RAPID ANTIGEN TEST COVID-19 SOFARMAPIU' NASAL QUALITATIVE DETECTION OF SARS-COV-2 ANTIGENS IN NASAL SWABS 20 PIECES PROFESSIONAL USE SOFARMAPIU'

Description
Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasal swab specimens. For in vitro self-diagnostic use only.
Single-use test kit intended to detect SARS-CoV-2 that causes COVID-19 in self-collected nasal swab specimens. 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.
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 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 lid of the tube with the extraction buffer and place the tube in the tube holder in the box.
Nasal swab sample collection
1. Remove the sterile swab from the pouch.
2. 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.
3. Gently remove the swab.
4. Using the same swab, repeat step 2 in the other nostril.
5. Remove the swab.
Sample preparation
1. 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.
2. Remove the swab by pressing the swab head against the inside of the extraction tube. Place the swab in the biosafety bag.
3. Close the cap or insert the tip of the tube 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: At the end of the test, place all components in the plastic biosafety bag and dispose of according to local regulations.
Reading the 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) 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 line appears in the test line region (T). It is unlikely that you have COVID-19. However, it is possible that this test gives 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. You can also repeat the test with a new kit. If you suspect you have COVID-19, 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 procedural 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
- 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 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 expiry date printed on the package.
- The test for children should be under the guidance of an 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.
Limitations
1. Performance was evaluated with nasal swab specimens only, using the procedures provided in this package insert.
2. The SARS-CoV-2 Rapid Antigen Detection Test (Nasal Swab) will only indicate the presence of SARS-CoV-2 antigens in the specimen.
3. If the test result is negative or non-reactive and clinical symptoms persist, it is because the virus of very early infection may not be detected, it is recommended to retest with a new kit or test with a molecular diagnostic device to exclude infection in these individuals.
4. Negative results do not exclude SARS-CoV-2 infection, especially in those who have been in contact with the virus. Follow-up testing with molecular diagnostics should be considered to exclude infection in these individuals.
5. Positive COVID-19 results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors.
6. Failure to follow these procedures may impair test performance.
7. False negative results may occur if a specimen is improperly collected or handled.
8. False negative results may 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). 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.
Validity of intact packaging: 24 months.

Format
Test cassette, sterile swab, biosafety bag, package insert, extraction swab.
20 pieces.

Code INCP-502