For qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in nasopharyngeal and nasal swab, and saliva specimens from individuals and is aid in rapid diagnosis of patients with suspected SARS-CoV-2 infection.
FEATURES
Ø Easy to use, easy results interpretation by naked eyes.
CLINICAL PERFORMANCE
- LoD: 1.5×102 TCID50 for virus lysate, 10pg/mL for recombinant Nucleocapsid protein antigen.
- Compared with NAT method, the specimens with the Ct range between 30-35 will be detectable.
- No cross-reactions with various bacteria, viruses and fungi normally available in respiratory track.
- Positive Agreement (95% CI): 30/31 96.8% (83.3% - 99.9%)
- Negative Agreement (95% CI): 80/80 100.0% (95.5% - 100%).