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The method for the diagnostic value evaluation of preparations, based on the calculation of the accuracy of test results and taking into account the spread of the diagnosed disease (the comparison of the PCR test systems for the diagnostics of hepatitis B and ureaplasmosis) is proposed. As shown in this work, evaluations obtained with the use of this method coincide with those obtained on the basis of prognostic value, but are more convenient in use and provide additional information.

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The diagnostic value of preparations is commonly characterized by sensitivity and specificity. But not all these characteristics make it possible to decide unequivocally which of the preparations to be compared is superior to the other one with respect to its diagnostic value. It is proposed that in the choice of a diagnostic preparation its capacity to provide data for exact diagnosis should be considered, i.e. the additional characteristic indicating the spread of the disease under study. As an example, the comparison of the diagnostic value of conventional methods and the polymerase chain reaction in the diagnostics of helicobacteriosis is presented. The described method for the evaluation of the diagnostic value of the preparation is well-grounded, simple and obvious.

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The method for checking the results of measurements of the analyzed substance and the calibrator for parallelism the immunological testing kit ABICAP-test-DIPHTHERIA, produced by ABION (Germany), is described. The international standard sample of diphtheria antitoxin human serum was used as calibrator, and human serum No. 18, obtained from the Biomed Group (Russia), was used as the substance to be analyzed. The described method made it possible to detect the parallelism of "dose-response" curves with the relative error not exceeding 20%. Such accuracy proved to be sufficient for practical purposes and was in agreement with the amplitude of oscillations in measured optical densities. The shift of graphs along the abscissa made it possible to estimate the concentration of the serum as exceeding the concentration of the standard sample 2.3 times. The use of analytical approximation for the standard seems to be an important feature in the described method.

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A diagnostic kit for the determination of IgG antibodies to diphtheria toxin ("Abion", Germany) the use of analytical columns "Abicap" was studied in the specialized laboratory of the Tarasevich State Control Institute with a view to determine the possibility of its official registration in the Russian Federation. The kit was evaluated by the following criteria: the correspondence of the specified properties of the preparation to those actually observed; meeting the norms stated in the documents supplied with the kit and WHO requirements; the presence of advantages in comparison with the enzyme immunoassay. In the course of the trial positive results were obtained on all these points.

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To evaluate a kit for the enzyme immunoassay (ELISA), the metrological approach was used: the total error of the method for the quantitative determination of antibodies, regarded as a multistage process, was determined as the result of the accumulation of errors made in measurements at different stages. The proposed algorithm made it possible to attest the positive control serum, to determine the total error of measurements, to mark a linear section in a limited range of values on a graduation diagram. This led to obtaining well-grounded results, comparable with the results of the reaction of neutralization at good correlation (lc = 0.9).

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Antibioticograms of enterohemorrhagic strains of serogroup O157 Escherichia coli isolated in the Russian Federation and Japan were comparatively studied. Strains with multiple drug resistance were detected. The main biochemical characteristics of the isolates were investigated. Significant differences in susceptibility spectra of the isolates and in their fermentative properties were revealed.

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Investigation of 108 P. aeruginosa strains isolated from various clinical material revealed that 54.63% of them belonged to serogroups 2, 5, 16, 18, 20 and 12.96% to serotype 4. Five strains were polyagglutinated. Monocultures of P. aeruginosa were isolated from 55% of patients, in the majority of cases (31 out of 36) these strains were isolated from the urine. Bacterial associations were more frequently detected in discharge from wounds (11 out of 21), in the material obtained by bronchoscopy (9 out of 15), and in the throat (5 out of 6). Assessment of antibioticograms of the isolated P. aeruginosa strains permitted us characterize polymixin, forte ceftazidime, and biseptol as effective agents.

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Commercial system of multimicrotests for biochemical identification of enterobacteria MMT E2 and routine tube tests were compared in a controlled epidemiologic experiment with 205 enterobacterial strains. The system has been developed at the Allergen Research and Production Amalgamation. System MMT E2 fairly well met the requirements to diagnostic preparations of this kind; its results were compatible and well reproducible. This system in complex with commercial MMT E1 system may be used for species identification of enterobacteria. Practical application of both the systems will considerably simplify the process of identification of these microorganisms.

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Comparative evaluation of a system of multimicrotests for biochemical identification of enterobacteria (MMT E1) developed at the ALLERGEN Research and Production Amalgamation and of tube tests for the same purpose in a controlled epidemiologic experiment has shown that the suggested system meets the requirements to such diagnostic preparations by all the major qualitative parameters (compatibility and reproducibility of the test results). Practical use of MMT E1 system will simplify and facilitate the process of enterobacteria identification.

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The first Soviet kits for the serological identification of streptococci, groups A, B, and C, on the basis of the coagglutination test were developed. Each kit was intended for 35-40 determinations. The optimum concentration of streptococci during their identification by means of the reagents making up the kit was about 1.6 x 10(9) cells/ml. The specificity of the reagents in comparison with the results of the identification of streptococci by reference methods was 97.3 +/- 0.9%. The reagents making up the kits can be presumably used for solving a number of practical problems in the epidemiological surveillance of streptococcal infection.

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Examinations of Pseudomonas aeruginosa strains isolated from clinical material from newborns and puerperae and from the environmental objects (washings off, water) have shown that 45.45% of these strains belonged to serotype 04, 24.55% to serotype 02, and 16.38% to other serotypes. Serotype 04 was the most incident in all the tested samples, it was detectable in newborns' biotopes and on environmental objects. Serotype 02 strains ranked second in incidence; they were detected in clinical material from the newborns but not on environmental objects.

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A previously developed serum reference sample containing the antinuclear factor (homogeneous) in a standard dilution 1:40 was used to estimate the working dilution of commercial lots of diagnostic fluorescing immunoglobulins against human IgG (H) (IGF). Use of a working dilution of IGF in the diagnostic titer helps optimize the immunofluorescence test and save IGF.

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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.

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Obtaining antibodies to individual components of Salmonella antigenic complex is highly important for investigations aimed at the study of the antigenic structure of bacteria, their serological identification and the development of diagnostic preparations. The method of obtaining antibodies by the oxidation of Salmonella antigens with sodium periodate and creating immunosorbents based on these antibodies with subsequent affinity chromatography has been developed. Monospecific antibodies thus obtained (O2, O4, O9) have been studied and used as monospecific preparations in the agglutination test, the immunofluorescence test and the immunosorbent assay. The development of methods for stabilizing these preparations, thus ensuring their wide practical use, may be of interest.

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A lytic enzyme isolated from P. lytica was studied with respect to its effect on pathogenic grampositive and gramnegative organisms. All the grampositive organisms were lyzed by the enzyme to this or that extent. The cells of staphylococci were the most sensitive. The gramnegative organisms were resistant. It was suggested that the lytic enzyme could be used in preparing drugs for treating certain skin diseases caused by pathogenic staphylococci.

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A variant of the immunoenzyme assay, reducing the duration of the assay procedure by 3 hours in comparison with the standard technique, is presented. This rapid variant is sufficiently sensitive and reproducible.

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