At present, there are many products for rapid detection of new crowns on the market. Hundreds of products are listed in the list of rapid detection reagents for COVID-19 new crown antigens on the EU official website, all of which have obtained CE certification. On this basis, the EU HSC has put forward stricter requirements for the rapid detection of new crown antigens. Manufacturers need to provide more verification data to prove the performance of the product before entering the Common list.

Checking address : https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2862

Pass requirements:

European Union Health and Safety Committee HSC common list for rapid antigen detection kits

1. The product has obtained CE certification.

2. Actual use in at least one EU member state and has been verified (such as PEI testing) in at least one EU member state;

3. Clinical performance is based on nasal, oropharyngeal and/or nasopharyngeal swab samples, while rapid antigen tests for sample types such as saliva, sputum, blood and/or stool will not be included in the list.

Under the background of the normalization of the new crown epidemic, the demand for new crown antigen reagents in the EU market is also gradually increasing. Hangzhou Funworld Bio’s Covid-19 antigen rapidtest is widely recognized by users, and its quality is well received. Funworld Biotech closely follows the development trend of the new crown epidemic to carry out product updates and iterations, improve the clinical detection rate, and does not affect the detection of variant strains. It has become a powerful means of prevention and control of the new crown epidemic. Through the testing of the EU official laboratory, its performance has been further effectively verified, indicating that the product has been fully recognized by HSC from clinical data to technical documents, and has a positive effect on the sales of the product in the EU and other international markets.