Our Point-of-Care Tests(POCT) is designed as an in vitro devices for qualitative testing of SARS- CoV-2, either are antibody test, testing the immunoglobulins IgM / IgG in human serum or whole blood samples or during as antigen test for testing the infection by detecting specific epitopes of the virus in sputum and swap.
An essential feature of our point-of-care tests is the very high level of specificity for the good detection of healthy patients.
Our competitors and their medical devices for SARS-CoV-2 were in the benchmark. Our view on the available products is
- Sample collection, whether for the nasal region or the mouth and throat, requires too much logistical effort.
- The logistics supply the laboratories, so that e.g. RT-PCR tests can be evaluated. This is cumbersome, time-consuming and especially expensive.
- Laboratories are not mobile. RT-PCR tests require time from recording to results.
- A very fast detection of the infection with SARS-CoV-2 cannot be carried out easily and daily on site, in schools, universities, companies, at the airport, etc. and evaluated immediately.
- There is no solution, no antigen test that shows in less than 5 minutes whether an infection with SARS-CoV-2 tests is present.
- The number of captured epitopes of different antibody tests is not sufficient or not precise enough.
PRECISE ANTIBODY SCREENING-TEST
Whether or not a patient is already in acute infection with the SARS-CoV-2 (Corona 2019) virus, our rapid test detects in less than 20 minutes whether or not the patient is infected.
The Point-of-Care Test (POCT) is an in vitro device for the qualitative testing of SARS- CoV-2 using the immunoglobulins IgM / IgG in human serum or whole blood samples. An essential feature of our point-of-care test is its high specificity for the detection of healthy patients.
The application of the test kit is very simple: only two drops of capillary blood from the fingertip and 2 drops of flux are required. The test is evaluated after less than 20 minutes.
The Point-of-Care Test (POCT) is an in-vitro device for the qualitative testing of SARS- CoV-2 using the immunoglobulins IgM / IgG in human serum or whole blood samples. An essential feature of our point-of-care test is its high specificity for the detection of healthy patients.
We have achieved a 99.8% agreement in relation to the PCR smear test in the detection of healthy people who are not infected with SARS-CoV-2, neither acutely nor previously infected with the virus.
The validation was carried out over a total of 1,809 tests. For the sensitivity determination 643 and for the specificity 1,166 measurements were evaluated.
- Sensitivity: IgM 98.1% IgG 98.2%
- Specificity: IgM 99.5% IgG 99.7%
- Accuracy: IgM 99.0% IgG 99.2%
Antibody rapid test IgM/IgG vs RS-PCR (Illustration)
FASTEST ANTIGEN SCREENING TEST
Infection with the SARS-CoV-2 (Covid 2019) virus is detected by our newly developed rapid antigen test in less than 5 minutes, without the need for additional equipment or aids. The test will be available in October 2020.
An essential feature of our point-of-care test is the extremely short detection time. You will know within minutes whether or not an infection with SARS-CoV-2 is present. It is the expected product for daily use.
The use of the test kit is deliberately kept very simple. We want to offer the possibility that the test can be used both by qualified personnel and instructed users. The reaction container (A), the sample container (P) and a cotton swab to swab the nasal cavity are all that is needed to use the test.
The intended performance data have not yet been conclusively validated. Internal results show the following data:
- Sensitivity: ~ 95%
- Specificity: ~ 95%
- Accuracy: ~ 95%