Risk Management in the Manufacturing and Use of the Medical Product for <i>in vitro</i> Diagnostics: Reagent Kit “Lyophilized Erythrocyte Antigenic Tularemia Diagnosticum”

The aim of the work was to implement the risk management strategies in the manufacturing and use of medical products for in vitro diagnostics by the example of the experimental series of the reagent kit “Lyophilized erythrocyte antigenic tularemia diagnosticum”.Materials and methods. We tested experimental series of the reagent panel “Lyophilized erythrocyte antigenic tularemia diagnosticum”. To carry out the identification, assessment and analysis of risks regarding the considered medical product, failure mode and effects analysis (FMEA) was proposed and adapted under production conditions. Identification of risks associated with manufacturing and control of medical products for in vitro diagnostics was carried out using technological regulations, standard operational procedures and manufacturing notes.Results and discussion. The main outcome of the study is the development of a corrective actions system aimed at reducing the risks and ensuring consistent monitoring. The proposed schemes for carrying out the risk management process can be used as standard ones in the design and development of medical products for in vitro diagnostics, taking into account the specifics of each individual manufacturing. The reporting documents developed within the framework of the system are applicable during the inspection of good manufacturing practice and in terms of completing the registration profile of a diagnostic product with subsequent registration in the healthcare system of the Russian Federation

Molecular Plasmonic Silver Forests for the Photocatalytic-Driven Sensing Platforms

Structural electronics, as well as flexible and wearable devices are applications that are possible by merging polymers with metal nanoparticles. However, using conventional technologies, it is challenging to fabricate plasmonic structures that remain flexible. We developed three-dimensional (3D) plasmonic nanostructures/polymer sensors via single-step laser processing and further functionalization with 4-nitrobenzenethiol (4-NBT) as a molecular probe. These sensors allow ultrasensitive detection with surface-enhanced Raman spectroscopy (SERS). We tracked the 4-NBT plasmonic enhancement and changes in its vibrational spectrum under the chemical environment perturbations. As a model system, we investigated the sensor’s performance when exposed to prostate cancer cells’ media over 7 days showing the possibility of identifying the cell death reflected in the environment through the effects on the 4-NBT probe. Thus, the fabricated sensor could have an impact on the monitoring of the cancer treatment process. Moreover, the laser-driven nanoparticles/polymer intermixing resulted in a free-form electrically conductive composite that withstands over 1000 bending cycles without losing electrical properties. Our results bridge the gap between plasmonic sensing with SERS and flexible electronics in a scalable, energy-efficient, inexpensive, and environmentally friendly way.</p

CLINICAL PSYCHIATRIC INTERVIEW (LECTURE)

Aim. To reflect the theoretical foundations and create a minimum set of practical skills of diagnostic and treatment interviewing in psychiatry.Materials and methods. To achieve this goal a thematic selection of scientific literature sources of both classical and modern domestic and foreign authors was carried out. In addition, the authors focused on the rich personal experience of interviewing, which allowed choosing and describing the most effective, practically significant methods and methods of clinical diagnosis in psychiatry in the form of psychiatric interviewing.Results. The factors that determine the nature and content of the interview: place, time, participants of the interview – doctor and patient have been described and analyzed. The analytical description of the main psychotechnologies which are used by the psychiatrist (psychotherapist) in the course of interview is given: establishment of contact, technology of hearing of and listening to the patient, technology of asking questions, technology of a pause and silence, technology of tactile contact, technology of using humour, advice, recommendation, interpretation, technology of finishing the interview and its structuring.Conclusion. Clinical interview is the main diagnostic and psychotherapeutic tool of a psychiatrist, and especially of a psychotherapist. The diagnostic effectiveness of a psychiatric interview is determined by the extent to which the information obtained in the course of it is structured into a diagnostic concept, the therapeutic effectiveness is determined by the extent to which the patient accepts the concept of understanding by the doctor of his painful condition (achieved compliance)

Influence of human peripheral blood samples preprocessing on the quality of Hi-C libraries

The genome-wide variant of the chromatin conformation capture technique (Hi-C) is a powerful tool for revealing patterns of genome spatial organization, as well as for understanding the effects of their disturbance on disease development. In addition, Hi-C can be used to detect chromosomal rearrangements, including balanced translocations and inversions. The use of the Hi-C method for the detection of chromosomal rearrangements is becoming more widespread. Modern high-throughput methods of genome analysis can effectively reveal point mutations and unbalanced chromosomal rearrangements. However, their sensitivity for determining translocations and inversions remains rather low. The storage of whole blood samples can affect the amount and integrity of genomic DNA, and it can distort the results of subsequent analyses if the storage was not under proper conditions. The Hi-C method is extremely demanding on the input material. The necessary condition for successfully applying Hi-C and obtaining high-quality data is the preservation of the spatial chromatin organization within the nucleus. The purpose of this study was to determine the optimal storage conditions of blood samples for subsequent Hi-C analysis. We selected 10 different conditions for blood storage and sample processing. For each condition, we prepared and sequenced Hi-C libraries. The quality of the obtained data was compared. As a result of the work, we formulated the requirements for the storage and processing of samples to obtain high-quality Hi-C data. We have established the minimum volume of blood sufficient for conducting Hi-C analysis. In addition, we have identified the most suitable methods for isolation of peripheral blood mononuclear cells and their long-term storage. The main requirement we have formulated is not to freeze whole blood

Quality Management System in Stavropol Research Anti-Plague Institute

The analysis of the structure of quality management system and the areas of its activity is presented. Trends for its further improvement are defined

Modern criteria for demarcated mental norm and mental pathology

The article describes the complexity of modern theoretical and practical approaches to the understanding of mental health and disease. Nozotsentrichesky and normotsentrichesky approaches are analyzed. The possibility of the use of general medical criteria dichotomy «norm/pathology» is discussed. From the standpoint of the modern paradigm of biopsychosocial unity of man analyzes the specificity criteria of mental norms of social and ethnocultural conditions. It describes the current criteria for the analysis - the presumption of mental health

Here and there: the double-side transgene localization

Random transgene integration is a powerful tool for developing new genome-wide screening approaches. These techniques have already been used for functional gene annotation by transposon-insertion sequencing, for identification of transcription factor binding sites and regulatory sequences, and for dissecting chromatin position effects. Precise localization of transgenes and accurate artifact filtration are essential for this type of method. To date, many mapping assays have been developed, including Inverse-PCR, TLA, LAM-PCR, and splinkerette PCR. However, none of them is able to ensure localization of both transgene’s flanking regions simultaneously, which would be necessary for some applications. Here we proposed a cheap and simple NGS-based approach that overcomes this limitation. The developed assay requires using intentionally designed vectors that lack recognition sites of one or a set of restriction enzymes used for DNA fragmentation. By looping and sequencing these DNA fragments, we obtain special data that allows us to link the two flanking regions of the transposon. This can be useful for precise insertion mapping and for screening approaches in the field of chromosome engineering, where chromosomal recombination events between transgenes occur in a cell population. To demonstrate the method’s feasibility, we applied it for mapping SB transposon integration in the human HAP1 cell line. Our technique allowed us to efficiently localize genomic transposon integrations, which was confirmed via PCR analysis. For practical application of this approach, we proposed a set of recommendations and a normalization strategy. The developed method can be used for multiplex transgene localization and detection of rearrangements between them

Validation of Technological Process of Production of Liquid Brucellosis Diagnosticum for Agglutination Reaction, Suspension for Diagnostic Purposes

Presented are the results of validation of technological process of production of brucellosis diagnosticu