Description
Description:
Hotgen Coronavirus 2019-nCoV Antigen Test for self-testing by lay persons + 5 FFP2 masks
This test kit is a rapid test or self-test for self-administration by laypersons. It is listed at the BfArM and has a special approval according to §11 paragraph 1 Medical Devices Act (MPG) of antigen tests for self-administration by laypersons. (Self-test)
The swab is performed in the anterior nasal region at the so-called qualitative in vitro determination. Instructions for use can be found in the package.
This test is used as a rapid test for individuals with suspected COVID-19 and can also be used as a confirmatory method for discharged cases. A positive test result indicates that the specimen contains coronavirus antigen. However, a negative test result does not rule out the possibility of infection.
ATTENTION: In the event of a negative test result, the hygiene and distance rules must be observed.
- COVID-19 Antigen Rapid Test for Private Use
- BfArM listed, file number: 5640-S-057/21
- Test result in 15 min.
- CE certified
- Sensitivity: 96.30%
- Specificity: 99.13%
- Accuracy: 97.76%
- Individually packaged
- Contains all materials necessary for the test
Certifications:
Federal Institute for Drugs and Medical Devices
File number of the special approval of the BfArM: 5640-S-057/21
Storage and shelf life
The set should be stored at 4-30°C and the shelf life is fixed at 18 months.
After opening the foil bag, it should be used within 30 minutes. (Temperature 10-30°C, Humidity ≤ 70%)
The sample extraction buffer should be used within 18 months after opening (temperature 10-30°C, humidity ≤ 70%).
Production and expiry date see label
Package contents (individually packaged test kit)
- 1x Coronavirus 2019-nCoV Antigen Test Cassette
- 1x nasal swab
- 1x buffer bottle
- 1x extraction tube
- 1x instruction manual
Frequently asked questions
When can I test myself?
You can test yourself at any time, whether you have symptoms or not. As a general rule, please note that the test result is a snapshot valid for that point in time. Tests should therefore be repeated as required by the relevant authorities.
What do I have to pay attention to in order to get the most accurate test result?
Always follow the instructions for use exactly. Perform the test immediately after taking the sample. Dispense the drops from the test tube only into the designated well of the test cassette. Dispense four drops from the test tube. Too many or too few drops may result in a false or invalid test result.
The test strip is very discoloured. What is the reason for this or what am I doing wrong?
The reason for a clearly visible discoloration of the test strip is the release of an excessive amount of droplets from the sample tube into the well of the test cassette. The indicator strip can only hold a limited amount of liquid. If the control line does not appear or if the test strip is heavily discoloured, please repeat the test with a new test kit according to the instructions for use.
What should I do if I have performed the test but do not see a control line?
In this case, the test result is to be considered invalid. Please repeat the test with a new test kit according to the instructions for use. I am unsure about the interpretation of the results. What should I do? If you cannot clearly determine the result of the test, contact the nearest medical facility using the regulations of your local authorities.
My results are positive. What to do?
If both a horizontal colored line is visible in the control area (C) and the test area (T), your result is positive and you should immediately contact the medical facility as directed by your local authorities. Your obtained test result may be reviewed and next steps will be explained to you.
My results are negative. What to do?
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 and taste, contact the nearest medical facility using the regulations of your local authorities. In addition, you can repeat the test with a new test kit.
Can this test cassette be reused or used by more than one person?
This test cassette is intended for single use and cannot be reused or used by more than one person.
EN 
DE 
ES