Celltrion Receives European CE Certification for COVID-19 Neutralizing Antibody Diagnostic Kit

"Comprehensive Portfolio Prepared for COVID-19 Diagnosis"

[Asia Economy Reporter Kim Ji-hee] Celltrion announced on the 28th that it has obtained the European CE certification for 'Techitrust,' a COVID-19 neutralizing antibody diagnostic kit jointly developed with the bio medical diagnostics company Micobiomed. CE certification is an integrated standard certification that signifies compliance with all requirements under the European Union (EU) Council directives related to safety, health, environment, and consumer protection. With the addition of the neutralizing antibody diagnostic kit, Celltrion is evaluated to have established a comprehensive portfolio for COVID-19 diagnostics.

Techitrust is a diagnostic kit utilizing enzyme-linked immunosorbent assay (ELISA) to determine whether neutralizing antibodies are produced after COVID-19 vaccination. Using the enzyme immunoassay method, it can quantify the titer (potency) of neutralizing antibodies capable of neutralizing the COVID-19 virus, and clinical results have secured a sensitivity of 94.4% and specificity of 100%. Unlike existing COVID-19 antibody diagnostic kits that detect antibody production after infection, Techitrust is characterized by its ability to confirm whether neutralizing antibodies that provide actual defense are produced after vaccination.

Celltrion began developing Techitrust in February, anticipating a surge in demand for diagnostic kits that verify the formation of neutralizing antibodies as COVID-19 vaccination accelerates worldwide. Celltrion plans to focus on the global supply of Techitrust by pursuing additional approval procedures targeting countries with rapid vaccination progress, including Europe and the United States.

With this, Celltrion has established a comprehensive portfolio for COVID-19 diagnostics, including rapid antigen diagnostic kits, rapid antigen self-test kits, and neutralizing antibody diagnostic kits. On the 19th, Celltrion obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for 'Diatrust,' a rapid antigen diagnostic kit jointly developed with in vitro diagnostics specialist Humasis, and began supplying Diatrust to the U.S. market. Humasis also initiated the FDA EUA process for the COVID-19 self-test kit, which received conditional approval from the Ministry of Food and Drug Safety on the 23rd.

A Celltrion official stated, "Techitrust uses a method that binds a color-developing enzyme to antigens or antibodies to confirm antigen-antibody reactions, offering advantages such as low cost and the ability to analyze large quantities." He added, "We have established a comprehensive portfolio for COVID-19 diagnostics by supplying Techitrust to countries where vaccine distribution is accelerating and Diatrust to countries where COVID-19 is still prevalent."

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