In late May, a law that envisaged mass checks of the Ukrainian population for antibodies to Covid-19 came into force, and the Ministry of Health introduced ELISA testing into the standards of care for coronavirus disease.
For almost two months, from border guards, doctors, pathologists, national guards should have ELISA testing. And at the end of June, the Kyiv mayor, in fact, added to this list, obliging business employees who massively contact customers to conduct IFA testing too.
Does this mean that now people in the capital’s stores and hospitals across the country are being served by people with antibodies to the coronavirus, how much do these checks cost, and are they really necessary?
Why IFA testing is needed
Testing by enzyme immunoassay is actively used in the world to understand the real picture of the formation of collective immunity. After all, you can get sick without symptoms. Given that many Ukrainians may have antibodies to the virus, it probably no longer poses a threat to society with which we associate it.
Ukraine also considered the possibility of allowing citizens to travel abroad on the basis of a so-called health passport, which would confirm the presence of antibodies in citizens. Montenegro, by the way, included ELISA tests and changed the conditions for entry into its territory for tourists. The mere fact that a person already had coronavirus is not significant enough. Not all patients with coronavirus have antibodies. According to the Kharkiv Regional Center for the Preparation and Processing of Plasma, 55% of ill patients with antibodies to Covid-19 did not have. That means they could have been infected again.
The third and perhaps most important aspect of the use of ELISA testing is the fact that antibodies to coronavirus can be removed and used to treat patients with Covid-19. Antibodies are necessary to create a vaccine against coronavirus. During quarantine in Kharkiv-Plasma center for the preparation and processing of plasma, only a fifth part of the necessary plasma was collected from donors. Mass testing in this case can save lives.
ELISA testing differs from the usual rapid test, which also shows the presence of antibodies, but with a lesser degree of confidence. With the ELISA method, blood serum is taken from a vein, and in the case of a quick check, the blood itself is taken from the finger. Unlike the rapid test, the results of the test by enzyme immunoassay will have to wait several hours. And the wait for confirmation of its results in the laboratory may drag on for several days.
ELISA testing is different. It is possible to check for immunoglobulins G, the presence of which in the blood indicates that a person has already been ill – with a high degree of probability, it is asymptomatic. These antibodies appear approximately two weeks after the illness.
A test for immunoglobulins A will show that the patient is ill with an acute form of coronavirus (representative on about the 4th day). A test for immunoglobulins M will confirm that a person is already recovering from Covid-19, since antibodies have begun to be produced. This type of immunoglobulin can be detected about a week after the onset of the disease. It will tell how easily a person is able to tolerate coronavirus.
If immunoglobulins A or M are detected, the person is also checked by PCR. So, in fact, an ELISA test identifies patients. If we analyze the prescription for testing from the Cabinet of Ministers, then it is proposed to carry out comprehensive tests - both for immunoglobulins M and G.
Local authorities often do not delve into these nuances. In Odesa, for example, 15,000 tests for immunoglobulins A and M were procured.
Kyiv mayor did not give any clarifications to the inspections of the service personnel. This means that business representatives who do not understand all types of tests, would only check for immunoglobulins G, so they might miss the virus, for which these antibodies have not yet been developed. Those who will test for immunoglobulins A and M would miss those employees who have long passed the disease, but already have antibodies.
How a business conducts IFA checks
One of the most popular metropolitan malls Gulliver informed that the mall is not subjected to such an order. It should be carried out by the retail chains themselves, that is, brands that rent rooms in the mall’s premises. The developer does not have its own stores, in which employees would work with customers. Thus, representatives of the shopping center, which measure the temperature of visitors, will not undergo IFA testing. Gulliver mall representatives say they did “everything possible, and even more” for their part: they systematically carry out cleaning, implement the requirement to wear masks, and put on sanitizers.
The requirement also does not apply to the online services that operate like freelance platforms, such as Kabanchik, Glovo, Uklon. So taxi drivers, food deliveries, home masters of all trades for antibodies are not tested.
Most of the restaurants and shops we interviewed (more than 15 businesses in various fields of activity) that were previously actively prepared to cooperate and provided information on their activities in a short time, ignore requests for information on this topic.
Given this fact, a refusal to provide information can only be regarded as confirmation that the business does not conduct these checks. At least for now. Employees of the surveyed restaurants unofficially confirm: ELISA tests have never been done.
A clear answer was not provided even by such a giant as McDonald's. Only one of the real estate companies conducted such testing but has no plans to repeat it yet, contrary to the decree. Most likely, the business has now “taken a break” to understand whether it is possible to do without monthly compliance with this rule.
The Union of Ukrainian Entrepreneurs told us that the business as a whole agrees with the demand of the authorities. However, the opinions of individual entrepreneurs and representatives of the Ukrainian Business Council, with whom 112.ua spoke, are fundamentally different. Yuriy Sivitsky, the member of this council and founder of Intecracy Group, is convinced that entrepreneurs should not pay for testing.
Matter value during a pandemic
Ukraine became the fifth country in the world to develop its own ELISA tests. Manufacturers claim that the cost of one test of domestic production without the cost of laboratory research is 2 USD against 40 USD per foreign copy.
This makes ELISA testing highly beneficial. In addition, Ukraine has more laboratories for the analysis of ELISA tests than for PCR ones.
The "Boris" clinic assures that the extended test would cost 30 USD, IgG – 25 USD. In the "Dobrobut" clinic the cost of the test for IgM was not announced and they refused to conduct it without consulting a doctor. But the IgG test there can be purchased for 35 USD. At Adonis Clinic its cost is 13 USD, at Sinevo – 22 USD. the most expensive IFA test are in the "EuroLab" clinic – over 50 USD, a consultation without which they refuse to do it - another 8 USD. Also, blood sampling will cost 2,5 USD.
From July 3, everyone can be tested in state hospitals. Testing is not for free, but much cheaper than in private clinics. According to the Kyiv mayor, it would cost 11 USD. In the Chernivtsi regional clinic - for 7 USD. In the Khmelnytsky region, it would amount to 6,7 USD. Such a difference in price is observed due to purchases by local authorities - they are carried out separately in each region of the country.
Some clinics organize medical visits to the company for testing at least ten employees, one test costs 40 USD.
If the restaurant employs 20 people, its owner would have to pay a lot. IFA testing will cost the monthly rate of one of the team members. In addition, it is necessary to buy protective equipment, disinfectants for employees, and pay extra to cleaners for processing. All these quarantine costs already cost about a thousand dollars a month. All this load is in a post-quarantine crisis, when a business just opened after downtime and tries to adapt to the ever-changing rules of the game.
Does this mean that the owners of cafes and shops will face fines, will they need certificates confirming the presence of antibodies? Most likely, the business has nothing to be afraid of. IFA testing remains on the conscience of the business.
Testing of the civil servants
As of July 9, only 7% of the doctors of the Uzhgorod maternity hospital have passed IFA testing. In the Kyiv region, less than 10% of the medical staff did tests. Ukrainian guards are not massively tested either. The State Border Service reports in response to a UNN request that tests are done primarily for those who were at risk of infection. As for the police, as of June 18, less than 2,000 people out of about 130,000 employees passed inspections (this is 1.5%).
As of June 24, that is, for the month of mass testing, according to the Ministry of Health, about 150,000 ELISA tests were carried out – more than 130,000 police officers, 53,000 border guards. 60,000 people serve in the National Guard. All of them should have been tested for antibodies during this time at least once. There are 570,000 doctors who should be checked once a month. And those who work with coronavirus patients should undergo checks even more often. In addition, testing was planned for those who had contact with patients and for whom PCR showed a negative result. That is, only 150,000 checks, however, millions were planned.
This proves that full-fledged testing, which would require about 38 million tests per month, is just a fantasy. What motivation should a business have to implement a recommendation if antibody testing has not started at the state level?
Problems can most likely arise with Ukrainian laboratories. The Ministry of Health reported that our laboratory network is ready to conduct a million tests per day. But the data in the media is different. Doctors say that laboratories are overloaded, in particular, in the West of Ukraine. The director of the Lviv Regional Laboratory Center announced delays in research results up to 5-6 days due to a lack of staff.
The reason may be a lack of ELISA tests. The capacities of Ukrainian manufacturers in order to produce a million tests a month, judging by their statements, are enough. But until June 22, they could not be purchased under a simplified procedure.
In addition, the financial issue is acute. The purchases are handled by local authorities and clinics. The state, issuing instructions on testing, has removed itself from the problem of providing tests. And this is against the backdrop of underfunded health facilities and a lack of money in local budgets.
What will the sabotage of mass testing lead to?
Of course, as another indicator of the unsystematic struggle of the authorities against coronavirus, the current testing statistics are depressing. On the other hand, there is reason to believe that this is not so critical since the idea of mass testing in Ukraine is obviously a failure.
An IFA test is actually, contrary to popular belief, far from the most reliable. There is a risk that antibodies will appear that protect the body not from Covid-19, but from other infections of the same group of coronaviruses. The identification of collective immunity can be prevented by the influence of statistical error.
First, initially, Ukraine focuses on groups of people with a high probability of infection, which makes the sample unrepresentative. Of the 11,000 studied in Lviv, 8% had antibodies, in Kharkiv - only 0.57% of 16,000. In the second case, checks were carried out not only for doctors and those who were in contact with infected people but also for everyone who wanted to be blood plasma donors.
Secondly, in Ukraine, there are too few cases for mass testing. The U.S. Centers for Disease Control says Covid antibody tests fail in half the time. Former rector of the Bogomolets Medical University, Kateryna Amosova, explains this: if 5% were ill, half of the positive results would in fact be false positive. But if more than half the population has been ill, the test system will have less than 5% false-positive results. We will gain an understanding of collective immunity when (and if) the majority of the population gets coronavirus.
But even if the tests were as reliable as possible, it is not entirely clear how the business should use their results. If an employee does not have antibodies, can he not work with clients?
Antibody data cannot be used to weaken quarantine precautions. The fact is that individuals with antibodies with a certain degree of probability can still get infected. Therefore, they will have to wear masks in public places, even with a positive IgG test result. The German Ethics Council is against antibody testing, as it may result in precautionary measures not being followed.
Another problem is related to the frequency of testing announced in the Ministry of Health. If you analyze the decision of the Cabinet of Ministers, the tests will be conducted until they are positive. That is, if antibodies are detected once, a person will not be tested.
The duration of immunity from coronavirus depends on how seriously the person was ill. If we talk about the Middle East epidemic of MERS in 2015, then in asymptomatic patients, antibodies ceased to be produced three months after the disease. How much antibodies to coronavirus will be in human blood is unknown. They may completely disappear a month after verification, but they will not be tested again. It turns out that he will be falsely convinced of his safety. From the recommendation of the Kyiv mayor, it is not at all clear whether a check is planned after a positive analysis.
Violetta Yanyshevskaya, the President of the World Medical Tourism Association, tells that it makes no sense to focus on antibodies in terms of additional opportunities for citizens. It is easier to implement safety certificates for restaurants, hotels and resorts, clinics. The New York City Department of Health also explicitly states that these tests should not be used to diagnose an infection or to assess immunity. Even chief sanitary doctor of Ukraine Viktor Lyashko himself says that mass testing will not give anything but a false sense of security. So is it worth it to spend finance and laboratory capacity on it?
According to the rating of PCR testing, Ukraine is in the second hundred countries but plans to break into the top five by IFA. Although this is only an auxiliary mechanism for detecting coronavirus, and not the main one: antibodies are not always produced in patients with coronavirus disease. Perhaps it would be worth investing more in the purchase of PCR systems and increasing the number of jobs for epidemiologists?
Large-scale antibody testing is advisable or not, centralized procurement of ELISA tests, and clear rules for business are needed. Otherwise, the actions of the authorities in preventing a new outbreak of Covid-19 will continue to resemble the fight against windmills.