[The capacities of current test systems to verify early HIV infection].

The purpose of the present investigation was to comparatively evaluate the performance characteristics of the test systems designed to verify the positive results of screening survey for HIV infection, such as the solid-phase immunoassay DS-EIA-HIV-AB/AG-SPECTR (Diagnosticheskiye Sistemy (Diagnostic Systems) Research-and-Production Association, Nizhni Novgorod) and tests based on immune blotting (IB). The investigation examined 15 seroconversion panels produced by ZeptoMetrix (USA) and BBI (USA). The use of the DS-EIA-HIV-AB/AG-SPECTR test system determined 88 of the 167 seroconversion panels as HIV positive. The IB-based tests revealed only 45 of the 167 samples as positive. Consequently, the application of the DS-EIA-HIV-AB/AG-SPECTR test system is more effective than the IB-based tests in early HIV infection.

[Vitaherpavac is the first Russian herpes simplex virus vaccine obtained on the Vero B continuous cell line].

Vitaherpavac, a dry inactivated herpes simplex virus (HSV) culture vaccine, has been obtained, by using the Vero B continuous cell line as a substrate for accumulation of herpes simplex virus types 1 (US strain) and 2 (VN strain). Vitaherpavac and the similar vaccine Herpovax made by the Research Institute of Vaccines and Sera, Saint Petersburg (for which preparation a primary trypsinized chick embryo cell culture used as a substrate for accumulation of HSV types 1 and 2), underwent comparative clinical trials. The tolerability and therapeutic effectiveness of the vaccine were tested in patients diagnosed as having chronic frequently recurring herpes. The trials have yielded positive results that suggest that it is expedient to introduce of the new vaccine Vitaherpavac into practice to treat chronic recurrent herpetic infection of various localizations. Vitaherpavac has been registered in the Russian Federation and permitted for medical application.

[Vaccines, immunoglobulins, and test systems for the prevention and diagnosis of tick-borne encephalitis].

The quality of drugs used in the Russian Federation to prevent and diagnose tick-borne encephalitis (TBE) was analyzed. The TBE vaccines made in Russian were shown to be as effective as those manufactured in foreign countries and to have the similar production techniques and quality indices therefore they may be interchangeable in the population's vaccination. The specific activity of has recently increased in terms of the content of TBE virus antibodies. In Russia, a wide range of enzyme immunoassay systems have been designed and manufactured for the detection of human serum (plasma) IgM and IgG antibodies to TVE virus and for that of TBE viral antigen in the biological objects, primarily in the ticks.

[ELISA and PCR test systems used to detect Crimean-Congo hemorrhagic fever virus].

Studying the sensitivity and specificity of enzyme-linked immunosorbent assay (ELISA) for the indication of Crimean-Congo hemorrhagic fever (CCHF) virus antigens and those of reverse transcription and polymerase chain reaction (RT-PCR) for the detection of CCHF virus RNA, and those of a intercerebral infection method in newborn albino mice systems for the determination of viral infectious activity established that the sensitivity of ELISA was 1-2 orders of magnitude less than that of RP-PCR. The latter proved to be better in studying the sera sampled from patients with CCHF. The results of studying the samples of H. marginatum ticks, the CCHF virus vectors by ELISA and RT-PCR were similar.

[Comparative study of hemostasis and cytokine production in experimental Dengue virus infection].

Some parameters of hemostasis and cytokine production during the fatal and nonfatal course of experimental human versus murine infection caused by Dengue virus (DV) were studied. Its lethal dose administration induced a rapid development of anemia, thrombocytopenia and a change in packed cell volume. These changes were not so profound in the nonfatal group of infected mice. There was an excess production of both proinflammatory (TNF-alpha, IL-1beta) and anti-inflammatory (IL-6, IL-10) cytokines in the fatal group. In mice of this group, the early rise of IFN-gamma and IL-12 corresponded to the parameters observed in patients with severe forms of DV infection. The findings provide evidence that the proposed model may be used for the experimental study of the immunopathogenesis of the disease.

[Immune response in vaccinated and non-vaccinated mice infected with tick-borne encephalitis virus].

The paper deals with an investigation of an immune response in BALB/c mice immunized with tick-borne encephalitis (TBE) vaccine and infected with TBE virus and in non-immunized mice. The parameters of specific humoral (IgG and IgM) and cellular (gamma-interferon (IFN) and cell proliferation) immunities and the activity of cytokines (necrosis tumor factor-alpha, interleukin (IL)-1beta, IL-2, IL-6, IL-10, and IL-12) were studied. There were significant differences in the specific and nonspecific immune response of immunized and non-immunized animals. Noteworthy is the difference in the time course of changes in the levels of IL-6, IL-2, IL-12, and gamma-IFN in the immunized and non-immunized animals.

[Adaptation of different modifications of enzyme immunoassay and immune blot assay to assess the candidate vaccine HIVREPOL against HIV/AIDS].

A preclinical trial of the vaccine HIVREPOL provided a complex of methods for assessing the identity and specific activity of vaccines against HIVIAIDS. The identity of "HIVREPOL" has been assessed by indirect enzyme immunoassay (EIA): the vaccine specifically binds the antibodies of the sera from HIV-infected individuals. Immune blot assay was the most informative method for assessing the identity of the candidate vaccine. The sera from HIVREPOL-vaccinated mice recognized the proteins gp41, p24, p55 of cultured HIV1 on "New-Lay-Blot1" strips. The bands corresponding to p24 were revealed in the line blots "Blot-HIV-1/2+O" and "INNO-LIA-HIV-Confirmation". The specific activity of the HIVREPOL vaccine was confirmed from the reactivity of sera of the mice vaccinated with recombinant proteins of the immunosorbents available in EIA test systems for the detection of HIV antibodies. Competitive EIA established the antigen-binding activity of sera from HIVREPOL-vaccinated mice against the native reference HIV-1 antigen.

[Preparations for serodiagnosis of diseases due to causative agents of ixode tick-borne Borreliosis (Lyme disease). Communication 2. Comparative study of recombinant enzyme immunoassay test-systems (rELISA) for serological diagnosis of ixode tick-borne Borreliosis]. / Preparaty dlia serodiagnostiki zabolevanii, vyzyvaemykh vozbuditeliami iksodovykh kleshchevykh borreliozov (bolezn' Laima). Soobshchenie 2. Sravnitel'naia otsenka rekombinantnykh immunofermentnykh test-sistem (rELISA), ispol'zuemykh v serodiagnostike iksodovykh kleshchevykh borreliozov.

One foreign and two Russian recombinant enzyme immunoassay test-systems were comparatively investigated under conditions of an encoded experiment. Sensitivity in the experiment with the Russian test-systems Borreliosis-ELISA-IgG and Lyme Best was 63.8 and 68.8% respectively. As for the test-system Borrelia IgG Recombinant, it was 47.5%. All the test-systems were highly specific (94.4 to 99.5%). The test-systems Lyme Best and Borrelia IgG Recombinant revealed partial cross reactions with sera from patients with systemic lupus erythematosus and leptospirosis.

[Preparations for serodiagnosis of diseases due to causative agents of ixodes tick-borne borreliosis (Lyme disease). Communication 3. Comparative study of enzyme immunoassay test-systems for detection of IgM to Borrelia burgdorferi sensu lato]. / Preparaty dlia serodiagnostiki zabolevanii, vyzyvaemykh vozbuditeliami iksodovykh kleshchevykh borreliozov (bolezn' Laima). Soobshchenie 3. Sravnitel'noe izuchenie immunofermentnykh test-sistem, ispol'zuemykh dlia vyiavlenia IgM k Borrelia burgdorferi sensu lato.

Three foreign and one Russian ELISA test-systems for detection of IgM to Borrelia burgdorferi sensu lato were comparatively studied with the use of the clinical material in an encoded experiment. In the foreign ELISA test-systems based on the use of native antigens of borrelia, cross reactions with sera from patients with syphilis, Epstein-Barr infection, cytomegalovirus infection and systemic lupus erythematosus were detected. The Russian recombinant ELISA test-system Borreliosis-ELISA-IgM showed high sensitivity and specificity. The simultaneous use of the test-systems for detecting IgG and IgM significantly increased the efficacy of diagnosis of early borreliosis.

[Preparations for serodiagnosis of diseases due to causative agents of ixode tick-borne borreliosis (Lyme disease). Communication 1. Comparative study of the 1st generation enzyme immunoassay test-systems for detection of antibodies to Borrelia burkdorferi sensu lato]. / Preparaty dlia serodiagnostiki zabolevanii, vyzyvaemykh vozbuditeliami iksodovykh kleshchevykh borreliozov (bolezn' Laima). Soobshchenie!. cravnitel'noe izuchenie immunofermantnikh test sistem 1 pokoleniia, napravlennikh na vyiavlenie antitel k Borrelia burgdorferi sensu lato.

Four foreign and one Russian 1st generation test-systems for detecting class G antibodies or summary antibodies to Borrelia burkdorferi sensu lato were comparitively investigated with the use of the clinical material under conditions of an encoded experiment. Cross reactions with sera from patients with syphilis, Epstein-Barr infection, cytomegalovirus infection and systemic lupus erythematosus were observed. The best specificity and sensitivity parameters were provided by the Enzygnost Borreliosis test-system.

[Activity of cytokines in immunization with a vaccine against experimental tick-borne encephalitis]. / Aktivnost' tsitokinov pri immunizatsii vaktsinoi protiv kleshchevogo éntsefalita v éksperimente.

An experimental double immunization of BALB/c mice with a vaccine against tick-borne encephalitis was accompanied by the production of IL-1b, IL-2, IL-4, IL-6, IL-10, IL-12, TNFa and gamma-IFN in the blood serum of animals. After the first immunization of animals with the vaccine against tick-borne encephalitis, the activity of cytokine was indicative of an activation of macrophages as well as of an activation and differentiation of T- and B-lymphocytes. After the second immunization and unlike the first one, there were changes in the production only of IL-10, IL-12 and gamma-IFN, which can be indicative of a regulation of balance between Th1 and Th2.

[Evaluation of the first domestic immunoenzyme recombinant test-system "Khlami-IGA-DS-Tr" for detection of class A antibodies to Chlamydia trachomatis]. / Otsenka pervoi otechestvennoi immunofermentnoi rekombinantnoi test-sistemy "Khlami-IGA-DS-Tr" dlia vyiavleniia antitel klassa A k Chlamydia trachomatis.

A test system for detecting species-specific class A antibodies to Chlamydia trachomatis, making use of recombinant chlamydial antigen, is developed in Russia for the first time. Its efficiency was demonstrated in blind clinical trials. The sensitivity, specificity, activity, and use of Chlamy-IgA-DC-Tr test system are not inferior to foreign analogs.

[Serodiagnosis of chlamydiosis: "Chlamy-IgG-DS-Tr"-- the first domestic immunoenzyme recombinant test-system for determination of anti-Chlamydia trachomatis class G antibodies]. / Serodiagnostika khlamidiozov. "Khlami-IgG-DS-Tr"--pervaia otechestvennaia immunofermentnaia rekombinantnaia test-sistema dlia vyiavleniia antitel klassa G k Chlamydia trachomatis.

The first Native test-system for determination of class G antibodies to Chlamydia trachomatis with chlamydia recombinant antigen was elaborated Test-system efficacy was demonstrated in clinical trials. The sensibility, specific activity and suitability of the "Chlamy-IgG-DS-Tr" were the same as for import analogous.

[A cultured concentrated inactivated vaccine against tick-borne encephalitis studied during the immunization of children and adolescents]. / Izuchenie kul'tural'noi kontsentrirovannoi inaktivirovannoi vaktsiny protiv kleshchevogo éntsefalita pri immunizatsii detei i podrostkov.

The word deals with the results obtained in the study of the reactogenicity and immunological activity of concentrated and inactivated tissue-culture tick-borne encephalitis vaccine, manufactured by the Chumakov Institute of Poliomyelitis and Viral Encephalitides, in the immunization of children and adolescents. The vaccine proved to be moderately reactogenic and exhibited pronounced immunological activity. In 91.5% of the immunized children the fourfold increase of the antibody level was observed. On the basis of the data obtained in this study the tick-borne encephalitis vaccine was recommended for use in medical practice for the prophylaxis of tick-borne encephalitis among children and adolescents.

[Sensitivity and specificity of the PCR-test-system for diagnosing HIV infections]. / Chuvstvitel'nost' i spetsifichnost' PTsR-test-sistemy dlia diagnostiki VICh-infektsii.

Sensitivity and specificity of the Russian PCR test system (experimental lot) were assessed with materials from 107 Russian patients with HIV infection and 100 donors without specific antibodies to HIV-1. The electrophoretic and hybridization-enzymatic methods for amplicon detection were compared. The sensitivity of electrophoresis was 89.9%, specificity 91%; for hybridization-enzymatic detection these values were 96.1 and 100%, respectively. Samples which yielded false-negative results were repeatedly tested by two-staged amplification (nested PCR) with external and internal primers. The main cause of false-negative results was a low concentration of proviral HIV-1 DNA in some blood samples.

[Development of sera reference panels for quality control of ELISA diagnostic kits in Russia]. / Razrabotka standartnykh panelei syvorotok dlia kontrolia kachestva immunofermenthykh test-sistem v Rossii.

In the past 5 years, the investigators of the "VECTOR" SRB VB and the L.A. Tarasevich State Institute of Standardization and Control of Medical Biological Preparations have jointly designed sera reference panels containing anti-HIV-1 IgG, anti-HCV IgG, and anti-HAV IgM which have been approved as national standard panels. The panels are intended for use in controlling the specificity and stability of the most widely used ELISA diagnostic kits and immunoblot test systems during production, control, and application stages. Some problems of development and production of these panels, including the representation of different sera in the panels and the selection of specific IgG concentrations in the different sera in the panel are described. The authors also attract attention to the stabilization of the specific characteristics of panel sera during storage and transportation.

[Design of reference panels of serum for testing the quality of HIV antibody tests in practical laboratories]. / Konstruirovanie otsenochnykh panelei syvorotok dlia testirovaniia kachestva provedeniia analizov na antitela k VICh v prakticheskikh laboratoriiakh.

The authors define the scientific basis for development of panels of reference sera intended for effective control of the quality of enzyme immunoassay of HIV antibody screening. Special attention was paid to developing the technology of preparing standards highly stable serum samples with a preset concentration of anti-HIV antibodies. The resultant panel of reference sera was tried in screening for anti-HIV antibodies by enzyme immunoassay at seven diagnostic laboratories. Mathematical analysis of the results permits the detection of the minimal errors in studies with the use of serum panel of practical laboratories.

[Collection of pathogenic viruses: state of the problem and prospects]. / Kollektsionirovanie patogennykh virusov: sostoianie i perspektivy problemy.

The organizational and methodological separateness in the collection of pathogenic viruses impedes the development of universal approaches to practical collection. The authors propose a universal research program for the creation of specialized National Museums of Pathogens as reference and methodological centers within the framework of the Russian State Collection of Microorganisms. Further improvement of methods for virus collection is desirable.

[Comparative study of inactivated cultured vaccines against tick-borne encephalitis manufactured in Russia and in Austria by the "Immuno" firm]. / Sravnitel'noe izuchenie inaktivirovannykh kul'tural'nykh vaktsin protiv kleshchevogo 7entsefalita otechestvennogo proizvodstva i proizvodstva firmy "Immuno" (Avstriia).

Inactivated culture vaccine against tick-borne encephalitis (TBE) FSME-Immun-Inject produced in Austria ("Immuno") was compared to vaccine produced in the Institute of Poliomyelitis and viral encephalitis by immunological activity, safety, reactogenicity. In mice, no significant differences in protective activity of the vaccines were found when test-strains were diverse strains of TBE virus. Seroconversion in the sera from the vaccinated two times was not significantly different by the level of antibodies determined for both eastern and western serotypes of TBE virus.