IntronBio Obtains European CE Certification for COVID-19 Rapid Antibody Diagnostic Product

[Asia Economy Reporter Hyunseok Yoo] Intronbio announced on the 23rd that it has obtained European CE certification for its COVID-19 rapid antibody diagnostic product developed using a novel coronavirus antigen developed in-house.

The 'LiliF GBN COVID-19 IgG' kit, developed by Intronbio using various technologies secured during the development of biopharmaceuticals such as endolysin and applying the COVID-19 antigen developed in-house, is a rapid antibody diagnostic product that can quickly detect antibodies (IgG) produced 5 to 6 days after COVID-19 virus infection. It was reported that clinical trials were conducted on a total of 158 patient samples at the Department of Laboratory Medicine, Seoul National University Hospital.

The COVID-19 rapid antibody diagnostic product is a rapid diagnostic product that can test within 15 minutes whether antibodies against the COVID-19 virus exist in the body. It can be used for sero-epidemiologic testing for infection monitoring and management, or for antibody testing during vaccination after vaccine development in the future.

According to the clinical trial results conducted on 158 COVID-19 samples at Seoul National University Hospital, the clinical sensitivity (accuracy) was 96.1%. When limited to patients more than 5 to 6 days after COVID-19 infection, it showed 100% sensitivity. Generally, since IgG is detectable from 5 to 6 days after virus infection, considering this, it can be said to have a 100% diagnostic rate.

Seol Jaegoo, Executive Director of Intronbio RDT Center, said, "Usually, if antibodies against a virus exist in the body, the risk of infection by that virus is low," and added, "It is very important to accurately test whether antibodies against the COVID-19 virus are produced to determine the safe return to daily life for economic activities in the post-COVID era. This product was developed to be utilized for such sero-epidemiologic testing."

Yoon Kyungwon, CEO of Intronbio, stated, "With the acquisition of European CE certification for the COVID-19 rapid antibody diagnostic kit, following the qRT-PCR-based COVID-19 diagnostic kits and extraction products, we are now able to export COVID-19 antibody diagnostic products as well," and added, "We will actively supply these products to overseas markets."

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