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Vol 69, No 7 (2024)
- Year: 2024
- Published: 27.08.2024
- Articles: 6
- URL: https://kld-journal.fedlab.ru/0869-2084/issue/view/9186
Original Study Articles
Quality control of laboratory parameters of the thrombodynamics test in real clinical practice: cross-sectional study
Abstract
BACKGROUND: In-laboratory quality control determines the correctness and reliability of research. Coagulological research should comply with the general requirements for the standardization of clinical and laboratory studies developed by the International Organization for Standardization, World Health Organization, and Ministry of Health of Russia.
AIM: To verify the integral method of studying the hemostasis system, namely, “thrombodynamics,” and its successful use in real clinical practice.
MATERIALS AND METHODS: This study used citrate fresh plasma obtained from 14 patients according to the standard rules of blood collection and in compliance with all conditions of the pre-analytical stage for coagulological studies and commercial pooled plasma.
RESULTS: The coefficients of variation (individual and group) for the hypo, normo, and hyper models were ≤10%, indicating that the analytical characteristics obtained in the laboratory correspond to the recommended characteristics of the manufacturer. A sample preparation algorithm of three levels has been developed for commercial control of plasmas.
CONCLUSION: The thrombodynamics test enables obtaining information about the risks of bleeding and thrombosis and evaluating the effectiveness of anticoagulant therapy with heparins.
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Applying validated control materials of hepatitis B surface antigen to assess the sensitivity of enzyme-linked immunosorbent assays in chemiluminescence immunoassays
Abstract
BACKGROUND: The use of externally validated reference materials ensures quality control in laboratory research. The use of domestically produced control materials traceable to international standards and registered as independent medical devices is significant. Currently, enzyme-linked immunosorbent assays and chemiluminescence immunoassays are frequently employed to detect hepatitis B surface antigen (HBsAg), the main marker of the relevant infectious disease. Standard control samples meeting the above requirements are available for sensitivity assessment of enzyme-linked immunosorbent assay test systems, whereas there are no such quality control materials for chemiluminescence immunoassays.
AIM: Тo demonstrate whether certified control materials for in-laboratory quality control of the measurement of HBsAg by the enzyme-linked immunosorbent assay method can be used for studying analytical sensitivity of chemiluminescence immunoassays.
MATERIALS AND METHODS: Domestic standard samples “DS-SO-HBsAg” (RPC Diagnostic Systems, Russia) and “HBsAg — standard serum panel” (Vector-Best, Russia) were used for testing the sensitivity of two registered foreign-made medical devices for chemiluminescence immunoassays: kit for evaluating the hepatitis B surface antigen (HBsAg CLIA kit) in a human clinical sample by immunochemiluminescent method on analyzers of the CL series (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China) and in vitro diagnostic reagents for the qualitative detection of the surface antigen of the hepatitis B virus (HBsAg) using the “ARCHITECT I” analyzer (ARCHITECT HBsAg Qualitative II Reagent, Abbott, Ireland).
RESULTS: The chemiluminescence immunoassay kits interacted accurately with the control materials used within the limits of the characteristics stated in the operational documentation.
CONCLUSION: The results indicate that validation of the use of reference materials for quality control of test systems, which are based on fundamentally similar but not identical methods of analysis, contributes to improving the quality control system for clinical laboratory diagnostics by expanding the scope of use of registered control materials.
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Uric acid levels and metabolic shifts in hypertensive patients with moderate excretory dysfunction
Abstract
BACKGROUND: Development of hyperuricemia — elevated level of uric acid — is often associated with arterial hypertension. Owing to the widespread prevalence of hyperuricemia in Russia, additional diagnostic markers and pathogenetic correlations between uric acid and other metabolic markers should be studied. In contrast to uric acid, homocysteine, citrulline, and homoarginine content in the blood depends on transmembrane transport and enzymatic reactions in kidney tissue.
AIM: To study the correlation between uric acid levels and metabolic dysfunction markers in hypertensive patients under moderate impairment of excretory function.
MATERIALS AND METHODS: The levels of uric acid, citrulline, homoarginine, total homocysteine, methionine, and other clinical and laboratory parameters were determined for 115 patients with arterial hypertension, with a median age and interquartile range of 64 [54–71] years and an estimated glomerular filtration rate of 45 ml/min/1.73 m2.
RESULTS: In 57 (50%) patients, the uric acid level exceeded the threshold value of 360 μM, indicating an increased risk of cardiovascular complications. Reduced metabolic functions of the kidneys under decreased citrulline, total homocysteine, methionine, and homoarginine levels in the entire group of patients and separately in subgroups of men and women were observed significantly more often than an elevated uric acid level or decreased estimated glomerular filtration rate. The uric acid level was positively correlated with markers of carbohydrate-lipid metabolism: triglycerides (Rs=0.334, p=0.018), glucose (Rs=0.252, p=0.046), and body mass index (Rs=0.396, p=0.001). Similar to uric acid, the homoarginine level showed a positive relationship with body mass index (Rs=0.302, p=0.003). After adjusting for gender and estimated glomerular filtration rate, an association analysis regarding the role of body mass index was performed. It was found that the close correlation between uric acid level and body mass index was significant over others (r=0.421, p=0.0011). In predicting uric acid levels, the relative contribution of estimated glomerular filtration rate and body mass index was equivalent according to multiple regression analysis, that is, an increase in uric acid levels is associated with both renal dysfunction and accumulation of adipose tissue.
CONCLUSION: Renal metabolic insufficiency with hyperuricemia under the initial stages of hypertension is asymptomatic, thus, additional markers have been proposed for the evaluation of remodeling of tissue metabolism in the kidneys, including citrulline, homoarginine, and total homocysteine.
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Amino acid profile of umbilical cord blood plasma of premature newborns in early diagnosis of necrotizing enterocolitis: a pilot study
Abstract
BACKGROUND: Necrotizing enterocolitis is a common emergency condition in premature infants, which is characterized by high rates of mortality and disability. Its diagnosis is complex and often ineffective, thus, the search for biomarkers for prognosis and early diagnosis of the disease is underway.
AIM: To identify changes in the amino acid spectrum of umbilical cord blood plasma that precede the development of necrotizing enterocolitis in extremely premature infants.
MATERIALS AND METHODS: The study was conducted from June 2023 to May 2024. Umbilical cord blood was obtained from physiological and operative deliveries of extremely preterm newborns of ≤32 weeks gestational age, considering the informed consent obtained from the mother, absence of standard contraindications, and exclusion criteria. The children were observed from birth to discharge. Necrotizing enterocolitis was diagnosed by identifying laboratory signs of a systemic inflammatory response in combination with clinical and instrumental data. Amino acid levels in cord blood plasma were determined by capillary electrophoresis. Based on the results of monitoring patients, two groups were retrospectively formed: the comparison group including 10 extremely premature newborns who did not develop necrotizing enterocolitis during the entire observation period, and the main group consisting of 5 patients with necrotizing enterocolitis. The study participants were comparable in body weight and Apgar and Ballard scores at birth. In the main group, necrotizing enterocolitis of stages I–III was diagnosed within 2 weeks of birth.
RESULTS: The development of necrotizing enterocolitis is preceded by a decrease in proteinogenic amino acid level in the umbilical cord blood plasma by 13.9% (p=0.019). This includes the levels of arginine and proline (by 36.2 and 32.8%, p=0.008 and p=0.028, respectively), leucine and isoleucine (41.8 and 36.9%, p=0.030 and p=0.005, respectively), and tryptophan (by 35.5%, p=0.019). A decrease in the levels of methionine (by 28.0%, p=0.028), serine (by 24.1%, p=0.013), and phenylalanine (by 15.8%, p=0.040) was less pronounced, but statistically significant.
CONCLUSION: Comparing the data obtained to the results of other studies, disturbances in the biosynthesis and/or transplacental transfer of amino acids (primarily arginine and amino acids with branched hydrocarbon radicals) can be considered as crucial links in the pathogenesis of necrotizing enterocolitis. The present study used umbilical cord blood obtained at the birth of a child, hence, the identified changes should be considered not as a consequence of intestinal damage but as specific changes in the pool of free amino acids, against which necrotizing enterocolitis is highly possible to develop.
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Clinical Case Reports
Mixed infection of the tracheobronchial tree caused by the bacteria Elizabethkingia anophelis in a victim with a traumatic brain injury: etiology and diagnostic and antibacterial therapy (clinical case)
Abstract
A clinical case of tracheobronchial tree infection caused by Elizabethkingia anophelis in a man with traumatic brain injury is presented. The pathogen is characterized by its active ubiquity and resistance to several antimicrobial drugs, including ampicillin, chloramphenicol, kanamycin, streptomycin, and tetracycline. Additionally, poly-resistant bacteria Acinetobacter baumannii and Klebsiella pneumoniae were found in the discharge of other loci. Microbiological diagnostics performed using modern bacteriological analyzers Vitek 2 Compact and Phoenix M50 with a 99 and 90% reliability, respectively, showed Elizabethkingia meningoseptica. The Autof MS 1000 mass spectrometer was used to determine Elizabethkingia anophelis, with a high confidence >9.5 of 10. The pathogen under study was found to be resistant to the main groups of antibacterial agents, but sensitive to high levofloxacin doses. The use of combined antibacterial therapy regimens using meropenem, linezolid, and levofloxacin for 7 days and additional inhalation administration of sodium colistimethate on day 15 showed a positive result with the elimination of all identified microorganisms. The study of this clinical case is beneficial in avoiding difficulties in identifying Elizabethkingia anophelis using modern bacteriological analyzers and selecting effective antibacterial therapy regimens and optimizing the duration of their administration, which thus prevents the appearance of a new hospital infection and improves the prognosis of the clinical course of the underlying disease.
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Editorials
Erratum in “Iron metabolism in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension”. DOI: https://doi.org/10.17816/cld629834
Abstract
Available from: https://kld-journal.fedlab.ru/0869-2084/article/view/629834
On page 36, in Figures 1, 2, color ranges were incorrectly indicated to describe the prevalence of anemia in the general population and among women: pulmonary arterial hypertension (ЛАГ) and chronic thromboembolic pulmonary hypertension (ХТЛЭГ) were confused in places. The original figures are attached.
On page 36, in Figures 1, 2, color ranges were incorrectly indicated to describe the prevalence of anemia in the general population and among women: pulmonary arterial hypertension (ЛАГ) and chronic thromboembolic pulmonary hypertension (ХТЛЭГ) were confused in places. The original figures are attached.
The corrected figures are attached below.
Fig. 1. Prevalence of anemia in the general population according to various criteria: A — World Health Organization criteria for anemia, 1 — serum ferritin <30 µg/l, 2 — serum ferritin <100 µg/l, 3 — transferrin saturation <20%, 4 — serum ferritin <100 or <299 μg/l with transferrin saturation <20%, 5 — soluble transferrin receptors: for females — >4.4 mg/l, for males — >5.0 mg/l, 6 — soluble transferrin receptors to logarithm of ferritin ratio >3.2, 7 — soluble transferrin receptors to logarithm of ferritin ratio >2.0, ЛАГ — pulmonary arterial hypertension, ХТЭЛГ — chronic thromboembolic pulmonary hypertension.
Рис. 1. Распространённость анемии в общей популяции в соответствии с различными критериями: А — критерии анемии согласно Всемирной организации здравоохранения, 1 — сывороточный ферритин <30 мкг/л, 2 — сывороточный ферритин <100 мкг/л, 3 — насыщение трансферрина железом <20%, 4 — сывороточный ферритин <100 или <299 мкг/л при насыщении трансферрина железом <20%, 5 — концентрация растворимых трансферриновых рецепторов (у женщин — >4,4 мг/л, у мужчин — >5,0 мг/л), 6 — отношение растворимых трансферриновых рецепторов к логарифму ферритина >3,2, 7 — отношение растворимых трансферриновых рецепторов к логарифму ферритина >2,0, ЛАГ — лёгочная артериальная гипертензия, ХТЭЛГ — хроническая тромбоэмболическая лёгочная гипертензия.
Fig. 2. Prevalence of anemia among women according to various criteria: A — World Health Organization criteria for anemia, 1 — serum ferritin <30 µg/l, 2 — serum ferritin <100 µg/l, 3 — transferrin saturation <20%, 4 — serum ferritin <100 or <299 μg/l with transferrin saturation <20%, 5 — soluble transferrin receptors >4.4 mg/l, 6 — soluble transferrin receptors to logarithm of ferritin ratio >3.2, 7 — soluble transferrin receptors to logarithm of ferritin ratio >2.0, ЛАГ — pulmonary arterial hypertension, ХТЭЛГ — chronic thromboembolic pulmonary hypertension.
Рис. 2. Распространённость анемии среди женщин в соответствии с различными критериями: А — критерии анемии согласно Всемирной организации здравоохранения, 1 — сывороточный ферритин <30 мкг/л, 2 — сывороточный ферритин <100 мкг/л, 3 — насыщение трансферрина железом <20%, 4 — сывороточный ферритин <100 или <299 мкг/л при насыщении трансферрина железом <20%, 5 — концентрация растворимых трансферриновых рецепторов >4,4 мг/л, 6 — отношение растворимых трансферриновых рецепторов к логарифму ферритина >3,2, 7 — отношение растворимых трансферриновых рецепторов к логарифму ферритина >2,0, ЛАГ — лёгочная артериальная гипертензия, ХТЭЛГ — хроническая тромбоэмболическая лёгочная гипертензия.
Fig. 1. Prevalence of anemia in the general population according to various criteria: A — World Health Organization criteria for anemia, 1 — serum ferritin <30 µg/l, 2 — serum ferritin <100 µg/l, 3 — transferrin saturation <20%, 4 — serum ferritin <100 or <299 μg/l with transferrin saturation <20%, 5 — soluble transferrin receptors: for females — >4.4 mg/l, for males — >5.0 mg/l, 6 — soluble transferrin receptors to logarithm of ferritin ratio >3.2, 7 — soluble transferrin receptors to logarithm of ferritin ratio >2.0, ЛАГ — pulmonary arterial hypertension, ХТЭЛГ — chronic thromboembolic pulmonary hypertension.
Рис. 1. Распространённость анемии в общей популяции в соответствии с различными критериями: А — критерии анемии согласно Всемирной организации здравоохранения, 1 — сывороточный ферритин <30 мкг/л, 2 — сывороточный ферритин <100 мкг/л, 3 — насыщение трансферрина железом <20%, 4 — сывороточный ферритин <100 или <299 мкг/л при насыщении трансферрина железом <20%, 5 — концентрация растворимых трансферриновых рецепторов (у женщин — >4,4 мг/л, у мужчин — >5,0 мг/л), 6 — отношение растворимых трансферриновых рецепторов к логарифму ферритина >3,2, 7 — отношение растворимых трансферриновых рецепторов к логарифму ферритина >2,0, ЛАГ — лёгочная артериальная гипертензия, ХТЭЛГ — хроническая тромбоэмболическая лёгочная гипертензия.
Fig. 2. Prevalence of anemia among women according to various criteria: A — World Health Organization criteria for anemia, 1 — serum ferritin <30 µg/l, 2 — serum ferritin <100 µg/l, 3 — transferrin saturation <20%, 4 — serum ferritin <100 or <299 μg/l with transferrin saturation <20%, 5 — soluble transferrin receptors >4.4 mg/l, 6 — soluble transferrin receptors to logarithm of ferritin ratio >3.2, 7 — soluble transferrin receptors to logarithm of ferritin ratio >2.0, ЛАГ — pulmonary arterial hypertension, ХТЭЛГ — chronic thromboembolic pulmonary hypertension.
Рис. 2. Распространённость анемии среди женщин в соответствии с различными критериями: А — критерии анемии согласно Всемирной организации здравоохранения, 1 — сывороточный ферритин <30 мкг/л, 2 — сывороточный ферритин <100 мкг/л, 3 — насыщение трансферрина железом <20%, 4 — сывороточный ферритин <100 или <299 мкг/л при насыщении трансферрина железом <20%, 5 — концентрация растворимых трансферриновых рецепторов >4,4 мг/л, 6 — отношение растворимых трансферриновых рецепторов к логарифму ферритина >3,2, 7 — отношение растворимых трансферриновых рецепторов к логарифму ферритина >2,0, ЛАГ — лёгочная артериальная гипертензия, ХТЭЛГ — хроническая тромбоэмболическая лёгочная гипертензия.
These errors do not affect the conclusions of the article. The article has been corrected online.
Authors confirm the accuracy of the information provided in this letter about the composition of the team of authors, and that the contribution of each author complies with the recommendations of the ICMJE. The original article has been updated.
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