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.

Calibration↗

PubMedDate not supplied

[Evaluation of reactogenicity and immunogenicity of Bubo-M, the Russian combined vaccine for immunization of adults against diphtheria, tetanus and viral hepatitis B].

Bubo-M, the first Russian associated vaccine, was found to have low reactogenicity and high immunogenic potency. The frequency of postvaccinal reactions in the group of persons immunized with Bubo-M (20%) appeared to be considerably lower than among persons who received the combined injection of adsorbed DT toxoid with reduced antigen content and vaccine against hepatitis B (47.7%). Following the course of vaccination the level of anti-HBs considerably exceeded the protective level. Immune response to the diphtheria and tetanus components of Bubo-M exceeded that observed after immunization with absorbed DT toxoid with reduced antigen content (p < 0.05).

Adolescent↗

PubMedDate not supplied

[Reactions to and immunogenic properties of the combined vaccine Bubo-M for immunization of children against diphtheria, tetanus and viral hepatitis B].

Bubo-M, the first Russian combined vaccine, was found to have low reactogenicity. The difference between the number of postvaccinal reactions in the group of children immunized with Bubo-M (25.9%) and those in the group of children who had been simultaneously injected into different sites of the body with ADS-M toxoid (adsorbed DT toxoid with reduced antigen content) and hepatitis B vaccine (26.7%) was not statistically significant. Following immunization a considerable increase in the level of diphtheria and tetanus antibodies (p < 0.005) was observed in all children (100%), the level of HBs antibodies in the group of children immunized with Bubo-M (the geometric mean titer: 13,721 IU/l) essentially exceeding that observed in the control group injected with ADS-M toxoid and hepatitis B vaccine (the geometric mean of the titer: 2,441 IU/l). Bubo-M was duly registered and allowed for industrial production and medical use.

Antibodies, Bacterial↗

PubMedDate not supplied

[Evaluation of the reactogenicity and immunogenic potency of combined vaccine "Bubo-Kok" in the immunization of children against diphtheria, tetanus, pertussis and viral hepatitis B].

Combined vaccine "Bubo-Kok" is characterized by safety and high immunological activity. The number of postvaccinal reactions in children aged 1 and 2 years, immunized with vaccine "Bubo-Kok", was not statistically different from those in groups of children immunized with adsorbed DPT vaccine, as well with such vaccine in combination with vaccine against hepatitis B. After the completion of the primary course of immunization 100% of children had protective antibody titers against diphtheria, tetanus and hepatitis B. Antibody titers against pertussis, equal to or exceeding protective titers, were found in more than 70% of immunized children. The immunogenic potency of vaccine "Bubo-Kok" with respect to all its components was not inferior to that of adsorbed DPT vaccine and vaccine against hepatitis B, when introduced simultaneously in different areas of the body. Vaccine "Bubo-Kok" successfully passed state trials and was recommended for registration.

Antibodies, Bacterial↗

PubMedDate not supplied

[Scientific achievements in the field of anatoxin production].

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Biotechnology↗

PubMedDate not supplied

[Use of membrane separation methods in the production of Clostridium perfringens toxoid].

The dynamics of ultrafiltration was found to depend on the composition of the nutrient medium in which C.perfringens toxin accumulated. A new composition of casein-pancreatic medium with the reduced content of high-molecular peptides ensuring a high effect of membrane separation was developed. The influence of the main factors (pressure, concentration, the number of diafiltration cycles) on the characteristics of the membrane separation of type A C.perfringens culture. The optimum conditions for the purification of C.perfringens toxin by ultrafiltration were established with due regard to the data obtained in this investigation. Toxin concentrates were found to contain a fraction inhibiting their sorption capacity, and the method of the elimination of the inhibiting component was developed. C.perfringens toxoids, considerably exceeding commercial preparations in specific activity and immunogenic potency, were obtained.

Biotechnology↗

PubMedDate not supplied

[Detection of exotoxins of the pathogens of anaerobic gas infection using enzyme immunoassay].

To detect the exotoxins of the causative agents of the main anaerobic gas infection (Clostridium perfringens, C.oedematiens, C.histolyticum, C.septicum) a rapid and easily reproducible variant of the enzyme-linked immunosorbent assay (ELISA), based on the use of the sandwich modification activated due to avidin-biotin interaction, was proposed. The possibility of using the avidin-biotin variant of ELISA for the detection of C.perfringens, C.oedematiens, C.histolyticum and C.septicum toxins in experimental gas gangrene in guinea pigs was shown. The method made it possible to reproducibly detect 0.02-0.2 ng of antigens (gangrene toxins-toxoids) with the immunoassay being highly specific.

Anaerobiosis↗

PubMedDate not supplied

[Certification of a kit for immunologic tests].

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.

Diphtheria Toxin↗

PubMedDate not supplied

[A multistage metrologic approach to the problem of evaluation of the results of the quantitative enzyme immunoassay determination of antitoxic antibodies].

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).

Algorithms↗