{"product_id":"test-antigenico-rapido-covid-19-vivadiag-pro-autodiagnostico-determinazione-qualitativa-antigeni-sars-cov-2-in-tamponi-nasali-nasofaringei-orofaringei-mediante-immunocromatografia","title":"VIVADIAG PRO COVID-19 RAPID ANTIGEN TEST SELF-DIAGNOSTIC QUALITATIVE DETERMINATION OF SARS-COV-2 ANTIGENS IN NASAL\/NASOPHARYNGEAL\/OROPHARYNGEAL SWABS BY IMMUNOCHROMATOGRAPHY","description":"\u003ch1\u003eVivaDiag Pro\u003c\/h1\u003e \u003ch2\u003eRapid Test\u003c\/h2\u003e \u003cdiv align=\"justify\"\u003e \u003cb\u003eDescription\u003c\/b\u003e\u003cbr\u003e The VivaDiagTM Pro SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in humans. The test is for in-vitro diagnostic use only. It is intended for self-testing. It only provides an initial screening test result. More specific alternative diagnostic methods (molecular diagnostics 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 samples from individuals aged 16 to 69 years. Sample collection and testing performed by individuals under 16 and over 69 should be done under adult supervision. For people who are unable to perform the test themselves, the test should be conducted by legal guardians; sick\/disabled individuals (including those with visual impairments) should be assisted during the test.\u003cbr\u003e The VivaDiagTM Pro SARS-CoV-2 Ag Rapid Test is based on immunochromatography technology. Each test device will show an anti-SARS-CoV-2 antibody line identified as the detection line (T line) and an anti-mouse IgG antibody line identified 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 coated anti-SARS-CoV-2 antibody on the detection line. If the sample contains the 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 C line that must appear red to validate the test. If the quality control C line is not shown, the test result will be invalid even if the detection line is present.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eDirections for use\u003c\/b\u003e\u003cbr\u003e Sample collection\u003cbr\u003e Anterior nasal swab sample Wash hands with soap and water or use hand sanitizer: it is important to obtain as much secretion as possible. Open the swab package at the stick end and remove the swab. Do not touch the swab tip. Insert the sterile swab into one nostril. Make sure the entire tip of the swab has been inserted into the nostril (about 1.5 cm). Rotate the swab 5 times against the mucous membrane inside the nostril to ensure that both mucus and cells are collected. Repeat this process for the other nostril to collect an adequate sample quantity from both nasal cavities (use the same swab).\u003cbr\u003e Sample handling\u003cbr\u003e Samples should be tested as soon as possible after collection (it is recommended to test them within 5 minutes).\u003cbr\u003e Test procedure\u003cbr\u003e 1. Open the extraction solution (in the sealed tube).\u003cbr\u003e 2. Collect the sample referring to the Sample Collection section.\u003cbr\u003e 3. Insert the swab with the collected sample into the extraction tube containing the extraction solution. Rotate the swab 5 times by 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.\u003cbr\u003e 4. Place the dropper tip onto the tube.\u003cbr\u003e 5. Remove a test device from its sealed pouch and place it on a clean, flat surface.\u003cbr\u003e 6. Apply 3 drops of the extracted sample into the sample well. Avoid bubble formation during application.\u003cbr\u003e 7. Read the test result after 15 minutes. Do not read the result after 20 minutes.\u003cbr\u003e Note: do not swap or mix extraction solution from different batches.\u003cbr\u003e Handle the extraction solution carefully, do not touch eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.\u003cbr\u003e Interpretation of results\u003cbr\u003e 1. Positive result\u003cbr\u003e Both the quality control line C and the detection line T are displayed. Any shade of color in the test line (T) region should be considered positive.\u003cbr\u003e If COVID-19 infection is suspected:\u003cbr\u003e - contact your doctor\/GP or local health facility immediately;\u003cbr\u003e - follow local self-isolation guidelines;\u003cbr\u003e - perform a confirmatory PCR test. \u003cbr\u003e 2. Negative result\u003cbr\u003e Only the quality control line C is displayed, no other line appears in the detection area.\u003cbr\u003e Continue to follow all applicable rules regarding contact with others and protective measures.\u003cbr\u003e - An infection may be present even if the test is negative.\u003cbr\u003e - In case of suspicion, as coronavirus cannot be accurately detected at all stages of an infection, contact your doctor\/GP or local health facility immediately.\u003cbr\u003e 3. Invalid result\u003cbr\u003e The quality control line C is not displayed, indicating that 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.\u003cbr\u003e - Possibly caused by an incorrect test.\u003cbr\u003e - Repeat the test.\u003cbr\u003e - If the test results are still invalid, contact your doctor\/GP or local health facility immediately.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eWarnings\u003c\/b\u003e\u003cbr\u003e - SARS-CoV-2 antigen test results should not be used as the sole basis for diagnosing or excluding SARS-CoV-2 infection or for informing infection status.\u003cbr\u003e - No medical decision should be made without first consulting a doctor.\u003cbr\u003e - Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up molecular diagnostic and\/or CT tests should be considered to rule out infection in these individuals.\u003cbr\u003e - Positive results may be due to an existing infection with SARS-coronavirus strains. Follow-up molecular diagnostic and\/or CT tests should be considered to confirm the test result.\u003cbr\u003e - Negative results may occur if the antigen level in the sample is below the test's detection limit.\u003cbr\u003e - Inaccurate results may occur due to visibly bloody or excessively thick\/sticky samples, insufficient sample volume, or bubble formation during application.\u003cbr\u003e - Do not use damaged or unusable swabs.\u003cbr\u003e - Individuals with color vision problems may not be able to properly interpret test results.\u003cbr\u003e - For in-vitro diagnostic use only, for self-testing.\u003cbr\u003e - Keep out of reach of children.\u003cbr\u003e - Use the test device within 60 minutes of opening the foil pouch.\u003cbr\u003e - Do not perform the test in direct sunlight.\u003cbr\u003e - Do not use the test device if it has been exposed to household cleaning products (especially bleach).\u003cbr\u003e - Keep foreign substances away from the test device during the testing process.\u003cbr\u003e - Please take necessary safety measures (e.g., face mask, gloves) when performing tests for other people.\u003cbr\u003e - The equipment used for testing and all tested components must be disposed of in accordance with local requirements, and can be placed in a tightly sealed bag and disposed of as household waste.\u003cbr\u003e - Further molecular diagnostic and\/or CT testing is recommended to identify the actual physical situation.\u003cbr\u003e - Do not open the test device's foil pouch, exposing it to the surrounding environment until you are ready for its immediate use.\u003cbr\u003e - Do not use damaged test devices or materials.\u003cbr\u003e - Do not reuse the test device.\u003cbr\u003e - Handle the extraction solution carefully, do not touch eyes or skin. In case of contact with eyes or skin, wash thoroughly with water.\u003cbr\u003e - Do not use the test kit beyond the expiration date.\u003cbr\u003e - Collect the sample for testing only from the anterior nasal part. Follow the package insert for accurate results.\u003cbr\u003e - Wash hands thoroughly after handling and wash hands before sample collection and testing.\u003cbr\u003e - This test does not determine the etiology of respiratory infection caused by microorganisms other than SARS-CoV-2 virus.\u003cbr\u003e - The accuracy of the test depends on the quality of the sample collected with the swab; false negative results may occur due to poor sampling.\u003cbr\u003e - Failure to follow the testing procedure may negatively impact test performance and\/or invalidate the test result.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eStorage\u003c\/b\u003e\u003cbr\u003e Store the test kit in a dry place between 2-30 °C. Keep away from light. Exposure to temperatures and\/or humidity outside the specified limits can cause inaccurate results. Do not freeze. Use the test kit at temperatures between 15-30 °C. Use the test kit between 10-90% humidity. Do not use the test kit beyond the expiration date.\u003cbr\u003e Shelf life of unopened packaging: 24 months.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eFormat\u003c\/b\u003e\u003cbr\u003e 1 test, 1 reagent (in sealed tube), 1 dispenser cap, 1 tube holder, 1 sterile swab, instruction leaflet.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eCode.\u003c\/b\u003e VCD-16-10-013\u003c\/div\u003e","brand":"DIACARE Srl","offers":[{"title":"Default Title","offer_id":52463798059275,"sku":"983778376","price":1.47,"currency_code":"EUR","in_stock":true}],"url":"https:\/\/farmaonline24.it\/en\/products\/test-antigenico-rapido-covid-19-vivadiag-pro-autodiagnostico-determinazione-qualitativa-antigeni-sars-cov-2-in-tamponi-nasali-nasofaringei-orofaringei-mediante-immunocromatografia","provider":"FarmaOnline24","version":"1.0","type":"link"}