Essential Information about the COVID-19 Antigen Self-Test for Home Use
Key Facts
The COVID-19 Antigen Self-Test Kit is designed for effortless and painless testing infection with SARS-CoV-2 at home. It requires a nasal swab and 20 minutes of your time.
- Intended use: Detection of specific SARS-CoV-2 antigens.
- For self-testing: No experience needed.
- Sample type: Nasal swab.
- Testing time: 20 minutes
- Accuracy: Sensitivity 98.03%, Specificity 100%.
- Certificates: ISO 13485, CE0483
- Compliance: European directive 98/79/EC on the in vitro diagnostic medical devices.
- Trade name: COVID-CHECK-1 Antigen®
- Made in France
Kit Contents
Each packaging of the COVID Self-Test contains two test kits to perform two analysis.
- 2 test devices
- 2 swabs for nasal sampling
- 2 dropper bottle with extraction solution
- detailed instructions for use with the illustrative step-by-step testing procedure.
Testing Procedure
Testing with this COVID-19 Antigen Self-Test is straightforward.
Individuals need about 3 minutes to perform the test. Then you need to wait 20 minutes for the result.
- Swab nostrils to collect a sample.
- Mix the sample with an extraction solution.
- Apply the extract on the testing device.
- Wait 20 minutes for the results.
The test kit includes instructions for use with a step-by-step testing procedure. If you follow the instructions, you will not have any difficulties performing the test.
Interpretation of the Results
The result of the COVID-19 antigen test is interpreted visually as positive, negative, or invalid.
The Colour intensity of the test line and control line can be different. If the line is visible, you should take the result into account.
Positive result: Control (C) and Test (T) lines appear.
Negative result: Only a Control line (C) appears.
Invalid result: Invalid result appears if you do not carefully follow instructions for use. Please take a photo of such a test result and contact us at help@patris-health.com
Frequently Asked Questions about the COVID-19 Antigen Self-Test for Home Use
Two test kits are included with a purpose so that you can repeat testing.
Due to the antigen concentration curve (viral load increases in the first 7 days after infection) it is possible that at the first testing, the concentration of antigens is too low to be detected and the result may be therefore false negative.
To overcome this, you should repeat testing with a second test kit on a third day after testing with a first test kit, but both within 7 days after contact with an infected person.
The main difference is that test kits for self-testing can be performed by non-trained individuals. Contrary, only medical or healthcare professionals should perform tests for professional use.
Yes, the test kit is certified for self-testing. It means that also individuals with no experience in medical testing can perform the analysis.
Please note that children younger than 15 years old should not use the test.
The test should be performed within 7 days after potential contact with an infected person.
A second test should be performed on a third day after first testing to decrease likelihood of false-negative results due to low viral load.
Our test is more accurate than most of the COVID rapid antigen tests on the market. In a clinical performance evaluation study, the test showed an excellent correlation with the PCR laboratory method.
Sensitivity: 98.03%
Specificity: 100%
Moreover, the test is very reliable and ensures consistent results. It is Made in France according to the ISO13485 and CE certified for home use by the EU Notified Body 0483.
If, for any reason, the test does not work, please take a photo of it, and send it to us by email at help@patris-health.com
Please note: Our tests are straightforward and designed for non-professionals. Errors happen when individuals do not follow instructions for use strictly. You must not skip any step of the testing procedure. The test kit comes with illustrated and explanatory instructions for use. If you follow them, you will not have any difficulties.
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