{"product_id":"test-antigenico-rapido-covid-19-vivadiag-determinazione-qualitativa-antigeni-sars-cov-2-in-campioni-salivari-mediante-immunocromatografia-uso-professionale","title":"Vivadiag COVID-19 Rapid Antigen Test Qualitative Determination of SARS-CoV-2 Antigens in Saliva Samples by Immunochromatography Professional Use","description":"\u003cp\u003e\u003c\/p\u003e\u003ch2\u003eVivaDiag\u003c\/h2\u003e \u003ch1\u003eSARS-CoV-2 Ag Saliva\u003cbr\u003e Rapid Test\u003c\/h1\u003e \u003ch2\u003e\u003cfont color=\"red\"\u003eProfessional use\u003c\/font\u003e\u003c\/h2\u003e \u003cdiv align=\"justify\"\u003e \u003cb\u003eDescription\u003c\/b\u003e\u003cbr\u003e The test is intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in human saliva.\u003cbr\u003e It provides only an initial screening result. More specific alternative methods (molecular diagnostics and\/or CT) should be used for confirmation of SARS-CoV-2 infection.\u003cbr\u003e It is based on immunochromatographic technology. Each test device is equipped with a SARS-CoV-2 monoclonal antibody detection line (T line) and a anti-human rat IgG monoclonal antibody band on the quality control line (C line).\u003cbr\u003e When the extracted sample is added to the sample well, it reacts with the labeled antibody to form a complex, then the mixture passes through the membrane by capillarity and interacts with the anti-SARS-CoV-2 monoclonal antibody on the detection line.\u003cbr\u003e If the sample contains the SARS-CoV-2 antigen, the purple-red detection line will appear, indicating SARS-CoV-2 antigen positivity.\u003cbr\u003e Otherwise, the test result will be negative.\u003cbr\u003e The test device contains a C quality control line which should appear in purple-red for all valid tests. If the C quality control line does not appear, the test result is invalid, even if the detection line appears.\u003cbr\u003e The test is for professional in vitro diagnostic use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing. Not for home use.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eInstructions for use\u003c\/b\u003e\u003cbr\u003e \u003cu\u003eTest procedure\u003c\/u\u003e\u003cbr\u003e Before performing the test, wait for the test devices and solution to stabilise at room temperature (15-30 °C or 59-86 °F).\u003cbr\u003e Do not place anything in the mouth (including food, chewing gum, drinks or tobacco) for 10 minutes before sample collection.\u003cbr\u003e \u003cbr\u003e After returning the test card to room temperature, open the foil pouch and remove the test card.\u003cbr\u003e Do not eat\/drink\/smoke\/chew anything for 30 minutes before the test. Rinse your mouth before the test.\u003cbr\u003e Cough deeply to transfer saliva from the deep throat and enrich the saliva in the mouth. Remove the cover and insert the swab into the oral cavity. Allow the swab to soak completely in saliva and wait 2 minutes to ensure the saliva reaches the test window.\u003cbr\u003e Remove the kit and cover it. Read the test result at 15 minutes. Do not read the result after 20 minutes.\u003cbr\u003e Rinse your mouth immediately after using the test kit.\u003cbr\u003e \u003cbr\u003e \u003cu\u003eInterpretation of results\u003c\/u\u003e\u003cbr\u003e Positive result: both the C quality control line and the T detection line appear. The test should be considered positive if the T line is present, regardless of its intensity.\u003cbr\u003e \u003cbr\u003e Negative result: only the C quality control line appears, without any other lines.\u003cbr\u003e \u003cbr\u003e Invalid result: the C quality control line does not appear, which means the test is invalid, regardless of whether the detection line appears or not. Collect a new sample and perform another test with a new test device.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eWarnings\u003c\/b\u003e\u003cbr\u003e For professional in vitro diagnostic use only.\u003cbr\u003e The results of the SARS-CoV-2 antigen test should not be used as the sole basis for diagnosing or excluding SARS-CoV-2 infection or for communicating infectious status.\u003cbr\u003e Negative results do not rule out SARS-CoV-2 infection, especially in individuals who have been in contact with the virus. Follow-up tests with molecular diagnostics and\/or CT should be considered to rule out infection in these individuals.\u003cbr\u003e Positive results may be due to an existing infection caused by SARS coronavirus strains. Follow-up tests with molecular diagnostics and\/or CT should be considered to confirm the test results.\u003cbr\u003e Incorrect results may be due to a viscous or insufficient sample or bubble formation during application.\u003cbr\u003e Do not use with UTM not verified\/authorised by the manufacturer. May lead to false positive or false negative results.\u003cbr\u003e Further testing with molecular diagnostics and\/or CT is recommended to establish the actual physical situation.\u003cbr\u003e Do not open the test device's foil pouch, exposing it to the surrounding environment, until the test device is ready for use.\u003cbr\u003e Do not use damaged test devices or materials. Do not reuse the test device.\u003cbr\u003e Do not use beyond the expiry date.\u003cbr\u003e Specific training or guidance is recommended if operators are not experienced with sample collection and handling procedures.\u003cbr\u003e Use only saliva as a sample. Follow the instructions on the package leaflet for accurate results.\u003cbr\u003e Wear protective clothing such as lab coats, disposable gloves, and eye protection during sample collection and evaluation procedures.\u003cbr\u003e All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after cleaning and disinfection. Follow appropriate precautions and all local regulations when disposing of used kits.\u003cbr\u003e Wash hands thoroughly after handling.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eStorage\u003c\/b\u003e\u003cbr\u003e Store the kit in a cool, dry place between 2-30 °C (36-86 °F). Keep away from light. Exposure to temperature and\/or humidity outside the specified conditions may cause inaccurate results. Do not freeze or refrigerate.\u003cbr\u003e Do not use the kit beyond the expiry date.\u003cbr\u003e Shelf life unopened: 24 months.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eFormat\u003c\/b\u003e\u003cbr\u003e The kit contains the test devices and the package leaflet.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eBibliography\u003c\/b\u003e\u003cbr\u003e 1. Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2 [J]. Nature Microbiology, 5, 536-544 (2020).\u003cbr\u003e 2. Perlman, S. Netland, J. Coronaviruses post-SARS: update on replication and pathogenesis. Nature Reviews Microbiology 7, 439-450, doi: 10.1038\/nrmicro2147 (2009).\u003cbr\u003e 3. Lauer SA, Grantz KH, Bi Q, et al. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020; 172 (9): 577-582. doi: 10.7326\/M20-0504.\u003cbr\u003e 4. McCarron, MM, et al. Detection of Phencyclidine Usage by Radioimmunoassay of Saliva. J Anal Tox.1984 Sep-Oct.; 8 (5), pp 197-201.\u003cbr\u003e 5. B. Korber et al. Tracking Changes in SARS-CoV-2 Spike: Evidence that D614G Increases Infectivity of the COVID-19 Virus. Cell, vol. 182, no. 4, pp. 812-827.e19, Aug. 2020, doi: 10.1016\/j.cell.2020.06.043.\u003cbr\u003e 6. Investigation of novel SARS-CoV-2 variant: Variant of Concern 202012\/01, GOV.UK.\u003cbr\u003e 7. New SARS-CoV-2 variant, GOV.UK.\u003cbr\u003e 8. D. C. Dinesh et al. Structural basis of RNA recognition by the SARS-CoV-2 nucleocapsid phosphoprotein. PLoS Pathog, vol. 16, no. 12, p. e1009100, Dec. 2020, doi: 10.1371\/journal.ppat.1009100.\u003cbr\u003e 9. J. Mariën et al. Evaluating SARS-CoV-2 spike and nucleocapsid proteins as targets for antibody detection in severe and mild COVID-19 cases using a Luminex bead-based assay. Journal of Virological Methods, vol. 288, p. 114025, Feb. 2021, doi: 10.1016\/j.jviromet.2020.114025.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eCode.\u003c\/b\u003e VCD17-01- 019\u003c\/div\u003e","brand":"DIACARE SRL","offers":[{"title":"Default Title","offer_id":57340354724184,"sku":"983437308","price":7.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0968\/9301\/0264\/files\/983437308.jpg?v=1779339265","url":"https:\/\/www.globalpharmacy.it\/en\/products\/test-antigenico-rapido-covid-19-vivadiag-determinazione-qualitativa-antigeni-sars-cov-2-in-campioni-salivari-mediante-immunocromatografia-uso-professionale","provider":"Global Pharmacy","version":"1.0","type":"link"}