How safe are home tests?

Many people wonder how safe our home tests are. In fact, they are very reliable. The knowledge of how In Vitro Diagnostic (IVD) tests are performed is becoming more widespread, thanks to the internet and that knowledge being easily searchable. For those working in healthcare or medical technology, IVD tests are an obvious choice, a technology that is also respected and considered reliable.

Our self-tests are made in France. This means they are controlled by a European Notified Body. A Notified Body is an inspection body that strictly verifies that the manufacturing, labeling and product meet the stringent requirements of the European authorities. This is basically the same procedure that is applied to medicines and other equipment used by healthcare professionals.

When the manufacturer meets all the requirements, a so-called CE mark is obtained, which has a unique reference code and a CE number. In this way, a product can always be traced to the responsible manufacturer.

Quicktest has a unique cooperation agreement with manufacturers, we participate in product development and we have an ongoing dialog with doctors and researchers who have insight into the development of IVD products. For example, we were the ones behind our Gluten Test, the development took about 2 years and today it is one of our most sold tests!

To measure reliability, various instruments are used and the results are checked with other measurement methods. These are performed both internally and externally.

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