Boditech Med (CEO Choi Eui-Yul), a company specializing in next-generation Point of Care diagnosis, announced that it has completed export certificate for ‘ichroma™ COVID-19 SP/NP IgG’ from KFDA.
This product is a test kit that can determine the history of COVID-19 virus infection depending on type of antibody present in the blood.
In general, when infected with the COVID-19 virus, antibodies to various proteins of the virus are formed. In particular, antibodies against NP (Nucleocapsid protein) are formed the most, and antibodies against SP (Spike protein), which act as neutralizing antibodies, are also formed. On the other hand, all vaccines inoculated in Korea use SP as an antigen (except for inactivated vaccines used in other countries). Because of this, only antibodies to SP are formed in the vaccinated person.
This product was developed based on this antibody formation, and basically it can identify the breakthrough infection in vaccinated person. If a person with no history of infection with the COVID-19 is vaccinated, only the IgG antibody against SP is positive. In case both the IgG antibody to NP and SP are positive, it could be results of breakthrough infection. Especially, breakthrough infection is often no or mild symptoms, so it can provide useful information.
A person infected with or recovered from the SARS-CoV-2 virus, is normally has antibodies against both SP and NP proteins. In Israel, a person who has antibody after recovered from COVID-19, is regarded as protected from infection, and green pass is issued when antibody is positive in diagnostic test.
In addition, if the vaccinated person tests positive for an IgG antibody against SP, it means that a normal immunity against COVID-19 has been formed.
A company official said, "Boditech Med is the first company in the world to launch a product that could determines the history of COVID-19 infection. This product has more than 95% accuracy and can produce the test result within 10 minutes with a single drop of blood. We have already completed the European CE certification, and product will be released the beginning of next year.