{"product_id":"test-antigenico-rapido-covid-19-reagen-determinazione-qualitativa-antigeni-sars-cov-2-in-tamponi-nasofaringei-orofaringei-mediante-immunocromatografia-uso-professionale-25-pezzi","title":"Reagen Covid-19 Rapid Antigen Test Qualitative Determination of SARS-CoV-2 Antigens in Nasopharyngeal\/Oropharyngeal Swabs by Immunochromatography Professional Use 25 Tests","description":"\u003cp\u003e\u003c\/p\u003e\u003ch2\u003eREAGEN\u003c\/h2\u003e \u003ch1\u003eSARS-CoV-2 Antigen IVD Kit SWAB\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 In vitro diagnostic test for the qualitative detection of novel coronavirus antigens in human nasopharyngeal swabs and oropharyngeal swabs, using the rapid immunochromatographic method.\u003cbr\u003e Identification is based on specific monoclonal antibodies to the novel coronavirus antigen. It will provide information to clinicians to prescribe correct medications.\u003cbr\u003e It is a membrane immunochromatographic test that uses highly sensitive monoclonal antibodies against the novel coronavirus.\u003cbr\u003e The test strip consists of a sample pad, reagent pad and reaction membrane. The reagent membrane contains colloidal gold conjugated with monoclonal antibodies against the novel coronavirus; the reaction membrane contains secondary antibodies for the novel coronavirus and polyclonal antibodies against mouse globulin, which are pre-immobilized on the membrane.\u003cbr\u003e When the sample is added to the device, the dried conjugates in the reagent pad dissolve and migrate along with the sample.\u003cbr\u003e If coronavirus is present in the sample, a complex formed between the anti-coronavirus conjugate and the virus will be captured by the specific anti-coronavirus monoclonal antibody coated on the T region.\u003cbr\u003e Regardless of whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) which binds to the remaining conjugates, thus producing a red line on the C region.\u003cbr\u003e The test is intended for use by healthcare professionals or trained operators who are familiar with performing rapid antigen tests.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eHow to use\u003c\/b\u003e\u003cbr\u003e \u003cu\u003eSample collection and preparation\u003c\/u\u003e\u003cbr\u003e The sample must be collected using the collection tools provided with the kit. Follow the instructions for use. No other collection tools should be used for this test.\u003cbr\u003e \u003cbr\u003e Nasopharyngeal swab: Insert the swab into the nasal cavity, slowly and gently. Do not overdo it to avoid traumatic bleeding. When the tip of the swab touches the posterior parts of the nasopharyngeal cavity, leave the swab in place for a few seconds (about 3 seconds) and gently rotate it. Then remove the swab.\u003cbr\u003e \u003cbr\u003e Oropharyngeal swab: Do not put anything in your mouth, including food, drinks, gum, tobacco, water and mouth cleaning products for at least 10 minutes before sample collection. Have the patient tilt their head back and open their mouth, thus exposing the tonsils from both sides. Swab the root of the tongue. Clean the pharyngeal tonsils on both sides, applying some force for at least three times.\u003cbr\u003e \u003cbr\u003e \u003cu\u003eTest procedure\u003c\/u\u003e\u003cbr\u003e Allow the test device, sample and extraction tube to reach room temperature (15-30 °C) before testing.\u003cbr\u003e Remove the aluminum seal from the sample extraction tube. Immerse the swab containing the sample in the tube, rotate it and press it 5 times. Remove the swab and dispose of it. Insert the cap on the extraction tube.\u003cbr\u003e Gently shake the extraction tube for about 5 seconds to ensure the sample mixes well with the extraction solution.\u003cbr\u003e Transfer 2-3 drops of solution vertically into the test card and start the timer.\u003cbr\u003e Read the result at 15 minutes. Do not interpret the result after 20 minutes.\u003cbr\u003e \u003cbr\u003e \u003cu\u003eInterpretation of results\u003c\/u\u003e\u003cbr\u003e POSITIVE: two red lines appear. A red line appears in the control region (C) and a red line in the test region (T). The result should be considered positive regardless of the shade of color of the line in the test region (T).\u003cbr\u003e \u003cbr\u003e NEGATIVE: only one red line appears in the control region (C), while no line appears in the test region (T). A negative result indicates that there are no novel coronavirus particles in the sample or that the number of viral particles is below the detection limit of the test.\u003cbr\u003e \u003cbr\u003e INVALID: no red line appears in the control region (C). The test is invalid even if a line is present in the test region (T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the failure of the control line to appear. Review the test procedure and repeat the test using a new device. If the problem persists, stop using the kit and contact the local distributor.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eWarnings\u003c\/b\u003e\u003cbr\u003e For in vitro diagnostic use only.\u003cbr\u003e Do not use after the expiration date.\u003cbr\u003e Ensure that the aluminum pouch containing the test device is not damaged before opening for use.\u003cbr\u003e Wear gloves when handling samples. Avoid touching the reagent membrane and the sample window on the test card.\u003cbr\u003e All samples and used components must be treated as infectious agents and disposed of according to local regulations.\u003cbr\u003e Do not use bloody samples.\u003cbr\u003e The kit is an acute phase screening test for qualitative detection. The collected sample may contain an antigen concentration below the detection limit of the reagent, so a negative test result does not rule out novel coronavirus infection.\u003cbr\u003e The kit detects vital and non-vital novel coronavirus antigen. Test performance depends on the antigen load in the sample and may not correlate with cell culture performed on the same sample.\u003cbr\u003e A positive result does not rule out the possibility that other pathogens may be present. Results must, therefore, be compared with all available clinical and laboratory information to make an accurate diagnosis.\u003cbr\u003e If the level of extracted antigen in a sample is below the detection limit of the test or if the sample is collected inaccurately, a negative test result may be generated.\u003cbr\u003e Positive results do not exclude co-infections with other pathogens.\u003cbr\u003e Negative results do not exclude the possibility of other coronavirus infections (non-SARS-CoV-2).\u003cbr\u003e \u003cbr\u003e \u003cb\u003eStorage\u003c\/b\u003e\u003cbr\u003e Store at room temperature or in the refrigerator (4-30 °C). Do not freeze.\u003cbr\u003e Validity with intact packaging: 24 months.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eFormat\u003c\/b\u003e\u003cbr\u003e The kit contains:\u003cbr\u003e - test card;\u003cbr\u003e - sterile swab;\u003cbr\u003e - extraction tube;\u003cbr\u003e - instructions for use;\u003cbr\u003e - extraction tube cap.\u003cbr\u003e \u003cbr\u003e \u003cb\u003eCod.\u003c\/b\u003e RNS92048B\u003c\/div\u003e","brand":"GLOBALLY SRL","offers":[{"title":"Default Title","offer_id":57389245333848,"sku":"983761444","price":306.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0968\/9301\/0264\/files\/983761444.jpg?v=1779984563","url":"https:\/\/www.globalpharmacy.it\/en\/products\/test-antigenico-rapido-covid-19-reagen-determinazione-qualitativa-antigeni-sars-cov-2-in-tamponi-nasofaringei-orofaringei-mediante-immunocromatografia-uso-professionale-25-pezzi","provider":"Global Pharmacy","version":"1.0","type":"link"}