Celltrion obtained conditional permission from the Ministry of Food and Drug Safety (MFDS) on April 30 for the "Celltrion DiaTrustTM COVID-19 Ag Home Test," a self-examination kit that allows individuals to test for COVID-19 infection on their own.
"DiaTrust Home Test" is an antigen-type kit that detects certain components of the virus in samples of COVID-19 virus symptom patients by applying Celltrion's independent development antibody that binds specifically strongly to COVID-19.
Without the help of experts, individuals can visually check the test results within 15 minutes if they collect samples from the nose with a cotton swab enclosed in the kit.
Celltrion co-developed "DiaTrust Home Test" with Humasis, an in vitro diagnostic company, to contribute to preventing the spread of the Covid-19 virus through its flagship kit, and plans to supply it through various distribution networks in Korea, including Celltrion Pharmaceuticals.
The DiaTrust Home Test features the highest level of accuracy by maximizing sensitivity with a "Dual Antigen" method that detects both N and S antigens, as opposed to methods that typically detect only one antigen. However, since self-examination kits are an auxiliary means, suspected infections with clear mechanical connections must be inspected at a screening clinic run by the quarantine authorities.
Judging that global demand for self-test kits will increase, Celltrion submitted the results of clinical trials conducted on about 450 children and adults in the U.S. over February and March to the Food and Drug Administration (FDA) and is currently waiting for the results of the screening.
Celltrion also obtained FDA emergency use approval for the "Celltrion DiaTrust™ COVID-19 Ag Rapid Test" on April 19 and began supplying it to the U.S. market.
An official from Celltrion said, "As the DiaTrust Home Test, developed based on Celltrion's excellent antibody technology, has received conditional permission, we will hurry to supply products so that ordinary people can buy and undergo tests as soon as possible."
Meanwhile, Celltrion plans to submit additional clinical performance test data for self-test kits to the MFDS within three months under the conditional permission.
