Immunoenimen test systems "DS-IFA-HBEAG" and "DS-IFA-Anti-HBE. Analysis on syphilis

For a comprehensive assessment of the state of the body, an IFA method of diagnostics is applied. An immunoferment blood test is intended to diagnose infectious, hematological, primary and secondary immunodeficiency.

What is an IFA analysis

Many patients are interested in the IFA method: what is it for which a study is carried out. An immununimal analysis began to be used relatively recently. Initially, antigenic structures were studied with it, and it was carried out only for scientific purposes. Then scientists came to the conclusion that with the help of enzymes, specific antibodies arising in response to the occurrence of the disease can be identified.

Initially, this technique was used only by narrow-profile medical institutions, mainly at blood transfusion stations. Of particular importance is the ELISA method for detecting HIV infection.

To date, this method has a wide scope of application. Modern laboratories use it to diagnose:

• tumors;
• hormonal disorders;
• infections;
• chronic or previously transferred infectious processes;
• helmintes.

If an infectious process proceeds in the body, then this type of diagnosis is considered the most optimal to determine the type of disease.

The essence of the method and its types

The IFA method is what it is, what is the essence of this type of study? This and many other questions are interested in patients. The basis of this method of diagnosis is the binding of the body's immune cells with antigens of causative agents of infection. The resulting complex is determined using a special enzyme.

To understand the principle of the ELISA method, you need to know how the antigen antibody reaction is. The antigen is alien for the body of a molecule of protein origin, which penetrates along with infection. Particles of someone else's blood, inconsistent with the group, are also considered antigens. In the body, they provoke an immune response aimed at protecting against alien substances. Therefore, the human body produces antibodies - immunoglobulins that can join antigens, forming an immune complex. Such compounds are much easier to recognize and destroyed by cells of immunity.

The reaction to the presence of such immune complexes is carried out in laboratory conditions, applying ready-made connections to determine whether they are in the blood like them.

The essence of the IFA method is quite simple, however, due to the fact that the blood test is carried out to identify many infections and diseases, there are several types of its varieties. Each is distinguished by the implementation scheme and the application area. May be straight or indirect ELISA. The direct method involves the fact that immobilized antibodies react with antigens are used. The main advantage of this method is that all processes can be automated, and therefore the diagnosis takes a little time.

The indirect method implies that the antibodies of a secondary nature are used. And on the solid phase is immobilized by the antigen. The analysis allows you to identify antibodies to various antigens. It helps to achieve a more accurate result, but the method is characterized by complexity.

Benefits of research

The IFA method has many advantages in comparison with other diagnostic methods. The main one can attribute such:

• high sensitivity;
• stability when storing ingredients;
• diagnostic speed;
• you can use a small amount of material under study;
• there is the ability to automate all processes;
• you can identify infection in the earliest stages.

This diagnostic method is universal, therefore suitable for conducting a mass examination. With the help of the analysis, it is possible to trace the dynamics of the infectious process.

Indications for analysis and fence

Conducting research using the IFA method can be assigned in suspected many diseases:

Venous blood is investigated for antibodies. Before analyzing it, elements that may complicate the study are distinguished from it. There may be fence and other biological fluids.

To get the most accurate information, blood fence is carried out on an empty stomach. If the procedure has been appointed to determine the hidden infection, then a few weeks before the analysis, it is necessary to stop taking antibacterial and antiviral drugs. Depending on the equipment of the laboratory, where the material was taken, the result can be obtained during the day. In emergency cases, this time is reduced to several hours.

Analysis on syphilis

The use of the IFA method helps to determine the presence of many infections in the body, in particular syphilis. For the study, blood is taken from Vienna on an empty stomach. Then a study is carried out to help determine not only the presence of a disease in the body, but also the exact time of its start, since during the disease, some antibodies are replaced by others in a strictly defined order.

Under the acute phase, indicating the prolonged course of the disease, or with the exacerbation of chronic infection in the blood, immunoglobulins of the type M will be detected. The presence of type A immunoglobulins indicates that infection inhabits in the body of more than 4 weeks. The immunoglobulins of the Group G are talking about the height of the disease or the previously performed therapy.

According to the degree of color of the wells, the intensity of the infectious process is estimated, since its saturation depends on the number of generic immune complexes.

HIV analysis

The IFA method applies to the analysis on this case, has certain features that are associated with the flow and progression of the disease. This research method is considered to be the most acceptable to determine, but it is necessary to conduct it no earlier than a month after the impact of risk factors. This is due to the presence of an incubation period occurring from 45 days and up to 6 months. That is why the analysis must be repeated in six months.

• ascaridosis;
• giardiasis;
• toxoplasmosis, etc.

Despite all the advantages, there are also disadvantages of the IFA method. The main disadvantage is that during the study, the doctor should have a predetermination of the disease.

If it is not possible to accidentally find the pathogen and determine its immunoferment properties. The test only indicates the presence of antibodies in the blood of the patient. In addition, it is quite expensive analysis.

Deciphering Analysis

The result of high-quality ELISA will be either the presence of antibodies, or their absence in the blood. If a quantitative analysis is performed, the concentration of antibodies can be expressed in a digital value, or in a certain number of signs +.

In addition, indicators are analyzed as:

IGM indicator indicates the flow of an acute infectious process in the body. His complete absence can talk about the absence of a causative agent of the disease or transition to it in chronic staging.

An IGA indicator with a negative result of the IGM test indicates a chronic or hidden infection. The simultaneous presence of IGM and IGA indicates that the disease is in acute stage. The presence of IgG speaks of the transition of the disease into a chronic stage or the full recovery and development of immunity.

Now there are special tests of the ELISA that can be conducted independently.

RU 2515051 patent owners:

The invention relates to the field of biotechnology and medicine. An immununimal test system for determining the likely time of infection of a type of type 1 immunodeficiency virus (HIV-1), including the HIV-1 group O, in serum (plasma) of human blood. The test system includes an immunosorbent based on human immunodeficiency virus-type virus (ENV HIV-1 and HIV-1 group O), a solution for dilution of samples (RRS) and detecting reagents (conjugates, chromogen / substrate). The invention also relates to a method for determining the probable deadlines for infection with a type of type 1 immunodeficiency (HIV-1), including the HIV-1 of the group o, in serum (plasma) of a person by testing the serum of the patient with the help of the described immunoferment test system. The invention allows you to quickly and easily identify the likely deadlines for HIV infection. 2 N.P. F-lies, 4 tab., 2 pr.

The invention relates to the field of biotechnology and medicine. And it can be used to determine the likely deadlines for infection with a type of type 1 immunodeficiency virus (HIV-1), including HIV-1 of the group O, in serum (plasma) of human blood.

The spread of HIV infection remains a real problem. modern Mira. Since timely and high-quality diagnosis is a real means to reduce the range of spread of HIV infection, the development of an effective test system capable of determining the likely life of infection is an important task of modern society.

Analysis of the prior art showed the existence of a number of methods and tests proposed by different authors to determine the stages of HIV infection using various methods. It is known, for example, a molecular genetic test based on the determination of the viral load of peripheral blood by the polymerase chain reaction method (PCR) (Kravchenko A.V., Serebrovskaya L.V., Golokhvostova E.L. and others. Timazid in combination with Hivid Inwhase in the complex therapy of patients with HIV infection. - Epidemiology and infectious diseases. - 1998. - №5 - p.51-52). There is a method of assessing the stages of HIV infection (clinical immunology and allergology ed. G.Lolora junior. - M.: Practice, 2000. - S.585-587), which consists in determining the level of serum β 2 -imkroglobulin. The method of diagnosing the stages of HIV infection is described (V.Pokrovsky et al. " Clinical diagnostics and treatment of HIV infection. "- M.: GOU WONMTS RF, 2001. - C.11), which consists in determining the absolute number of CD4 + peripheral blood lymphocytes. Also known is a method for diagnosing the stages of HIV infection, based on the fact that The patient's serum by the method of immununimenal analysis (ELISA) determines the optical density (OP) of the original serum sample, reflecting the level of HIV-specific antibodies, and the OP of the original serum sample incubated for 10 minutes from 100 μl of 3.5 M sodium isothiocyonate solution. When declining op 40% and less diagnosed stage A - generalized lymphadenopathy, with a decrease in OP in the range of 40-60% - the stage of Bacillalar Angiomanation, orofarenucleon candidiasis, etc., and with a decrease in OD by 60% and more - the stage C - AIDS (RU 2251701).

Thus, the analysis of the prior art showed that none of the existing sources can serve as the closest analogue to the claimed invention, since all these documents relate to methods and tests determining the stage of HIV infection, and none of the sources described contains technical Decisions aimed at determining the likely time interval of infection. The claimed invention relates to a test system that determines the likely time to infect HIV infection. Analysis of the prior art did not reveal similar solutions aimed at solving the task.

In the present invention, a set of reagents "DS-IFA-HIV-AT-Time" reagents are declared to determine the likely deadlines for infection with a type of human immunodeficiency (HIV-1), including HIV-1 of the group O, in serum (plasma) of human blood. The test is designed for additional studies of HIV-positive samples with a confirmed positive result in the immune blot. It is possible to study samples with an indefinite or negative result of the study in the immune blot, which confirmed the presence of HIV RNA and / or antigen P24 HIV-1.

In the present invention, it is also a method for using this set of DS-IFA-HIV-AT-Dale reagents to determine the likely time of infection with a type of type 1 immunodeficiency virus (HIV-1), including HIV-1 group O, serum (plasma ) Human blood.

The technical result of the claimed invention is to determine the probable deadlines for infection with the human immunodeficiency virus (HIV-1), including the HIV-1 group of O, simplicity of the test, which allows the application of the claimed invention for the epidemiological surveillance over the dynamics of the spread of HIV infection, during the dynamics Detection of seroconverters in a certain population (polo-age, social population), as well as in the epidemiological investigation of cases and foci of HIV infection.

The essence of the proposed technical solution is that the definition of a probable term of infection of HIV-1 is carried out using a test system, which includes an immunosorbent based on human immunodeficiency virus (ENV HIV-1 and HIV-1 group O), mortar for breeding Samples (RRS) and detecting reagents (conjugates, chromogen / substrate). The studied samples are tested by native and divorced in the solution for sampling. According to the results of testing, the samples are divided into "early" and "late". "Early" samples - the likely life of infection up to 9 months from the moment of infection, the "Late" samples is the likely time of infection 9 or more months from the moment of infection. The belonging of the sample to the "early" or "late" is estimated on the percentage of the inclusion of the optical density (OP) of the diluted sample relative to the undiluted.

These examples serve to illustrate specific embodiments of the invention and are not aimed at narrowing the rights of the applicant. Under the scope of the applicant's rights, all possible embodiments of the invention fall, including those not specified in this section.

As an immunosorbent, recombinant antigens containing immunodominant regions of ENV HIV-1 and HIV-1 group O. Conjugate-1 is a mixture of recombinant antigens GP41 HIV-1 and GP41 HIV-1 conjugated groups conjugated with biotin. At the first stage, the studied samples, control samples and their dilution 1: 101, as well as the PPCs are incubated with conjugate-1. Specific antibodies present in the studied and control positive samples are binding to antigens sorbed into the microplate wells, and antigens conjugated with biotin, and form stable complexes. Excess samples and conjugate-1 is removed when washing. At the next stage, streptavidine conjugated with horseradish peroxidase (conjugate-2) is added to the wells. Conjugate-2 binds to a complex of antigen antibody antigen present in the well. Excess conjugate-2 is removed by washing, and then chromogen / substrate is added to the wells. In the wells with a tied conjugate-2, blue staining is developing, which is replaced by yellow when adding a stop solution. Accounting results are carried out using a spectrophotometer.

As an immunosorbent, recombinant antigens containing immunodominant regions of ENV HIV-1 and HIV-1 group O. are used by one conjugate - a mixture of recombinant GP41 antigens HIV-1 and GP41 HIV-1 groups conjugated with horseradish peroxidase. In the process of analysis, the samples, controls and their dilutions, as well as the RRS incubate with the conjugate in the antigen coated wells of the tablet. The resulting steady complex after removing the excess of the sample and the conjugate is manifested by adding chromogen / substrate. At the same time, blue staining is developing, which is replaced by yellow when adding a stop solution. Accounting results are carried out using a spectrophotometer.

The belonging to the samples under study to the "early" or "late" is estimated by% of the fall of the OP in the dilution of the sample, which is calculated by the formula:

% P A D E N E O P \u003d 100% - O P R A Z C A - O P S R. R r s o p c E l n o g o o b r a zc a × 100%

where OPS PRS is the average value of the PPP (calculated by several values \u200b\u200bof the PPP).

The studied samples are regarded as "early": if the fall of OP\u003e 40%.

The studied samples are regarded as "Late": if the fall is OP≤40%.

An example of calculating the% fall in the OD during sample dilution is given in Table 1.

For accounting and processing results, it is convenient to use the Excel program. The use of this application will allow calculations automatically. A program for processing test results is located on a disk applied to the set, or it can be found on the company's website.

When developing and evaluating the test, samples of seroconversion panels (BBI, Inc., Zeptometrix, USA) and HIV-positive blood serum (plasma) samples (plasma) were used with the probable diagram of infection. The likelihood of properly determining the limitation of infection with a type of human-type immunodeficiency (HIV-1), including the HIV-1 group of the on-serving panels, is 100% (the data is presented in Table 2), according to sera samples of persons with a conditionally established period of infection (n \u003d 129) is 94% (Tables 3, 4; data are partially shown).

In the test "DS-IFA-HIV-AT-Time", the possibility of studying serum samples (plasma) of blood containing antibodies to HIV-1 different subtypes, including HIV-1 group O: Reference panel QCS 42-28-327 -03p (HIS) (subtype A, B, C) (with the exception of sample No. 24 containing antibodies to HIV-2), 1st International Reference Panel Anti HIV (NIBSC Code: 02/210) (Subtype A, B, C, E) (with the exception of sample No. 5 containing antibodies to HIV-2), serum samples (plasma) of blood containing antibodies to HIV-1 group O (No. 1342, K00175, K00259; Biomex). The results indicate the possibility of studying samples of serum (plasma) of blood containing antibodies to HIV-1, belonging to various subtypes, including the HIV-1 group O, in the DS-IFA-HIV-AT term test.

The specificity of the recruitment set "DS-IFA-HIV-AT-term" was determined in the study of serum samples donor blood (n \u003d 352) who demonstrated a negative result in IFA. Specificity was 100%. Additionally, 255 serum samples were tested (negative in ELISA):

■ 167 serum samples from pregnant women and patients with infectious diseases;

■ 128 serum samples from patients with different non-infectious diseases.

Specificity was 100%.

The data obtained show the high efficiency of the developed test system "DS-IFA-HIV-AT-Time" when determining the likely deadlines for the type of human immunodeficiency virus (HIV-1), including HIV-1 group O, serum (plasma) human blood.

1. Immuno-immunimal test system to determine the likely time of infection of the type of type 1 immunodeficiency virus (HIV-1), including HIV-1 group O, in serum (plasma) of human blood, characterized in that it includes an immunosorbent based on virus antigens Human immunodeficiency type 1 (ENV HIV-1 and HIV-1 group O), sample dilution solution (RRS) and detecting reagents that are conjugates, chromogen / substrate.

2. A method for determining the likely deadlines for infection of the type of type 1 immunodeficiency virus (HIV-1), including HIV-1 group O, in serum (plasma) of a person, based on different antibody content, depending on the rate of infection, including the separation of the sample into two parts and breeding one of them; The study of both (native and diluted) parts of the sample of the serum of the patient with the help of an immunoferment test system described in claim 1; determination of the optical density (OP) of native and diluted samples and RRS; The calculation of the average value of the OP RRS; Calculating the percentage of the fall of the OP Diplocked Sample relative to the undiluted according to the formula
% P A D E N E O P \u003d 100% - O P R A Z C A - O P S R. R r s o p c E l n o g o o b r a zc a × 100%
in this case, the probable term of infection is regarded as "early", if the fall of OP\u003e 40%, and as "late" - if the fall of op≤40%.

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A.P. Obdatin, T.I. Ulanova
LLC "Scientific and Production Association" Diagnostic Systems ",

Nizhny Novgorod
Immunoenimen test systems "DS-IFA-HBEAG" and "DS-IFA-Anti-HBE" for specific diagnosis and prediction of the outcomes of acute and chronic hepatitis in
Hepatitis B - viral infectionCharacterized by heavy

inflammatory lesion of the liver. About 1% of lethal outcomes is observed in

a sharp period of illness, in 4-10% of cases there is a transformation into chronic

process with possible formation in the subsequent liver cirrhosis and primary

hepatocarcinoma.

Despite the tendency to reduce the incidence of acute hepatitis B, a group of patients who first raised the diagnosis of chronic viral hepatitis, as well as a group of pathogen carriers for the first time, was continued to form. An unfavorable prognosis is maintained associated with the high incidence of hepatitis in the population of reproductive age, as well as among adolescents.

Therefore, the issues of treatment, prevention and diagnosis of hepatitis V. Currently, the methods of immununimal analysis are widely used to detect the markers of this infection. The most important serological markers of HBV include E-antigen (HBEAG) and E-antigen antibodies (anti-HBE). Hbeag is associated with a high blood infection, indicating the active replication of the hepatitis B virus (HBV). It has been established that high HBEAG titers correspond to high DNA polymerase activity and are always combined with the detection of complete particles of Dane. In case of serum containing Hbeag, in the blood of a healthy person, the danger of infection for many orders is higher than after the occurrence of seroconversion.

When acute hepatitis in HBEAG is found in the blood in the early stages of the infectious process at first clinical manifestations Diseases, lagging behind the week from the appearance of HBsag. Acute hepatitis B (OGA) cyclic flow is characterized by a short-term circulation of HBEAG. Soon, for 2-3 weeks of the jaundice period, anti-HBE appear, which allows predicting the favorable outcome of the disease.

Anti-HBE circulate in the blood for 2-5 years, less often a few months.

HBEAG anthbe seroconversion occurrence marks a sharp decline in activity

infectious process. The discovery of HBEAG in the blood of patients after 2 months of the disease denotes the chronization of the pathological process. In this case, anti-HBE can be formed after many years after the appearance of antibodies to HBCag or not to detect.

The appearance of anti-HBE may have unfavorable prognostic value in

acute period of HBV in severe forms, which corresponds to mutation in the Pre-Core zone with

education HBV "E-" strain.

Purpose This work was the development of highly sensitive and specific

envuno-immunimal test systems for the detection of HBEAG and anti-HBE and evaluation of their main characteristics.

Materials and methods.

1. Immuno-confinement test system "DS-IFA-HBEAG". The current beginning of the test

they are polyclonal goat antibodies to recombinant HBEAG, the production of NGOs "Diagnostic Systems", Nizhny Novgorod, sorbed onto the solid phase, and a conjugate, which is polyclonal goat antibodies to recombinant HBEAG, labeled Hren peroxidase, manufactured by NGO "Diagnostic Systems", Nizhny Novgorod. The analysis scheme is a single-sided "sandwich". The duration of the reaction is 1.5 hours. Serum sample is analyzed undressed.

2. Immuno enzyme test system "DS-IFA-Anti-HBE". The test of the test is made

recombinant HBEAG (AHBV 102), Production of NGOs "Diagnostic Systems",

Nizhny Novgorod, sorbed on solid phase and anti-IgG conjugate with horseradish peroxidase, production "Sorbent Service", Moscow. The reaction takes place in two stages. The immobilized antigen is added to the studied serum in dilution 1/10 and, after incubation and removal of non-contacted components, the detection of specific immunocomplexes are detected using mouse monoclonal antibodies against human IgG labeled chrine peroxidase.

3. 2178 serum samples were used to evaluate the developed test systems.

blood. Of these, 480 samples of serum healthy donors. 1680 samples are represented

samples of blood serum containing various markers of Hepatitis V. virus

Eighteen samples were obtained in dynamics from patients with a clinical diagnosis "acute viral hepatitis B". Previously, all samples were checked for HBSAG, HBEAG, anti-HBE, anti-HBC using test systems for NGO Diagnostic Systems, Nizhny Novgorod: "IFA-NVSAG / M", "DS-IFA-NVAG", " DS-IFA anti-HBE, "IFA-Anti-NVS".

4. A comparative assessment of the developed test systems was carried out using

commercial preparation "Monolisa HBE", produced by Bio-Rad, France;

Results and discussion.In NGOs, "Diagnostic Systems" developed 2 new diagnostics: "DS-IFA-HBEAG" and "DS-IFA-Anti-HBE". The test system "DS-IFA-HBEAG" is designed to detect the E-antigen of the hepatitis V virus in serum (plasma) of the blood of people by the method of immununimenal analysis and can be used for specific diagnostics, determining the activity of the infectious process, predicting the severity and expenditure of hepatitis V.

The test system "DS-IFA-Anti-HBE" is designed to identify the IgG class antibodies to the E-antigen of the hepatitis B virus in serum (plasma) of human blood and may be

used in the forecast of the course of the infectious process and control of the therapy under Hepatitis V.

To study the specificity of new tests, distribution was carried out

optical density (OP) serum samples containing and not containing

NVEG or anti-low. Samples of blood serums of healthy donors and blood serum samples selected by various hepatitis virus markers were used.

blood transfusion stations. The results of the study showed a reliable separation of two populations. The values \u200b\u200bof the OP samples that do not contain NWEG are fluidated in the range from 0.011 to 0.111, and the main peak of serum samples containing NWEG was in the range from 2.186 to 3.186 (Figure 1A).

Fig.1a. The distribution of OP samples of serum containing and not containingHbeag in the test system "DS-IFAHbeag»
The peak corresponding to a group of serum with a low OD (0.3-0.6) is likely to be serum samples selected in the early stages of the infectious process.

Already in the incubation period, patients are naturally registered in the NVSAG and NVAG blood, which confirms their potential epidemiological hazard.

The range of optical density of serum serum non-anti-nve

it was in the range from 0.002 to 0.122, and the main peak of OP samples of serum containing anti-HVE was in the range of 2.431 to 3.231 (Figure 1B).

Fig. 1b. The distribution of OP samples of serum containing and not containing anti-nBE., in the test system "DS-IFA-AntiHbeag»
The features of the distribution of op anti-low of positive samples were studied

serum containing ( n.\u003d 78) and not containing HBSAG ( n.=56).


Fig. 2a. HBE.-poble serum samples containingHbsag. in the test system "DS-IFA-AntiHBE.».

Fig.2b. Features of the distribution of op antiHBE.- positive samples of serum not containing Hbsag. in the test system "DS-IFA-AntiHBE.».
Optical density of 87% of anti-HBE-positive samples of serum serums that do not contain HBSAG were in the range from 0.41 to 0.81 (Figure 2B). At the same time, only 14% of anti-HBE-positive samples of serum containing HBSAG, OP was in this range (Figure 2a). It is known that in the phase of late reconvalues, with a negative reactivity on HVSAG, it is gradually a decrease in antibody titers to NBEAG (Figure 2B). Therefore, it is possible that the advantageous concentration of anti-nve-positive samples corresponded to the OP is less than 0.8.

The data obtained indicate the reliability of the separation of positive and

negative serum samples regardless of the disease stage. The study of the sensitivity and specificity of the test systems "DS-IFA-HBEAG" and "DS-IFA-Anti-Hbeag" was carried out in comparison with the test "Monolisa HBE" ("Biorad", France) (Table 1).

Table 1
Comparative characteristics of sensitivity and specificity

dS-IFA-HTEAG and DS-IFA-AnthB test systems

The data shown in Table 1 shows a 100% coincidence of the results.

It is known that additional prognostic value is the combined indication of the NTAG and Anti-NVE, especially their quantitative assessment. The rapid increase in anti-NVA titer characterizes an active humoral immune response and practically eliminates the threat of chronic. We analyzed the change in the content of NveAg / Anti-HVE in samples of blood serum patients with a clinical diagnosis "acute viral hepatitis B" (Table 2).

table 2
Dynamics of Seroconversion of NveAg / Anti-HVE in patients

* from entering the hospital
All serum samples were investigated for serological markers.

OGE: NVSAG, anti-NVS, anti-NVS IGM. The observation period varied from 13 to 38 days. Patients number 1, №2 and №6 anti-NVE found already on the background of a decrease in the NVEA titer. In patients number 3 and №4, Anti-HVE appeared after the disappearance of NVEG serum 21 and 8 days, respectively. Analysis of the detection of NVEG in the serum of the patient No. 5 during admission to the hospital showed a negative result. At the same time, conversion was registered on Anti-Nve on the first day of the survey.

All the examinations traced the trend towards an increase in antibody titer to the NVEG in

blood serum, which allows you to predict the favorable clinical dynamics

manifestations of the OGV and a quick recovery.

The study of the new test system has shown their high diagnostic reliability. The results of the comparison of DS-IFA-HBEAG "and" DS-IFA-Anthbe "showed a 100% coincidence with the Monolisa HBE test.

In the study of samples of sera patients with hepatitis in dynamics, tests

confirmed high sensitivity and specificity.

A short time of incubation of the studied samples and conjugate (1 h) allows you to determine the correct tactics of the holding in the minimum time medical events. Created test systems are convenient in the formulation, economical (50 μl of serum is required to determine HBEAG and 10 μl of serum to determine the anti-HBE). High quality characteristics of tests allow you to successfully use them in the forecast of the flow of the infectious process and control the therapy under Hepatitis V.
LITERATURE

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3.Sinson S.N. Viral hepatitis / S.N.Sorinson. - St. Petersburg, Tseza, 1997.- 306 S.

4. Baumeister M. Hepatitis B Virus E Antigen Specific Epitopes and Limitations of Commercial Anti-HBE Immunoassays / M. Baumeister // Journal of Medical Virology.- 2000.-N 60.- R.256-263.

5.Kane M. Global Program for Control of Hepatitis B Infection / M. Kane // Vaccine. - 1995.-N131 (Suppl. 1). - R.47-6. Shunichi Sat.about. Hepatitis B Virus Strains with Mutations in the Core Promoter in Patients with Fulminant Hepatitis / Shunichi Sato, Kazuyuki Suzuki // Annals of Internal Medicine. - 1995.- N122.- R.241-248.

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Published: J. "Clinical laboratory diagnostics"- 2005.-№6-S.-34-37