Corona rapid test self-test COVID-19 antigen test, 20 pcs
Nasal swab test: quick and easy determination by means of a nasal swab. Result immediately after 15-20 minutes
Independent use for people between 14 and 70 years of age. In children under 14 years of age, the test should be carried out under adult supervision. People over the age of 70 should seek assistance in collecting the nasal swab.
Each pack of 20 contains: 20x antigen test cassettes (each sealed in foil pouch), 20x sterile swabs, 20x extraction tubes, 20x extraction solution, 1x instructions for use, 1x tube rack
The Deni COVID-19 Antigen Test is a rapid antigen test for personal use, which is used for the rapid qualitative determination of SARS-CoV-2 virus antigens in anterior nasal swabs.
With the exception of a stopwatch, the Deni COVID-19 antigen test contains everything you need to simply take a nasal swab yourself and evaluate it on site. The result of the test is available after 15-20 minutes.
Using the Deni COVID-19 Antigen Test
1) Open the extraction solution, hold it away from your face when opening and do not spill any of the liquid
2) Pour all of the extraction solution into the extraction tube. Both containers should not have any contact with each other.
3) Place the opened extraction tube in the tube rack.
4) Feel the soft, textile side of the swab in the closed packaging and open the packaging on the opposite side of the textile tip and remove the swab. Do not touch the textile side with your hands.
5) Carefully insert the swab up to an inch deep into the nostril. Do not insert the swab any deeper if there is pain or resistance. Rotate the swab along the mucous membrane in the nostril to collect mucus and cells. Turn the swab 3-4 times and leave it in the nostril for a few seconds. Repeat the process with the same swab in the other nostril.
6) Insert the swab with the sample into the extraction tube. Turn this 3-5 times in the extraction tube and then leave the swab in the extraction buffer solution for one minute.
7) Remove the swab from the solution by squeezing the tube while pulling it out to keep as much solution as possible in the extraction tube. Discard the swab.
8) Close the extraction tube with the cap.
9) The kit must have reached room temperature. Open the packaging, remove the test cassette and place it on a clean and flat surface. The test cassette must be used immediately after opening.
10) Turn the extraction tube upside down and apply 3 drops of the liquid to the round sample well by pressing lightly. Avoid the formation of air bubbles in the sample well.
11) The result can be read after 15-20 minutes. Caution: After more than 20 minutes, an incorrect result can be displayed.
Important: This is a simplified representation of the application. Before performing the test, read the instructions for use enclosed with the product completely and follow the step-by-step instructions contained therein.
Interpretation of results
How the result is determined and interpreted can be found in the instructions for use enclosed with the product. Please read them carefully. All details should be understood prior to performing the test.
If you are unsure about the interpretation, a doctor should be contacted according to local authority recommendations.
A positive result provides the first indications of a SARS-CoV-2 infection. Contact your doctor or local health department immediately for further instructions. Do not go to your doctor unsolicited and without an appointment. Negative results do not rule out infection. If you have symptoms, contact your doctor or local health department.
If the result is invalid, please repeat the test following the instructions.
According to the manufacturer, the test has a sensitivity of 96.80% and a specificity of 100.00%.
Sensitivity describes how good a medical test is at recognizing those who are actually ill, i.e. those who have tested positive. Specificity describes the proportion of people who tested negative, i.e. healthy, received a correct result.
Current developments in the number of cases and the spread of the coronavirus (SARS-CoV-2): www.rki.de
Please note the warning notices.
Instructions for use
Please note the warning notices.
Warnings and important information
• Please read the instructions for use carefully.
• The test must be stored in the unopened original pouch at temperatures between 4 and 30 ° C. It must not be frozen.
• The product must not be used if the packaging is damaged or the seal is broken.
• The product must not be used after the expiration date.
• Use the product at room temperature (15-30 ° C). If the product has been stored at lower temperatures, leave it in the test room for 30 minutes before use.
• Treat all samples as potentially infectious.
• Inaccurate or inadequate specimen collection, storage or transport can lead to inaccurate test results.
• Only use the swabs included in the test kit for sampling in order to guarantee the best possible performance.
• The most important step in this test is correct specimen collection. Make sure that you collect sufficient material (nasal secretions), especially when collecting anterior nasal specimens.
• Blow your nose several times before taking a sample.
• Examine the samples immediately after collection.
• Put the drops of the test sample only in the sample well (S).
• Too many or too few drops of extraction solution can cause an incorrect or invalid test result to be displayed. Adolescents and children under the age of 14 should be assisted by an adult to perform the test.
• A negative result of the test, apart from SARS-CoV-2, does not rule out another viral infection and should be confirmed by molecular diagnostic methods if COVID-19 is suspected.
• A positive result does not rule out co-infection with other pathogens.
• The samples should be tested immediately after collection, but no later than within 2 hours.
• This test is not suitable for determining the exact concentration of SARS-CoV-2 virus antigen. It is only suitable for the qualitative detection of SARS-CoV-2 virus antigen in anterio-nasal swab samples (nose in front).
• The test can show a negative result if the viral load is below the detection limit of the test.
• The sensitivity of nasal or oroparyngeal swabs may be lower than that of nasopharyngeal swabs. It is advisable to have a nasopharyngeal smear carried out by a healthcare professional.
• This test kit has been validated with the swabs included. Using other swabs can produce false negative results.
• Correct collection of the sample is crucial. Incorrect practice can lead to inaccurate test results. Improper removal, storage or freezing and thawing of the sample can lead to inaccurate test results.
• A final clinical diagnosis should not only be based on the performance of this one test, but should be verified by the treating physician after evaluating all results and laboratory findings.
• As the disease persists, the amount of antigen in a sample will decrease. Rehearsals from 5th to 7th Day of illness are more likely to test negative than an RT-PCR test.
• The SARS-CoV-2 rapid antigen test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARSCoV-2 rapid test is viral load dependent and may not correlate with other diagnostic methods performed on the same sample.
• Monoclonal antibodies that have minor amino acid changes in the target epitope region may not be able to detect SARS-CoV-2 viruses or may be able to detect them with less sensitivity.
• The validity of the SARS-CoV-2 Antigen Rapid Test has not been demonstrated for the identification / confirmation of tissue culture isolates and should not be used in this capacity.