Do express tests have any official status?
Formally, information about the types of rapid tests, their regulation, and mechanisms of use is contained in at least two key documents: sanitary and epidemiological rules on the prevention of a new coronavirus infection of Rospotrebnadzor and during temporary guidelines for the prevention, diagnosis and treatment of coronavirus of the Ministry of Health (information in both documents is constantly updated).
The rules of Rospotrebnadzor emphasize that research can be carried out in laboratories that have the appropriate conclusions to work, and specialists who have been trained in biological safety are allowed to do so. From the point of view of the department, a confirmed case of COVID-19 is considered to be laboratory confirmation of a test system that is able to determine the antigen of the pathogen and is registered in Russia.
Read on RBC Pro
The interim guidelines of the Ministry of Health state that the main diagnostic methods are methods for detecting coronavirus RNA by amplifying nucleic acids (the most common of them is a PCR test), as well as detecting a virus antigen using immunochemical methods (rapid tests for antigen and antibodies to virus).
The document highlights:
- the sensitivity and specificity of rapid antigen tests may be lower than those of PCR tests;
- a positive result can be considered as confirmation of coronavirus, but a negative result does not rule out COVID-19;
- such tests may be used when PCR diagnosis is not possible, such as in remote areas.
How does a rapid test work and how does it differ from PCR
PCR tests (polymerase chain reaction) are designed to detect RNA in the body, that is, the genetic material of the coronavirus.
The PCR test is based on a technology in which the patient’s genetic material is repeatedly copied, this happens to the extent that the device does not see it – special reagents are aimed at this piece of genetic material. PCR tests are highly sensitive, but they require special equipment, and data analysis takes time, Larisa Popovich, director of the HSE Institute of Health Economics, explained to RBC.
There are two types of rapid tests: some are aimed at detecting the coronavirus antigen and its proteins, others are able to detect the presence of antibodies in the patient’s blood – to show whether he is currently sick or had been ill some time ago. In both cases, this type of testing does not require special equipment. Express tests are represented by test strips on which the patient’s biological material is applied, so the entire study takes 15 minutes, explains Sergei Voznesensky, Associate Professor of the Department of Infectious Diseases of the Peoples’ Friendship University of Russia.
As in the case of the rules of Rospotrebnadzor, the recommendations of the Ministry of Health state that diagnostics can be carried out in laboratories that have the appropriate permits to work with pathogens and special personnel.
None of the documents contains information or descriptions of testing by a person at home on their own. Now the issue of independent use of express tests for the SARS-CoV-2 antigen in smears of the upper respiratory tract is not regulated by law, RBC was confirmed in the Ministry of Health.
Indeed, the existing rules and recommendations contain information about rapid tests, however, based on the instructions, these medical devices can only be used by medical workers with professional training, said Vladimir Chulanov, chief freelance infectious disease specialist of the Ministry of Health. RBC’s interlocutor also recalls that the interim recommendations of the World Health Organization say: rapid testing should be performed by trained personnel, there is currently insufficient data on the effectiveness of self-administration of such tests without prior training.
How popular are rapid tests
Retail sales of COVID-19 rapid test kits in the first three weeks of 2022 are seeing tremendous growth in both monetary and quantitative terms. By the end of the first month of this year, Russians bought more than 48.1 thousand rapid tests in pharmacies for the amount of 106.9 million rubles. against about 10 thousand pieces in the amount of 17.79 million rubles. a year earlier, follows from the data of the analytical DSM Group.
Representatives of distributors of express tests in a conversation with RBC also drew attention to the increased demand in 2022. The portfolio of R-Pharm includes tests of predominantly Russian and Korean origin, the company said. Among them are both those that are intended for use by medical professionals in laboratories, and those that can be used by the patient on their own, at home. Now the company fixes the demand for tests for self-use.
At the end of January 2022, there was a serious increase in demand for express tests, Mikhail Stepanov, CEO of the Irvin pharmaceutical distributor, told RBC, before that there was a clear surge in June-July 2021. He explained that the company specializes in budget supplies, so the tests are intended for use by healthcare professionals. The company’s portfolio includes Russian, Chinese and South Korean manufacturers of test systems. Neither R-Pharm nor Irvine disclose absolute sales numbers.
Chulanov – RBC: It is naive to think that the evolution of COVID will stop on the omicron
Rapid tests are now used to a limited extent in medical institutions as a guide to decide which patient is in front of the doctor: with COVID-19, the flu or another disease, says Olga Malinovskaya, head of the medical department of the KDL medical laboratory network (there are no rapid tests in the network’s assortment . — RBC).
Tests for the coronavirus antigen are most informative at the early stage of the disease, when the concentration of the virus in the biomaterial is the highest, after one to two weeks from the onset of the clinical manifestations of the disease, a blood test for antibodies to SARS-CoV-2 will be more informative, RBC was told in the press service ” Invitro” (in the assortment of the network there is one express test of the Korean manufacturer. — RBC). The rapid antigen test is a good diagnostic tool, but the result is an indication, lasts for a short time and therefore cannot be used by the attending physician after a while, they say.
Does a rapid test give the status of a sick person?
Lawyers and experts interviewed by RBC agree that a positive rapid test result that a person received as a result of self-testing will not serve as an official confirmation of the diagnosis of COVID-19, since the status of rapid testing is still not defined by law. The law also does not provide for a mandatory course of action if the rapid test is positive.
Due to the fact that independent express testing is outside the legal field, a positive result does not impose an obligation to report it to a medical institution and register, draws attention to the lawyer, head of the Knyazev and Partners ICA Andrey Knyazev. In order to officially confirm the diagnosis, a person needs to contact a medical facility. Only on the basis of a clinical examination, anamnesis data and laboratory test results (PCR test) can a diagnosis of a “new coronavirus infection” be made.
Marina Kelbakh, a lawyer at the A-Pro Law Office, clarifies that even a rapid test made at the clinic during the initial examination and with symptoms of coronavirus will not be considered a confirmation of the diagnosis.
Coronavirus vaccination for teenagers: what you need to know
“The tests that the person himself acquired are of an informational nature, their results are not taken into account anywhere. This is similar to pharmacy pregnancy tests, when a woman sees a positive result, but the fact of pregnancy can only be established by a doctor at the appointment, ”explains Olga Malinovskaya, a representative of the KDL laboratories.
If a person does not have symptoms of SARS, influenza, coronavirus, or has mild symptoms and he has carried out an independent express test, he is advised to stay at home, call the unified service “122” or the clinic and report the test result and his health, summarizes Vladimir Chulanov.
How do regions feel about rapid tests
In the regions surveyed by RBC, the authorities are wary of the use of rapid tests at home.
- In St. Petersburg, only medical workers use express tests, and their use is not independently regulated by the Ministry of Health, RBC was told in the press service of the Health Committee, adding that there is no regulatory framework for such tests.
- The operational headquarters of the Sverdlovsk region told RBC that in the event of a positive rapid test for coronavirus, the patient must call a doctor at home and act in accordance with the recommendations of health workers. “Rospotrebnadzor receives information about cases of infectious diseases only from medical institutions,” they said.
- The press service of the Ministry of Health of the Nizhny Novgorod Region reported that rapid tests are guided by by letter Roszdravnadzor, which considers such tests screening and does not recommend for laboratory diagnostics.
Is it possible to get sick leave with a positive rapid test result
On the website Stopcoronavirus.rf said, that with a confirmed diagnosis of coronavirus infection, you do not need to come to the clinic – sick leave can be ordered by phone and delivered to your home. For its registration, you need to call the clinic or the hotline of the region. In a recently published memo Ministry of Health also is talkingXia that a certificate of incapacity for work can be obtained without violating self-isolation.
Open sick leave electronically urged employers and the governor of the Sverdlovsk region Evgeny Kuyvashev. Nevertheless, the Minister of Health of the Nizhny Novgorod Region, David Melik-Guseinov, informed in their social networks that it is still difficult to open a sick leave without a face-to-face visit to the doctor in the region. “A new federal order is being prepared to simplify this mechanism,” he assured.
How the authorities solve the problem of queues in clinics. Photo report
Possibility to apply for sick leave remotely appeared from the end of January in Moscow, after consultation with a doctor. In the case of SARS – for seven days, in case of detection of coronavirus and a positive PCR test – for 14 days.
As with a diagnosis, a positive COVID-19 test taken at home on its own will not be considered grounds for a sick leave, Kelbach notes. However, it can be opened after contacting the clinic or calling a doctor at home if the patient has symptoms of a respiratory disease.
Lawyer Andrei Knyazev agrees that only the date of the official diagnosis will be the starting point for the sick leave, but “not preliminary express testing.”