MDU-tested ‘flu test kit goes on sale in Europe
We received some excellent news last week when one of our clients reported that their ‘flu test kit has received a CE marking and is being sold in Europe. The test kit has also been cleared by the FDA.
We carried out the usability validation testing on the kit in July 2017 in London, to meet regulatory requirements for CE marking. Three user groups interviewed for the study ranged from trained lab staff, technicians and nurses to Healthcare Assistants to administration staff. The latter group would not be expected to use the test kit day-to-day but could use it safely and effectively if a ‘flu pandemic hit the UK and staff numbers were drastically reduced.
The test kit is small and portable so can be moved quickly and easily around a hospital or GP surgery and can return a test result in 30 minutes, thus avoiding the need for lengthy quarantine and isolation and speeding up transfers to wards when patients come into hospitals from the A&E department for example.