SARS COV-2 RAPID TEST

AN EFFECTIVE SCREENING POINT-of-CARE-TEST

Whether contact with the SARS-CoV-2 (Corona 2019) virus has been present or not, our rapid test detects in only 20 minutes whether a patient is infected.

The detection of SARS-CoV-2 infection is based on the detection of SARS-CoV-2 specific IgM and IgG antibodies in capillary blood, whole blood or serum.

PERFORMANCE

The Point-of-Care Test (POCT) is an in vitro device for testing the presence of SARS CoV2 virus qualitatively 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 a healthy patient.

We have achieved a 99.8% accuracy in relation to the PCR smear test in the detection of healthy individuals who are not infected with SARS-CoV-2, neither acutely nor previously infected with the virus.

The quick test lightens the workload of process management for physicians in general practice and in general hospitals. The rapid, uncomplicated risk identification everyday use with the detection of existing immunoglobulins IgM/IgG, allows the separation of tested who have been infected humans and those which have developed the specific antibodies against SARS-CoV-2.

Database

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%

APPLICATION OF THE “COV-2 RAPID TEST”-KIT

The application of the test-kit is very simple: Only two drops of capillary blood from the fingertip and 2 drops of flux are needed. The test is evaluated after 20 minutes.

If only the control band “C” is colored, no antibodies against the virus were detected. If one or both test lines IgM and/or IgG show a coloration after 20 minutes, antibodies against the virus are present, so an acute or earlier infection with SARS-CoV-2 is most likely. If a positive IgM test line is visible, this indicates an infection in the early phase. If the positive IgG test line is visible, infection is in a later phase of the disease.

The evaluation is based on the graph below, which illustrates the course of the infection.

Antibody rapid test IgM/IgG vs RS-PCR (Illustration)