[Experience with the use of pharmacopoeial reference material for the activity of measles vaccine].

INTRODUCTION: Due to the increased incidence of measles in Russia and in many other regions of the world, vaccines for the measles prevention are especially in demand. Ensuring the quality of the measles vaccine for effective disease prevention is within the scope of the tasks of the state policy of our country. OBJECTIVE: Evaluation of the experience of using a pharmacopoeial standard material of measles vaccine activity for measurement of the specific activity of the measles virus in vaccines with a measles component that are used in the Russian Federation for measles prevention. MATERIALS AND METHODS: The object of the study was the Pharmacopoeia reference material (PRM) of the activity of the live measles vaccine of series 10. The activity of PRM was analyzed when determining the specific activity of the measles, mumps-measles and combined vaccines for the prevention of measles, rubella and mumps, as well as based on the materials of the summary protocols for the production of these vaccines. RESULTS: The titer of the measles virus in the PRM for each determination of the specific activity of the measles virus in vaccines in the Scientific Centre for Expert Evaluation of Medicinal Products in 2021-2022, as well as according to the summary production protocols, was within the boundaries of the certified value (4.63 ± 0.5) lgTCD50/0.5 ml, and the test results met the acceptance criteria in accordance with the requirements of regulatory documentation. During the observation period, the average value of the PRM titer (4.61 lgTCD50/0.5 ml) practically did not differ compared to the average value of the certified characteristics of the PRM, the standard deviation of the mean value of the measles virus titer in the PRM did not exceed 0.15 lgTCD50, which indicated the stability of the analytical work at the enterprise and in IC. CONCLUSION: The data obtained indicate the stable activity of PRM, the correctness of the determination of the measles virus titer in the vaccination dose of the vaccine, and the validity of the method for monitoring the specific activity of the measles virus in vaccines.

ANALYSIS OF THE QUALITY OF NATIONAL VACCINE AGAINST RUBELLA.

Until recently Rubella has been a wide spread infection. Thanks to vaccination against rubella, taking part in the global elimination program of "manageable infections" of WHO and adoption of the program "Elimination of measles and rubella in Russian Federation" the morbidity index of rubella has reached the sporadic level. One of the determining conditions of rubella elimination is application of high-quality vaccines that satisfy international standards. In Russian Federation, foreign rubella vaccines certified in our country were used for several years. In 2008, the commercial production of domestic vaccine began. It is widely known that the required quality of immunobiological medications is achieved using adequate production conditions and standard technological process. That is why during the production of domestic rubella vaccine, all the rules and requirements of Russian regulatory authorities and international recommendations are followed. In this article, a retrospective analysis of domestic vaccine against rubella according to laboratory options of quality in 2012-2017 is given. The results of the analysis show that the medication demonstrates stable high quality that is indicative of secure production technologies.

[Quality assessment of HCV RNA detection by PCR method in Federal System of External Quality Assessment in 2005 - 2007].

Part of the Federal System of External Quality Assessment of Clinical Laboratory Tests named "PCR-identification of hepatitis C virus (HCV)" and aimed at detection of HCV RNA by polymerase chain reaction (PCR) assay is functioning from 2000. Ninety, 98, and 112 laboratories from more than 50 regions of Russian Federation participated in it in 2000, 2006, and 2007 respectively. Analysis of results of control samples tests, which were performed by participated laboratories, showed increasing proportion of method of amplification in the presence of fluorescent-marked probes both in real-time and in end-point regimens. In these circumstances, significant increase of specificity and sensitivity of tests was observed. In 2007, proportion of correct results obtained by the participants for tests with negative control samples was 96 - 97%, whereas during detection of HCV RNA in concentration 10(3) IU/ml the proportion of correct results was 80 - 83%. Significant proportion of laboratories, which did not detect HCV RNA in concentration 10(3) IU/ml, points on the necessity to improve sensitivity of this important method of laboratory tests.

[The evaluation of the diagnostic value of PCR test systems according to the results of state trials].

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.

[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.

[Stability of hepatitis C virus RNA in human blood plasma in a panel of control samples]. / Stabil'nost' RNK virusa gepatita C v plazme krovi cheloveka v paneli kontrol'nykh obraztsov.

The stability of hepatitis C virus (HPC) RNA concentration in 5 human plasma samples after storage at +22 degrees C for two months, at -20 degrees C, and +4 degrees C for six months after 10 freezing-unfreezing cycles was evaluated. In this study, the concentration of HCV RNA in the samples was stable after six months of storage at -20 degrees C. The concentration of HCV RNA decreased on the average of 92% after 2-month storage at +22 degrees C. After six months of storage at +4 degrees C and after 10 freezing-unfreezing cycles, that decreased by 28 and 42%, respectively. Based on their own findings, the authors developed a HCV-RNA panel containing 5 positive human plasma samples with RNA levels of 103-105 IU/ml. The panel may be recommended both for the standardization of PCR kits and for the intra- and interlaboratory quality control of PCR laboratories.

[Quantitative determination of phenol in allergens and vaccines by gas liquid chromatography]. / Kolichestvennoe opredelenie fenola v allergenakh i vaktsinakh metodom gazozhidkostnoi khromatografii.

A method for measuring phenol by gas liquid chromatography has been developed. Metrological characteristics of the method were evaluated: similarity (V no more than 1.62%), reproducibility (V no more than 1.60%), and correctness (98.7-102.3% phenol is detected). The sensitivity of the method is 5 mcg/ml. The method can be used for measuring phenol in noninfectious allergens, tuberculin, and some vaccines.

[An immunoglobulin preparation as a calibrating agent for the gel filtration method]. / Preparat immunoglobulina v kachestve kalibranta dlia metoda gel-fil'tratsii.

The fractional composition of commercial immunoglobulin was studied by the method of gel filtration on ultragel AcA-34 and the possibility of its use for the calibration of a chromatographic column was shown. The fractionation of a specimen of IgG revealed the presence of 4 fractions. Their molecular weights corresponded to dimers, monomers, Fab fragments and low-molecular peptides. The qualitative fractional composition of the preparation was shown to be stable during 3 years of storage, as well as after keeping the preparation at 37 degrees C for 1 month. The attested characteristic of each IgG fraction, the distribution coefficient (Kav), was established. The use of a specimen of immunoglobulin obtained with the use of the modified Cohn's method--as calibrant will make it possible to calibrate the columns for a shorter period and to control the correctness of the analysis.

[Diagnostic value of some cytological parameters of alveolar lavage fluid in restrictive lung diseases]. / Diagnosticheskoe znachenie nekotorykh tsitologicheskikh pokazatelei bronkhoal'veoliarnogo smyva pri ogranichennykh porazheniiakh legkikh.

The time course of cytological parameters of alveolar lavage fluid in restrictive lung disease of tuberculous or other genesis during tuberculin provocative test was studied. A focal response as higher levels of alveolar macrophages, plasma and epithelioid cells was noted in 62.5% of patients with tuberculosis. The method promotes greater diagnostic efficiency for pulmonary tuberculosis.

[Development of an optimal scheme for calculating results of the use of an immunoenzyme test-system for determining the antigenic activity of a cultured antirabies vaccine]. / Otrabotka optimal'noi skhemy ucheta rezul'tatov pri primenenii immunofermentnoi test-sistemy dlia opredeleniia antigennoi aktivnosti kul'tural'noi antirabicheskoi vaktsiny.

Ninety-eight lots of commercial antirabies vaccine manufactured by Immunopreparat Research and Production Amalgamation have been tested using enzyme immunoassay system for the detection of rabies virus antigens. Comparison of different variants of interpreting and expressing the results helped define the optimal method for assessment of vaccine titer and reference values: optical density value equal to 0.2 is taken as the cut-off. Antigenic activity of the vaccine may be expressed in international units, similarly as immunogenic activity.

[The use of rocket immunoelectrophoresis for determining glycoprotein in concentrated rabies vaccines]. / Primenenie raketnogo immunoélektroforeza dlia opredeleniia glikoproteina v kontsentrirovannykh antirabicheskikh vaktsinakh.

Rocket immunoelectrophoresis (RIE) was shown to be useful for the evaluation of glycoprotein (GP) content in concentrated rabies vaccines, and disintegron B., a zwitterionic detergent made in this country, for treatment of the vaccines for these evaluations. The values of GP content obtained by RIE and single radial immunodiffusion test were similar. The highest values were obtained for all the vaccines tested with anti-PM GP serum compared with anti-ERA and Vnukovo-32 GP serum. When anti-PM and anti-Vnukovo-32 GP sera were used for RIE two components were revealed in the vaccines. All the preparations under study contained soluble GP.

[Biological and chemical characteristics of allergen preparations from Neisseria (N. meningitidis, N. gonorrhoeae, N. perflava)]. / Biologicheskaia i khimicheskaia kharakteristika allergennykh preparatov iz neisserii (N. meningitidis, N. gonorrhoeae, N. perflava).

Various methods of isolating allergen fractions from N. meningitidis, N. gonorrhoeae and N. perflava were tested. The biological activity of the preparation was found to depend on the method of its production, which determined its chemical composition. When gonococcal and meningococcal allergens and N. perflava allergen were used in skin tests, cross reactions were observed. Nevertheless, as the intensity and size of skin reaction was much greater when a homologous preparation was administered, it was possible to differentiate the presence of sensitization to a definite microbial species. Electrophoresis in acrylamide gel revealed the heterogeneity of allergen preparations. The ability of the preparation to induce skin reaction was not connected with its serological properties.