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15 pages, 2292 KiB

Open AccessArticle

Novel Usefulness of M2BPGi for Predicting Severity and Clinical Outcomes in Hospitalized COVID-19 Patients

by Mikyoung Park, Mina Hur, Hanah Kim, Chae Hoon Lee, Jong Ho Lee, Hyung Woo Kim, Minjeong Nam and Seungho Lee

Diagnostics 2025, 15(7), 937; https://doi.org/10.3390/diagnostics15070937 - 6 Apr 2025

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Abstract

Background/Objectives: Mac-2 binding protein glycosylation isomer (M2BPGi) is a novel biomarker for liver fibrosis, and its prognostic role has never been explored in coronavirus disease 2019 (COVID-19). We compared the M2BPGi level simultaneously with age, severe/critical disease, the sequential organ failure assessment (SOFA) [...] Read more.

Background/Objectives: Mac-2 binding protein glycosylation isomer (M2BPGi) is a novel biomarker for liver fibrosis, and its prognostic role has never been explored in coronavirus disease 2019 (COVID-19). We compared the M2BPGi level simultaneously with age, severe/critical disease, the sequential organ failure assessment (SOFA) score, and the National Early Warning Score 2 (NEWS2) in a total of 53 hospitalized patients with COVID-19 (mild/moderate [n = 15] and severe/critical [n = 38]). Methods: M2BPGi levels were measured using the HISCL M2BPGi assay (Sysmex, Kobe, Japan) in an HISCL-5000 analyzer (Sysmex), and clinical outcomes were analyzed according to M2BPGi and the clinical variables, using the receiver operating characteristic (ROC) curve, Kaplan–Meier survival, and Cox proportional hazards regression analyses. Results: M2BPGi levels differed significantly according to disease severity, 30-day mortality, and 60-day mortality (p = 0.045, 0.011, and 0.002, respectively). In the ROC curve analysis, the M2BPGi, age, SOFA score, and NEWS2, except for severe/critical disease, significantly predicted clinical outcomes (all p < 0.01). In the survival analysis, the hazard ratios of M2BPGi added to each clinical variable were higher than that of each clinical variable alone, and M2BPGi was the only independent prognostic factor for the mortality. Conclusions: This study demonstrated that M2BPGi may be a useful biomarker for assessing disease severity and clinical outcomes in hospitalized COVID-19 patients. Combined with conventional clinical assessment, M2BPGi would provide objective and valuable information for prognosis prediction in these critically ill patients. Further studies are warranted to extend its utility in other clinical settings. Full article

(This article belongs to the Special Issue Biochemical Testing Applications in Clinical Diagnosis)

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17 pages, 2642 KiB

Open AccessArticle

The Prognostic Value of Inflammatory Indices in Acute Pulmonary Embolism

by Mihai Ștefan Cristian Haba, Oana Mădălina Manole, Ana Maria Buburuz, Ionuț Tudorancea, Irina-Iuliana Costache-Enache and Viviana Onofrei

Diagnostics 2025, 15(3), 312; https://doi.org/10.3390/diagnostics15030312 - 29 Jan 2025

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Abstract

Background: Acute pulmonary embolism (PE) is a condition with increased morbidity and mortality. It is important to identify patients with high mortality risk. Inflammation and thrombosis are interconnected in the pathophysiology of PE. The aim of the study was to investigate the prognostic [...] Read more.

Background: Acute pulmonary embolism (PE) is a condition with increased morbidity and mortality. It is important to identify patients with high mortality risk. Inflammation and thrombosis are interconnected in the pathophysiology of PE. The aim of the study was to investigate the prognostic value of multiple blood cellular indices such as neutrophil-to-lymphocyte ratio (NLR), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte platelet ratio (NLPR), systemic immune–inflammation index (SII), systemic inflammation response index (SIRI) and aggregate index of systemic inflammation (AISI) in acute PE. Methods: A total of 157 patients with acute PE confirmed by chest computed tomographic angiography (CTPA) were enrolled. These patients were divided into two categories according to the simplified pulmonary embolism severity index (sPESI): high risk and low risk. Results: Univariate logistic regression analysis showed that right ventricle dysfunction, NLR, SII and SIRI were significantly associated with high risk of acute PE. NLR of 4.32 was associated with high-risk PE with a sensitivity of 57.4% and specificity of 65.7% (AUC = 0.635). SII of 1086.55 was associated with high-risk PE with a sensitivity of 55.7% and specificity of 71.4% (AUC = 0.614). SIRI of 2.87 was associated with high-risk PE with a sensitivity of 59% and specificity of 62.9% (AUC = 0.624). Multivariate logistic regression analysis demonstrated that right ventricle dysfunction, NLR, PLR and NLPR are independent predictors of high-risk acute PE. Secondly, NLR, NLPR, SII and SIRI were significantly correlated with in-hospital mortality of acute PE. Based on receiver-operating characteristic (ROC) curve values of 7.66 for NLR (AUC 0.911, sensitivity of 85.7% and sensibility of 83%), 0.02 for NLPR (AUC 0.871, sensitivity of 85.7% and sensibility of 70%), 1542.71 for SII (AUC 0.782, sensitivity of 71.4% and sensibility of 72%) and 5.72 for SIRI (AUC 0.788, sensitivity of 71.4% and sensibility of 73%) could predict in-hospital mortality. Conclusions: The blood cellular indices (NLR, NLPR, SII and SIRI) are associated with high-risk acute PE and in-hospital mortality. Right ventricular dysfunction, NLR and NLPR are independent predictors for high-risk acute PE. Full article

(This article belongs to the Special Issue Biochemical Testing Applications in Clinical Diagnosis)

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15 pages, 1915 KiB

Open AccessArticle

Calcitonin-Gene-Related Peptide in Migraine and Tension-Type Headache in Children During Interictal Period

by Jadranka Sekelj Fures, Vlasta Duranovic, Jasna Lenicek Krleza, Ana Katusic Bojanac, Lana Loncar, Ivana Dakovic, Sanja Pejic-Rosko, Katarina Vulin, Andrijana Pilon-Far and Andrea Simic Klaric

Diagnostics 2024, 14(23), 2645; https://doi.org/10.3390/diagnostics14232645 - 24 Nov 2024

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Abstract

Background/Objectives: Research on calcitonin-gene-related peptide (CGRP) in adult migraine is extensive, but its role in childhood migraine remains unclear. This study aimed to evaluate serum CGRP levels in children experiencing migraine and tension-type headache (TTH) during interictal periods, comparing these levels to age-matched [...] Read more.

Background/Objectives: Research on calcitonin-gene-related peptide (CGRP) in adult migraine is extensive, but its role in childhood migraine remains unclear. This study aimed to evaluate serum CGRP levels in children experiencing migraine and tension-type headache (TTH) during interictal periods, comparing these levels to age-matched healthy controls. Methods: A total of 66 migraine patients, 59 with TTH, and 53 controls were recruited and stratified by headache onset age: under 7, 7–12, and over 12 years. CGRP levels were quantified using enzyme-linked immunosorbent assay (ELISA). Results: The migraine patients showed significantly higher serum CGRP levels than both the TTH patients and the controls (p < 0.001), with no significant difference between the latter two groups. Among the migraine patients, those without aura (MO) exhibited higher CGRP levels than those with aura (MA). The CGRP levels were lower in the. MA patients whose headaches began between ages 7 and 12 compared to the subjects with MO, while no significant differences were found in the patients whose headaches began after age 12. Conclusions: These findings suggest that elevated serum CGRP is indicative of pediatric migraine, with variations based on migraine type and age of onset. The difference in CGRP in preadolescent migraineurs with and without aura suggest that CGRP levels may vary depending on age and on migraine type. Full article

(This article belongs to the Special Issue Biochemical Testing Applications in Clinical Diagnosis)

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12 pages, 607 KiB

Open AccessArticle

Early Diagnostic Prediction of Infective Endocarditis: Development and Validation of EndoPredict-Dx

by Milena Ribeiro Paixão, Bruno Adler Maccagnan Pinheiro Besen, Lucas Zoboli Pocebon, Marilia Francesconi Felicio, Remo Holanda de Mendonça Furtado, Pedro Gabriel Melo de Barros e Silva, Danielle Menosi Gualandro, Marcio Sommer Bittencourt, Tânia Mara Varejão Strabelli, Roney Orismar Sampaio, Flávio Tarasoutchi and Rinaldo Focaccia Siciliano

Diagnostics 2024, 14(22), 2547; https://doi.org/10.3390/diagnostics14222547 - 13 Nov 2024

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Abstract

Background: Infective endocarditis is a life-threatening disease with diverse clinical presentations, making diagnosis challenging and requiring a range of complementary tests. The level of suspicion, based on clinical judgment, guides decisions regarding the initiation of empirical treatment and the selection of appropriate diagnostic [...] Read more.

Background: Infective endocarditis is a life-threatening disease with diverse clinical presentations, making diagnosis challenging and requiring a range of complementary tests. The level of suspicion, based on clinical judgment, guides decisions regarding the initiation of empirical treatment and the selection of appropriate diagnostic tools. This study aimed to develop and validate the EndoPredict-Dx score for early prediction of infective endocarditis diagnosis. Methods: Patients admitted to a specialized cardiovascular hospital emergency department with suspected infective endocarditis between January 2011 and January 2020 were included. The primary outcome was left-sided infective endocarditis according to the Duke criteria. Logistic regression was used to derive the scoring system, with internal validation performed through bootstrapping. Candidate variables were obtained from the admission medical history, physical examination, and laboratory parameters. Results: Of the 805 individuals with suspected infective endocarditis (median age 56 years (40–73); 58.6% men), 530 confirmed the diagnosis based on the Duke criteria. The EndoPredict-Dx assigned points for male sex, previous endocarditis, petechiae, heart murmur, suspected embolism, symptoms lasting 14 or more days at the time of admission, hemoglobin level ≤ 12 g/dL, leukocyte level ≥ 10 × 10⁹/L, C-reactive protein level ≥ 20 mg/L, and urine red blood cells ≥ 20,000 cells/mL. Patients were divided into three risk groups. The AUROC was 0.78 (95% CI 0.75–0.81) for the derivation cohort and 0.77 for the internal validation. Conclusions: The EndoPredict-Dx score accurately predicted the likelihood of infective endocarditis using clinical and laboratory data collected at admission. Full article

(This article belongs to the Special Issue Biochemical Testing Applications in Clinical Diagnosis)

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13 pages, 1747 KiB

Open AccessArticle

Inflammatory Signals Across the Spectrum: A Detailed Exploration of Acute Appendicitis Stages According to EAES 2015 Guidelines

by Maximilian Dölling, Mihailo Andric, Mirhasan Rahimli, Michael Klös, Jonas Pachmann, Jessica Stockheim, Sara Al-Madhi, Cora Wex, Ulf D. Kahlert, Martin Herrmann, Aristotelis Perrakis and Roland S. Croner

Diagnostics 2024, 14(20), 2335; https://doi.org/10.3390/diagnostics14202335 - 21 Oct 2024

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Abstract

Background: In this retrospective study, we evaluate the diagnostic utility of C-reactive protein (CRP) and leucocyte count within the EAES 2015 guidelines for acute appendicitis (AA) in differentiating uncomplicated (UAA) from complicated AA (CAA). Methods: Conducted at a tertiary care center in [...] Read more.

Background: In this retrospective study, we evaluate the diagnostic utility of C-reactive protein (CRP) and leucocyte count within the EAES 2015 guidelines for acute appendicitis (AA) in differentiating uncomplicated (UAA) from complicated AA (CAA). Methods: Conducted at a tertiary care center in Germany, the study included 285 patients over 18 years who were diagnosed with AA from January 2019 to December 2021. Patient data included demographics, inflammatory markers, and postoperative outcomes. Results: CRP levels (Md: 60.2 mg/dL vs. 10.5 mg/dL; p < 0.001) and leucocyte count (Md: 14.4 Gpt/L vs. 13.1 Gpt/L; p = 0.016) were higher in CAA. CRP had a medium diagnostic value for detecting CAA (AUC = 0.79), with a cutoff at 44.3 mg/L, making it more likely to develop CAA. Leucocyte count showed low predictive value for CAA (AUC = 0.59). CRP ≥ 44.3 mg/L was associated with a higher risk of postoperative complications (OR: 2.9; p = 0.002) and prolonged hospitalization (OR: 3.5; p < 0.001). Conclusions: CRP, within the context of the EAES classification, presents as a valuable diagnostic marker to distinguish CAA from UAA, with a higher risk of postoperative complications and hospitalization. Leucocyte count showed low diagnostic value for the identification of CAA. Full article

(This article belongs to the Special Issue Biochemical Testing Applications in Clinical Diagnosis)

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14 pages, 2059 KiB

Open AccessPerspective

Desmosine: The Rationale for Its Use as a Biomarker of Therapeutic Efficacy in the Treatment of Pulmonary Emphysema

by Jerome Cantor

Diagnostics 2025, 15(5), 578; https://doi.org/10.3390/diagnostics15050578 - 27 Feb 2025

Viewed by 397

Abstract

Desmosine and isodesmosine (DID) are elastin-specific crosslinking amino acids that play a critical role in maintaining the structural integrity of elastic fibers, and their levels in body fluids may serve as biomarkers for alveolar wall injury. To support this concept, we present studies [...] Read more.

Desmosine and isodesmosine (DID) are elastin-specific crosslinking amino acids that play a critical role in maintaining the structural integrity of elastic fibers, and their levels in body fluids may serve as biomarkers for alveolar wall injury. To support this concept, we present studies demonstrating the use of DID to detect elastic fiber damage that reflects distention and the rupture of airspaces. The emergence of airspace enlargement may be modeled by a percolation network describing the effect of changing proportions of intact and weak elastic fibers on the transmission of mechanical forces in the lung. Following the unraveling and fragmentation of weakened elastic fibers, the release of DID may correlate with an increasing alveolar diameter and provide an endpoint for clinical trials of novel agents designed to treat pulmonary emphysema. The limitations of the DID measurements related to specificity and reproducibility are also addressed, particularly regarding sample source and analytical techniques. Standardizing protocols to isolate and quantify DID may increase the use of this biomarker for the early detection of alveolar wall injury, which permits timely therapeutic intervention. Full article

(This article belongs to the Special Issue Biochemical Testing Applications in Clinical Diagnosis)

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10 pages, 5320 KiB

Open AccessBrief Report

Effects of Different Voided Urine Sample Storage Time, Temperature, and Preservatives on Analysis with Multiplex Bead-Based Oncuria Bladder Cancer Immunoassay

by Sunao Tanaka, Kaoru Murakami, Toru Sakatani, Riko Lee, Wayne Hogrefe, Fernando Siguencia, Charles J. Rosser and Hideki Furuya

Diagnostics 2025, 15(2), 138; https://doi.org/10.3390/diagnostics15020138 - 9 Jan 2025

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Abstract

Background/Objectives: Urinalysis accuracy requires reliable sample stability that is dependent on the chosen collection and storage conditions. The multiplex Oncuria bladder cancer immunoassay currently needs urine samples stored at 4 °C until analysis, which requires more effort, equipment, and workflow than storing samples [...] Read more.

Background/Objectives: Urinalysis accuracy requires reliable sample stability that is dependent on the chosen collection and storage conditions. The multiplex Oncuria bladder cancer immunoassay currently needs urine samples stored at 4 °C until analysis, which requires more effort, equipment, and workflow than storing samples at room temperature. Thus, successful sample storage at room temperature (20 °C) may reduce laboratory handling time and expenses. This study evaluated whether different voided urine sample collection and storage parameters affected subsequent biomarker analysis with Oncuria. The Oncuria simultaneously quantifies 10 protein analytes in urine to generate a bladder cancer diagnostic signature. Methods: Samples were stored at varied temperatures (20 °C, 4 °C, −20 °C) for up to 1 month. The effects of adding two commercial urine sample stabilizers and antibiotics (trimethoprim) were also assessed. Subsequently, multiple potential biospecimen stabilizers were tested in urine samples and evaluated with Oncuria in hopes of allowing the urine sample to remain at room temperature for extended periods of time. Results: First, it was demonstrated that voided urine samples stored at room temperate without such stabilizers had different levels of the 10 analytes associated with the Oncuria test compared to voided urine samples stored at 4 °C. Next, we evaluated the effects of commercially available biospecimen stabilizers. Despite the addition of these stabilizers, the levels of the 10 analytes were altered when the samples were stored at room temperature for prolonged periods of time. Therefore, we could not identify a suitable biospecimen stabilizer that would not require sample refrigeration. Conclusions: To minimize sample degradation/alteration after collection, voided urine samples should be refrigerated until analyzed with Oncuria as the refrigeration is advantageous for the storage and the transport of these urine samples. Full article

(This article belongs to the Special Issue Biochemical Testing Applications in Clinical Diagnosis)

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8 pages, 447 KiB

Open AccessCase Report

Whole Exome Sequencing Facilitates Early Diagnosis of Lesch–Nyhan Syndrome: A Case Series

by Hung-Hsiang Fang, Chung-Lin Lee, Hui-Ju Chen, Chih-Kuang Chuang, Huei-Ching Chiu, Ya-Hui Chang, Yuan-Rong Tu, Yun-Ting Lo, Hsiang-Yu Lin and Shuan-Pei Lin

Diagnostics 2024, 14(24), 2809; https://doi.org/10.3390/diagnostics14242809 - 13 Dec 2024

Cited by 1 | Viewed by 1519

Abstract

Background: Lesch–Nyhan syndrome (LNS) is a rare X-linked recessive metabolic disorder caused by mutations in the HPRT1 gene, resulting in hypoxanthine–guanine phosphoribosyltransferase (HPRT) deficiency. Early diagnosis is critical for optimizing management and improving outcomes. This study presents a case series of three Taiwanese [...] Read more.

Background: Lesch–Nyhan syndrome (LNS) is a rare X-linked recessive metabolic disorder caused by mutations in the HPRT1 gene, resulting in hypoxanthine–guanine phosphoribosyltransferase (HPRT) deficiency. Early diagnosis is critical for optimizing management and improving outcomes. This study presents a case series of three Taiwanese patients diagnosed at a single medical center. Methods: Exome sequencing and biochemical testing were used to confirm the diagnoses. Early clinical manifestations, including hyperuricemia, hypotonia, and developmental delay, were documented during the initial stages of the disease. Results: All three patients had hyperuricemia, hypotonia, spasticity, and motor developmental delay. Pathogenic variants in the HPRT1 gene were identified in two patients, while the third was confirmed by biochemical testing. Two patients had orange-colored crystalline deposits in their diapers, indicative of hyperuricosuria. Self-injurious behavior had not yet developed in two patients due to their young age. Conclusions: Early clinical features such as hyperuricemia, hypotonia, and motor delay may suggest LNS in infancy. Molecular genetic testing, particularly whole exome sequencing, can facilitate an early diagnosis before specific manifestations occur, enabling timely interventions and improving patient outcomes. Full article

(This article belongs to the Special Issue Biochemical Testing Applications in Clinical Diagnosis)

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