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ALL TEST Rapid Swab for SARS-CoV-2 Antigen Description Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasal swab specimens. For in vitro self-testing only. Single-use test kit intended to detect SARS-CoV-2, the virus that causes COVID-19, in self-collected nasal swab specimens. The test is intended for use in symptomatic individuals who meet the COVID-19 case definition, 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 the patients history and other diagnostic information is required to determine the 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 the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol. Remove the lid from 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 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 significant resistance or pain. If 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 childs 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, making sure it touches the bottom, and swirl the swab to mix well. Press the head of the swab against the tube and swirl 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 after 15 minutes. Do not read the result after 20 minutes. Note: Upon completion 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, the presence of any shade of color in the test region (T) should be interpreted as a positive result. A positive result means that the person is highly likely infected with COVID-19; positive samples must be confirmed. Immediately self-isolate as required by local regulations and contact your healthcare provider or district health care provider as directed 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, 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 returned a negative result. Additionally, you can repeat the test with a new kit. If you suspect COVID-19, repeat the test after 1-2 days, as the coronavirus cannot be detected at all stages of infection. Even with a negative result, social 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 - For self-testing purposes 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 or touch the test window of the test cassette. - The kit must not be frozen or used after the expiration date printed on the package. - Children should be tested under the guidance of an adult. - Wash your hands thoroughly before and after handling. - Please ensure that an adequate amount of sample is used for testing. Too much or too little sample may lead to inaccurate 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 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 exclude infection in these individuals. 4. 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 molecular diagnostics should be considered to rule out 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 affect test performance. 7. False negative results may occur if a specimen is collected or handled improperly. 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. Shelf life of intact packaging: 24 months. Format Test cassette, sterile swab, biosafety bag, package insert, extraction swab. 20 pieces. Code INCP-502
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