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SCREEN CHECK TEST Rapid test for SARS-CoV-2 antigen Description Single-use test intended for the detection of SARS-CoV-2, which causes COVID-19, using nasal specimens taken from symptomatic individuals suspected of COVID-19 infection. The results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory tract 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 necessary to determine infectious status. Positive results indicate 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 exclude 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. Collection of nasal swab samples : 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 against the nasal wall along the inside of the nostril 5-10 times. Note: This may be uncomfortable. Do not insert the swab deeper if you feel significant resistance or pain. If the nasal mucosa is damaged or bleeding, it is not recommended to collect a nasal swab. If you are collecting swabs from other people, please wear a face mask. For children, it may not be necessary to insert the swab as far into the nostril. For very young children, another person may be needed to hold the childs head while you collect the swab. Gently remove the tampon. Using the same swab, repeat steps two in the other nostril. Remove the sterile swab. Sample preparation : Insert the swab into the extraction tube, making sure it touches the bottom, and swirl the swab to mix well. Press the end of the swab onto 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 extraction tube cap. Test : Remove the test cassette from the sealed foil pouch and use 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, 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 while the test is running. Read the result after 15 minutes. Do not read the result after 20 minutes. After completing the test, place all components in a biohazard plastic 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 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 very likely infected with COVID-19; positive samples should be confirmed. Self-isolate immediately, according to local regulations, and contact your healthcare provider or district health provider, as directed by local authorities. The test will be verified by a confirmatory molecular test (PCR) and instructions on next steps will be provided. NEGATIVE: A single colored line appears in the control region (C). No colored line appears in the test line region (T). It is unlikely that the person has COVID-19. However, this test may give an incorrect result (false negative) in some people with COVID-19. This means that they may have COVID-19 even if the test was negative. If you experience symptoms such as headache, migraine, fever, loss of taste and smell, contact your nearest doctor, as directed by your local authority. You can also repeat the test with a new kit. If you suspect the presence of the virus, repeat the test after 1-2 days, as the coronavirus cannot be detected at all stages of infection. Even in the case of a negative result, social distancing and hygiene rules should still be followed. INVALID: Control line does not appear. Insufficient sample volume or incorrect testing techniques are the most likely causes of 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 leaflet before performing the test. For self-testing only. For in vitro diagnostic use only. Do not use after the expiry date. Do not eat, drink, or smoke in the area where specimens or kits are being handled. Do not drink the liquid from 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 packaging is damaged or has been opened. This test kit should only be used as a preliminary test, and repeated abnormal results should be discussed with a doctor or healthcare professional. Strictly adhere to the indicated time. Use the test only once. Do not disassemble or touch the test window of the test cassette. The kit should not be frozen or used after the expiration date printed on the package. Keep out of reach of children. Testing of children and adolescents should be performed in the presence of an adult. Do not use the test on children under 2 years of age. Young children should be tested with the help of a second adult. Wash your hands thoroughly before and after handling. Please ensure that you use an adequate amount of sample for testing. Too much or too little sample may result in inaccurate 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, this is because the virus from very early infection may not have been detected. Retesting with a new kit or testing with a molecular diagnostic device is recommended to rule out infection in these individuals. Negative results do not rule out infection with SARS-CoV-2, especially in those who have been in contact with the virus. Further testing with a molecular diagnostic device should be considered to rule out infection in these individuals. Positive COVID-19 results may be caused by infection with non-SARS-CoV-2 coronavirus strains or other interfering factors. Failure to follow test procedures may affect test performance. False negative results may occur if a sample is collected or handled improperly. False negative results may occur if insufficient levels of virus are present in the sample. Conservation Store as packaged, in the sealed pouch, at room temperature or in a refrigerator (2-30°C), avoiding areas with excessive humidity. Do not freeze. The test is stable until the expiration date printed on the sealed pouch. The test should remain in the sealed pouch until use. Do not use after the expiration date. Shelf life with intact packaging: 12 months. Format The kit contains: - Test cassette; - Sterile swab; - The prospectus; - Extraction stick; - Biosecurity bag. Bibliography 1. Protocol for diagnosis and treatment of pneumonia caused by novel coronavirus (study version 7). National Health Commission and National Administration of Traditional Chinese Medicine. 2020
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