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- Manufactured in a factory with ISO 13485 medical device quality management system
- Produced in a workshop with GB/T 16294-2010 clean room (area) settling bacteria in the pharmaceutical industry class 10000
- Product tested at Paul-Ehrlich-Institut (PEI) by nasal swab sampling method with Ct≤25 and Ct 25-30 sensitivity of 100%, Paul-Ehrlich-Institut (PEI) until January 31, 2022 A total of 199 products on the market have been tested so far, and our products are ranked in the top ten in overall sensitivity.
-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
- The measurement data of nasal swab sampling reagent showed a sensitivity of 97.5% and a specificity of more than 99%
- The measurement data of the deep throat sampling reagent showed a sensitivity of 95.8% and a specificity of 98.4%
- The measurement data of the oral sampling reagent showed a sensitivity of 95.8% and a specificity of over 99.2%
- All products have obtained CE registration
- Oral sampling is specially introduced for the Hong Kong market, which reduces discomfort, is simpler and more convenient, and is especially suitable for the elderly and children.
- Effective detection of Delta and Omicron
-made in China