Warning with regard to self-testing for coronavirus
Home tests for determining whether you are carrier of the coronavirus are forbidden unless they have first been assessed by a notified body. Self-tests can give an incorrect result, positive or negative. Users then become unnecessarily alarmed or they are actually incorrectly reassured. That is why a notified body must always assess whether a self-test is usable and comprehensible for home use.
Self-tests are subject to legal requirements. Every self-test - regardless of the sickness or condition concerned - must be assessed by a notified body. The test must carry a CE marking. The CE marking must be followed by a code consisting of four digits. This is the unique identification code of the notified body that has assessed the test. It is important to ensure that the self-test can be carried out easily and correctly by a layperson in a home situation. This is evident from the packaging, as it specifies that the product concerned is a self-test.
In addition, a test for home use in the Netherlands must be accompanied by user instructions in Dutch. These instructions must also clearly state that the user should not take any decisions of a medical nature without first consulting his or her doctor. A test that is intended for professional use in a laboratory is not approved for domestic use.
It takes a certain amount of time for manufacturers to have new self-tests assessed by notified bodies. The Inspectorate has not received any information from notified bodies or from inspectorates in other member states of the European Union that there are self-tests for the coronavirus that have already been approved. Therefore, no permission has yet been granted for marketing this type of test.
Difference between laboratory tests and self-tests
Accredited laboratories such as the RIVM laboratory use tests that can determine whether the coronavirus is present in a patient. The self-tests that can be used at home use a different method to assess whether a person has come into contact with the virus. However, these self-tests cannot determine whether a person is harbouring the virus at the moment of testing.
Inspectorate can intervene
The Health and Youth Care Inspectorate (IGJ) monitors various types of tests, including self-tests. If necessary, the Inspectorate will take action against providers of self-tests that have not been approved. The Inspectorate also collaborates with fellow services in other EU member states and with the Ministry of Health, Welfare, and Sport to obtain a complete overview of the self-tests being offered on the European market.