. Using a combination of active flow and capillary action, the test is ready to be quantitatively measured in 20 minutes with an optical signal level proportional to the analyte concentration.
After addition of the patient sample, the entire test is performed within the Nexus IB10 analyzer which controls the temperature of the disc, as well as the sequence, duration of measurement, centrifugal flow, mixing, incubation, time, final signal measurement, quantitation and reporting of results. The disc also includes a positive internal control to ensure that the test device has operated properly.
Each lot of discs is calibrated for the specific analytes to be measured to ensure that the lot-to-lot variability is minimized. Lot specific calibration along with additional information such as the lot expiration date is contained on the QR code label affixed to each disc. It is recommended that external controls also be tested at appropriate time intervals to confirm that the reagent lot is performing within acceptable limits.
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.