LLC «IMBIAN LAB» ООО «ИМБИАН ЛАБ»

Legal address: Юридический адрес:

630559, Novosibirsk Region, 630559,Новосибирская область,
Work settlement Koltsovo, Sadovaya st. 2/7, Р.П. Кольцово, ул. Садовая 2/7, этаж 2,
2nd floor, room 2. помещение 2.
De facto address: Фактический адрес:
630559, Novosibirsk Region, 630559,Новосибирская область,
Work settlement Koltsovo, Sadovaya st. 2/7 Р.П. Кольцово, ул. Садовая 2/7

What is SARS-CoV-2 and COVID-19

SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is the official name of the virus
that caused the COVID-19 epidemic. COVID-19 (coronavirus disease 2019 - coronavirus
disease 2019) is the name of the disease that a new type of coronavirus induces.
The source of transmission of SARS-CoV-2 infection is, in most cases, a sick person, including
those in the incubation period of the disease, which ranges from 2 to 14 (on average 5-7) days.
Clinical manifestations may be similar to nonspecific symptoms of acute respiratory viral
infections (fever, dry cough, difficulty breathing). Additional epidemiological signs - probable or
confirmed contact with COVID-19 patients, as well as manifestations in the form of pneumonia
with characteristic changes in the lungs according to computed tomography (CT) data - indicate
a high probability of COVID-19.
SARS-CoV-2 stimulates the humoral and cellular responses of the infected person's immune
system.
The humoral response is characterized by the
production of antibodies of IgM and IgG classes,
which are able to specifically recognize and bind
foreign proteins characteristic of the pathogen,
participating in the mechanisms of its neutralization
and removal. IgM antibodies appear first, a few days
after the onset of symptoms. IgG appears almost
simultaneously or soon after them (in more than half
of patients in the period 8-14 days from the onset of
clinical signs of infection, and in the period from 15
days or more - in 99% of patients). In terms of the
level and dynamics of the concentration of antibodies
in the blood, the humoral immune response varies
individually, including depending on the severity of the disease. The IgM level decreases to
undetectable, usually within up to one, less often - two months from the onset of the disease,
while IgG antibodies can persist in the blood for a long time (3-5 months or more), performing a
protective function.

What is RBD

When infected with the SARS-CoV-2 virus, antibodies are

produced to a greater extent to the nucleocapsid (N) protein (in
almost 100% of cases) and to the spike (S) protein of the
coronavirus (in about 20% of cases). This is due to the fact that
antibodies are produced to the S protein in the first days of
infection (incubation period), when the virus has not yet
penetrated into the cells of the body (1-2 weeks), and
antibodies to the N protein are produced during the active
introduction and attack of the virus (5 -6 weeks). Thus, the
production of antibodies to the S protein depends on how
strong the person's immunity is.
 The four structural proteins that the SARS-CoV-2 RNA encodes are spike
(S), envelope (E), nucleocapsid (N), and membrane (M). Structures that
protrude on the surface of the virus like spikes and give the virion a
similarity to the corona are formed by a spike (S) protein. The S-protein
consists of two subunits (S1 and S2). The nucleocapsid and spike
proteins induce the most pronounced antibody response during infection.
At the same time, the neutralizing activity of antibodies produced against
SARS-CoV-2 is predominantly correlated with antibodies to the S-protein
(which is the main target in vaccinology). On the S1 subunit of this
protein, there is a receptor-binding domain (RBD), which is able to tightly
bind to angiotensin-converting enzyme (ACE2) receptors located on cells
of various tissues, including the epithelium of the pulmonary alveoli. The
interaction of the RBD domain with ACE2 receptors is the initial stage of the introduction of the
virus into the cell. Antibodies that specifically bind to the RBD region of the S1 subunit of the
coronavirus spike protein are able to inhibit its binding to cellular receptors, providing a
pronounced neutralizing effect.

Test system for detecting protective antibodies in COVID-19 patients and

vaccinated "SARS-CoV-2 IgG RBD-IMBIAN-ELISA"

Since most of the registered and developed vaccines against SARS-CoV-2 target antibodies to
the S-protein, the determination of IgG antibodies to SARS-CoV-2 S-protein (RBD) can be an
informative method for assessing the presence and dynamics of the immune response to
vaccination.

Scope of the ANTI-RBD ANTIBODY analysis

1 Those who have had COVID-19 for the

presence of protective antibodies to the
RBD antigen SARS-CoV-2.
2 To assess the risk of re-infection and
determine the need for vaccination.
3 To control the formation of antibodies in
the post-vaccination period.
4 For selection of donors with the best
indicators of the content of "protective" anti-
RBD antibodies.

The effectiveness of this set of reagents was

confirmed in the study of the immune status
of patients after vaccination with the Sputnik
V vaccine.
What tests for antibodies are on the market today and what are their
differences

Nowadays, test systems are mainly present on the market to detect antibodies to the SARS-
CoV-2 antigen complex, which allow the detection of antibodies to coronavirus in patients who
have undergone COVID-19 and vaccinated with Sputnik V. However, not all antibodies to
SARS-CoV-2 are effective in the fight against COVID-19 and the above reagent kits do not
allow the identified antibodies to be divided into "useful" and "useless". Based on the results of
such studies, it is impossible to reliably judge the presence of "neutralizing" antibodies in
patients.

What is the difference between the new test for ANTI-RBD ANTIBODIES from
other tests for antibodies to coronavirus

Antibodies to antibodies - strife.

Studies aimed at finding mechanisms to combat coronavirus show that neutralizing ("beneficial")
antibodies are only against the RBD site, which is the domain of the S1 protein. Penetrating into
the body, the SARS-CoV-2 virus attacks cells with its spikes - Receptor-binding-domain (RBD),
which are responsible for the entry of the virus into the cell.

Anti-RBD antibodies block these parts of the virus and thereby neutralize the virus, preventing
SARS-CoV-2 from entering the cells of the human body. This principle of neutralizing the
coronavirus was used in the development of the Sputnik-V vaccine. At the same time, it was
revealed that anti-RBD antibodies are not produced in all COVID-19 patients - the necessary
antibodies can be produced by the human body after vaccination, however, the effectiveness of
vaccination and the presence of a protective titer of anti-RBD antibodies must be checked.

Advantages of using the SARS-CoV-2 IgG RBD-IMBIAN-ELISA test

- Determination of protective antibodies in patients who have been ill and vaccinated;
- Getting the result in 15-20 minutes;
- Ease of use;
- Includes everything you need to carry out the test;
- Does not require special equipment.

Interpretation of results

01. Positive

IgG antibodies to N-antigen were detected

Immunity is not protective: the patient has had the disease, but no neutralizing antibodies have been
detected.
02. Positive

IgG antibodies to RBD-antigen were detected.

Immunity is protective: the patient has had an illness or has been vaccinated.

03. Positive

IgG antibodies to N and RBD antigen were detected.

Immunity is protective: the patient has had an illness or has been vaccinated.

04. Negative

No antibodies detected.

05. The test is invalid

The testing should be repeated.

Expiration date 24 months.