Celltrion’s test kit to confirm coronavirus-neutralizing antibody wins CE mark

Celltrion said Wednesday that TekiTrust, a test kit developed jointly with MiCo BioMed to check the formation of coronavirus-neutralizing antibody after vaccination, has won European Union’s Conformite Europeen (CE) certificate.

Celltrion said Wednesday that its TekiTrust, a test kit that confirms coronavirus-neutralizing antibody formation, has won Conformite Europeen (CE) mark.

The CE mark has completed the company’s comprehensive portfolio of Covid-19 diagnostic kits, including neutralizing antibody and antigen testing.

Celltrion obtained emergency use approval from the U.S Food and Drug Administration for DiaTrust, a rapid antigen diagnosis kit jointly developed with Humasis, on April 19. The two companies are preparing to supply the test kits to the U.S. market.

TekiTrust is a diagnostic kit that uses an enzyme-linked immunosorbent assay to check the production of neutralizing antibodies in vaccinated people. The test kit can quantify the neutralizing antibody titers using enzyme immunoassay and recorded 94.4 percent sensitivity and 100 percent specificity in the clinical trials.

Unlike the existing Covid-19 antibody test kits, which identify whether patients produce antibodies after infection, TekiTrust can confirm whether vaccinated people generate antibodies neutralizing the coronavirus.

Celltrion has pushed for developing TekiTrust, believing the demand for diagnostic kits that confirm the formation of neutralizing antibodies would increase rapidly, with countries speeding up vaccination processes.

It plans to focus on receiving approval from more countries, including the U.S. and Europe, to supply more of its test kits.

“TekiTrust uses chromogenic substrates that bind either to antigen or antibody to check responses, and it is relatively cheaper than other testing devices and allows mass analysis,” a Celltrion official said. “We will contribute to ending the Covid-19 pandemic by supplying Tekitrust to countries that began vaccination and providing DiaTrust to those suffering from a viral wave.”