- LoDs of ORF1ab and N gene were confirmed to be 10 copies/reaction.
- Able to detect all circulating variants of SARS-CoV-2 (Analyzed 38388 sequences downloaded from GISAID).
- Does not cross-react with related pathogens, common respiratory flora, and other viral pathogens.
- The results showed 100% agreement with positive clinical specimens, and 96.6% agreement with negative clinical specimens.
- TFDA EUA approval TFDA EUA No.1096820509; CE IVD: DE/CA09/0760/S21/001-02