[PRINCIPLE]

The Device uses the principle of the double antibody sandwich method for detecting the nucleoprotein (N) of SARS-CoV-2. The marker is composed of the anti-N antibody 1 labeled with colored particles. When testing, the sample was added into the sample well and migrated to the absorbent pad by the capillary effect. If the virus exists, it will react with the marker and captured by the anti-N antibody 2 coated in the NC membrane. Then there is a colored line produced at the test area, indicating a positive result. If there is no virus in the sample, the colored line will not show at the test area and it means a negative result. Regardless of whether the virus contained in the sample, as a procedural control, a colored line will always appear at the control area, indicating that proper volume of specimen has been added and the correct test procedure is conducted.