SCREEN CHECK TEST Covid-19 Saliva Oral Fluid Test Description Single-use test intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid. The test is intended for home use with self-collection of oral fluid samples from symptomatic individuals suspected of being infected with the COVID-19 virus. It is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antigens in human oral fluid samples. The test provides only a preliminary result; final confirmation must be based on clinical diagnostic results. How to use Before taking the test, do not put anything in your mouth, including food, drinks, chewing gum, or tobacco products, for at least 10 minutes before taking the test. Wash your hands with soap and water for at least 20 seconds before taking the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol. Step 1: Sample collection Remove the funnel and plastic tube from the package, insert the funnel into the tube, and cough deeply 3-5 times. Note: Wear a face mask or cover your mouth and nose with a cloth when coughing and maintain social distancing. Gently spit the oral fluid into the funnel. The oral fluid (without bubbles) should reach the height indicated by the reference line. Note: If the fluid collected is not sufficient, repeat the sample collection steps. Insert the used funnel into the biosafety bag. Step 2: Sample preparation Place the tube in the plastic holder. Pull to open the buffer solution and pour the entire solution into the tube with the oral fluid. Replace the cap on the tube. Gently squeeze the tube 10-15 times to mix well. Step 3: Running the test Remove the test device from the sealed 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 device on a flat surface. Invert the tube and place 2 drops of solution into the well (S) of the test device, then start the timer. Do not move the device while performing the test. Read the results after 15 minutes. Do not interpret the results after 20 minutes. After completing the test, place all test kit components in a biosafety bag and dispose of it according to local regulations. Do not reuse any used kit components. Wash your hands thoroughly after disposing of the test. Step 4: Reading the results Please inform your healthcare provider of your results and carefully follow local COVID guidelines/regulations. - 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). 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 should be verified with a confirmatory molecular (PCR) test, and instructions on the next steps will be provided. *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 specimen. Therefore, the presence of any shade of color in the test region (T) should be interpreted as a POSITIVE result. - NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test 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 results are negative. If you experience symptoms such as headache, migraine, fever, or loss of taste or smell, contact your nearest healthcare provider in accordance with your local health authoritys guidelines. You can also repeat the test with a new kit. If you suspect the virus, 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 continue to be observed, and mitigation/travel, event attendance, and so on should follow local COVID guidelines/requirements. - INVALID: The control line does not appear. Insufficient sample volume or incorrect procedure 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 Read the package leaflet carefully before performing the test. The test is intended for in vitro self-diagnosis only. The test is for single use only; do not reuse. 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 buffer solution provided in the kit. Handle the buffer solution with care and avoid contact with skin and eyes. In case of contact, rinse immediately with plenty of running water. Do not use the test if the package is damaged. Wash hands thoroughly before and after handling. If the preliminary result is positive, inform your doctor and carefully follow local instructions/regulations for COVID cases. Tests performed on children and adolescents must be carried out in the presence of adults. The used test must be disposed of according to local regulations. Failure to follow some steps in the test procedure may result in incorrect results. The results obtained with the test should be considered in addition to other clinical results from other tests and laboratory evaluations. If the test result is negative or nonreactive but clinical symptoms persist, its because the virus may not be detectable in the early stages of infection. Its recommended to repeat the test 1-2 days later or go to the hospital to rule out infection. Positive COVID-19 results may be due to infection with non-SARS-CoV-2 virus strains or other interfering factors. Conservation Store the test at temperatures between 2-30°C. Do not freeze. Do not open the package until you are ready to perform the test. Shelf life when packaging is intact: 12 months. Format The kit contains: • Test device; • Sample collection device (funnel, tube and tube cap); • Buffer solution; • Package leaflet; • Bio-security bags. Bibliography 1. BACKINGER, CL and KINGSLEY, PA, Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care, Rockville, MD, US Food and Drug Administration, Center for Devices and Radiological Health, HHS Pub. FDA 93-4258