South Korean President Moon Jae-in discusses policies to deal with the coronavirus outbreak during a … [+]
South Korean Presidential Blue House via Getty Images
South Korean manufacturers of kits for testing for COVID-19 are gearing up for exports worldwide, notably to the U.S., after having produced them for testing more than 300,000 Koreans since the first cases in the country were confirmed in January.
Korean companies were eager to ship test kits to the U.S. after a telephone conversation between U.S. President Donald Trump and South Korea’s President Moon Jae-in in which Trump suggested Korea send “medical equipment” to the U.S. The Blue House, the center of presidential power in Seoul, not the White House, reported the request, and the State Department confirmed the U.S. has reached out to a number of companies for test kits and other equipment, including ventilators.
Moon, visiting Seegene, one of Korea’s leading makers of biomedical equipment, praised the company for rapidly developing test kits needed to stop the epidemic from spreading. The Korea Centers for Disease Control and Prevention has approved Seegene and four other companies for making test kits that are now in widespread use in Korea and may be ready for export pending approval by other countries, including the U.S. CDC.
The online Korea Biomedical Review said the need for testing was such that the test kits won rapid approval in Korea through a system under which medical institutions were permitted “to use temporarily unauthorized medical supplies or diagnostic reagents for emergencies during an epidemic.”
The Review article quoted Chun Jong-yoon, Seegene CEO, as saying “the urgent use approval system helped us get approval in just one week and supply the product.” Seegene, he said, “could rapidly develop the reagent and the kit by adding our know-how to the disclosed coronavirus sequence data.”
As for doubts expressed by foreigners about the accuracy of the kits, the article quoted a government source as calling that claim “not true.” In fact, said the article, the World Health Organization and others recognized the validity of the method used by the kits “to amplify viral DNA in a patient’s sample to determine the presence or absence of a virus.” That method, it said, involved RT-PCR, “real-time polymerase chain reaction.”
Besides Seegene, several other companies have already received licenses to manufacture test kits for use inside Korea while also looking for customers in Europe and the middle east. Seegene has reportedly exported 50,000 test kits to the United Arab Emirates while rival Solgent has shipped kits to Europe. Others are lining up to look for markets for their products.
“Korea’s quick and extensive testing capability is drawing the world’s attention,” said the Korea Biomedical Review. “The nation’s remarkably fast and massive testing is attributed to the early development and release of COVID-19 testing kits by domestic in vitro diagnostics companies.”
The website BioWorld said normally approval would take up to a year but “under urgent-use approval this time frame is shortened to one to two months.” The process said such approval would be requested only if the device “required to fight a pandemic is rare or does not exist.”
BioWorld reported that the Hong Kong University of Science and Technology claims to have developed a test capable of detecting a virus in 40 minutes—“the fastest known COVID-19 diagnostic kit.”
The Seegene kit, said BioWorld, “can perform 1,000 tests simultaneously and deliver the diagnosis in less than four hours” while Solgent’s kit can come up with a diagnosis in under two hours. Research for a kit manufactured by another Korean company, Kogene, it said, benefited from experience “used to speed up development and production” during the MERS-CoV outbreak in 2015.
“As of March 9, 15,971 kits to perform 522,770 tests have been produced and of these 11,478 kits have made their way to 381,500 patients,” BioWorld reported. “The companies have left 4,493 kits to test 141,270 people as backup stock. One kit can perform between 25 to 50 tests.”
While exporting test kits, however, Korea is short on face masks that virtually all Koreans are routinely wearing.
The Ministry of Trade, Industry and Energy has authorized the import of special fabric filters for four companies producing the masks, according to Yonhap news agency. One company, Toray Advanced Materials Korea, an offshoot of Japan’s Toray Industries, is converting facilities for making diapers to produce the masks.
“Some mask producers in the country were on the verge of suspending operations due to shortages of the material,” said Yonhap, reporting a shortage of masks “despite a sharp increase in daily output.”