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Antigen Test (home Test Kit) Hotgen Alupoly Bag 1 PC(S) Sars-cov-26970297534073
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Antigen Test (home Test Kit) Hotgen Alupoly Bag 1 PC(S) Sars-cov-2
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Item Code: |
6 970297 534073 / 6970297534073 |
Manufacturer's Information: Covid-19 Hotgen rapid self-diagnostic nasal antigen test Test single-phase immunochromatographic in vitro. It was designed for the rapid qualitative detection of SARS-CoV-2 virus antigens on anterior nasal swab samples (anterior part of the nose) of subjects with suspected COVID-19 infection. EAN code: Description Single-phase immunochromatographic in vitro test. It is designed for the rapid qualitative detection of SARS-CoV-2 virus antigens on anterior (anterior part of the nose) nasal swab specimens from individuals with suspected COVID-19 infection within the first seven days of symptom onset. The SARS-CoV-2 Rapid Antigen Test should not be used as the sole basis for diagnosis or to rule out SARS infection -CoV-2. Children under 14 must be cared for by an adult. Preparation Prepare a flat, clean and dry surface. Check the package contents. Make sure nothing is damaged or broken. Take the timer. Blow your nose several times before taking the sample. Wash your hands. Procedure Open the extraction solution. Open it away from your face and make sure you don't spill the liquid. Pour the entire contents of the extraction solution into the extraction tube. Avoid contact between the two containers. The swab is in the sealed package. Locate the soft fabric tip. Open the swab package and carefully remove the swab. Try not to touch the soft fabric tip with your hands. Carefully insert the swab into one nostril. The tip of the swab should be inserted no less than 1 inch deep from the edge of the nostril. Rotate the swab along the mucosa inside the nostril to ensure both mucus and cells are collected. Rotate the swab 3-4 times. Leave the swab in the nostril for a few seconds. Repeat the procedure with the same swab in the other nostril. This can be unpleasant. Do not insert the tampon deeper if you feel severe resistance or pain. Insert the swab with the sample into the extraction tube. Now rotate the swab three to five (3-5) times. Leave the buffer in the Extraction Buffer for 1 minute. Press the extraction tube with your fingers trying to remove the solution from the swab as best you can, while taking it out and throwing it away the tampon itself. Place the cap with the dropper on the extraction tube. Leave kit components at room temperature before testing. Open the pouch and remove the test cassette. Place the test cassette on a flat, straight surface. After opening, the test cassette should be used immediately. Rotate the extraction tube and pour 3 drops (75 mcL) of the sample onto the well (S) by gently squeezing the extraction tube. Avoid the formation of air bubbles in the well (S). The result is displayed after 15-20 minutes. Warning: after more than 20 minutes the result may be wrong. The product used can be disposed of with normal household waste in accordance with applicable local regulations. Interpretation of results - POSITIVE: if within 15-20 minutes two colored lines appear, one line in the control area (C) and a line in the test area (T), the test is valid and positive. The result is considered positive, no matter how faint the colored line is in the test area (T). A positive result does not rule out co-infection with other pathogens. - NEGATIVE: if within 15-20 minutes a colored line appears in the control (C) but no colored line is seen in the test area (T), the test is valid and negative. A negative result does not rule out a SARS-CoV-2 viral infection and should be confirmed by molecular diagnostics if COVID-19 is suspected. - INVALID: if within 15-20 minutes no colored line appears in the control area (C), the test is invalid. Repeat the test with a new test cassette.
Warnings: Read the instructions carefully. Do not use the product if the envelope is ¨ damaged or the seal is broken. The product must be used at room temperature (15° C to 30° C). If the product has been stored in a colder environment (temperature below 15 ° C), leave it at a normal room temperature for 30 minutes before use. Treat all specimens as potentially infectious. Improperly conducted specimen collection, storage and transport or inaccurate may lead to inaccurate test results. Use the swabs provided in the package to ensure optimal test performance. The correct sampling is of fundamental importance for the execution of the test. Be sure to collect enough sample material for analysis (nasal secretions) with the swab, especially for the nasal sample collection in the front. Blow yourself nose several times before taking the sample. Samples should be examined as soon as possible after collection. Introduce the drops of sample to be analyzed only in the well (S). Too many or too few drops of the extraction solution can make the test result invalid or incorrect. Children under 14 must be cared for by an adult. The test should only be used for the qualitative detection of SARS-CoV-2 virus antigens in anterior nasal swab specimens ( front of the nose ). The exact concentration of SARS-CoV-2 virus antigens cannot be determined with this test. Correct sampling is essential. Failure to follow the procedure can lead to inaccurate test results. Inadequate specimen collection, storage, and freezing and thawing may lead to inaccurate test results. If the viral load of the specimen Is below the detection limit of the test, the test may give a negative result. As with all diagnostic tests, a final clinical diagnosis it should not be based on the result of a single test, but should be formulated by the physician following the evaluation of all clinical and laboratory results. Regardless of SARS-CoV-2, a negative result does not rule out a viral infection and should be confirmed by molecular diagnostics if COVID-19 is suspected. A positive result does not rule out co-infection with other pathogens. The rapid antige test ne SARS-CoV-2 can detect both the presence of viable and non-viable SARS-CoV-2 material. The performance of the SARS-CoV-2 Rapid Antigen Test is viral load dependent and may not correlate with other diagnostic methods performed on the same specimen. Users should test samples as quickly as possible after collection and in any case within two hours of collection. The sensitivity of nasal or oropharyngeal swabs may be lower than that of nasopharyngeal swabs. The nasopharyngeal swab method should be performed by healthcare professionals. Monoclonal antibodies that have undergone slight amino acid changes in the target epitope region, may fail to detect or detect the SARS-CoV-2 virus with less sensitivity. The amount of antigen in a sample may decrease with l increase in the duration of the disease. Samples taken after the 5th-7th day of illness are more likely to be negative than an RT-PCR test. The kit Has been verified with the swabs provided. Use of other swabs may lead to false negative results. The validity of the SARS-CoV-2 Rapid Antigen Test is not It has been tested for identification / confirmation of tissue culture isolates and should not be used in this function. The cross-reactivity of the cassette trial was evaluated by testing viruses and other microorganisms. Definitive concentrations of viruses and other microorganisms are documented in the Cross-Reactivity study. The viruses and other microorganisms listed there, with the exception of the human SARS coronavirus, have no influence on the test cassette test results. Positive test results do not exclude packs with other pathogens. Positive results can occur in case of SARS-CoV-2 infection. Preservation Store the test at a temperature between 4 and 30 ° C in the original sealed pouch. Do not freeze. Do not use the product after the expiration date. Validity in intact packaging: 18 months. |
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