Endothelial dysfunction (ED) is a universal developmental mechanism of most diseases of various body systems, characterized by a decrease in vasodilation and the development of proinflammatory and prothrombotic conditions. Impaired vasodilation is primarily associated with a decrease in production and bioavailability of endogenous nitric oxide (NO). One of the methods for ED assessment is measuring the level of markers of its damage in blood serum, such as homocysteine (HCYS), monocyte chemotactic protein‑1 (MCP‑1), proteins of vascular endothelial growth factor (VEGF) family, and many others with low diagnostic effectiveness. In recent years, a number of studies have shown a reliable association between the level of Heparan Sulfate Proteoglycan (hHSPG) and endothelial damage in various acute and chronic diseases.

The purpose of the study. To perform a pilot study of hHSPG levels in comparison with other biomarkers of endothelial damage in blood serum and to identify the correlation of their levels with blood flow rates and endothelial function in microcirculatory system and large vessels in healthy medical workers.

Material and methods. The study involved healthy male medical workers (n=21). The levels of hHSPG, HCYS, MCP‑1, VEGF‑A in blood serum were measured by enzyme immunoassay. According to the results of the study, two groups were formed – an experimental group (n=6) with a significant increase in hHSPG level and a control group (n=15) with a normal level of this marker. In these groups blood flow and endothelial function were assessed using bulbar conjunctival capillaroscopy, laser Doppler flowmetry (LDF) of the skin and photoplethysmographic examination of upper extremity vessels.

The results of the study. In experimental group a high level of hHSPG was detected, exceeding the upper reference range for this marker by more than 2 times to values of 26.6 [24.775; 28.15] ng/ml compared with the control group, where the level of this marker was 4.879 [3.84; 6.944] ng/ml (p=0.001). In addition, there was a tendency in MCP‑1 marker increase in experimental group – 201.96 [91.9; 220.2] pg/ml compared with the control group 104.91 [72.62;127.67] pg/ml (p=0.052). Correlation analysis of hHSPG with markers HCYS, MCP‑1, VEGF‑A showed a strong positive association between hHSPG and MCP‑1 (r_s=0.746), as well as between HCYS and VEGF‑A (r_s=0.436) and between MCP‑1 and VEGF‑A (r_s=0,286). According to the results of blood circulation instrumental study a significant difference in the characteristics of capillary blood flow between the groups was revealed: a decrease in capillary density (10,15 [2.57; 11.60]% in main and 14.90 [10.90; 17.00]% in control (p=0.018)) in bulbar conjunctival microscopy, as well as decrease in capillary bed perfusion (6.80 [5.39; 15.98] in main and 25.02 [18.9; 32.98] in control (p=0.005)) and decreased endothelial function (0.14 [0.02; 0.31] in main and 0.76 [0.55; 1.04] in control (p=0.002)) in LDF. In plethysmographic examination there were no differences in arterial stiffness index (SI) and reflection index (RI). Correlation analysis of laboratory and instrumental ED parameters showed the presence of a moderate inverse relationship between the level of Heparan Sulfate Proteoglycan and endothelial function (Ae) measured by LDF (p=0.024, r_s= –0.491).

Conclusion. An increase in Heparan Sulfate Proteoglycan is a promising marker of ED at the initial stage of its development in microcirculatory system.

A global increase in allergic diseases is being observed worldwide, characterized not only by an increasing incidence but also by increasing severity. In recent decades, allergic diseases have become one of the most significant global challenges for healthcare systems and society. This is due to three key trends: high prevalence (allergies rank third globally after cardiovascular and oncological pathologies, and in some regions, they are the leading cause of disease), a rapidly increasing incidence (doubling every ten years), and increasing severity. Despite medical advances, more severe forms of allergic diseases lead to increased cases of temporary disability and permanent disability, which reduces patients’ quality of life. The Russian Federation faces a similar situation. Since most allergic diseases are caused by immediate reactions, timely and accurate clinical laboratory diagnostics are key to their effective treatment. Modern allergy diagnostics offer a wide range of effective methods that allow for a more precise diagnosis for each individual patient and predict the success of treatment. Allergen‑specific immunoglobulin E (sIgE) is a key player in immediate allergic reactions. Its detection underlies many diagnostic procedures. Testing is performed for both individual allergens of various types and for allergen complexes (panels). The results are presented as both the sIgE concentration and the allergic reaction class. This review examines the comparison of sIgE test results using test kits from various manufacturers used for clinical laboratory diagnosis of immediate allergic reactions in the Russian Federation.

Burn disease is accompanied by the development of anemia of critical conditions, the pathogenesis of which is multifactorial and includes blood loss, hemolysis, systemic inflammatory response, inhibition of erythropoiesis, and impaired iron metabolism. The diagnosis of these disorders is traditionally based on standard peripheral blood parameters. However, an in‑depth assessment of erythropoiesis, including reticulocyte parameters and bone marrow examination, remains an insufficiently studied but important task for understanding the development of anemia and its pathogenetic correction.

The purpose of the study. To study the features of clinical blood analysis and myelogram indicators in patients with burn disease upon admission, depending on the severity of the burn disease, in order to improve the diagnosis of anemia syndrome.

Material and methods. The study included 58 men with burn disease. Depending on the Franck index (FI), patients were divided into two groups: Group 1 (FI90, unfavorable prognosis, n=31). The examination was performed 3–5 days after the injury. Clinical blood analysis was performed on a Sysmex XN‑1000 hematology analyzer (Japan) with an assessment of erythrocyte and reticulocyte parameters. Additionally, patients underwent aspiration bone marrow biopsy followed by myelogram counting using the traditional method of light microscopy and automated examination of bone marrow punctate using a Sysmex XN‑1000 hematology analyzer.

The results of the study. Significantly lower concentrations of RBC were found in patients of the 2nd (FI>90) group compared with the 1st (FI¹²/ l and 4,12 [3,64; 4,35]×10¹²/l (p=0,05) and higher values of the indicator RDW‑SD – 46,9 [45,1; 49,7] fl and 44,8 [43,5; 46,1] fl (p=0,017), respectively. There was a tendency to decrease HGB, HCT and WBC with an increase in the severity of burns. The erythrocyte indices (MCV, MCH, MCHC) corresponded to the normochromic normocytic type of anemia in both groups. Evaluation of reticulocyte parameters revealed an increase in IRF mainly due to high‑fluorescence forms (HFR) without statistically significant intergroup differences. The RPI index tended to decrease in patients of the 2nd group (FI>90), remaining within the reference values. The analysis of the myelogram in patients of the 2nd group (FI>90) revealed a statistically significant increase in the number of basophilic erythroblasts – 0,6 [0,4; 1,6]% compared with the 1st group (FI90) and the absence of significant differences in the number the sum of erythrocaryocytes, which is consistent with the data of the classical myelogram.

Conclusion. A comprehensive analysis of peripheral blood and bone marrow parameters allows an in‑depth assessment of the nature and degree of erythropoiesis disorders in burn disease, which may be important for predicting the course of anemia syndrome and developing pathogenetically sound approaches to its correction.

Background. Timely clinical decision-making regarding interventional management in transplant recipients to preserve allograft function depends on the accuracy of correlating in vitro biomaterial characteristics with native in vivo intermolecular interactions.

Aim. To develop a system for short‑term risk stratification and prediction in kidney transplant recipients based on the analysis of functional and morphological pattern dynamics using medical informatics methods.

Materials and methods. The analysis included data from 160 kidney transplant recipients comprising a total of 5,531 observations. Current risk assessment was performed using clinically validated in vitro threshold values reflecting allograft function and systemic inflammatory activity. A time‑series analysis model based on Long Short‑Term Memory (LSTM) recurrent neural network was employed for risk category prediction.

Results. The predictive system demonstrated high accuracy in short‑term risk classification (approximately 90%) when at least three consecutive days of dynamic monitoring were available. Risk state formation is determined not by isolated deviations of individual parameters, but by coordinated changes in functional and morphological patterns, primarily the most energy‑intensive cyclic ion transport processes and inflammatory markers.

Conclusion. The proposed approach may serve as a clinical decision support tool for timely therapy adjustment and allograft function preservation.

The article defines reference values for von Willebrand factor activity, von Willebrand factor ristocetin cofactor activity, von Willebrand factor antigen, Factor VIII Chromogenic assay activity, d‑dimer and Plasminogen activator inhibitor activity according to existing standards on the automatic coagulometer Sysmex CS‑2000i.

The aim of the study: to determine reference values for specific parameters of the hemostasis, which may vary depending on the type of analyzer and utilized reagents.

Materials and methods. After receiving informed voluntary consent from donors for medical survey and blood and (or) its components donation, blood samples were obtained from 100 donors of blood and (or) its components of both sexes: 51 males (51%) и 49 females (49%). We established reference values with the Sysmex CS‑2000i (Sysmex Corporation, Japan) hemostasis analyzer and reagents from Siemens (Healthcare GmbH, Germany).

Results. Reference values obtained for von Willebrand factor activity (46,65–181,45%), von Willebrand factor ristocetin cofactor activity (16,77– 164,37%), von Willebrand factor antigen (52,11% – 169,27%), Factor VIII chromogenic assay (45,08–158,35%), d‑dimer (17,69–368,13 mcg/l) and Plasminogen activator inhibitor activity (–2,54–4,48 E/ml), were compared with the literature data and the data presented in the instructions for the reagents used. The results obtained for von Willebrand factor antigen (52,11–169,27%) and d‑dimer (17,69–368,13 mcg/l) are comparable to the available data. There are no data on other studied parameters of hemostasis for the Sysmex CS‑2000i analyzer and the reagents used in the work. The obtained reference intervals are generally consistent with the manufacturer’s recommendations.

Conclusions. Reference values vary significantly depending on the analytical systems and reagent kits used, which confirms the need for local derivation or validation of reference intervals for each specific analytical system and in each laboratory.

Background. Restoration of normal platelet functional activity is important in the rehabilitation period of acute poisoning treatment. Microscopy techniques, using fluorescent dyes, are effective for detailed study of morphofunctional status platelet rate.

The aim of work. To study the functional features of platelets in patients with acute exogenous poisoning in the rehabilitation period and to evaluate the relationship between morphofunctional parameters of platelets and other blood parameters in this pathology.

Materials and methods. The study was conducted in 38 patients with psychopharmacological agents poisoning (PsP) and neurotoxicants poisoning (NtP) in the rehabilitation period, 19 patients received vibroacoustic therapy (VAT) in addition to basic therapy. Total concentration of platelets and leukocytes in the blood, blood viscosity and viscoelasticity, collagen‑induced platelet aggregation activity were evaluated, using standard laboratory techniques. To determine the morphofunctional parameters of platelets, we used vital staining and fluorescence microscopy.

Results. In examined patients with PsP and NtP before treatment we observed normal values basic morphofunctional parameters of platelets. At the same time, in many patients platelets with granules had a pronounced tendency to spontaneous activation or hyperactivation. The presence of spontaneous platelet activation or hyperactivation did not correlate with level of platelets with granules and content of damaged platelets. The use of VAT significantly reduced the tendency of platelets to spontaneous activation and hyperactivation. In patients with PsP and NtP before and after treatment there was a direct correlation between parameters of impedance aggregometry (amplitude, Ohms) and morphofunctional parameters of platelets. A similar correlation persisted after treatment in the groups where VAT was used.

Conclusions. Patients with PsP and NtP had increased tendency of platelets to spontaneous activation and hyperactivation before treatment, while altered platelet forms do not noticeably affect the development of these processes. Statistically significant correlation was revealed between parameters of impedance aggregometry and morphofunctional parameters of platelets.

Objective. To analyze international approaches to lot‑by‑lot quality control of high‑risk in vitro diagnostic medical devices and to assess the feasibility of implementing lot verification in the Russian Federation. The review also considers lot‑to‑lot variability as a factor affecting the reliability of laboratory testing.

Materials and methods. An analytical review was conducted, including scientific publications, international models of lot‑by‑lot control applied across various regulatory jurisdictions, and data from Russian state surveillance reports on substandard lots of in vitro diagnostic devices for the period 2015–2025. International models were compared according to independence of expertise, organizational feasibility, throughput capacity, and the ability to prevent the release of lots with deviating performance characteristics.

Results. Lot‑by‑lot verification of third‑risk‑class in vitro diagnostic medical devices is a key mechanism for ensuring the reliability of laboratory testing and reducing the likelihood of diagnostic errors. International and Russian data indicate that lot‑to‑lot variability is a significant risk factor capable of reducing the sensitivity and specificity of diagnostic assays. Despite the existing mechanisms of state registration and post‑market surveillance, in the Russian Federation lot‑related defects are predominantly detected only during clinical use.

Conclusion. The implementation of independent lot‑by‑lot verification represents a justified and necessary measure for improving the quality of diagnostic devices and enabling timely prevention of clinically significant deviations.

Justification. The spread of HIV infection is one of the most acute problems of our time, as a result of which mortality is increasing, the number of able‑bodied people is decreasing, and the pace of economic growth of the state is slowing down.

The purpose of the study. To analyze the indicators of morbidity and coverage of HIV testing in the Ural Federal District to justify further measures to counter the spread of infection.

Materials and methods. Data from 19 newsletters of the Federal State Budgetary Institution “Central Research Institute of Epidemiology” of Rospotrebnadzor were analyzed. The data for 2023 were obtained from the State Reports of the Chief State Sanitary Doctors of the UFD regions and statistical materials of the Central Research Institute of the Russian Academy of Medical Sciences. The data on the coverage of the population by screening for HIV infection, posted on the EMISS website, were studied (www.fedstat.ru). The methodology for analyzing the collected data included a retrospective epidemiological analysis.

Results. In 2023, the incidence of HIV infection in the Ufa region turned out to be the highest in the Russian Federation and amounted to 73,56 cases per 100,000, the incidence of HIV in the Ural Federal District was higher than the national average (45,26 °C) by 38,47%. During the entire observation period, two local peaks were formed in the dynamics of HIV infection in the UFD region – in 2001 (162.94°/0000) and in 2015 (141.86°/0000). In the Russian Federation and the UFD region, since 2014, there has been an annual increase in the coverage of medical examinations for HIV infection, with a one‑time decrease in 2020 (an average annual growth rate of 4,35%). In 2023, the target for the coverage of antiretroviral therapy set by the State Strategy was reached in the Ural Federal District (32%). The target rate for antiretroviral therapy coverage set by the State Strategy in 2023 is 84%. Since 2014, the Ural Federal District has seen an increase in the coverage of antiretroviral therapy (an average annual growth rate of 10.79%, Mann‑Kendall test S=60, p <0.001), in 2023 the figure was 86,7%.

Conclusion. In the UFD region, over the past 9 years (from 2015 to 2023), there has been a decrease in the incidence of HIV infection from 141,8°/0000 to 73,56°/0000, with an average annual rate of decrease of 6,1%. In 2023, the targets of the State Strategy were achieved in UFD region, such as coverage of the population with HIV screening and coverage of antiretroviral therapy.

Background. Psoriasis (PsO), psoriatic arthritis (PsA), and metabolic syndrome (MetS) share common immune-inflammatory mechanisms. MicroRNAs are considered potential molecular links integrating inflammatory and metabolic disturbances.

Objective. To evaluate the expression of hsa-miR‑210–3p, hsa-miR‑10b‑5p, hsa-miR‑130a‑3p, and hsa-miR‑126–5p in young patients with PsO and PsA, taking into account the presence of MetS.

Materials and methods. The study included 38 patients with PsO and 37 with PsA under 45 years of age. Plasma microRNA expression was assessed using RT-qPCR (2^-ΔΔCt method). PERMANOVA, SIMPER, ROC analysis, and correlation analysis were performed.

Results. The results of paired multivariate PERMANOVA analysis for the PsO and PsA groups demonstrated statistically significant differences in the overall expression pattern of the studied microRNAs (p=0.003). Statistically significant differences in expression between patients with PsO and PsA were found for two microRNAs: miR‑130a‑3p and miR‑10b‑5p: 57.3 % (p=<0.001) and 22.5 % (p=0.021). The presence of MS in patients with PsA was accompanied by an increase in the expression of miR‑10b‑5p (FC=0.68, p=0.03; log2(2^(–dct) PsA without MS –0.56 [–1.387; –0.198] compared to PsA with MS –1.465 [–1.842; –0.67], p=0.032). The expression level of miR‑130a‑3p positively correlated with glucose, insulin and HOMA-IR.

Conclusion. hsa-miR‑130a‑3p and hsa-miR‑10b‑5p may reflect the transition from cutaneous to articular forms of psoriatic disease and participate in the integration of metabolic and inflammatory pathways, representing potential biomarkers of PsO-to-PsA transformation.

Background. The article presents the results of a comparative analysis of the effectiveness of automated and manual (microscopic) methods for counting hematopoietic stem cells in peripheral blood and leukocyte concentrate samples.

The aim of the study was to evaluate the diagnostic value of automated counting of hematopoietic stem cells (HSC) in various types of biomaterial (peripheral blood, leukapheresis product) of patients undergoing the procedure of mobilization and collection of HSC at the clinic of the R.M. Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantology in the period 2018–2019.

Materials and methods. A retrospective analysis of the medical records of 98 patients was conducted. A total of 278 valid observations were analyzed: 172 peripheral blood samples and 106 leukapheresis product samples. The study compared two methods for leukocyte (WBC) quantification: automated counting on a Sysmex XN‑1000 hematology analyzer (Sysmex Corporation, Japan) and manual microscopic counting in a Goryaev chamber. Statistical analysis of the obtained data was performed using the Python programming language (version 3.9.6). Quantitative indicators are presented as median and interquartile range (Me [Q1; Q3]).

Results. The study found that the implementation of automated hematopoietic progenitor cell counting (HPC parameter) on the Sysmex XN‑1000 platform has fundamentally changed the paradigm of leukapheresis laboratory support. The key advantage of this technology is the ability to standardize monitoring, eliminating the variability inherent in manual methods. Statistical analysis demonstrated the need to abandon the traditional leukocyte counting in the Goryaev chamber.

Conclusions. The HPC parameter on the Sysmex XN‑1000 platform has proven itself as a precision tool for optimizing diagnostic testing and ensuring the timely procurement of high‑quality transplants. Given the method’s proven reliability, the next stage of the study will aim to verify it against the reference method (flow fluorescence cytometry of CD34+ cells) for the final validation of the developed diagnostic algorithms.

Objectives. To study the sources of variation (SV) in reference values (RV) for 22 key immunoassays and to determine reference intervals (RIs), a multicenter study of the Russian population was conducted.

Methods. In accordance with the protocol of the Committee on Reference Intervals and Limit Values (C‑RIDL) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), 758 healthy volunteers were included in the study, conducted in St. Petersburg, Moscow, and Yekaterinburg. Five tumor markers and 17 hormones and related analytes were analyzed in serum samples using the UniCel DxI 800 immunoassay analyzer from Beckman Coulter. SVs were analyzed using multiple regression analysis (MRA) and analysis of variance (ANOVA). The primary criterion for separating the study population by sex and age was a standard deviation ratio (SDR) of 0.4.

Results. When assessing differences between groups of volunteers participating in the study in different cities, the SDR was less than 0.4. The following secondary exclusion criteria were used: for female sex hormones – contraceptive use (8%); for CA19–9—presumably Lewis negative blood type (10.5% of men and 11.3% of women); for insulin – BMI ≥28 kg/m2 (31%); for thyroid hormones – the presence of thyroid antibodies (10.3% of men and 24.5% of women); for carcinoembryonic antigen (CEA)—smoking (30% of men and 16% of women). For all analytes except CA19–9, CA15–3, thyroid function tests, parathyroid hormone, and insulin, RIs had to be separated by sex. For alpha‑fetoprotein (AFP), CEA, all female sex hormones, follicle‑stimulating hormone (FSH), and progesterone, RIs had to be separated by age for both sexes. Typically, RIs were determined parametrically after Gaussian transformation using a modified Box‑Cox formula. Exceptions were growth hormone, estradiol in postmenopausal women, and progesterone in premenopausal women, which required nonparametric calculation due to bimodal distributions and/or insufficient detection limits.

Conclusions. RIs for key hormones and tumor markers specific to the Russian population were determined in accordance with a current international standardized protocol with a thorough examination of the RI for each analyte.