Technical specification :
- Accuracy (Overall): 97.02% (95% CI: 94.43%~98.52%)
- Sensitivity : 95.06% (95% CI: 90.56%~97.48%)
- Specificity : 99.29% (95% CI: 96.29%~99.87%)
- LoD(Limit of detection)3.5 x10^2 TCID50/mL (direct swab)
Package contents : 1 Test / box
- Test Cassette
- Extraction Buffer (0.3 mL/tube)
- Dropping cap
- Sample collection swab
- Instructions for Use
Manufacturer
Sugentech, Inc., South Korea
Approvals
MHRA, CE
* Source: EU Commission, Health Security Committee