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20th November 2020  Author: Paul Carton

Urgent Demand From ECDC to Validate COVID-19 Rapid Antigen Tests

The European Centre for Disease Prevention and Control (ECDC) is urging member countries to begin validating rapid antigen tests to enhance each country's SARS-CoV-2 containment strategy. 

The ECDC has provided clinical validation results on nine CE-marked rapid antigen tests in a new guidance document, released on 19th November. The ECDC is now advising countries to only use tests that have a sensitivity of 90% or greater and a minimum of 97% specificity. 

The results come from several labs around the world, who have evaluated each kit's specificity and sensitivity. Some of these tests have a significant variation in diagnostic accuracy depending on where they were performed, the number of people used in the study, the number of days from onset of symptoms and the type of specimen used. 

These validations are carried out by following the model presented by FIND; where the performance of a new test should be compared to the current gold standard RT-PCR.

However, the ECDC don't believe the buffers used for specimen collection in rapid antigen testing are reliable in de-activating the virus within the short processing time, and it is now a requirement for all rapid antigen testing to apply appropriate biosafety measures. 

You can view the full document here.




Date Published: 20th November 2020

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