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SCREEN VERIFICATION TEST RBD test for Covid-19 Description A rapid immunochromatographic assay for the qualitative detection of IgG antibodies to the receptor binding domain (RBD) of the spike (S) protein of SARS-CoV-2 in whole blood collected by human finger prick approximately 10 days after vaccination. It is designed to help identify individuals with an adaptive immune response to SARS-CoV-2. The results are for the detection of IgG S-RBD antibodies to SARS-CoV-2. Positive results indicate the presence of IgG antibodies to SARS-CoV-2. How to use Before the test: Bring the test and buffer solution to room temperature (15-30°C) before use. Wash your hands thoroughly with warm water and dry them. Remove the test cassette from the sealed pouch and use it within 1 hour. Do not touch the test area (the strip next to the letters C, T and S) of the test strip. Best results are obtained if the test is performed immediately after opening. Place the test on a flat, clean surface. 1. Use the alcohol swab to clean the tip of your middle or ring finger where you want to prick it. Let it dry for 10 seconds. 2. Gently twist and remove the lancet cap. Open the lancet just before testing. 3. Press the sterile lancet firmly onto the tip of your middle or ring finger. 4. To increase blood flow, use your thumb and forefinger to apply gentle pressure around the puncture site. 5. Without pressing the pipette, apply it to the blood. The blood should reach the line indicated on the pipette. You can massage the finger again to obtain more blood if the line is not reached. Avoid air bubbles; if air bubbles appear, discard the blood into a plastic bag (e.g., a biosafety bag), then repeat the previous collection steps. 6. Place the pipette tip in contact with the center of the sample well(s) and release all blood immediately after collection. 7. Add 2 drops of buffer solution to the sample well (S) and start the timer. Do not move the test during development. 8. Read results after 10 minutes. Do not interpret results after 20 minutes. Positive: *Two colored lines appear. One colored line in the control region (C) and another in the test region (T). A positive result in the test region indicates the detection of IgG S-RBD SARS-CoV-2 in the sample. *Note: The intensity of the color in the test line (T) varies depending on the amount of IgG S-RBD SARS-CoV-2 present in the sample. Therefore, any shade of color in the test region (T) should be considered positive. Negative: A colored line appears in the control region (C). No colored line appears in the test region (T). A negative result indicates that the IgG S-RBD SARS-CoV-2 antibody was not detected in the specimen. Invalid: Control line does not appear. Insufficient sample volume or improper procedural techniques are the most common reasons for control line failure. Review the procedure and repeat the test with a new device. If the problem persists, discontinue use of the test immediately and contact your supplier. warnings 1. This package insert should be read in its entirety before performing the test. Failure to follow the instructions in the package insert may result in inaccurate test results. 2. For in vitro diagnostic self-testing use only. 3. Keep out of reach of children. Testing on children and young people should be performed by an adult. 4. Do not eat, drink, or smoke in the sample or kit handling area. 5. Do not use if the test packaging is damaged. 6. Wash your hands thoroughly before performing the test. 7. Make sure to use an adequate amount of sample during the test. Too little or too much sample may lead to inconsistent results. 8. Do not touch the test reaction area on the device strip. 9. The used test should be disposed of according to local regulations. Do not reuse any kit components. 10. Do not drink the buffer solution contained in the kit. Handle the buffer solution carefully to avoid contact with skin or eyes; if this occurs, rinse immediately with running water. 11. The rapid test for the detection of IgG S-RBD antibodies for SARS-CoV-2 (whole blood taken by finger prick) should only be used in individuals vaccinated against COVID-19. Do not use the kit after the expiration date printed on the sealed package. Do not open the sealed package until you are ready to perform the test. Conservation Store in the sealed container at room temperature or in a refrigerator (2-30°C). Do not freeze. Format Package containing: - test cassette (each cassette is in a sealed package with desiccant); - the prospectus; - buffer; - alcohol swab; - sterile lancet; - pipette; - biosecurity bag
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