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26th March 2021  Product update: rapidvirology staff writer

ECDC Encourage Self-Testing with Rapid Antigen COVID-19 Assays

The European Centre for Disease Prevention and Control (ECDC) has told member states that the potential benefits of self-testing using rapid antigen detection assays can counter-balance effects from their low sensitivity. 

In the technical report 'Considerations on the use of self-tests for COVID-19 in the EU/EEA' published on 17 March 2021, the ECDC has outlined components that each country should implement in its self-testing strategy. These include, but are not limited to: Kits should be made affordable (if not free); System collects results for national surveillance system; and tests should be provided by a central source, making it more accessible to the public.

The report also references two modeling studies (Bootsma et al. and Larremore et al.) that concluded the frequency of self-testing is more important than sensitivity and that self-testing just once a week could reduce the reproductive number by a third. 

At present, there is no CE-marked rapid antigen test kit sold for home use that complies with Directive 98/79/EC, which requires a performance evaluation to be carried out on the device before placing it on the EU market.

However, there are some CE-marked rapid antigen tests designed for self-testing for sale in several countries. These kits have been approved by the medical device regulation body in those countries. Aldi and Lidl began selling these tests online and at-the-counter but could not meet demand and quickly ran out-of-stock. 

In conclusion, the ECDC believes self-testing using rapid antigen detection tests is cheaper, faster, and could further prevent the virus from spreading. However, it states that any false negatives could lead to an inappropriate sense of safety and increase transmission. 



Date Published: 26th March 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.

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