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 usually detectable in upper respiratory tract samples during the acute phase of infection.
Positive results indicate the presence of viral antigens, but 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 provider. 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 continue to experience COVID-like symptoms should contact their healthcare provider.

How to use
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 cap from the extraction swab tube 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.
Note: This may be uncomfortable. Do not insert the swab further if you feel strong resistance or pain. When the nasal mucosa is damaged or bleeding, collecting a nasal swab 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 while collecting the swab.
Gently remove the swab.
Using the same swab, repeat steps two in the other nostril.
Remove the sterile swab.

Sample preparation :
Place the swab in the extraction tube, make sure it touches the bottom and shake the swab to mix well. Press the head of the swab 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 biosafety bag.
Close the cap of the extraction tube.

Test :
Remove the test cassette from the sealed foil pouch and use it within one hour. 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 sample 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 :
POSITIVE: Two distinct colored lines appear. One colored line should appear in the control region (C) and another colored line should appear in the test region (T). The intensity of the color in the test line region (T) varies depending on the number of SARS-CoV-2 antigens present in the sample. Therefore, any shade of color in the test region (T) should be interpreted as a POSITIVE result. A positive result means that the person is very likely to have COVID-19, positive samples should be confirmed. Immediately self-isolate as per local regulations and contact your healthcare provider or district health care provider as instructed by local authorities. The test will be verified by a confirmatory molecular (PCR) test and instructions on the next steps will be provided.

NEGATIVE: Only one colored line appears in the control region (C). No colored lines appear in the test line region (T). It is unlikely that the person has COVID-19. However, this test may give an incorrect result (a false negative) in some people with COVID-19. This means that you may have COVID-19 even if the test gave a negative result. If you experience symptoms such as headache, migraine, fever, loss of taste and smell, contact your nearest healthcare provider according to the rules of your local authority. You can also repeat the test with a new kit. If you suspect coronavirus, repeat the test after 1-2 days, as coronavirus cannot be detected at all stages of infection. Even with a negative result, distancing and hygiene rules must still be observed.

INVALID: The control line does not appear. Insufficient sample volume or incorrect procedure techniques are the most likely causes of the missing control line. Review the procedure and repeat the test with a new kit or contact your healthcare provider or a COVID-19 testing center.

Warnings
Please read all information in the package leaflet before performing the test.
For self-testing in vitro self-diagnostic use only. Do not use after the expiration date.
Do not eat, drink, or smoke in the area where specimens or kits are handled.
Do not drink the swab liquid contained in the kit. Handle the swab with care and avoid contact with skin or eyes, rinse immediately with plenty of running water in case of contact.
Please do not use if the foil package is damaged or has been opened.
This test kit should be used only as a preliminary test and repeatedly abnormal results should be discussed with a doctor or medical professional.
Strictly follow the indicated time.
Use the test only once. Do not disassemble and touch the test window of the test cassette.
The kit must not be frozen or used after the expiration date printed on the package.
Keep out of reach of children.
Testing for children and adolescents should be done in the presence of an adult.
Do not use the test on children under 2 years of age.
Young children should be swabbed with the help of a second adult.
Wash hands thoroughly before and after handling.
Please ensure that adequate amount of sample is used for testing. Too much or too little sample may lead to deviation of results.
Performance was evaluated with nasal swab samples only, using the procedures provided in the package insert.
The test only indicates the presence of SARS-CoV-2 antigens in the sample.
If the test result is negative or non-reactive and clinical symptoms persist, it is because the virus from very early infection may not be detected. It is recommended to retest with a new kit or test with a molecular diagnostic device to rule out infection in these individuals. Negative results do not rule out SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Positive COVID-19 results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors.
Failure to follow test procedures may impair test performance.
False negative results can occur if a sample is improperly collected or handled. False negative results can occur if there are insufficient levels of virus in the sample.

Conservation
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30° C), avoiding areas of excessive humidity. Do not freeze.
The test is stable until the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
Do not use beyond expiration date.
Validity with intact packaging: 12 months.

Format
The kit contains:
- Test cassette;
- Sterile swab;
- Package leaflet;
- Extraction swab;
- Biosafety bag.

Bibliography
1. Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7). National Health Commission & National Administration of Traditional Chinese Medicine.2020.