SEOUL -- Celltrion, a South Korean bio firm involved in the development of anti-body treatment, is ready to roll out a highly sensitive and accurate antigen diagnostic kit that can yield results in 20 minutes. The kit provides both the speed of existing rapid diagnostic kits and the high sensitivity of molecular diagnosis so that COVID-19 patients can be sorted out in the early stages of infection.
Celltrion said that it has completed the development of a point-of-care antigen testing kit for COVID-19 together with BBB, a South Korean company that specializes in blood testing and lab-on-a-chip technology. The kit is a portable device to support the early detection of COVID-19 patients in clinical settings.
The real-time polymerase chain reaction (RT-PCR) method that amplifies specific DNA samples and takes at least six hours to get results has been used widely in South Korea due to its reliability. Celltrion said its method showed a high sensitivity of more than 95 percent compared to RT-PCR, making it the highest level of completion among existing rapid diagnostic kits.
The antigen testing kit uses a microfluidic electrochemical biosensor which aims to give fast and accurate results, Celltrion said, adding it can show results within 15-20 minutes.
Celltrion said the antigen testing kit would seek a CE mark in Europe later this month, ahead of the expected launch in July. CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
Separately, Celltrion forged a distribution agreement with Humasis, an in vitro diagnostic medical device manufacturer in South Korea, to sell a rapid antibody diagnostic test kit globally this month. The kit can be used by hospitals to confirm patients to be discharged.
Celltrion and Humasis will cooperate in the development of an upgraded rapid antibody diagnostic test and a rapid antigen diagnostic test. Celltrion said it would leverage its advanced therapeutic technologies to expand the range of co-developed diagnostic devices beyond COVID-19 to other infectious diseases through cooperation with Humasis.
"We are keen to drive early diagnosis of COVID-19 through the availability of our testing portfolio," said Celltrion's R&D unit head Kwon Ki-sung. "We are committed to providing flexibility for testing needs as the pandemic evolves, and are using our expertise and past experience developing antibody treatments and targeting coronaviruses to fight this pandemic."
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