The test is used as a rapid test for suspected cases of the novel Coronavirus, but can also serve as a confirmatory method for nucleic acid detection in discharged patients.
Positive test results indicate the presence of viral antigens but do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definitive cause of the disease.
Negative results from people with symptoms lasting longer than seven days should probably be considered infected.
Humans are generally susceptible to COVID-19, which is a contagious and acute respiratory illness. Infected patients are currently the largest source of infection, and asymptomatically infected individuals are also a source of infection. The incubation period is 1 to 14 days, but mostly
3 to 7 days. The main symptoms include fever, dry cough, fatigue, loss of sense of smell and/or taste. A stuffy and/or runny nose, sore throat, muscle aches, and diarrhea may also occur.
This test can be used by medical laypersons as a self-test for home, work or other events.
Warnings and precautions:
- Do not use after expiration date or if bag is damaged or open.
- Use the tests only once.
- Do not mix different kit lots.
- Do not eat, drink or smoke in the area where specimens are handled.
- Handle all specimens as if they contain infectious agents.
- Wear protective clothing such as disposable gloves when testing specimens.
- Humidity and temperature can affect results.
- The extraction buffer contains a saline solution. In case of contact with skin or eyes, rinse immediately with plenty of water.
- Dispose of the used test materials according to local regulations.
- Store unused test equipment unopened at 15 - 22°C.
- For storage at 4 - 8 °C, ensure that the test device is brought to room temperature before opening.
- The specimen is stable until the expiry date printed on the sealed pouch.
- Do not freeze or expose the kit to temperatures above 30°C.
Instructions for use:
1. Please read the complete instructions before use.
2. Take your time to perform it calmly and conscientiously. Insufficient specimen collection or improper specimen handling may lead to incorrect results.
Find a clean work area with enough space for all utensils and have a watch available in addition to the test kit. Wash or disinfect hands thoroughly, before and after testing.
3. Before taking the sample, you should still blow your nose.
4. Take the swab out of the packaging without touching the wadding and carefully insert it, swab tip first, approx. 1.5 cm from the edge of a nostril until a slight resistance is felt.
Do not insert the swab deeper if you feel strong resistance or pain.
Roll the swab along the inner wall of the nose about 4 - 6 times to pick up as many cells and mucus as possible.
Repeat this process with the same swab at the other nostril to ensure that an adequate sample is collected.
5. Open the sampling tube at the large opening and insert the used cotton swab into it.
The sample must be soaked in the extraction buffer liquid for approximately 15 seconds, rotated several times and the swab head pressed 3 times.
6. To remove the swab, please squeeze the extraction tube and roll it against the inside of the tube while removing it to release as much liquid as possible. The extracted solution is used as a test sample.
7. Place the used swab in the enclosed plastic bag for contaminated waste and tightly seal the collection tube with a dropper tip.
8. For best results, the test should be performed within one hour:
Remove the test device from the sealed pouch.
Turn the specimen collection tube upside down and hold it upright.
Add 3 drops to the sample well and set the timer to 15 min - the result displayed after 30 minutes is invalid!
9. Interpretation of the result
Positive: A colored line appears in the control line area (C) and one in the test line area (T).
NOTE: The intensity of the color in the test line region depends on the concentration of COVID-19 antigen in the sample. Therefore, any color tone in the test line area should be considered positive.
Negative: If only a horizontal colored line is visible in the control area (C), this may mean, That you are negative or that the viral load is too low to be detected by the test.
If you experience symptoms such as headache, migraine, fever, loss of sense of smell/or taste, contact the nearest medical facility using the regulations of your local authorities. In addition, repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as coronavirus cannot be accurately detected at all stages of infection.
can not be detected accurately in all phases of an infection. Even in the case of a negative result, distance and hygiene rules must be observed!
Invalid: No line shows control line area (C) which means that the test is invalid. Insufficient buffer volume or incorrect procedural techniques are the most likely causes.
Please repeat the test with a new kit according to the instructions for use. If the problem persists, contact your physician or a COVID-19 testing center.
10. Pack all components of this test in the enclosed plastic bag for contaminated waste and dispose of it sealed in the residual waste.
11. Do not forget to wash and disinfect your Hands!
- For in vitro diagnosis only
- Not reusable
- Easy to use - anterior nasal swab
- Detects viable and non-viable viral antigens
- Rapid result within 15 min
- Storage: 4 - 30°C
- CE Certified
- Contents: 25 rapid test kits / package