NanoEntek Obtains Export Approval for COVID-19 Spike Protein Antibody Diagnostic Kit

[Asia Economy Reporter Jang Hyowon] NanoEntek (CEO Jeong Chan-il) announced on the 10th that it has obtained export approval from the Korean Ministry of Food and Drug Safety for its COVID-19 diagnostic kit (FREND COVID-19 SP), which detects antibodies against the spike protein of the novel coronavirus (COVID-19).

Recently, antibodies against the spike protein have been known to neutralize the COVID-19 virus, and vaccine development using this is in full swing. Therefore, detecting antibodies against this spike protein can not only diagnose COVID-19 infection but also assess the effectiveness of vaccines by determining whether the body has properly produced antibodies after vaccination.

NanoEntek's FREND point-of-care diagnostic system, including this COVID-19 diagnostic kit, uses an advanced lab-on-a-chip platform that integrates semiconductor design technology (MEMS) with biotechnology, enabling testing within 3 minutes. It also offers quantitative detection by expressing test results numerically according to the user's purpose, making it suitable for use not only in general screening centers but also in research institutions, vaccine companies, and various other settings.

Moreover, in the case of such pandemic diseases, managing a vast amount of patient results is very important. NanoEntek's FREND is equipped with a Laboratory Information System (LIS) function that automatically transmits results, allowing effective management of patient information without omissions. Therefore, it can be used not only for accurate and easy patient monitoring but also as a useful tool in establishing a government-level Infectious Disease Surveillance system.

NanoEntek had already received approval from the Ministry of Food and Drug Safety in August for domestic and overseas sales of FREND FLU A&B, a fluorescent immunoassay-based influenza diagnostic kit, so currently, both influenza and COVID-19 tests can be easily and conveniently performed using the FREND System.

With this, NanoEntek has completed export approval for three types of COVID-19 antibody kits (COVID-19 NC/SP/Ab) and a COVID-19 molecular diagnostic kit (PCR) related to infectious disease diagnosis. The influenza diagnostic kit (FLU A&B) is available for both export and domestic sales. Additionally, the antigen diagnostic kit (COVID-19 Ag), which enables early diagnosis of COVID-19 infection, has already been developed, and procedures for obtaining export approval are underway, actively responding to the increasingly threatening infectious diseases as winter approaches.

This content was produced with the assistance of AI translation services.