IVD test designed for self-testing for the detection of IgG and IgM antibodies against S1 (RBD) protein in the blood after COVID-19 disease. The test is also designed to detect the approximate level of IgG antibodies after vaccination. The product does not serve as the primary tool for early detection of COVID19!
Tested with major SARS-CoV-2/COVID-19 vaccines (Astrazeneca, Moderna, Pfizer, Johnson & Johnson and other)
The test is developed and tested for the general public for the use of blood samples taken from a finger.
IgG – 96,79% (CI 95%: 94,46%-98,33%) / 97,27 %; (CI 95%: 95,86%-98,30%).
IgM – 98,54% (CI 95%: 97,14%-99,37%) / 88,46% (CI 95%: 84,18%-94,92%).
100% responsiveness to complex range of COVID-19 IgG antibodies
If the control strip QCC (Quality Control – C) is visible and lines M and G do not stain, the sample is negative because no antibodies were detected.
2.1. If control strip “C” is displayed together with the “IgM” strip, IgM antibody has been detected and the sample is positive. IgM antibodies indicate an acute reaction of the immune system after an immediate encounter with the virus, but it can also be triggered by a vaccine.
2.2. If the control strip “C” is displayed together with the “IgG” strip, an IgG antibody has been detected and the sample is positive. Depending on the display speed of the IgG band, it is possible to orientatively determine the value of antibodies after infection or after vaccination. The presence of IgG antibodies in the body is desirable to increase protection against COVID-19
2.3. If control strip “C” is displayed together with the “IgG” strip and the “IgM” strip, both IgG and IgM antibodies have been detected and the sample is positive for both types of antibodies.