RACORDIAX

The digital, fast and accurate method to detect COVID-19 antibodies.

The RACORDIAX COVID-19 antibody rapid test was developed by BacTrace BioTec AG to simultaneously analyse the current status of IgM, IgG and IgA antibodies as quickly and accurately as possible via a digital platform. Manufactured in Germany, the CE-marked test provides a test result with 99.41% sensitivity and 99.13% specificity in just 10 minutes, using the appropriate smartphone iOS or Android RACORDIAX App.

Officially registered with the Federal Institute for Drugs and Medical Devices under form no. 00160442 and document ID 00098777.

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:

Negative

Positive

Positive in Recovery

Recovery

Consultation of a doctor is recommended.

Application

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 protection.

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.

COVID-19 Test Procedures

Source for detection of antibodies after 5 days of onset of symptoms: Wölfel, R., Corman, V.M., Guggemos, W. et al. Virological assessment of hospitalized patients with COVID-2019. Nature 581, 465–469 (2020)

PCR tests are currently the most commonly used COVID-19 tests. These tests only detect acute infections, depending on the quality of the respective test and the correct performance of the swab in the nasopharynx. This very sensitive method detects genetic information of the SARS-CoV-2 virus and must be performed by specialized laboratories, which delays provision of results significantly. It answers the question of whether a person is currently infected, but not whether they have been infected or are still contagious.

Antigen tests also require a swab in the nasopharynx and are based on the detection of SARS-CoV-2 proteins. This method must be carried out by medical personnel, allows testing outside a laboratory and is considered less sensitive.

Antibody tests are based on blood samples and can detect antibodies from approximately one week after infection. This test method provides information about the level of infection and can also be performed as a rapid test. The RACORDIAX COVID-19 Antibody Rapid Test allows coeval analysis of the main antibody classes IgM, IgG and IgA. It can thus provide accurate results on whether a person is negative, positive, positive in recovery or already recovered.

Possible Applications

Source: Johns Hopkins University

Rapid Testing
The RACORDIAX COVID-19 Antibody Rapid Test is particularly suitable for testing a large number of people within a very short time. It offers the opportunity for digital recording and continuous evaluation of the course of infection incidences. Depending on local regulations recovered people can then potentially return to normal life, work cycles, travel, events and social gatherings. The use of RACORDIAX is ideal for fast location-independent testing of not only the public sector and border controls, but also large organisations, elderly and nursing homes as well as all essential services.

Vaccine Testing
Now that there are several vaccines against the COVID-19 virus available, the RACORDIAX rapid test can quickly and reliably check whether COVID-19 antibodies are already present, thus avoiding unnecessary vaccinations. Following a vaccination, the test can detect the production of COVID-19 antibodies and thus confirm a successful vaccination.

Self-Testing
The RACORDIAX COVID-19 Antibody Rapid Test has been initially designed as a simple and location-independent self-test with smartphone app evaluation, which may currently only be performed by medically trained personnel. Approval as a self-test is subject to the respective national laws and regulations, which could soon change due to the overburdening of health care systems, thus accommodating the test's other possible applications.

Digitization

The digitalization of the healthcare system is one of the biggest challenges in the Corona Pandemic. Thanks to the protected and anonymous data acquisition, it is possible to create a sustainable test history and to connect the RACORDIAX App to contact tracing apps available around the world in order to better understand the infection chains. Depending on the different national data protection laws, anonymized personal or location-related data can also be used to monitor and evaluate the infection incidence via appropriately protected servers. This gives the RACORDIAX COVID-19 Antibody Rapid Test a unique proposition for the efficient combat against the pandemic.

Key Advantages of RACORDIAX

1. Developed, certified and manufactured in Germany
2. From test to result in just 10 minutes
3. 99.41%* sensitivity and 99.13 %* specificity and diagnosis by artificial intelligence
4. Easy to use through iOS and Android App, allowing for immediate contact tracing
5. Scalable application possibilities at any time and any place

* Based on several hundred tests, performed by independent medical institutes in Germany, and results checked with a variety of other certified test procedures.

Partnerships

BacTrace BioTec AG works closely together with a renowned and decorated Scientific Advisory Board

Prof. Dr. Dr. h.c. mult. Willi Jäger, Heidelberg University
Prof. Dr. Amrollah Mostafazadeh
Dipl.-Ing. Manfred Opel, Brigadier General (ret.)
Prof. Dr. Valentin N. Pavlov, Bashkir State Medical University
Priv.-Doz. Dr. med. Michael T. Pawlik, University Regensburg
Dr. med. Sören Wagner
Prof. Dr. med. Dr. h.c. mult. Wolf F. Wieland, University Regensburg
Dr. med. Hans Hermann Wörl