[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.

[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.

[Evaluation of the diagnostic efficacy of a test system for detecting hepatitis virus C RNA by polymerase chain reaction "AmpliSens(TM) HCV-240/BKO-440)"]. / Otsenka diagnosticheskoi éffektivnosti tests-sistemy dlia vyiavleniia RNK virusa gepatita C metodom polimeraznoi tsepnoi reaktsii "AmpliSens(TM) HCV-240/VKO-440".

The test system developed at the Central Research Institute of Epidemiology, Ministry of Health of the Russian Federation for identification of hepatitis C virus RNA was studied. The sensitivity of the test system which the rate of similar results was 100% with its 5-fold reproduction was evaluated. That was 5 x 103 genomic equivalents (or international units) per ml of a sample. A scheme for evaluation of the reproductibility of test systems based on the polymerase chain reaction (PCR) by using model samples is proposed. Whether it can be used for intra- and extra-laboratory assessment of the quality of PCR analyses is discussed.

[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 new drug for serodiagnosis of listeriosis]. / Novyi preparat dlia serodiagnostiki listerioza.

Development and introduction into practical public health of new rapid methods for laboratory diagnosis of listeriosis, that will be characterized by a high sensitivity and specificity, is still a pressing problem. Listeriosis erythrocytic diagnosticum developed at the Omsk Research Institute for Natural Focal Infections permits the detection of species-specific antibodies in patients' sera and convalescents after this infection and is characterized by a sufficiently high diagnostic efficacy. Use of this agent appears to hold good promise in the diagnosis of listeriosis in the acute period of the disease, in retrospective diagnosis, and in screening of risk groups.

[The results of a controlled field trial of a dried erythrocytic immunoglobulin diagnostic agent for detecting the hepatitis A virus antigen]. / Rezul'taty polevogo kontroliruemogo ispytaniia diagnostikuma éritrotsitarnogo immunoglobulinovogo sukhogo dlia vyiavleniia antigena virusa gepatitia A.

The results of the controlled field trial of lyophilized erythrocytic immunoglobulin diagnosticum for the detection of hepatitis A virus antigen in the urine and feces of patients are presented. This diagnosticum was used for the study of urine and fecal samples from 225 patients (of these, 176 had hepatitis A) and 54 healthy persons in the passive hemagglutination (PHA) test. Their blood sera were studied in the PHA test (to detect HBsAg) and the radioimmunoassay (to detect anti-HAV IgM). The immunoglobulin diagnosticum under study was found to be nonspecific and faintly sensitive and, therefore, unsuitable for use in medical practice.

[A comparative study of the sensitivity and specific activity of an immunoenzyme test system for determining class-M antibodies to the hepatitis A virus]. / Sravnitel'noe izuchenie chuvstvitel'nosti i spetsificheskoi aktivnosti immunofermentnoi test-sistemy dlia opredeleniia antitel klassa M k virusu gepatita A.

The diagnostic value of the first experimental production batches of assay kit "DIAGN-A-HEP", produced at the Institute of Poliomyelitis and Viral Encephalitides (USSR Acad. Med. Sci.) and intended for the determination of IgM to hepatitis A virus (HAV) in the enzyme immunoassay (EIA), has been studied in comparison with that of the internationally known and widely approved commercial EIA system "HAVAB-MEIA" for the determination of antibodies to HAV (the product of Abbott, USA). The study has revealed that the EIA kit "DIAGN-A-HEP" is highly sensitive and specific, and the diagnostic value of this kit is not inferior to that of the commercial assay system "HAVAB-MEIA". On the basis of this study the use of the EIA kits "DIAGN-A-HEP" in medical practice has been allowed by the decree of the Ministry of Health of the USSR.

[The diagnostic effectiveness of an immunoenzyme test system for determining diphtheria toxin antigens in the blood serum in a clinical laboratory trial]. / Diagnosticheskaia éffektivnost' immunofermentnoi test-sistemy dlia opredeleniia antigenov difteriinogo toksina v syvorotke krovi pri kliniko-laboratornym ispytanii.

The data on the approbation of the diagnostic value of the enzyme immunoassay (EIA) system for the determination of diphtheria toxin in the blood sera of diphtheria patients and persons suspected for diphtheria are presented. The EIA system was prepared on the basis of F(ab)2 fractions of purified antidiphtheria antibodies. 240 serum samples from diphtheria and tonsillitis patients and from healthy persons were studied. Diphtheria toxin was determined in all patients with the toxic form of diphtheria and in 41.3% of patients with its localized forms. Blood was taken mainly of the first week of the disease. In healthy persons the results of EIA were negative. Thus, the trial of the assay system in a clinical laboratory showed its good diagnostic effectiveness. The use of this EIA system in medical practice is believed to be quite promising.

[Comparative study of the diagnostic value of Brucella allergens in a controlled epidemiological trial]. / Sravnitel'noe izuchenie diagnosticheskoi tsennosti brutselleznykh allergenov v kontroliruemom épidemiologicheskon opyte.

The diagnostic value of 4 brucellar allergens used in Burnet's test has been studied in a controlled epidemiological trial. All these preparations have proved to be specific. According to the data of complex evaluation (taking into account reactogenicity, sensitivity, and specificity), the intradermal allergen consisting of the polysaccharide/protein complex extracted from acetone-dried cells of Brucella abortus vaccine strain 19 BA has shown the highest diagnostic effectiveness both in brucellosis patients and in persons immunized against brucellosis.

[Reactogenicity of a group A and C meningococcal polysaccharide bivalent vaccine]. / Reaktogennost' meningokokkovoi polisakharidnoi divaktsiny gruppy A i C.

A total of 1 968 persons aged 18-20 years belonging to organized groups were immunized with different doses of polysaccharide meningococcal divaccine, groups A and C, by means of syringes and jet injectors under the conditions of a controlled epidemiological trial. Systemic reactions to the injection of the preparation were found to be absent. Local reactions manifested by inflammation, swelling and tenderness at the site of injection were faintly pronounced and disappeared in 48 hours, which is indicative of low reactogenicity of the preparation under study.

[Comparative study of the sensitivity and specificity of dried and liquid meningococcal erythrocyte diagnostic agents A, C and Y in a controlled trial]. / Sravnitel'noe izuchenie chuvstvitel'nosti i spetsifichnosti sukhikh i zhidkikh éritrotsitarnykh meningokokkovykh diagnostikumov A, C i Y v usloviiakh kontroliruemogo opyta.

The comparative study of the sensitivity and specificity of dried and liquid meningococcal erythrocyte diagnosticums A, C and Y has been carried out in the indirect hemagglutination test with the sera of persons immunized with different doses of dried chemical meningococcal (group A) polysaccharide vaccine and persons receiving placebo under the conditions of a controlled epidemiological trial. The possibility of using, on principle, both liquid (A, C) and dried (A, C, Y) preparations in clinico-epidemiological studies has been established. The continuation of the research work aimed at the improvement of meningococcal diagnosticums and, in particular, at the development of polyvalent preparations seems to be justified.

[Comparative study of the reactogenicity and immunogenicity of various doses of a chemical polysaccharide meningococcal vaccine administered by syringe and jet injector]. / Sravnitel'noe izuchenie reaktogennosti i immunogennosti razlichnykh doz khimicheskoi polisakharidnoi meningokokkovoi vaktsiny pri shpritsevom i struinom metodakh ee vvedeniia.

The article presents the results obtained in the comparative study of the reactogenicity and immunogenic potency of different doses of chemical polysaccharide meningococcal vaccine, type A, introduced with a syringe and a jet-injector. The preparation has been shown to possess low reactogenicity, high immunogenic potency and to produce a sufficiently pronounced intensity of postvaccinal immunity. The preparation is recommended for wide use in immunization of adults in a dose of 75 micrograms.

[Comparative evaluation of different meningococcal group-specific erythrocyte diagnostic kits in passive hemagglutination test]. / Sravnitel'noe izuchenie razlichnykh meningokokkovykh gruppospetsificheskikh éritrotsitarnykh diagnostikumov v reaktsii passivnoi gemaggluitinatsii.

The comparative evaluation of the sensitivity and specificity of serogroup A, C, Y meningococcal antigenic preparations obtained by different methods was carried out by means of the passive hemagglutination test. In case of group 0 (I) human red blood cells sensitized with serogroup A and C vaccinal preparations obtained by Gotschlich's method (designated as A-1 and C-1) were used. In the other case formalin-treated sheep red blood cells sensitized with group-specific polysaccharides obtained by alcohol precipitation from the cultural fluid of group A, C and Y meningococci with subsequent heating (designated as A-2, C-2, Y) were used. Titrations with commercial immune rabbit sera showed that both variants of the antigenic preparations were similar in their specificity and sensitivity. In patients with the symptoms of meningitis the diagnostic titer was 1:40 for preparations A-1, C-1 and 1:80 for preparations A-2, C-2 and Y. The results of the examination of 164 patients (220 serum specimens) demonstrated that these preparations were of equal diagnostic value.

[Assessment of the diagnostic effectiveness of antigenic preparations from Sonne shigellae]. / Otsenka diagnosticheskoi éffektivnosti antigennykh preparatov iz shigell Zonne.

The authors studied the diagnostic possibilities of 4 diagnistic agents from Sh. sonnei. A total of 1500 from 1122 persons were investigated. Specificity and sensitivity of the diagnostic agents from Sh. sonnei were determined. Methodical priciples of the objective assessment of the diagnostic efficacy of the antigenic preparations in the controlled epidemiological trial were elaborated. A possibility of establishment of the etiological diagnosis of Sonne dysentery in the passive hemagglutination or blast agglutination tests by the results of testing with the diagnostic agents of the serum obtained from the patient once or by determining the dynamics of the antibody titre rise in coupled serum portions was not great.