SugenTech Obtains European CE Certification for COVID-19 Rapid Test Kit... "Full-Scale Overseas Export Begins"

[Asia Economy Reporter Hyunseok Yoo] SuzenTech announced on the 16th that it has obtained European CE certification for three rapid diagnostic kits that can quickly diagnose COVID-19 infection within 10 minutes using blood.

With this European CE registration, SuzenTech can now export not only to Europe but also to most overseas countries that recognize European CE certification. Requests for rapid diagnostic kits have already surged significantly, especially in Europe, the Middle East, and Asia. The demand has skyrocketed to the point that the initial mass production volume cannot meet the required quantity.

A SuzenTech official stated, “The COVID-19 rapid diagnostic kits test for antibodies in infected patients. We have obtained certification for the single antibody kits, IgM antibody diagnostic kit and IgG antibody diagnostic kit, as well as the multiple antibody kit, the IgG/IgM antibody simultaneous diagnostic kit. The IgG/IgM antibody simultaneous diagnostic kit can measure both IgM and IgG antibodies in one kit using fingertip blood or whole blood without a ‘plasma separation’ process, maximizing speed and convenience, which has led to high demand.”

He continued, “Currently used RT-PCR (genetic diagnosis) tests extract specimens from symptomatic patients to check for the presence of COVID-19 virus genes, requiring expensive testing facilities, equipment, reagents, and specialized clinical pathologists, which are difficult to establish on a large scale. Countries in Europe, the Middle East, and Asia that lack large-scale molecular diagnostic infrastructure acknowledge the limitations of testing capacity and are actively adopting rapid diagnostic kits. Even if the company operates at 100% capacity, it cannot meet the volume of requests,” he added.

Among the rapid diagnostic kits, the multiple antibody diagnostic kit is the most suitable testing method to be used alongside or as a complement to genetic diagnostic kits. Asymptomatic or mildly symptomatic patients have minimal viral load detectable by COVID-19 virus tests, so multiple antibody diagnostics (IgG/IgM antibody tests) using blood are used in conjunction with genetic diagnosis. In particular, China recommends IgG/IgM antibody testing not only for confirming COVID-19 patients but also as a guideline for release from quarantine. This is the reason for the significant increase in demand for multiple antibody rapid diagnostic kits, according to the company.

Son Mijin, CEO of SuzenTech, said, “Our research and quality control departments have devoted all their efforts to developing the technically challenging IgG/IgM multiple antibody simultaneous diagnostic kit and successfully obtained European CE certification.” She added, “Unexpectedly, orders and production volumes have surged rapidly, so we are concentrating company-wide capabilities not only on production but also on business departments.”

She further stated, “Domestic companies must obtain export approval from the Ministry of Food and Drug Safety to enable actual exports, so we are proceeding with the approval process simultaneously with mass production and expect to receive export approval before completing the first mass production. In the global situation where COVID-19 is spreading, we expect SuzenTech’s rapid diagnostic kits to play a role in preventing further spread,” she emphasized.

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