Sujentec Develops COVID-19 Rapid Diagnostic Kit... "Capable of Diagnosing Even Asymptomatic Infected Patients"

[Asia Economy Reporter Yoo Hyun-seok] SuzenTech announced on the 6th that it has succeeded in developing a rapid diagnostic kit capable of diagnosing COVID-19 infection within 10 minutes using blood.

In particular, the blood-based diagnosis can identify asymptomatic infected individuals, allowing the screening of potential carriers who might otherwise go unnoticed. Clinical trial approval has already been obtained from domestic university hospitals.

The kit developed by SuzenTech this time is a rapid diagnostic kit that tests for antibodies formed in the body of COVID-19 infected patients, developed in three types: IgM antibody diagnosis, IgG antibody diagnosis, and simultaneous IgG/IgM antibody diagnosis.

This kit can diagnose suspected infected patients within 10 minutes using whole blood or fingertip blood at general medical sites, not requiring separate isolated testing facilities. It is characterized by its speed and high accuracy, enabling rapid screening diagnosis for a wide range of suspected patients. Since it is blood-based rather than sputum-based, it can diagnose 'asymptomatic patients' without symptom manifestation, effectively enabling early containment of widespread COVID-19 transmission using this kit.

Currently, the method used on-site for COVID-19 diagnosis is the RT-PCR (genetic diagnosis) method. This method extracts sputum from the patient and tests whether the COVID-19 virus gene is present in the sputum, but it has the drawback that testing is only possible after symptoms have manifested.

Additionally, because it requires isolated testing facilities, expensive equipment, reagents, and specialized clinical pathologists to perform the tests, extensive testing of suspected patients is difficult. Also, depending on the progression of the infection, the amount of virus in the sputum varies, posing a risk of errors in test results.

South Korea has well-established testing facilities and personnel, enabling the identification of many confirmed cases through genetic diagnosis. However, many countries, including Japan, face limitations in genetic diagnostic testing capacity, making early diagnosis and screening challenging. Accordingly, the WHO (World Health Organization) recommends the introduction of easily usable antigen and antibody diagnostic methods alongside genetic diagnosis to prevent widespread COVID-19 transmission.

Son Mi-jin, CEO of SuzenTech, said, “Generally, the development of antibody rapid diagnostic kits takes several months, but based on close cooperation with health authorities, medical institutions, Chinese partners, and the efforts of our research team, we have exceptionally accelerated the development timeline.” She added, “We have completed registration for certification with ‘FIND,’ an international organization supporting the development and certification of innovative in vitro diagnostic devices, and have obtained clinical trial approval (IRB) from domestic university hospitals to conduct clinical trials on patients.”

She continued, “We plan to proceed with European CE registration as soon as clinical results are available and have requested the Korea Disease Control and Prevention Agency to announce emergency use authorization for the antibody rapid diagnostic kit.”

With COVID-19 rapidly spreading in Europe and the Middle East recently, many local companies are in discussions with SuzenTech for the supply of rapid diagnostic kits. Additionally, SuzenTech plans to send prototypes to Wuhan Humanwell Group in China to proceed with Chinese approval and sales.

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