EU’s COVID-19 IVD Guidelines Reflect Need For Nuanced Approach To Testing For Member States
New European Commission guidelines on COVID-19 IVD tests and their performance not only explain the regulatory requirements, but also detail why different levels of precision may be acceptable in different contexts.
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Acting early but not too soon has made Germany a model of COVID-19 preparedness. Its testing rates are still increasing, and a new app is designed to ensure even greater detection efficiency is being developed. An antibody test eludes, however.
The shortage of medical equipment to manage the COVID-19 pandemic is leading many countries to take measures to allow unregulated devices onto the market. Belgium is creating its own solutions.
While the UK is moving forward quickly to provide COVID-19 antibody self-testing, the Belgian government considers the tests not sufficiently accurate to be used in the pandemic.