The kit is used for the qualitative detection of new coronavirus nucleocapsid (N) antigen in human oropharyngeal and/or nasopharyngeal swab samples in vitro. It is used as a supplementary detection indicator for suspected cases of new coronavirus. It cannot be used as the only basis for the diagnosis and exclusion of pneumonitis infected by new coronavirus.
The test is developed and tested for the use of nasal samples.
Sensitivity: 97,7% (95% CI: 93,40% – 99,52%)
Specificity: >99,9% (95% CI: 98,85% – 100%)
One band/line appears in the control region “C”, and another band/line appears in the “T” region (picture A).
Only one band/line appears in the control region “C” with no other bar sign elsewhere (picture B).
No band/line appears in the control region (C), whether a test band “T” is present or not. Repeat invalid tests with a new sample, new test device and reagent. Insufficient sample volume, inaccurate operating procedure or expired tests may yield an invalida result. Contact your local distributor if the problem continues. (picture C).