The review focuses on summarizing information about new approaches to the assessment of reference intervals (RI) and substantiating the relevance of their further application in clinical practice. The article considers the concept of RI using the thyroid panel as an example. The advantages and limitations of alternative methods for determining RI are discussed kits MINDRAY.

A study was conducted involving 14 patients in the control group and 38 patients in the experimental group. In the experimental group, pituitary adenomas of various morphologies and hormone profiles were examined using fluorescence in situ hybridization (FISH). The analysis targeted DNA regions of the CDKN 2A gene at 9p21, the TP53 gene at 17p13, and the CCND1 gene on chromosome 11q13. The objective was to assess the frequency of genetic alterations such as deletions/inactivations, duplications, or polysomy. The results revealed deletions/inactivations at 9p21, supporting the hypothesis that prolactin-secreting pituitary adenomas are associated with inactivation or deletion in this region. Additionally, duplications of 9p21 and polysomy of chromosome 9 were observed. It is hypothesized that duplications may be related to epigenetic dysregulation, such as hypermethylation of the CDKN 2A promoter, which is a common mechanism of gene inactivation. The highest frequency of deletions was detected at 17p13 (the TP53 gene), particularly in non-functioning pituitary adenomas. These findings confirm that deletion of 17p13 leads to reduced TP53 expression, potentially contributing to tumor development. In somatotropinomas, a high percentage of deletions and duplications was observed, likely reflecting both gene losses and compensatory genetic rearrangements, such as accumulation of mutant p53 forms. Deletions or inactivations of the 11q13 region (CCND1) were moderate and not characteristic of tumor processes, as loss of the CCND1 oncogene is generally not associated with tumorigenesis. However, complex genetic rearrangements may include the loss of the 11q13 region.

Multiple myeloma is among the most common malignant diseases of the hematopoietic system. The mortality rate is high, accounting for 18 % of all hematologic malignancies. Early diagnosis and timely initiation of treatment are crucial for improving treatment outcomes in hemato-oncological diseases. Ossalgic syndrome, present in over 70 % of patients at disease onset, is often not recognized as a sign of a hemato-oncological disorder, making laboratory diagnostics of primary importance in such cases. The use of modern blood analysis technologies, such as flow cytometry, opens new possibilities for identifying diagnostic markers, including for multiple myeloma. Sysmex XN scattergram analysis can serve as an additional laboratory marker for detecting pathological leukocytes, thereby enhancing the diagnostic potential of the clinical blood test. This article, based on clinical case studies, discusses the interpretation and clinical significance of WDF channel scattergrams from hematology analyzers Sysmex XN as potential laboratory markers for diagnosing multiple myeloma. Case analyses demonstrated that assessing the location of leukocyte clusters on the Sysmex XN scattergram is a key factor in the correct interpretation of flow cytometry results. The fluorescent flow cytometry method used in hematology analyzers XN enables clear separation of cell subpopulations. A characteristic scattergram pattern – observed in all presented cases – showing a pathological population in the region of antibody-producing lymphocytes, when combined with morphological examination of a peripheral blood smear, can serve as an additional diagnostic laboratory marker of multiple myeloma.

Objectives. The introduction of an alternative method for measuring the erythrocyte sedimentation rate (ESR) and its combined implementation with a complete blood count (CBC) analysis into automated hematology analyzer offers a number of significant advantages for large and medium-sized laboratories: increased efficiency, standardization of the analytical process, cost reduction, and faster turnaround time. In this study, we assess the consistency of clinical results obtained using the modified Westergren method and the alternative ESR measurement method in the context of a technology transition in a high-volume laboratory practice.

Materials and methods. 414 clinical samples were studied, selected during routine testing in such a way that their ESR values were evenly distributed across the entire analytical range of this parameter. Routine testing was performed on a Ves-Matic Cube 200 analyzer (manufactured by Diesse (Italy)); samples were also tested using the alternative method implemented on a BC-6800 Plus hematology analyzer (manufactured by Mindray (PRC)). Data comparison was carried out using linear regression analysis algorithms and Bland-Altman plots.*

Results. The ESR results measured by the two methods correlated well with each other (r=0.93, y= 3.387 + 0.695x). The methods demonstrated a high degree of result agreement (P>0.05).

Conclusion. The consistency of the ESR measurement results during the transition from the modernized Westergren method to an alternative research method was ensured by a high correlation of the results obtained on both devices over the entire analytical range. The functional ESR measurement unit of the Mindray BC-6800 Plus analyzer demonstrated high accuracy and good reproducibility, which provided a faster, safer and more reliable ESR measurement method.

Background. Since the 16th century the phenomenon of “Sedimentum lateritium” (SL) has been known. It consists in the formation of a gel-like substance, cryogel (CG), in some cooled urine samples, along with salt sediment. The diagnostic value of the CG formation effect was studied in a series of studies based on a laboratory model – a cold urine sample (CUS) [1].

Aim. To determine the diagnostic significance of the SL phenomenon for detecting disorders of uromodulin posttranslational processing.

Materials and methods. The analysis of CG formation is grounded in current concepts of the renal proteome, focusing on the functional characteristics of different isoforms of uromodulin (UMO, Tamm-Horsfall protein). CG is considered as the result of the “sol-gel” phase transition of stereochemically modified cylindrical UMO isoforms with a hydrodynamic size of about 400 nm and a molecular weight of 28х10⁶D -UMO (28).

Results. Gel formation in colloidal solutions presupposes the presence of filamentous high molecular weight compounds (HMWC), the interaction of which forms the overall structure of the gel. The most studied structures in urine that meet these characteristics are the isoforms of UMO in urolithiasis. A stable violation of the postgenomic processing of UMO leads to a change in the colloidal stability of urine and an increase in the crystallization of inorganic urine components.

Conclusion. Our results indicate that CG formation is a universal sensitive biomarker for impaired post-translational processing of UMO in nephron epithelial cells. This phenomenon characterizes renal damage of diverse etiologies and marks the onset of chronic kidney disease (CKD).

Hip and knee arthroplasty is currently considered as the surgery of the century. In terms of pain relief, correction of deformations and restoration of lost functions, the operation is second to none. Moreover, no surgical intervention has had such profound social consequences. The technique is really beneficial to patients because of early recovery. On the one hand, the number of primary arthroplastic surgeries, on the other hand, the number of revision surgeries is increasing as well. Significant number of revision surgeries is associated with periprosthetic joint infection. The latent course of the prosthetic joint infection is often mistaken for aseptic loosening, which significantly affects the tactics of surgical treatment and its outcomes, and increases the number of repeated revision interventions. New diagnostic algorithms have been developed over the years. Since none of the diagnostic tests has 100 % sensitivity and specificity, it is necessary to use a combination of various diagnostic procedures, including clinical, radiological, cytological, histological as well as microbiological tests. Proper diagnosis contributes to optimization of treatment tactics and results in favorable outcome. Thus, that is why the search for the “golden” test continues.

Numerous studies have confirmed the role of homocysteine as a marker of the risk of developing and adverse outcome of cardiovascular, neurodegenerative, oncological diseases and pregnancy. Quantitative criteria for homocysteinemia are used in clinical practice. The results obtained using different diagnostic systems and options for conducting the preanalytical stage may vary. The immunochemical methods discussed in the article generally demonstrate acceptable reproducibility and precision in measuring homocysteine concentrations. To assess the degree of harmonization of various methods, including enzymatic ones, it is necessary to introduce specialized external quality assessment programs and interlaboratory comparison systems with open access to their analytical reports into the practice of medical laboratories.

Based on the results of the analysis of laboratory data of 82 patients with pathology of the musculoskeletal system using the method of visualization of multidimensional relationships, the authors demonstrate the possibility of differentiated determination of the effect of eosinophils on bone metabolism in personal observations. At the same time, using in the calculations the panels of leukocyte ratios and water-electrolyte metabolism indicators, the authors come to the conclusion about the possibility of differentiating the quantitative redistribution of leukocyte subpopulations in circulating blood and their accumulation and activity in tissues. This conclusion is substantiated by known literature data. It has been established that the most frequent “image” is the participation of eosinophils in osteosynthesis processes. In this case, the osteosynthetic activity of eosinophils is consistently accompanied by a positive relationship with the activity of basophils. However, in some observations, the effect of eosinophils on osteosynthesis at the intersystem level can be suppressed by alternative mechanisms, for example, with the participation of neutrophils. At the same time, among the selected patients with a high influence of eosinophils on the parameters of water-electrolyte metabolism, the most common were patients with normal absolute values of leukocytes in a clinical blood test, but significant changes in associated relationships in the panel of electrolyte ratios. According to the authors, the proposed method for determining the distinctive functional properties of tissue leukocytes in individual observations can be used in linear healthcare facilities based on the obtained results of routine blood parameters. The obtained “images” of multidimensional connections are clearly distinguishable from each other and can become the beginning of the creation of a “knowledge base” (library), which can be further used to identify previously established typical “images” in the routine work of specialists and to select “targets” for targeted pharmacological correction in individual cases.

Regulatory T cells (Tregs) play a key role in maintaining peripheral immune tolerance. Disorders in their functioning are associated with the development of autoimmune, allergic and oncological diseases.

The aim of the study was to evaluate the involvement of circulating Treg cells in the development of solid malignancies.

Materials and methods. The level of Treg cells (CD 45⁺CD 4⁺CD 25⁺CD 127^-/low) in the peripheral blood of patients with cervical cancer (CC, n=10), prostate cancer (PC, n=23) and lung cancer (LC, n=10) was determined by flow cytofluorometry. The control group consisted of 40 healthy donors. The Mann-Whitney U-test was used to compare the indicators of the groups.

Results. The study showed an increased level of circulating Treg cells in patients with CC, PC and LC compared with the control group (p<0.05). In CC Treg cells levels were increased 1.5–fold (relative number) and 2.5-fold (absolute number); in PC, they were increased 1.8-fold (both relative and absolute), which possibly indicates the involvement of these cells in the pathogenesis of cancer regardless of gender. The most pronounced increase in Treg cells was observed in LC (2.7 and 3.2 times in percentage and absolute number, respectively), which correlates with the late stages of the disease.

Conclusion. The data obtained confirm the universal role of Treg cells in the development and progression of solid tumors, which indicates the promise of immunomodulatory approaches aimed at regulating the activity of these cells.

The immunochromatographic method (ICA) is widely used as a representative and screening study for forensic chemical and chemical-toxicological analysis. The method used has advantages and disadvantages. The disadvantages include both false positive and false negative results. A study was conducted on the detection of benzodiazepine receptor agonists of different chemical structures by the IHA method, the results of which have significant negative results on zaleplon and zopiclone. When tested for clobazam, the result is positive for benzodiazepines, and for phenazepam, it gives a false negative result when detected for a group of benzodiazepines.

The creation of intelligent fecal image analysis software based on machine-learning is dependent on the quality of image annotation by experts. A pilot study revealed an extremely low degree of inter- and intra-expert agreement in recognizing morphological objects, as measured by the F1-score. Three types of discrepancies were identified: in quantity, presence, and category of objects. It is proposed to use a consensus-based approach to mitigate subjectivity and enhance the reliability of algorithms for automation of general fecal examination.

The article presents the results of methodological decisions for objectifying criteria for the reliability of laboratory studies of biological materials isolated from “material evidence” during forensic biological examination, i. e. not commutable for traditional laboratory technologies. The study was performed using the example of the dynamics of the content of total prostate-specific antigen in volunteers’ sperm in a laboratory model, where gauze was used as the tissue basis of “material evidence”, and the concentration of total PSA was determined by ELISA. The criteria for the reliability of laboratory test results are based on the principles of in-laboratory quality control.

Relevance. Low levels of vitamin D, folic acid and inositol in pregnant women are associated with a history of both obstetric and perinatal complications, as well as extragenital diseases. Recently, an increasing number of studies have been focused on identifying cause-and-effect relationships between impaired micronutrient status during gestation and signs of gestational diabetes mellitus.

Objective. To review literature from the past 7 years in international (PubMed) and eLIBRARY.RU to study the micronutrient status in women with a history of gestational diabetes mellitus and to evaluate the impact of this condition on pregnancy.

Materials and Methods. Scientific databases PubMed and eLIBRARY.RU were analyzed for the period 2018–2025. A total of 107 publications were identified, of which 36 were selected for analysis.

Results. The obtained data indicate that supplementation with vitamin D and inositol in women with gestational diabetes mellitus correlated with a more favorable course of pregnancy and successful delivery. The study of folic acid’s impact on patients with this condition yielded directly opposite results.

Conclusion. Therefore, there is a need to implement systematic monitoring of micronutrient status in the pregravid period and throughout pregnancy to ensure timely correction of identified deficiency states.

Relevance. Human papillomavirus infection (HPV) is the most common sexually transmitted infection (STI) worldwide. High-risk human papillomavirus (HR-HPV) plays a key role in the development of cervical cancer (CC) and other malignant neoplasms (MN) of various localizations. The main tools of modern HPV prevention strategies are vaccination and high-coverage screening of target groups. Patients of dermatovenereological profile belong to high-risk groups for HPV infection and subsequent transmission.

Purpose of the study. To investigate the prevalence of different HPV genotypes and the main biomarkers of malignant neoplasm risk in patients with sexually transmitted infections.

Materials and methods. A total of 32,398 women, patients of healthcare facilities in Saint Petersburg, were examined in 2019–2023. HPV detection, genotyping, viral load determination, and the degree of HPV DNA integration into the human genome were carried out. In the Kaliningrad region, 51,536 women were examined in 2020–2024. Research methods: real-time PCR, clinical, epidemiological, and statistical methods.

Results and discussion. The prevalence of HR-HPV among dermatological-profile patients was 30.5 %–31.3 %, compared to 27.3 % in the gynecological-profile group; the differences were statistically significant (p<0.001). Analysis of viral load in dermatovenereological patients showed the presence of risk for HPV persistence and contact transmission. Among patients with STIs and high viral load, the frequency of HPV integration into the host cell genome was 7–20 times higher than in the non-dermatological profile group, indicating an increased risk of MN development. In the Kaliningrad region, the detection rate of HR-HPV among women aged 30–49 years averaged 9.5 %. However, 42 % of NILM (negative for intraepithelial lesion or malignancy) patients, 88 % of LSIL patients, and 100 % of HSIL patients were HPV-positive; cervical cancer was diagnosed in 71 cases. The most frequently detected HPV types were 16, 31, 33, and 58.

Conclusion. The high prevalence of oncogenic HPV types and the significant risk of malignant neoplasm development among patients with STIs and their contacts justify improving the screening system and including these groups among those recommended for HPV vaccination on epidemiological grounds.