Rapid antigen tests soon to be available for use as self-test
The rapid antigen tests currently being used at test centres to test people for coronavirus will soon be available for use as a self-test. A self-test is a test that a person can carry out themselves. Manufacturers of rapid tests can now apply for permission to market their tests as self-tests. The test kits will come with a special, shorter swab so that anyone can easily carry out the test themselves, with or without supervision. The self-test kits will be made available to employers and educational institutions. They will also be available to buy from supermarkets, chemists or pharmacies. The first self-test kits are expected to come onto the market in April.
Self-testing can be used widely
It goes without saying that anyone with symptoms must get tested immediately. But testing can also be useful for people with no symptoms. Some people may have the virus, but not be experiencing any symptoms. That’s why more and more preventive testing is being done. Although a test is always a snapshot of a particular moment in time, self-tests can help detect infections in people without symptoms more quickly, so they can self-quarantine sooner. That reduces the risk of spreading the virus. Hugo de Jonge, Minister of Health, Welfare and Sport: ‘This way we can stop the virus in its tracks. To keep it simple and accessible, we’re offering this new option: bringing the tests to the people, not the people to the tests. That why in the Netherlands we’re now making it possible for manufacturers of reliable rapid tests to produce a self-test version.’
Self-testing can be used widely and on a large scale, and this can play a major role in tackling the pandemic. As soon as the first self-test kits are available in the Netherlands, they will be used to make it safer for pupils and teachers to go to school and for those who can’t work at home to go to the workplace. Employers and educational institutions can offer self-tests to staff and pupils that they can carry out themselves or under supervision. Pilots are being carried out at schools for self-testing under supervision of a doctor or other healthcare professional. The government is providing funding to schools and businesses working with these supervised self-tests. Ultimately, self-testing without supervision should become possible, too. People will then be able to buy self-test kits from supermarkets, chemists and pharmacies.
Scientific research has shown that rapid antigen tests are reliable and very well suited to self-testing. Self-testing does, however, require clear instructions or supervision by a trained professional. Self-test kits will come with a special, shorter swab that will make it easier and safer to take the sample yourself.
Applying for a temporary exemption
Currently rapid tests are formally classified as medical devices and may only be used under the medical responsibility of a doctor. They cannot simply be marketed as self-tests. However, starting this week, manufacturers and distributors of rapid antigen tests will be able to apply for an exemption to market their product as a self-test. Manufacturers have to meet certain requirements to obtain such an exemption. For instance, the product must already bear a CE marking for professional use as a rapid antigen test and must have been validated for use as a self-test. Exemptions can be granted within a week. Please refer to the ‘Procedure to obtain exemption for rapid antigen test for use as self-test’ for the complete list of requirements and further information. Granted exemptions will initially be valid until 31 December 2021.
The ministry has asked a group of experts to come up with a practical solution by the end of this month to clear the way for supervised self-testing using antigen tests for businesses and educational institutions.