Celltrion said that the Ministry of Food and Drug Safety granted conditional approval for its Covid-19 self-test kit, DiaTrust COVID-19 Ag Home Test, last Friday.

Celltrion said Monday that its Covid-19 self-test kit, DiaTrust COVID-19 Ag Home Test, won conditional approval from the Ministry of Food and Drug Safety on April 30. (Celltrion)
Celltrion said Monday that its Covid-19 self-test kit, DiaTrust COVID-19 Ag Home Test, won conditional approval from the Ministry of Food and Drug Safety on April 30. (Celltrion)

The company has to submit additional clinical data in three months to obtain formal approval.

Celltrion said it plans to supply its kits through its subsidiary Celltrion Pharm and various other distribution channels, including iMarket Korea.

DiaTrust COVID-19 Ag Home Test uses an antibody that strongly binds to the Covid-19 virus and detects specific viral components in the infected patients’ samples. Users can check the result visually within 15 minutes after collecting the nasal sample with a swab enclosed in the kit without professionals’ aid.

DiaTrust COVID-19 Ag Home Test shows increased sensitivity and high accuracy, s it detects both N and S antigens, unlike other products that mostly check for only one antigen.

However, the company stressed that suspected patients with a clear epidemiological connection to infection must receive PCR tests at screening centers run by health authorities, pointing out that self-test kits should serve as a supportive device.

Meanwhile, Celltrion had submitted the results of the U.S. clinical study of DiaTrust COVID-19 Ag Rapid Test conducted on 450 people, including children, to the Food and Drug Administration, expecting that the global demand for its self-test kit will increase over time. The test kit won FDA’s emergency use approval on April 19, and Celltrion has started its supply in the U.S.

 “As we have received conditional approval for the DiaTrust COVID-19 Ag Home Test, we will speed up the supply so that the public can buy the product and check for infection as soon as possible,” a Celltrion official said.

With the latest approval, the number of homegrown Covid-19 self-test kits has increased to three, including those of SD Biosensor and Humasis.

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