Description
A safe, painless COVID-19 antigen nasal cavity test directly from the manufacturer’s domestic brand representation! Detection of recent infections and infectivity. Controlled series, in original packaging. 98.7% accuracy, even for mutations. Choose a secure source of supply!
Sampling is done painlessly in the anterior nasal cavity rather than in the nasopharynx.
Sampling type: anterior nasal cavity, with sampling stick
Result: within 15-20 minutes
Sensitivity: 96,77%
Specificity: 99,20%
Expiry date: 18 months
CE Notified Body: 0123
OGYÉI registration number: OGYÉI/31356-3/2021
Study data on sampling of the lay population:
99.1% were able to complete the test without the help of a professional.
97.87% correctly interpreted the different results.
A KÉSZLET TARTALMA
Ingredients 1 Test/pack
1 SARS-CoV-2 Antigen test cassette (in foil pack)
1 Sterile sampling stick
1 Extraction tube
1 sample buffer
1 Instructions for use
1 Pipe rack
PLEASE READ THE FOLLOWING BEFORE USE!
1. Read the instructions carefully.
2. Do not use the test after the expiry date.
3. Do not use the test if the foil package is damaged or opened.
4. Store the device between 4 and 30°C in unopened packaging. Do not freeze.
5. The test should be used at room temperature (between 15°C and 30°C). If you store the test in a colder environment, leave it at room temperature for 30 minutes.
6. Consider all samples as potentially infectious.
7. Improper sampling, storage, or transport may lead to inaccurate results.
8. Use the sampling stick provided to ensure a good result.
9. Proper sampling is a key part of the testing process. Collect a sufficient amount of sample (nasal secretions) with the sampling stick, especially if you are taking a sample from the anterior nasal cavity
10. Blow your nose thoroughly before sampling.
11. Carry out the testing procedure with the sample taken as soon as possible.
12. Drop the sample-buffer mixture only into the sampling port (S).
13. Too much or too little sample-buffer mixture may lead to incorrect or invalid results.
Children under 14 should take the test with the help of an adult.
SHELTERS
1. The test is intended for the qualitative detection of SARS-CoV-2 virus antigen only, from an anterior nasal cavity specimen. The specific SARS-CoV-2 virus antigen concentration cannot be determined by the test.
2. Proper sampling is vital. Errors in the testing procedure can lead to inaccurate results. Incorrect sampling, storage, freezing and thawing can also lead to inaccurate results.
3. If the virus concentration is below the detection limit, the test may give a false negative result.
4. As with all tests, the clinical diagnosis cannot be based solely on the test result. Your doctor should assess your clinical symptoms and other laboratory results.
5. A negative result does not exclude the possibility of other viral infections, and SARS-CoV-2 infection should also be tested by molecular diagnostics if COVID-19 is suspected.
6. A positive result does not exclude the presence of other infectious agents.
7. The test can detect both infectious and non-viable viruses. The performance of the test depends on the viral load and the results may not correlate with those of other diagnostic tools.
8. Carry out the testing procedure as soon as possible, and in any case do not wait longer than two hours.
9. The sensitivity of the test may be lower when using a nasal cavity sample than when using a nasopharyngeal sample. Nasopharyngeal sampling should be performed by medical personnel.
10.Monoclonal antibodies are not able to detect SARS-CoV-2 virus variants that have undergone minor amino acid changes in the targeted epitope region, or only with lower sensitivity.
11.As the disease progresses, the amount of antigen in the sample may decrease. Disease 5-7. samples collected after the day of the RT-PCR test are more likely to be negative compared to the RT-PCR test result.
12.The kit has been validated with the supplied sampling stick. Using alternative samplers may lead to false negative results.
13.The SARS-CoV-2 antigen rapid test has not been validated for the identification or confirmation of tissue culture isolates and should not be used in this capacity.
14.The cross-reactivity of the test was evaluated by testing for viruses and other microorganisms. Final test concentrations of viruses and other microorganisms are documented in the cross-reactivity study. The viruses and other micro-organisms listed therein, with the exception of the human SARS-CoV virus, have no effect on the test result.
15.A positive test result does not exclude the possibility of infection with other pathogens. The test can also give a positive result in the case of SARS-CoV infection.
TESTING PROCEDURE
1 Rotate the buffer solution storage cap. Attention! Open away from your face and be careful not to spill any liquid. 
2 Squeeze all the extraction buffer from the bottle into the extraction tube. Attention! Avoid contact between the bottle and the tube.
3. Find the sampling stick (in sealed package). Identify the soft, swabbed end of the sampling stick.
4. Open the sample stick packaging and carefully remove the sample stick. Attention! Never touch the soft, swabbed end of the sampling stick with your hand.
5.Carefully insert the swab end of the sampling stick into one of the front nostrils. The stick should be inserted at least 2.5 cm from the edge of the nostril. Swirl the swab 3-4 times on the mucous membrane of the nose (nasal wall). Leave the stick for a few seconds in the
in the nostril. Using the same stick, repeat this process for the other nostril. Pull the stick out of the nasal cavity. Attention! This can feel uncomfortable. Do not drive the tampon deeper if you feel resistance or pain.
6. Insert the swabbed end of the sampling stick into the extraction tube. Rotate the stick 3-5 times in the buffer solution. Leave the stick in the extraction buffer for 1 minute.
7.Pinch the extraction tube with your fingers and squeeze the solution out of the sampling stick as far as possible. 
8. Fit the drip cap tightly onto the extraction tube.
9. The components of the kit should be at room temperature before testing. Open the foil pouch and remove the test. Place the test on a horizontal surface. Attention! The test should be used immediately after opening.
10. Invert the extraction tube and gently squeeze the tube to drop 3 drops (approximately 75 μL) of test sample into the sample well (S). Attention! Avoid the formation of air bubbles in the sample collection section (S).
11. Read the results within 15-20 minutes.
Attention! Results after 20 minutes may not be accurate.
Positive: if two colour bars appear within 15-20 minutes, one colour bar in the control zone
test zone (T), the result is positive. Attention! It does not matter how faint the colour bar is in the test zone (T),
shall be deemed to be.
Negative: if a colour bar appears in the control zone (C) and does not appear in the test zone (T) within 15-20 minutes
and color bar, the result is negative.
Invalid: If no colour line appears in the control area (C) within 15-20 minutes, the test procedure is repeated with a new test.
WASTE MANAGEMENT
The test kit can be disposed of with normal household waste, subject to local regulations.
TESTING PROCEDURE
Use a clean, dry and flat surface. Check the contents of the test kit. Make sure that nothing is damaged. Have a timing device handy. Blow your nose thoroughly before taking a sample. Wash your hands.
This test is suitable for all ages. The recommended age of the test taker is between 14 and 90 years. Children under 14 should take the test with the help of an adult. Do not continue the test if the child feels pain.
45/2014. (II. 26.) Korm. Regulation, the product cannot be returned after delivery for health or hygiene reasons; therefore, the 14-day right of return does not apply to this product.
29. § (1) The consumer may not exercise the rights under Article 20. § (consumer’s right of withdrawal) e) in respect of a product in a sealed package which cannot be returned after opening after delivery for health or hygiene reasons.
