Korean firm accelerates COVID-19 rapid diagnostic kit, secures European CE certification
Korean firm accelerates COVID-19 rapid diagnostic kit, secures European CE certification
  • Lee Kyung-sik
  • 승인 2020.06.22 17:52
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Amid continuously spreading COVID woes around the world

By Staff Reporter Ms. Kim Ka-hee


COVID-19 woes are gripping the world with a total of over nine million people confirmed affected as of June 22, of whom over 400,000 people died with a mortality rate estimated at 5.2%.

In Korea, the situation is much better off thanks to the government efforts and solutions put out by he pharmaceutical companies. In Korea as of that date, 12,438 COVID-19 cases have been confirmed, of whom, 280 persons died with a mortality rate of 2.25%.


CEOs Jeon Hong Ryul (left) and Sung Ki-hong
CEOs Jeon Hong Ryul (left) and Sung Ki-hong

Against this backdrop, a competitive Korean pharmaceutical company has come up with an effective diagnostic kit. The company in point is CTCBIO.

According to Public Relations Manager Park Sang-kuk of the company, CTCBIO has completed all the regulatory procedures for export, by obtaining the European CE certification and ISO13485 certification following the export approval from Korean Ministry of Food and Drug Safety (MFDS) for the rapid diagnostic kit for the novel COVID-19 infection. Excerpts from the announcement of CTCBIO follow:

Reporter Kim Ka-hee of The Korea Post Media
Reporter Kim Ka-hee of The Korea Post Media

In order to export diagnostic kits produced in Korea, the export permit by MFDS and marketing authorization in the country of sale are required. CTCBIO has completed the European CE certification, which is accepted in most countries including Europe, Asia, the Middle East, Latin America, and Africa. With this European CE certification, CTCBIO can essentially export to most countries around the world, said CTCBIO.

Currently, CTCBIO has signed a supply agreement with JDJ group to export COVID-19 Rapid Diagnostic Kit in Latin America regions with an upfront of approximately US$10 million (KRW 13.2 billion), as announced on 16th. Also, it became possible to actualize the exportation to countries such as Africa, Middle East, and Europe where discussion on the distribution has been ongoing.


COVID-19 Rapid Diagnostic Kit:

“CTC™ COVID-19 IgM/IgG Combo Test of CTCBIO is a kit that diagnoses IgG and IgM antibodies at the same time. This drew attention as it can promptly detect the COVID-19 infection within 10 minutes using only a drop of blood at the tip of finger or the whole blood, without need for plasma separation. Thus, there had been multiple requests for distribution from worldwide.”, said an associate of CTCBIO. He said they’re “trying their best to increase the volume of production to meet the increasing demand”.

He also mentioned that RT-PCR (genetic diagnosis) currently in use extracts samples from the subject and tests for the presence of COVID-19 virus gene, which requires expensive testing facilities, equipment, reagents, and professional clinical pathologists, and it is hard to be fully equipped as such. Thus, countries that are not well-equipped with large-scale molecular diagnostic infrastructure, such as Europe, the Middle East, and Asia, admitted the limitations of the test capacity and are actively introducing the rapid diagnostic kit”.

The representatives of CTCBIO Inc., Ki-Hong Sung and Hong-Ryeol Jeon, announced that they have been thoroughly supplying diagnostic kits from the beginning of May, and have expanded the capacity to respond to the required exporting quantity from their overseas customers. So they have the ability to produce more than 300,000 kits per day, which can be increased upon future market demand.

CTCBIO has signed a contract with Ecuador in South America to supply 1.8 billion won worth of diagnostic kits for the new coronavirus infection kit.

Amid concerns over the possibility of a simultaneous pandemic of the Corona 19 and seasonal flu in South America as the new coronavirus (Corona 19) soon enters winter, Ecuador in South America reportedly has 4,007 deaths as of yesterday, with a mortality rate of 8.3 percent among 48,490 people.

The cumulative supply contract of Citi Bio's diagnostic kit has exceeded 15 billion won following the signing of a 13.2 billion won supply contract with JDJ Group for Latin America. It has recently completed facility expansion and started producing 300,000 units per day, and plans to expand additional facilities depending on the situation.


Editor’s note:

The Korea Post media, publisher of 3 English and 2 Korean-language news publications for the past 35 years, publishes a Special Report on Ecuador on the occasion of the National Days of the country in May and August. For story and pictures, visit: http://www.koreapost.com/news/articleView.html?idxno=20938



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