Authorities in search of antibodies - massive testing for COVID-19

2024 Author: Seth Attwood | [email protected]. Last modified: 2023-12-16 15:55

Without special tests, it is almost impossible to distinguish coronavirus from other infections, and there are much more people who have had it than those who sought medical help. To find out how many people are faced with a new disease, and to make a decision on the withdrawal or extension of quarantine, antibody tests are used. "Knife", together with the Center for Advanced Management Solutions, continues a special project on the reaction of states to the pandemic and understands how different countries have identified sick and already ill with COVID-19.

General context

After several months of raging infection and tough quarantine measures, states are gradually weakening the restrictions imposed, allowing businesses to open, gathering in small groups, and in some cases even accepting tourists. To make such decisions, government agencies need to understand the general epidemiological picture in the country, namely, to know the most accurate number of people who have been ill and people with developed immunity against infection.

This indicator can be obtained using two types of tests. The first, polymerase chain reaction (PCR) analysis, is used to identify patients at the moment. The main disadvantage of this method is the low (1-2 days) execution speed. The second type of test - antibody tests or serologic testing - determines whether a person has had an immune response to an infection in the past.

Unlike PCR, antibody tests can give results on the same day, so they can better help understand the overall epidemiological picture across the country.

However, both types of tests cannot guarantee 100% accuracy of the results, and therefore countries have to use different approaches to testing and disease control.

Government authorities in different countries defined the sample and the size of the tested in their own way, gave access to private commercial structures (pharmaceutical companies, laboratories), and also began to conduct tests at different times. These three variables were influenced, on the one hand, by the scale and trajectory of the epidemic in the country, and, on the other, by the specific decisions of officials. The Knife and the CPDD tried to figure out how the strategies of states differ and depend on when conducting mass testing.

1. South Korea: high speed and admission of private pharmaceutical companies

868,666 tests completed by May 28

The South Korean approach to testing and disease control has been shown to be highly effective, with the country suppressing the epidemic in less than a month. The first cases of infection were recorded in early January, and by the end of February, the spread of the virus in South Korea was one of the highest in the world. However, by the end of March, the government managed not only to reach a plateau in morbidity, but also to significantly reduce the number of daily cases - their number varied within a hundred.

The country was not only able to extremely quickly suppress the spread of the infection, but also avoided the introduction of strict quarantine restrictions and reached one of the lowest death rates from coronavirus - just over two percent.

When did testing start?

The South Korean strategy to combat the epidemic was based on the principle of "test, track, contain". When it comes to testing, the authorities adhered to the most aggressive tactics. The first infected was detected on January 20, and on February 4, Korean pharmaceutical companies were able to offer PCR tests to the government.

How was the testing carried out?

The government has relied on the speed, availability and massiveness of testing. All persons who came under the suspicion of medical specialists were subject to testing: people with symptoms and those who could have contact with patients. From the very beginning, the average number of daily tests ranged from 12 to 20 thousand. Such volumes made it possible to quickly identify and localize the foci of infection.

To implement such a program, a network of free mobile test centers was deployed throughout the country. They worked according to the walk-thru and drive-thru systems - special points were organized with equipment for passing the test, where the medical worker was isolated from the tested person (or vice versa). The test itself took no more than 10 minutes, and the results came the next day.

Large-scale testing was combined with widespread awareness of the situation and the use of communication tools to track patients, which increased the quality and accuracy of the epidemiological picture. In total, as of May 28, more than 850 thousand tests have been done in South Korea. Of these, only over 11 thousand were positive.

Thus, the testing that the Korean authorities launched mainly consisted of PCR tests, and not tests for antibodies. This happened because the government was able to suppress the epidemic at the initial stage. The screening system is built in such a way that any infected person is quickly calculated and isolated - this is also confirmed by statistics. As a result, South Korea does not need to urgently arrange for antibody testing.

What is the role of private companies?

The pharmaceutical industry in South Korea is extremely successful both domestically and abroad, therefore, back in January, immediately after the first case of coronavirus infection was recorded, the state turned to medical companies for help in the early development and large-scale production of test systems. To this end, the government further simplified the registration of tests. In addition, all private manufacturers and laboratories were allowed to distribute the tests and conduct the testing itself.

2. United Kingdom: priority - risk groups and high accuracy of tests

3,918,079 tests completed by 28 May

Initially, the UK did not take active measures to counter the epidemic - the British government started from the concept of herd immunity. However, under pressure from the public, this concept was abandoned, and the government announced a quarantine and adopted a plan to combat the coronavirus, consisting of the following phases: containment, delay, research and mitigation.

When did testing start?

Testing for coronavirus in the UK began relatively early. Back in late January, the head of the National Health Service (NHS) announced that the country has world-class test systems. However, the scale of testing still did not satisfy either real needs or public opinion. Therefore, since mid-March, the government has increasingly promised to increase test capacities. To this end, the National Strategy for the Expansion of Testing was developed in early April. It involved scaling up PCR and antibody tests with massive private sector involvement. Together, the strategy was expected to allow for about 100,000 tests per day - with the potential to raise the ceiling to 250,000.

How was the testing carried out?

In mid-April, a list of professions was fixed in Britain, the representatives of which are primarily subject to testing (mandatory in the presence of symptoms). It included employees of emergency services and health care systems, law enforcement officers and social workers. The rest of the citizens were tested in a lower priority order. Tellingly, this regulation is valid only in England - Scotland, Northern Ireland and Wales establish their own rules.

As a result, the government managed to pass the mark of 100 thousand daily tests by the end of April and maintain approximately this level throughout May. However, the professional association NHS Providers criticized the 100,000 target as it distracts attention from other serious testing-related issues.

In total, about 4 million tests were conducted in the UK by May 28, while the government temporarily suspended the publication of information on how many people were tested in order to ensure consistency in reporting across different areas of testing. Of this number, about 250 thousand are antibody tests. The government announced the start of a full-scale serological testing program on May 22.

Serological tests will also not be massive, officials said. It is likely that they will be used in the selective testing program, which is foreseen in the already mentioned NHS strategy

What is the role of private companies?

The relatively small scale of testing is due to the limitations of the British health care system at the start of the epidemic. In order to quickly expand the network of laboratories and sampling stations, the government immediately aimed at cooperation with private pharmaceutical companies and laboratories. To facilitate the work of companies in mid-March, the authorities simplified the procedure for registering tests. At the same time, such measures became the reason for accusing officials of excessive privatization of the health care system.

15,766,114 tests completed by May 28

The introduction of coronavirus testing in the United States has been accompanied by major challenges. As a result of the failure of testing at the first stage, the authorities missed the beginning of the epidemic, which then brought the country to the first place in the world in terms of the number of infected.

When did testing start?

The first cases of coronavirus in the United States were recorded at the end of January. The US government, represented by the Center for Disease Control (CDC), has abandoned the use of test kits recommended by the WHO, instead announcing the development of its own tests. The first batch was delivered in early February, but a few days later the CDC reported serious technological problems and withdrew the tests back.

It took the CDC several days to fix the errors, with the result that the labs received no information for two weeks. This can be seen in the official statistics of the CDC: the first test results began to arrive only on February 29th. But even then, testing was not carried out in all states - only from March 16, tests became available throughout the country.

How was the testing carried out?

Initially, in the United States, the sample of people for testing was very limited. Only those who had been to China could pass the test - even the presence of characteristic symptoms was not a reason for testing. It wasn't until early March that the CDC expanded the criteria for passing tests. However, the CDC is not the final authority that sets the categories of citizens to be tested. Specific decisions are made at the state and local government levels.

As of May 28, nearly 16 million tests were performed in the United States, both in public and private laboratories. Of these, 1.9 million, or 12% of the total, were positive. CDC aggregates information based on data received from states. Some of them send in the results of both PCR tests and serological tests, but the CDC strives to ensure that the figures reflect only the number of PCR tests.

What is the role of private companies?

In February, the CDC took a long time to come up with a policy on unregistered test systems. Due to existing limitations, laboratories initially had to use only those tests that were developed by the CDC. This led to the creation of a bottleneck: all tests had to be sent for analysis to the CDC headquarters in Atlanta.

Only by the end of February, the FDA made changes to the regulations for registering tests. In the usual way, the test must first be registered, and then the final decision must be received. In the context of the epidemic, alternative tests (both proprietary and commercial) became available to laboratories in public health facilities without obtaining such a decision from the FDA. However, private laboratories and clinics began to connect to testing only in March. Now, according to weekly reports from the CDC, private testing accounts for a significant proportion of the total number of tests.

4. Russia: the monopoly of the regulator and the leading role of Moscow

10,000,061 tested by 28 May

Russia met the coronavirus epidemic 2-3 weeks later than many countries in the world. However, the government was unable to fully dispose of this time, including preparing the infrastructure of test systems to timely track the foci of the spread of the virus. As a result, the country is now in third place in terms of the number of positive cases after the United States and Brazil.

When did testing start?

The first test system was registered on February 11 - it was developed by the state research center "Vector" of Rospotrebnadzor, located in Novosibirsk. Until early March, it was the only officially available PCR test for coronavirus. On February 19, Rospotrebnadzor reported that all hygiene and epidemiology centers under its jurisdiction in the constituent entities of Russia are provided with diagnostic test systems. As of February 18, about 25 thousand tests were carried out among citizens who returned from China.

How was the testing carried out?

At the first stages of the epidemic, when the infrastructure for testing was completely unprepared, several categories of citizens had to take PCR tests: those who returned from countries with a large number of cases (Iran, Italy, South Korea); those who returned from countries with at least one case of infection in the presence of ARVI symptoms; weekly surveyed persons with ARVI and all persons with community-acquired pneumonia; those who have been in contact with patients with coronavirus infection.

In mid-March, the authorities announced a manifold increase in the number of testing in the future. In this regard, the list of categories of test subjects was expanded - there appeared people with characteristic symptoms of acute respiratory viral infections and community-acquired pneumonia, as well as doctors working with infected people. And when private laboratories were connected to testing at the end of March, people had the opportunity to make a test of their own free will for money.

Since about mid-May, serological tests have also been carried out in Russia. In Moscow, where the largest number of cases in Russia was recorded, a program for large-scale testing of citizens for antibodies was launched. Within the framework of this program, a special sample of people was compiled, who received offers to undergo free testing in city polyclinics.

The randomized sample takes into account the age structure of the population and the district of residence. Over the period from May 15 to May 23, 50 thousand people passed antibody tests. In total, it is planned to test for antibodies from 3 to 6 million Muscovites.

The rest of the regions are significantly behind Moscow in the preparation of serological tests. According to experts, the results of serological testing in Moscow - 12.5% of positive results - may reflect the real epidemiological picture.

In general, according to Rospotrebnadzor, as of May 28, 10 million tests were done in the country.

What is the role of private companies?

For quite a long time Russia did not give the private sector the opportunity to test and use alternative test systems. One of the reasons for this delay could be intradepartmental conflicts. For example, in March, The Bell published a material stating the desire of Rospotrebnadzor to retain the monopoly right to diagnose coronavirus.

But, apparently, the department had to give in, and on March 8 it issued a clarification about the requirements for the organization of laboratory research - in fact, this meant preparing for admission to the market of private laboratories. In early April, the government did indeed grant the appropriate permission. But only on April 17, the Ministry of Health established a temporary simplified procedure for the registration and import of medical devices to combat coronavirus.

Why is this happening?

A possible explanation of why some states are more successful in organizing the infrastructure for testing, while others are less successful, may be the hysteresis effect - a strong dependence of current decisions generated by the system (for example, the government system) on the accumulated baggage. In institutional theory, this effect is usually called path dependence, or the rut effect. It was first formulated in the early 1990s by political economists Douglas North, Sven Steimo, and Kathleen Thelen.

The rut effect is associated with the fact that the rules for the functioning of a system or institution established in a certain way are difficult to change in the future, even if these initial rules were ineffective or erroneous. To illustrate the rut effect, the modern QWERTY keyboard layout is usually cited as an example. It was created at the end of the 19th century for typewriters and, despite its inefficiency and low efficiency, it still persists, since it is impossible to create a sufficient number of incentives to change it, given the number and different nature of the players that this the layout suits and who are used to it (manufacturers, states, ordinary citizens).

One of the authors of the theory of historical institutionalism, S. Page in his work Path Dependence, published in 2006, formulated 4 properties characteristic of the preservation and reproduction of situations of the rut effect:

Probably, decisions on the deployment of a testing infrastructure in the country, the choice in favor of one or another type of tests, and the admission of private companies to testing are significantly influenced by the country's accumulated “baggage” to combat COVID-19. Officials are forced to make decisions based on the steps they have taken and the mistakes they have made.

So, the British authorities initially adhered to the concept of developing herd immunity, which they then abandoned under pressure from society, and in order to compensate for this failure, they tried to immediately increase the volume of testing. Due to the fact that it is impossible to do this quickly at the beginning of the epidemic, the authorities have repeatedly postponed the implementation of promises.

The United States, which relied on the development of its own test, could not ensure its quality, missed the arrival of infection in the country and now, upon exiting quarantine, is striving to perform the maximum number of antibody tests, including in order to show that the United States is in the lead by number infected have their own plus - the proximity of the development of herd immunity.

Russia reports a large number of tests done, despite the fact that many of them can give false negative results, and at the beginning of the epidemic, testing was organized extremely slowly. At the same time, South Korea, based on its own experience of dealing with epidemics in the 2000s, was able to establish the work of its services and suppress the spread of infection.

However, the rut effect can manifest itself not only in the dependence of current decisions on the recent political past, but also at a more institutional level. The issue of involving private pharmaceutical companies in organizing and conducting testing for coronavirus can also be largely dictated by the existing "legacy".

South Korea, where the pharmaceutical industry is highly developed, occupies one of the leading sectors of the economy and already has experience in working with government agencies to quickly introduce new developments into use, and was able to promptly help the government organize testing. In addition, South Korea's economy as a whole is built on much closer cooperation between government agencies and large corporations.

In Britain, there are very few legal obstacles for private business, which is why he started helping the government with such ease. In the United States, despite the traditionally high role of the free market and the power of the private sector, it is the pharmaceutical industry that has recently been overregulated due to the spread of ideas about the excessive influence of the "pharmacological lobby" on decision-making by Congress and active attempts by pharmaceutical companies to get large-scale government contracts.

In Russia, the activities of private business, including the pharmaceutical industry, are highly regulated in principle, and among the control authorities that must issue licenses for new drugs and test systems, there is a widespread distrust of private players.