Banitore - novel antigen SARS-COV-2 detection kit (COVID-19 test) - oral test kit

Banitore Novel Antigen SARS-CoV-2 Detection Kit (COVID-19 Test)
(Colloidal Gold Method)
Nasal Swabs and Deep Throat/Buccal Tests
The product specifications are as follows:
- 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 by nasal swab sampling method at Paul-Ehrlich-Institut (PEI) with Ct≤25 and Ct 25-30 with 100% sensitivity, 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 more than 99.2%
- All products have obtained CE registration
-Buccal 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
- Convenience and confidence guarantee