Essential information about the COVID-19 Antibody Test, COVID-19-CHECK-1
This test is a highly specific rapid in-vitro diagnostic test for the qualitative detection of antibodies against SARS-CoV-2 virus that causes COVID-19. It is clinically validated and certified for professional use.
- Intended use: qualitative detection of the anti-SARS-CoV-2 IgM/IgG antibodies
- For professional use: 10 tests in a kit
- Sample types: whole blood, serum, plasma
- Testing time: 10 minutes
- Accuracy: 94.42%
- Certificates: ISO 13485, CE
- Compliance: European directive 98/79/EC on the in-vitro diagnostic medical devices
- Made in France
The test can help to determine if a person has had COVID-19 in the past.
Frequently asked questions about the COVID-19 antibody test
Testing kit includes all the accessories needed to perform 10 analysis.
- 10 testing devices
- 10 micropipettes for blood sample transfer
- 1 diluent
- 1 instructions for use
Clinical performance evaluation study showed the following characteristics:
- Diagnostic sensitivity: 92.17%
- Diagnostic specificity: 97%
- Overall agreement: 94.42%
No. Only legal entities can buy the test.
These tests are for professional use. This means that only medical healthcare professionals can carry out the analysis with these tests.
Test for past infection with SARS-CoV-2
This rapid test is especially helpful in identification if a person had an infection with the SARS-CoV-2 virus in the past.
The test should not be used to diagnose a current infection.
When a person comes into contact with the SARS-CoV-2 virus, the body’s immune system produces specific antibodies directed against the virus to eliminate it.
If specific antibodies are present in the blood, you may conclude that the person has been in contact with the virus.
1 Lee N, Li C, Tsai H et al. “A case of COVID-19 and pneumonia returning from Macau in Taiwan: Clinical course and anti-SARS CoV-2 IgG dynamic”. J. of Microbiology, Immunology and Infection. 2020, 1-3.
Accuracy and reliability of the COVID-19 antibody test
Clinical performance evaluation study showed the following characteristics:
- Diagnostic sensitivity: 92.17%
- Diagnostic specificity: 97%
- Overall agreement: 94.42%
All the studies have been performed in France using well documented serum samples originating from Europe.
The test is manufactured in France according to the ISO 13485. It is CE certified for professional use and fully complies with the European directive 98/79/EC on the in-vitro diagnostic medical devices.
SIGNIFICANT ADVANTAGE
This test does not react to antibodies against other common human coronaviruses (HCov-NL63, HCov-HKU1 and HCoV-OC43).
3-step testing procedure
This rapid COVID-19 antibody test is very easy to use. It does not require any laboratory instruments or specialized laboratory personnel to perform the test.- Collect a blood sample.
- Apply the blood on the testing device.
- Add diluent.
How to interpret the result?
The result is interpreted visually as positive, negative or invalid.
There are separate test fields for IgM and IgG.
Positive: control and test lines appear.
Negative: only control line appears.
Invalid: please take a photo of such test result and contact us at medical@patris-health.com.
For orders please contact us by email at medical@patris-health.com
