Our highest priority in the last year has been the creation of new GMDN Terms to urgently meet the needs of regulators and users to identify IVDs for the diagnosis and treatment of SARS-CoV-2, the virus responsible for the current COVID-19 pandemic. There are now over 55 new GMDN Terms available.
We have recently received enquiries for SARS-CoV-2 neutralizing antibody tests which are intended for the detection of antibodies that block an infection, either in response to natural infection or to vaccination.
Also, we have seen enquiries for rapid tests, either for antibody or antigen testing. A convenient rapid test for which we made a Term recently, is intended for the detection of both SARS-CoV-2 and Influenza antigens, which is particularly useful for the differential detection of COVID-19 and the flu, especially during the Winter period.
One of the most innovative devices we have seen is a cartridge-based portable analyser for the detection of nucleic acid antigens from SARS-CoV-2. There is also a Term for software used to manage SARS-CoV-2 rapid test validation, for use with a COVID-19 ‘immunity passport’ some countries are implementing.
All these new GMDN Terms, which all include the search phase 'SARS-CoV-2', can be found on our database.
This activity supports the argument to use the GMDN system which is dynamic and able to respond to the urgent need of regulators during a health crisis. Not all systems can do this.
If you have any questions about GMDN Terms please contact our customer service team directly.