[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.