Description
Single-use test intended to detect SARS-CoV-2 that causes COVID-19 in self-collected nasal swab samples.
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 coinfection with other viruses.
Individuals who test negative and continue to experience COVID-like symptoms should contact their healthcare provider.
The test is intended for use in symptomatic individuals who meet the case definition for COVID-19 as well as in asymptomatic individuals, limited to contacts of confirmed or probable cases of COVID-19, and at-risk healthcare workers.

Instructions for use
Procedure :
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 it in the tube holder in the box.

Sample collection :
Remove the sterile swab from the pouch and insert it 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 resistance or pain.
Gently remove the swab. Using the same swab, repeat the process in the other nostril.
When the nasal mucosa is damaged or bleeding, nasal swab collection is not recommended.
If you are collecting swabs from others, 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.

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. Throw away the used swab in the bio-safety bag. Close the cap of the extraction tube.

Test execution :
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.
Invert the tube and pour 3 drops of solution into the sample well (S) of the test device and then start the timer.
Do not move the test cassette while performing the test.
Read the results after 15 minutes. Do not interpret results after 20 minutes.
At the end of the test, place all used test components in the bio-safety bag and dispose of it according to local regulations.

Reading the results :
Inform your doctor of the results