CHECKING THE SARS-CoV-2 RISK
Using 2 different IVD, we detect SARS-CoV-2 qualitative of the virus in the infection and/or in the acute phase.
BelTEST-IT CoV-2 reacts on the immunoglobulins IgM / IgG in human serum or whole blood samples.
BELMONITOR CoV-2 is designed for detecting several specific epitopes of the virus. The point-of-care tests offer a very high specificity in detecting healthy patients.
Antigen rapid test vs. RT-PCR (Illustration)
We have performed benchmarks on the available test devices in the market and have drawn conclusions. From our point of view, the comparison criteria for RT-PCR and antigen test are the following:
- Sample collection, whether nasal or oral, requires a significant logistical effort.
- The logistics supply the labs with test specimens from probands. This time and cost has always to be added to the net test time per RT-PCR.
- The processing of the RT-PCR test samples requires additional time for reporting.
- The processing cost are composed of PCR test module, execution by qualified personnel, shipment to laboratories and documentation.
- The antigen assays usually require additional materials and vary greatly in quality.
- The determination of SARS-CoV-2 infection can not be done in a total time of less than five minutes.
- Test times below 10 minutes are anticipated by schools, universities, companies, public transport and tourism, etc.
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%
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: ~ 97%
- Accuracy: ~ 95%