"This is how they made it in S. Korea, Large-Scale Diagnostic Tests"
  • Yuni Kim
  • Updated 2020.05.12 15:08
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Diagnostic testing is in the background of Korea's attention as a model of infectious disease prevention. Professor Hyuk-min Lee, an expert on infectious disease diagnosis, said that developing countries like in Africa may become a hotbed for infection and the world needs to create a cooperative system to overcome the problems ahead.

It was 8 in the morning of Friday, January 10, 2020. Around 20 infectious disease experts gathered at a conference room in Jung-gu, Seoul. It was the time when the cause of a cluster of pneumonia cases, first reported in Wuhan, China from late December of 2019, began to be identified. The Korea Center for Disease Control & Prevention (KCDC) quickly called the Special Committee on Infectious Disease Crisis Management upon the outbreak of the novel virus. 

At this meeting, doctors specializing in infectious diseases and responsible government officials focused on two issues: probability of its import to Korea and its impact on the country when imported. The experts anticipated high chances of the import. The second question, however, was tricky. The Chinese authorities had yet to confirm whether the novel virus was transmittable among people until then. No death was reported as yet.. Professor Lee from the Laboratory Medicine of Severance Hospital had a moment to talk KCDC at the meeting to Lee Sang-won, an infectious disease expert from the Laboratory Diagnosis Management under the Center for Laboratory Control of Infectious Diseases. “We did not expect the disease to be a pandemic like this but said that we would certainly need to have the testing capacity.”

Three months passed  since then. The pneumonia with etiologies unidentified was named COVID-19 and literally paralyzed the entire world. Advanced countries with excellent medical infrastructure were also caught off their guard. Italy, Spain and the US saw more deaths than China and the US accounted for 20% of all confirmed infections across the world. 

Prevention is the only measure to reduce new infections and deaths when there are no vaccines or treatment. South Korea is standing out for its pre-emptive model in  the fight against the coronavirus. Michael J. Ryan, Executive Director of the World Health Organization's Health Emergencies Program said, “South Korea detects patients early, isolates those in contact with the patients swiftly and promotes people’s active engagement is already materializing all factors and strategies that we envision at the WHO in response to COVID-19.”

At the center are the diagnostic tests. On January 13, three days after the meeting, the KCDC announced that they would begin developing a COVID-19 testing method. Test kits developed by local medical companies obtained emergency approval one by one from early February and the number of private test agencies soared to 110, pushing the country to have the greatest testing capacity for COVID-19 in the world. As of April 1, South Korea tested about 430,000 cases in total with the maximum daily capacity at 30,000.

Professor Lee is one of the experts in diagnosing infectious diseases in South Korea. He is now a member of the Special Committee on Infectious Disease Crisis Management under the KCDC and also a member of COVID-19 TF of the Korean Society for Laboratory Medicine (KSLM). He has been playing a bridging role in connecting the KCDC, the public sector, and the laboratory medicine, the private sector, to build the Korean testing system. Many nations developed coronavirus test kits earlier than South Korea. Germany reported its COVID-19 testing method to the WHO on January 17 followed by Hong Kong, China, Japan and the US. But no country was as fast as South Korea in carrying out large-scale tests. What was the key? Professor Lee has been busy reading the COVID-19 test results until 2 or even 5 in the morning.  SisaIN interviewed him on three occasions from March 25 whenever he had time to spare.

Professor Lee Hyukmin, Laboratory Medicine, Severance Hospital. Yonsei University. ⓒSISAIN CHO, NAM JIN

Do you run tests until late at night?

My lab at Shinchon Severance Hospital is running COVID-19 tests six times a day. We need to produce the result quickly so that we can take the next step quickly. If we begin testing the specimens at 10 at night, the result is out at 1 in the morning and, if we begin the test at 2 in the morning, we get the result at 5. People simply think that the machines automatically calculate and come out with figures. But all tests have a grey zone. We sometimes have unclear value between positive and negative. Laboratory medicine experts have to read the result of important tests like the one for the coronavirus.

The Special Committee on Infectious Disease Crisis Management  held a meeting on January 10 in response to COVID-19. It was 10 days before patient zero was identified in the country on January 20.

They are doing a great job about it at the KCDC. They continue to monitor infectious diseases that can come from outside. They put together and send overseas trend to the Committee members once a week. They built in 2017 the Center for Laboratory Control of Infectious Diseases dedicated to testing infectious diseases and also created the Emergency Use Authorization system (EUA). During the outbreak of MERS in 2015, they had already developed the MERS test method to prepare for local infection but could not keep up with the exploding test needs. They established the EUA, which is serving its purpose now (The emergency use authorization (EUA) facilitates assessment and availability of a test kit developed by a private company when test reagents are urgently needed for outbreak of a pandemic).

Did the readiness lead to competence?

We had the EUA cases to prepare for infectious diseases spreading in other countries before the coronavirus. When the Zika virus spread in Latin America, we were able to issue a public notice to develop the test kit by using the EUA and receive applications from the companies that were interested in it. We thought we would not have time to go through the EUA if Ebola virus hit us. So we built a pre-authorization procedure. The KCDC does tests and the KSLM evaluates experts. We did not use it as we did not have local infections. But it worked as an exercise for the domestic reagent producers to enhance the test kits’ performance. 

The MERS outbreak in 2015 seems to have been a painful experience for the infectious disease experts. 

Exactly. We thought, ‘How bad we are. This is nonsense (Laughter).’ We had lots of trouble in the initial response. When mass infection occurs, experts from diverse disciplines have to team up and see it in multiple perspectives. But the initial response team for MERS was made up of those from one discipline. They supervised everything in the frontline while the KCDC director was standing behind. In other countries, an administrator should always be the responding leader under any condition. As Director Jung Eun-Kyeong is now, the KCDC Director should have been the decision maker in charge.

Some argue otherwise. As infectious diseases or health issues are the domain of experts, they say, the government has to follow their opinion.

To be honest, doctors do not know much except for their own field. Like myself.  People like me are those who just got high scores on tests in school. It takes a lot to prevent the virus from spreading. Some insist banning inbound travelers. Well, if one is scared, stay home and to nothing for a month or whatever time it takes. But a society does not function that way; we need to go outside to work or go to a conference. The same applies to a nation. If a country decides to shut down, I can agree that this will definitely stop COVID-19. But is this feasible? And how long can such a situation last? Korean people account for 90% of all people arriving to South Korea. A quarantine measure is a national policy and the one with best understanding about it should make the final decision. I believe the experts should merely offer suggestions to help the officials in charge to make the right decisions. 

Medical technologists extracting nucleic acid from the specimens to test COVID-19 at a lab of Severance Hospital, Yonsei University. ⓒSISAIN CHO, NAM JIN

The KSLM continues to compile COVID-19 test results. Do you see a trend from the data?

Basically, the tests are conducted by the public sector and private medical institutes. The public sector is the Center for Laboratory Control of Infectious Diseases of the KCDC and 17 Research Institutes of Public Health and Environment in the country. They conduct about 2,000 tests. The private sector has hospitals and specimen testing agencies. They carry out approximately 20,000 to 25,000 tests. It is the results coming from the private sector that the KSLM can take a look at. The data shows that Daegu and Gyeongbuk Province account for 40% of new confirmed infections, airport quarantine 30%, Seoul and Gyeonggi Province 25% and the rest 5%, respectively (as of March 28). As many cases in Seoul and Gyeonggi Province are imported, we find pure local infections even fewer if we exclude Daegu and Gyeongbuk cases. It is hard to completely ban inbound travelers. But I think there should be strong punishment if they violate the self-quarantine regulation and all that. 

We now have a well-established COVID-19 testing system that can test as many as 30,000 cases a day. But I suppose, at some point, you were standing at a crossroad.

The meeting we had at Seoul Station on January 27, which was arranged by the Center for Laboratory Control of Infectious Diseases and KSLM, was critical. We invited and encouraged the reagent producers to develop the test kits. The KCDC shared the reagent protocol they developed. And they were quick to prepare for the EUA. We had a little bit of disagreement before choosing this direction. We had to decide whether the private companies should be allowed to manufacture the test kits or the KCDC should develop and distribute the test kit themselves like Japan and the US. It was worrying that the individual companies might struggle to secure raw materials in case the global test needs skyrocket. We thought that would not be the case. So, we turned the direction to have them mass produce the test kits.

Another issue was that the test kits have created a huge market since mid-February. That is when other companies began lobbying to sell reagents that were not properly assessed. I read many news reports that they developed a rapid test kit showing the result only in 10 minutes. Most of them used the antigen/antibody test, which presents lower accuracy than the RT-PCR (gene amplification) we are applying now. It is around 50 to 70%. We can use it if it is not a big deal to have incorrect results like influenza. Of course, we sometimes need easy and rapid test kits. But they are not for us as we are in the battle against COVID-19. US Congressman Mark Green recently stirred a controversy by saying the South Korean test is not adequate even for emergency use. The Korean test Mr. Green referred to, in fact, was the rapid test kit developed with the antigen/antibody method. We do not use them in Korea. We are wasting too much energy responding to something like this.

Did you have a moment when you thought, “wow, this is  big”?

It was when the mass infection linked to Shincheonji Church of Jesus broke out in Daegu. Back then, we conducted about 10,000 tests a day and could see 8,000 results in 24 hours and 2,000 results after 24 hours. I was concerned that private medical institutes like us could provide the results fast enough. Then, the reagent agencies expanded their test capacity. I was nervous when I personally witnessed the first positive in my hospital. We cannot be cautious enough in conducting such critical tests. My lab uses test kits of two companies. We do tests by using both kits and send them to the KCDC for crosscheck.

Foreigners from the UK testing for COVID-19 at open testing stations outside the Incheon International Airport on March 31. ⓒSISAIN CHO, NAM JIN

People continue to cast doubt about the reliability of the tests. 

We have carried out 800,000 tests so far (as of March 28). But the KCDC data shows about 400,000 in total because it is based on the number of the tested. Sometimes, we tested twice or had to test again to trace confirmed patients. That is why we have more in the cumulative total. This suggests there are 800 cases of false positive or false negative even though the test accuracy is 99.9%. In order to avoid that, the laboratory medicine doctors do the crosscheck and test again to find ways. Still, it is possible we might miss something. But we cannot afford to do nothing to find the patients because of those few cases.  

Some people complain that too many people are being  tested.

The mass infection broke out in Daegu and we identified the confirmed patients so fast that the medical infrastructure certainly had difficulty accommodating all of them. So, I think the testing centers are a good model. In general, it is very important to test people in a timely manner when the infection spreads. We need to do the test to keep the process going. We have to segregate those with the virus from those without it, isolate them, treat them and test them again to see if they are completely treated before returning them back to society. And we need to test and have the results to be able to know if the prevention method of our choice is effective. The diagnostic test is the first tool we must have to fight a pandemic.

Why other countries have not resorted to large-scale testing against COVID-19 when it is clear that diagnosis is a basic form of prevention. Western Europe, in particular, compared to South Korea is believed to have better medical infrastructure or public medical system, what happened there?

I also want to know why. Europe also has its own version of CDC that is responsible for the entire continent like we have the KCDC. When COVID-19 got serious in China, they already checked the testing capacity in the respective countries in early February. But they did not expand it. It was surely a mistake. I personally guess that it is due to the data from Japan, which announced that the virus is under control without conducting tests, and the number of patients and deaths was small.

We have to clearly see that currently the advanced countries are the ones with the highest number of those who have been infected. However, as they have testing capacity, they are increasing tests rapidly to find patients. As for the developing countries, I would say that it is not true that they do not have confirmed cases. Rather, it would be reasonable to say that they just cannot afford to conduct the test. As early as mid-February, Africa had only two test labs in the entire continent that can run RT-PCR (gene amplification) equipment. So, the WHO told them to send the specimen to its reference lab (WHO-certified lab) in South Africa. The developing countries are very likely to be the next new hot spot. They need support and global cooperation. One country alone, though it may be doing things right,  cannot fight and eradicate COVID-19.

A NATO transport aircraft is waiting at Incheon International Airport to depart for Romania carrying protective clothing and test kits. ⓒYunhap News

What kind of support do they need?

A cure would be the best but we don’t have it yet. The next best things is testing. But setting up the RT-PCR there now to test the virus? I don’t know. I understand that in some countries there are power outages.You can’t run the equipment there. What they need now are rapid test kits. So, we have to spend time to make good rapid test kits, not false poor ones.  They are no match to the RT-PCR but it’s better to be a little inaccurate than do nothing. At the same time, they must device quarantine measures that are suitable to the situation; they should be measures that take into account low resources. For this they will need advice from experts who should travel there and see the condition in person and help them set up a quarantine method that meets their needs.

Laboratory medicine is quite new to the general public.

They may not be familiar with the field as we are not clinicians who examine patients in person. We are also outnumbered by other disciplines. We have slightly more than 1,000 laboratory medicine doctors in the country. In fact, there are not so many countries with such a large specialist group dedicating to conducting tests as South Korea. In the US, for example, researchers carry out infection tests in the lab instead of medical doctors.

How long do you think the novel coronavirus will last?

The six weeks from February until early March were very critical and major countries missed that moment. I think it will peak before going away around June or July. The problem is the developing countries. It would be really troubling if the situation improves here but the virus circulates there and continues on.

You have been responding to COVID-19 since January. I guess you must exhausted from time to time.

I am hanging on here because I have to do it. I have doctors with me at my hospital and seniors and juniors working together in the COVID-19 TF of my society.

translated by Chul Min Park
translation supervised by Beckhee Cho