Description
Single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 in self-collected nasal swab specimens.
The test is intended for use in symptomatic individuals meeting the COVID-19 case definition as well as asymptomatic individuals, limited to contacts of confirmed or probable cases of COVID-19 and healthcare professionals at risk.
The results are for the detection of SARS-CoV-2 nucleocapsid protein antigens.
An antigen is usually detectable in upper respiratory specimens during the acute phase of infection.
Positive results indicate the presence of viral antigens, but a clinical correlation with patient history and other diagnostic information is needed to determine infection status. 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 professional. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not rule out SARS-CoV-2 infection. Individuals who test negative and who continue to experience COVID-like symptoms should contact their healthcare professional.

How to use
Procedure
Wash your hands with soap and water for at least 20 seconds before and after testing. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.

Remove the lid of the tube containing the swab extraction solution and place the tube in the tube holder on 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 operation can be annoying. Do not insert the tampon 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 not be necessary to insert the swab so far into the nostril.
For very young children, another person may be needed to hold the child's head steady during specimen collection.
Gently remove the swab. Using the same swab, repeat the procedure in the other nostril.
Remove the swab.

Sample preparation
Place the swab in the extraction tube, make sure it bottoms out, and shake the swab to mix it well. Press the swab head against the tube and swirl 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 biosafety 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 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 while running the test.
Read the result at 15 minutes. Do not read the result after 20 minutes.

At the end of the test, place all components in the biosafety bag