ImmoGnost GmbH is a German developer and manufacturer of rapid test systems specializing in Lateral Flow Analysis (LFA), based in Göttingen. ImmoGnost GmbH produces the RACORDIAX COVID-19 Antibody Rapid Test on behalf of BacTrace BioTec AG from Munich.
Developed, CE-marked and produced in Germany, the RACORDIAX COVID-19 Antibody Rapid Test analyzes the current immune status with the corresponding smartphone iOS or Android RACORDIAX App in only 10 minutes and delivers a test result with 99.41% sensitivity and 99.13% specificity.
This point-of-care test must be performed by medically trained personnel but does not require laboratories with specialized personnel. Instead, the RACORDIAX COVID-19 Antibody Rapid Test provides immediately the status of infection and enables contact tracing instantaneously upon receipt of the result.
The RACORDIAX COVID-19 Antibody Rapid Test uses a blood sample that is simply collected with a lancet and a pipette from the fingertip. This allows the test to be taken at any location quickly, efficiently and safely. To perform the test, one drop of blood and three drops of running buffer are added to a test cassette.
After 10 minutes the test cassette is scanned with the smartphone RACORDIAX App. The app, which can be adapted to different data protection regulations, compares the scan within seconds with a database that is secured on a cloud server in Switzerland. Through the support of an artificial intelligence assisted algorithm, a comprehensive diagnosis is then provided.
The test procedure identifies the three major antibody classes IgM, IgG and IgA, which are produced by the immune system in response to COVID-19. IgM antibodies indicate the initial
phase of the disease, IgG antibodies produced during recovery are relevant for long-term protection, and IgA antibodies provide information on the status of mucous membrane
These antibodies become detectable only after the appearance of the first COVID-19 symptoms. IgG and IgA remain detectable when the symptoms have already been overcome and mucous protection is still present.
* Based on several hundred tests, performed by independent medical institutes in Germany, and results checked with a variety of other certified test procedures.