COVID-19 Nasal Rapid Antigen Self-Test Qualitative Determination of SARS-CoV-2 Antigens in Nasal Swabs by Immunochromatography Sofarmapiu' Sofarmapiu'

Description
Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens present in nasal swab samples. For in vitro self-diagnostic use only.
Disposable test kit intended to detect SARS-CoV-2 which causes COVID-19 in self-collected nasal swab samples. 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 COVID-19 cases and at-risk healthcare workers.
The results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally 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 necessary 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 consult their healthcare provider.

Instructions for use
Wash your hands with soap and water for at least 20 seconds before and after the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
Remove the cap from the extraction tube and place the tube in the tube holder in the box.
Nasal Swab Sample Collection
1. Remove the sterile swab from its pouch.
2. Insert the swab into the nostril until slight resistance is felt (about 2 cm up the nose). Slowly rotate the swab, rubbing it along the inside of the nostril for 5-10 times against the nasal wall.
Note: This may be uncomfortable. 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 collecting swabs from others, please wear a face mask. With children, it may not be necessary to insert the swab as deeply into the nostril. For very young children, another person may be needed to hold the child's head still during swab collection.
3. Gently remove the swab.
4. Using the same swab, repeat step 2 in the other nostril.
5. Withdraw the swab.
Sample Preparation
1. Place the swab into the extraction tube, ensuring it touches the bottom, and swirl the swab to mix well. Press the swab head against the tube and rotate the swab for 10-15 seconds.
2. Remove the swab by pressing the swab head against the inside of the extraction tube. Place the swab in the biohazard bag.
3. Close the cap or insert the tube tip onto the tube.
Test Procedure
1. 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.
2. 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 during test development.
3. Read the result at 15 minutes. Do not read the result after 20 minutes.
Note: After the test is complete, place all components in the plastic biohazard bag and dispose of according to local regulations.
Reading Results
Positive: *Two colored lines appear. One colored line should appear in the control region (C) and another colored line should appear in the test region (T).
*Note: The intensity of the color in the test line region (T) will vary 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 it is very likely that the person is infected with COVID-19; positive samples must be confirmed. Immediately self-isolate as prescribed by local regulations and contact your doctor or healthcare district according to the instructions of local authorities. The test will be verified by a confirmatory molecular test (PCR) and instructions on the next steps will be provided.
Negative: Only one colored line appears in the control region (C). No colored line appears in the test line region (T). It is unlikely that you have COVID-19. However, it is possible that this test may give an incorrect result (a false negative) in some people with COVID-19. This means that you may have contracted COVID-19 even if the test yielded a negative result. Furthermore, you can repeat the test with a new kit. If suspected, repeat the test after 1-2 days, as the coronavirus cannot be determined in all stages of infection. Even with a negative result, social distancing and hygiene rules must continue to be observed.
Invalid: The control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the absence of the control line. Review the procedure and repeat the test with a new kit or contact your doctor or a COVID-19 diagnosis center.

Warnings
- For self-testing for in vitro self-diagnostic use only. Do not use after the expiration date.
- Do not eat, drink, or smoke in the area where samples or kits are handled.
- Do not drink the buffer liquid contained in the kit.
- Handle the swab carefully 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 packaging is damaged or has been opened.
- This test kit should only be used 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 or touch the test window of the test cassette.
- The kit must not be frozen or used after the expiration date printed on the packaging.
- Testing for children should be under adult guidance.
- Wash hands thoroughly before and after handling.
- Please ensure that an adequate amount of samples is used for testing. Too much or too little sample can lead to deviation of results.
Limitations
1. Performance has only been evaluated with nasal swab samples, using the procedures provided in this leaflet.
2. The Rapid Antigen Detection Test (Nasal Swab) for SARS-CoV-2 will only indicate the presence of SARS-CoV-2 antigens in the sample.
3. If the test result is negative or non-reactive and clinical symptoms persist, it is because the virus of very early infection might not be detected; it is recommended to re-test with a new kit or test with a molecular diagnostic device to rule out infection in these individuals.
4. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Control tests with molecular diagnostics should be considered to rule out infection in these individuals.
5. Positive results from COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors.
6. Failure to follow these procedures may alter test performance.
7. False negative results may occur if a sample is collected or handled improperly.
8. False negative results may occur if insufficient levels of virus are present in the sample.

Storage
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30 °C). 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 freeze. Do not use beyond the expiration date.
Intact packaging validity: 24 months.

Format
Test cassette, sterile swab, biohazard bag, leaflet, extraction buffer.

Code INCP-502H