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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Rapid COVID-19 antibody tests have been the subject of considerable criticism over the last year. With the prevalence of these tests skyrocketing and tighter IVD regulations still over a year away, the EU has come up with new guidance.
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.