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1. Manufactured in a factory with ISO 13485 medical device quality management system
2. Produced in a workshop with GB/T 16294-2010 clean room (area) of the pharmaceutical industry with a class 10000 sedimentation bacteria
3. The product is tested in Paul-Ehrlich-Institut (PEI) according to the nasal swab sampling method, and the sensitivity of Ct≤25 and Ct 25-30 is 100%, Paul-Ehrlich-Institut (PEI) until May 5, 2022 A total of 252 products on the market have been tested so far, and our products are ranked in the top ten in terms of overall sensitivity.
4. The product has been included in the EU’s common list of COVID-19 rapid antigen tests (Annex I) agreed by the Health Security Committee of European Union according to the nasal swab sampling method.
5. The measurement data of the nasal swab sampling reagent showed a sensitivity of 97.5% and a specificity of more than 99%
6. The measurement data of the deep throat sampling reagent showed a sensitivity of 95.8% and a specificity of 98.4%
7. All products have obtained CE registration
8. Effective detection of Delta and Omicron and other Omicron variants