vândut de liki24.co.uk
VivaDiag Pro Quick test Description The VivaDiag™ Pro Rapid Test for SARS-CoV-2 Antigen is intended for the rapid and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in humans. The test is intended for in vitro diagnostic use only. It is intended for self-testing. It provides only an initial screening test result. Alternative more specific diagnostic methods (molecular and/or CT) should be performed to confirm SARS-CoV-2 infection. The decision on the diagnostic procedure rests with the physician. This test is intended for home use with self-collected nasal swab specimens from individuals aged 16 to 69 years. Specimen collection and testing by individuals under 16 years of age and over 69 years of age should be performed under adult supervision. For individuals who are unable to perform the test themselves, the test should be performed by a legal guardian; ill/disabled individuals (including those with visual impairments) should be assisted during the test. The VivaDiag™ Pro SARS-CoV-2 Ag Rapid Test is based on immunochromatography technology. Each test device will display a line of anti-SARS-CoV-2 antibodies labeled as the detection line (T line) and a line of anti-mouse IgG antibodies labeled as the quality control line (C line). When the extracted sample is added to the sample well, it will react with the labeled antibody to form a complex; the mixture will then migrate through the membrane by capillary action and interact with the anti-SARS-CoV-2 antibody coated on the detection line. If the sample contains SARS-CoV-2 antigen, the detection line will appear red, indicating that the SARS-CoV-2 antigen is positive. Otherwise, the test result will be negative. The test device also contains a quality control line (C line), which must appear red to validate the test. If the quality control line C is not displayed, the test result will be invalid even if the detection line is present. How to use Sample collection Previous Nasal Swab Sample: Wash your hands with soap and water or use hand sanitizer: it is important to collect as much secretion as possible. Open the swab packaging at the end of the swab and remove the swab. Do not touch the tip of the swab. Insert the sterile swab into one nostril. Make sure the entire tip of the swab is inserted into the nostril (approximately 1.5 cm). Roll the swab 5 times on the mucosa inside the nostril to ensure that both mucus and cells are collected. Repeat this process for the other nostril to collect an adequate amount of sample from both nasal cavities (use the same swab). Sample handling Samples should be tested as soon as possible after collection (testing within 5 minutes is recommended). Testing procedure 1. Open the extraction solution (in the sealed tube). 2. Collect the sample by referring to the Sample Collection section. 3. Insert the swab with the collected sample into the extraction tube containing the extraction solution. Rotate the swab 5 times, pressing the head against the bottom and sides of the extraction tube. Remove the swab by pressing it against the sides of the tube to extract the liquid from the swab. Try to extract as much liquid as possible. 4. Insert the pipette tip into the test tube. 5. Remove a test device from the sealed pouch and place it on a clean, flat surface. 6. Apply 3 drops of the extracted sample to the sample well. Avoid forming bubbles during application. 7. Read the test result after 15 minutes. Do not read the result after 20 minutes. Note: Do not interchange or mix extraction solutions from different batches. Handle the extraction solution with caution; do not touch eyes or skin. In case of contact with eyes or skin, rinse thoroughly with water. Interpretation of results 1. Positive result Both the quality control line C and the detection line T are displayed. Any shade of color in the test line region (T) should be considered positive. If you suspect you have COVID-19: - contact your doctor/family doctor or local medical facility immediately; - follow local self-isolation instructions; - perform a confirmatory PCR test. 2. Negative result Only the quality control line C is displayed, no other line appears in the detection zone. Continue to follow all applicable rules regarding contact with others and protective measures. An infection may be present even if the test is negative. If you suspect the presence of coronavirus, as it cannot be accurately detected at all stages of an infection, contact your doctor/family doctor or local medical facility immediately. 3. Invalid result If the quality control line C is not displayed, the test is invalid, regardless of whether the detection line is displayed or not. Collect a new sample and perform another test with a new device. - Possibly caused by a faulty test. - Repeat the test. - If your test results are still invalid, contact your doctor/family doctor or local medical facility immediately. warnings SARS-CoV-2 antigen test results should not be used as the sole basis for diagnosing or ruling out SARS-CoV-2 infection or for informing about the stage of infection. - You should not make any significant medical decisions without first consulting your doctor. Negative results do not rule out SARS-CoV-2 infection, especially in those who have been in contact with the virus. Further molecular diagnostic tests and/or CT scans should be considered to rule out infection in these individuals. Positive results may be due to a current infection with a SARS coronavirus strain. Further molecular diagnostic testing and/or a CT scan should be considered to confirm the test result. - Negative results may occur if the antigen level in the sample is below the detection limit of the test. - Inaccurate results may occur due to visibly bloody or excessively thick/sticky samples, insufficient sample volume, or bubble formation during application. - Do not use damaged or unusable chopsticks. People with color vision problems may not be able to adequately interpret test results. - For in vitro diagnostic use only, it is for self-testing. - Keep out of reach of children. - Use the test device within 60 minutes of opening the foil pouch. - Do not perform the test in direct sunlight. - Do not use the test device if it has been exposed to household cleaning products (especially bleach). - Do not let foreign substances come into contact with the test device during the testing process. - Please take the necessary safety precautions (e.g. face mask, gloves) when testing other people. - The equipment used for the test and all tested components must be disposed of in accordance with local regulations and can be placed in a tightly sealed bag and disposed of as household waste. Additional molecular diagnostic tests and/or computed tomography are recommended to identify the actual physical situation. - Do not open the foil pouch of the test device or expose it to the environment until you are ready to use it immediately. - Do not use damaged devices or test materials. - Do not reuse the test device. - Handle the extraction solution with caution; do not touch eyes or skin. In case of contact with eyes or skin, rinse thoroughly with water. - Do not use the test kit after the expiration date. - Collect the test sample from the anterior nasal cavity only. Follow the package insert for accurate results. - Wash your hands thoroughly after handling and before collecting and testing samples. This test does not determine the etiology of respiratory infections caused by microorganisms other than the SARS-CoV-2 virus. - The accuracy of the test depends on the quality of the sample collected with the swab; false negative results may occur as a result of poor sampling. - Failure to follow the test procedure may negatively impact test performance and/or invalidate the test result. Conservation Store the test kit in a dry place between 2-30°C. Protect from light. Exposure to temperatures and/or humidity beyond the specified limits may result in inaccurate results. Do not freeze. Use the test kit at temperatures between 15-30°C. Use the test kit with humidity between 10-90%. Do not use the test kit after the expiration date. Shelf life of intact packaging: 24 months. Format 1 test, 1 reagent (in sealed tube), 1 measuring cap, 1 tube holder, 1 sterile swab, information leaflet. Code: VCD-16-10-013
Preț:
Vânzător: Liki24.co.uk
Brand: N/a
