NEOTEST N+
Covid -19 Antigen Rapid Testing Kit
Intended Use
The COVID-19 Antigen Rapid Testing Kit is a lateral flow immunoassay intended to qualitatively detect the nucleocapsid protein antigen from the SARS-CoV-2 virus that causes COVID-19 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. The test is authorized for non-prescription use with self-collected anterior nasal swab specimens directly from individuals age 14 and older, or with adult-collected anterior nasal samples specimens directly from individuals age 2 years and older, or for prescription use only tests, symptomatic individuals who are suspected of COVID-19 by a healthcare provider, or individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests.
Alternative testing intervals, such as testing every 3 days or testing twice a week (such as Monday/Thursday or Tuesday/Friday), may be considered for antigen tests intended for use as part of a testing program. The COVID-19 Antigen Rapid Testing Kit (Colloidal Gold) does not differentiate between SARS-CoV and SARS-CoV-2.
Operation Process
Peel open the swab wrapper and gently take out the swab by the stick part only.
Note: Never touch the fabric tip of the swab with your hands or touch any surfaces.
First nostril: Place the fabric tip of the swab just inside one nostril , ensure that the fabric tip of the swab is placed 3/4 in. inside the first nostril. Gently wipe the swab around the inside of your nostril in a circular motion 5 times. Ensure there is good contact between the fabric tip of the swab and the inside of the nostril. No force is needed, and you do not have to push far into your nostril.
Second nostril: With the same swab, place the fabric tip of the swab inside the second nostril ensuring that the fabric tip of the swab is placed 3/4 inside. Gently wipe the swab around the inside of your nostril in a circular motion 5 times. Ensure there is good contact between the fabric tip of the swab and the inside of the second nostril.
Rotate the swab 5 times in a circular while squeezing the tube.
Note: A false negative result may occur if the swab is not rotated five times.
Gently squeeze the tube and dispense 3 drops of solution into the Sample Well. Dispose the tube in the trash.
Note: A false negative may occur if less than 3 drops dispensed.
