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 with the extraction buffer and place the tube in the tube holder in the box.

Nasal swab 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 against the nasal wall. This 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 others, please wear a face mask. With children it may be necessary to insert the swab this far into the nostril. For very young children, another person may be needed 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.

Sample preparation
Place the swab into the extraction tube, 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 extraction tube. Place the swab in the bio-safety bag. Close the cap of the extraction 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 sample extraction tube. Add 3 drops of the extracted sample to the sample well (S) of the Test Cassette and start the timer.
Do not move the test cassette during test development.
Read the result after 15 minutes. Do not read the result after 20 minutes.
At the end of the test, place all components in a bio-safety plastic bag and dispose of according to local regulations.

Reading the results
Please share your test result with your healthcare provider and follow carefully