Hancom Healthcare Obtains Export Approval for COVID-19 Neutralizing Antibody Diagnostic Kit

[Asia Economy Reporter Buaeri] Hancom Healthcare, a subsidiary of Hancom Group, has received export approval from the Ministry of Food and Drug Safety for the COVID-19 neutralizing antibody diagnostic kit 'HB ELISA,' jointly developed with HB Healthcare.

According to Hancom Healthcare on the 20th, 'HB ELISA' is a diagnostic kit using the ELISA (enzyme-linked immunosorbent assay) method that can rapidly detect the presence of neutralizing antibodies against COVID-19. It is expected to be used in epidemiological investigations to confirm antibody production and immune response after vaccination. Hancom Healthcare has previously obtained the European in vitro diagnostic medical device certification (CE-IVD).

Neutralizing antibodies are binding antibodies produced when a virus invades the body. They prevent the virus from penetrating cells and neutralize the virus. Since general binding antibodies do not neutralize the virus, the industry considers neutralizing antibodies as a key indicator of COVID-19 immunity.

According to the company, the existing standard neutralizing antibody test method, PRNT (Plaque Reduction Neutralization Test), requires a sophisticated laboratory and specialized personnel and takes 3 to 5 days for diagnosis. In contrast, 'HB ELISA' can be tested with only a small amount of blood. The diagnostic time has also been reduced to within 90 minutes. Sensitivity and specificity have been secured at over 95%. Additionally, it can measure 90 samples simultaneously and quantitatively analyze the virus by ratio and value.

Oh Byung-jin, CEO of Hancom Healthcare, said, "We have been conducting evaluations for research purposes after product development, and through this export approval, we expect overseas sales as well," adding, "We will continue product development to expand new pipelines in the diagnostic kit field."