Description
Single-use test intended to detect SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimens from symptomatic individuals suspected of being infected with COVID-19.
The results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory tract specimens during the acute phase of infection.
Positive results indicate the presence of viral antigens, but clinical correlation with the patient's history and other diagnostic information is required to determine the status of the infection. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek further care from their healthcare provider. Positive results do not exclude bacterial infection or co-infection with other viruses.
Negative results do not exclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should contact their healthcare provider.

Instructions for use
Wash your hands with soap and water for at least 20 seconds before and after the test. If water and soap are not available, use a hand sanitizer with at least 60% alcohol.

Remove the lid of the tube containing the extraction solution and place the tube in the tube holder in the box.

Sample collection
Remove the sterile swab from the pouch.
Insert the swab into the nostril until you feel a slight resistance (about 2 cm up the nose). Slowly rotate the swab, rubbing it along the inside of the nostril 5-10 times. This process can be annoying. Do not insert the swab deeper if you feel strong resistance or pain. When the nasal mucosa is damaged or bleeding, nasal swab collection is not recommended.
If you are collecting swabs from other individuals, please wear a facemask.
With children, it may not be necessary to insert the swab so far into the nostril. For very young children, another person may need to hold the child's head still while taking the swab.
Gently remove the swab. Using the same swab, repeat the process in the other nostril. Remove the sterile swab from the nostril.

Sample preparation
Place the swab in the tube containing the extraction solution: make sure it touches the bottom and shake the swab to mix it well. Press the swab head against the tube and rotate the swab for 10-15 seconds.
Remove the swab by pressing the swab head against the inside of the tube. Break the swab shaft and place the swab in the biosafety bag.
Close the cap of the tube.

Testing procedure
Remove the test cassette from the sealed foil pouch and use it within one hour. The best results are obtained if the test is performed immediately after opening the foil pouch.
Place the test cassette on a flat surface.
Open the small cap and invert the tube containing the extraction solution and add 3 drops of the extracted sample to the well (S) of the test cassette and start the timer. Do not move the test cassette during test development.
Read the result at 15 minutes. Do not read the result after 20 minutes.

At the end of the test, place all components in a plastic biosafety bag and dispose of according to local regulations.

Reading the results
Notify your healthcare provider of your test results e