Diagnostics

16 pages, 346 KB

Open AccessSystematic Review

Explainable Artificial Intelligence in Mammography: A Systematic Review of Methods, Evaluation Practices, and Clinical Readiness

by Filippo Pesapane, Anna Rotili, Silvia Penco, Valeria Dominelli, Francesca Priolo, Irene Marinucci, Luca Nicosia, Roberto Grasso, Gabriella Pravettoni and Enrico Cassano

Diagnostics 2026, 16(9), 1412; https://doi.org/10.3390/diagnostics16091412 - 6 May 2026

Cited by 2 | Viewed by 595

Abstract

Background: Explainable artificial intelligence (XAI) is increasingly proposed to improve trust in mammography-based artificial-intelligence systems, but the validity and clinical readiness of published explanations remain unclear. We aim to systematically review XAI methods applied to mammography and synthesize how explanations are evaluated [...] Read more.

Background: Explainable artificial intelligence (XAI) is increasingly proposed to improve trust in mammography-based artificial-intelligence systems, but the validity and clinical readiness of published explanations remain unclear. We aim to systematically review XAI methods applied to mammography and synthesize how explanations are evaluated for validity, robustness, and clinical usefulness. Methods: We conducted a systematic review according to PRISMA 2020. MEDLINE/PubMed, Embase, Scopus, Web of Science Core Collection, and the Cochrane Library were searched from 1 January 2015 to 15 January 2026. Two reviewers independently screened records and extracted data; disagreements were resolved by consensus with a third reviewer. Included studies used mammography as the primary input and reported an explicit explanation or interpretability mechanism. Because the literature was methodologically heterogeneous, we performed a structured narrative synthesis and an adapted XAI-specific appraisal of explanation claims, quantitative evaluation, external validation, human-factor assessment, and reporting transparency. Results: Fourteen studies were included. Ten studies addressed detection or lesion classification and four addressed risk or outcome prediction. Primary XAI families were interpretable-by-design architectures (6/14), post hoc saliency or attribution methods (5/14), and feature-level explanation methods (3/14). Five studies remained at tier-1 qualitative plausibility only, seven reached tier-2 internal quantitative explanation evaluation, two reached tier-3 external or cross-dataset interpretability assessment, and none reported reader or workflow studies. In the dedicated mammography saliency benchmark, Pointing Game scores for Grad-CAM, Grad-CAM++, and Eigen-CAM ranged from 0.30 to 0.41, indicating only modest lesion-pointing reliability despite acceptable classifier performance. Conclusions: Mammography XAI remains dominated by visually plausible explanations that are inconsistently validated. The literature is moving toward task-aligned and intrinsically interpretable designs, yet external validation and clinician-centered evaluation remain rare. Future studies should pre-specify explanation claims, use task-appropriate quantitative metrics, report explanation robustness under distribution shift, and test whether explanations improve human decision-making. Full article

(This article belongs to the Special Issue Recent Advances in Diagnostic and Interventional Radiology)

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10 pages, 490 KB

Open AccessBrief Report

Bacterial Gastrointestinal Infections in Pediatric Inflammatory Bowel Disease (PIBD)—A Single-Center Experience of Epidemiology, Management, and Outcome

by Raffaela Miriam Planka, Almuthe Christine Hauer, Sebastian Bauchinger and Benno Kohlmaier

Diagnostics 2026, 16(9), 1411; https://doi.org/10.3390/diagnostics16091411 - 6 May 2026

Viewed by 556

Abstract

Background: Due to dysbiosis, intestinal barrier dysfunction, and immunosuppressive therapy, pediatric inflammatory bowel disease (PIBD) patients are more susceptible to infections. However, data on bacterial gastrointestinal (GI) infections in this population are scarce, and no guidelines explicitly address immunosuppressive therapy management during such [...] Read more.

Background: Due to dysbiosis, intestinal barrier dysfunction, and immunosuppressive therapy, pediatric inflammatory bowel disease (PIBD) patients are more susceptible to infections. However, data on bacterial gastrointestinal (GI) infections in this population are scarce, and no guidelines explicitly address immunosuppressive therapy management during such infections. This single-center study aims to address these knowledge gaps. Methods: A retrospective study of bacterial GI infections was conducted in PIBD patients aged 0–18 years, treated between 2011 and 2021 at the Department of Pediatrics and Adolescent Medicine, Medical University of Graz. Data to assess the study endpoints were extracted from the hospital information system. Results: A total of 139 PIBD patients were screened for bacterial GI infections. The mean follow-up time was 49 months (standard deviation ±33) and the total follow-up time amounted to approximately 473 person-years. Fourteen patients developed infections, with three experiencing them twice, resulting in 17 cases of infection. Most infections were caused by opportunistic bacteria, and 10 infections were treated with antibiotics (11 antibiotic prescriptions in total). At infection onset, 12 patients were on (combined) immunosuppressive therapy, including corticosteroids (3 patients), immunomodulators (9 patients), and/or biologics (3 patients). Six infections required escalation of immunosuppressive therapy due to increased PIBD activity. Hospitalization was required in five cases, and one Clostridioides difficile infection progressed to sepsis, necessitating intensive care unit admission. This corresponds to an incidence of three infections (95% confidence interval 1.75–4.80) and 0.2 severe infections per 100 person-years (95% confidence interval 0.01–1.11). Conclusions: The incidence of bacterial GI infections was 3 per 100 person-years (95% confidence interval: 1.75–4.80), with most cases being clinically mild. Clostridioides difficile was the most common pathogen. Immunosuppressive therapy was generally continued or intensified, when necessary, while antibiotic therapy was administered as indicated. Full article

(This article belongs to the Topic Advances in Comprehensive Management Strategies for Inflammatory Bowel Disease)

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Graphical abstract

15 pages, 2090 KB

Open AccessArticle

Factors Influencing Diagnostic Yield and Complication Risk in CT-Guided Transthoracic Lung Biopsy of Pulmonary Lesions: A Retrospective Analysis

by Augustina Mozerytė, Juozas Jarašūnas, Kipras Mikelis, Eimantas Dumskis and Donatas Jocius

Diagnostics 2026, 16(9), 1410; https://doi.org/10.3390/diagnostics16091410 - 6 May 2026

Viewed by 780

Abstract

Background/Objectives: CT-guided transthoracic lung biopsy is a broadly performed and minimally invasive procedure for obtaining tissue samples from pulmonary lesions, offering a high diagnostic yield, and remains a cornerstone of accurate lung cancer diagnosis. The primary objective of this study was to [...] Read more.

Background/Objectives: CT-guided transthoracic lung biopsy is a broadly performed and minimally invasive procedure for obtaining tissue samples from pulmonary lesions, offering a high diagnostic yield, and remains a cornerstone of accurate lung cancer diagnosis. The primary objective of this study was to assess the diagnostic yield of CT-guided transthoracic lung biopsies and to investigate the factors influencing this yield, with procedure-related complications being a secondary objective. Methods: A retrospective study was conducted on 356 CT-guided transthoracic lung biopsies performed between January 2021 and December 2023. The patient demographics, lesion characteristics (size, location) and histological findings were analyzed. The diagnostic yield was evaluated based on histological findings and, if necessary, follow-up information. Results: Of the 356 biopsies, 326 (91.6%) were found to be diagnostic, and 30 (8.4%) were non-diagnostic. The diagnostic yield was significantly influenced by lesion size and the number of biopsy cores, with lesions ≤2 cm associated with a higher diagnostic failure rate (p = 0.034). A significant interaction was also observed between lesion size and core number (p < 0.001). The overall complication rate was 11.5%, with pneumothorax being the most frequent event (7.0%). CIRSE grade 2 and grade 3 complications occurred in 4.8% and 3.1% of cases, respectively. Solid lesion morphology was identified as an independent predictor of complications (OR = 1.67, p = 0.022). Conclusions: In summary, CT-guided transthoracic lung biopsy demonstrates a high diagnostic yield with an acceptable safety profile and remains an important diagnostic tool in the evaluation of pulmonary lesions. Full article

(This article belongs to the Section Medical Imaging and Theranostics)

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18 pages, 72628 KB

Open AccessArticle

Forecasting Patient-Specific Abdominal Aortic Aneurysm Geometry with Mixed-Effects Models

by Juan C. Restrepo, Maria L. Bolanos, Seungik Baek, Satish C. Muluk, Mark K. Eskandari, Vikram S. Kashyap, Eanas Yassa and Ender A. Finol

Diagnostics 2026, 16(9), 1409; https://doi.org/10.3390/diagnostics16091409 - 6 May 2026

Viewed by 592

Abstract

Background/Objectives: Abdominal aortic aneurysm (AAA) surveillance is based largely on monitoring the maximum diameter, a single scalar metric that obscures regional remodeling and offers limited information on the location and time dependency of the growth rate. The present work addresses this limitation with [...] Read more.

Background/Objectives: Abdominal aortic aneurysm (AAA) surveillance is based largely on monitoring the maximum diameter, a single scalar metric that obscures regional remodeling and offers limited information on the location and time dependency of the growth rate. The present work addresses this limitation with a geometry-based patient-specific framework that learns local, linear evolution from longitudinal clinical imaging, yielding 3D forecasts of AAA geometry at arbitrary future times. Methods: Lumen and outer wall surfaces are represented on a centerline-anchored cylindrical grid, with subsequent implementation of individualized linear mixed-effects models. The model is explicitly interpretable as the fixed effects predict global trends and the random effects represent regional heterogeneity. In a multicenter cohort of 79 patients, we evaluated forecasts using spatial similarity (with the 95th percentile of the Hausdorff distance—HD95) and clinically relevant global geometric scalars such as maximum diameter and volume. Results: When forecasting a future AAA geometry, the model achieved sub-millimetric HD95 spatial errors and less than 6% error for the aforementioned global scalars. The model was deployed in an interactive application named the Aneurysm Forecasting Studio, which allows a user to visualize the AAA in an explorable forecast space. Conclusions: During typical clinical surveillance intervals, AAA geometric remodeling is reasonably approximated as locally linear in time, enabling transparent, fast forecasts that support surveillance optimization, threshold timing, and digital twin-based interventional planning. Full article

(This article belongs to the Special Issue Vascular Diagnostic Imaging)

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24 pages, 884 KB

Open AccessEditor’s ChoiceArticle

Congenital Gastrointestinal Malformations in a Romanian Tertiary Centre (2020–2024): A Retrospective Cohort Study of Diagnosis, Distribution, and Outcomes

by Iulia Stratulat-Chiriac, Raluca Ozana Chistol, Lăcrămioara Perianu, Elena Țarcă, Viorel Țarcă, Alina Mariela Murgu, Paula Popovici, Ioana-Alina Halip, Elena Cojocaru, Valeriu Chisălău and Cristina Furnică

Diagnostics 2026, 16(9), 1408; https://doi.org/10.3390/diagnostics16091408 - 6 May 2026

Cited by 1 | Viewed by 505

Abstract

Background/Objectives: Congenital gastrointestinal malformations (CGIMs) are important causes of neonatal surgical morbidity with potential long-term consequences. Although some can be suspected on prenatal ultrasound, data on their clinical spectrum, burden, and distribution remain limited in Eastern Europe. This study aimed to describe the [...] Read more.

Background/Objectives: Congenital gastrointestinal malformations (CGIMs) are important causes of neonatal surgical morbidity with potential long-term consequences. Although some can be suspected on prenatal ultrasound, data on their clinical spectrum, burden, and distribution remain limited in Eastern Europe. This study aimed to describe the diagnostic spectrum, timing of diagnosis, documented prenatal ultrasound suspicion, and the early outcomes of CGIMs managed at a Romanian tertiary referral centre between 2020 and 2024, a period overlapping the COVID-19 pandemic. Methods: We conducted a retrospective, single-centre observational study including all consecutive paediatric patients with a CGIM admitted between January 2020 and December 2024. Cases were analysed by index anatomical diagnosis, phenotypic complexity, and etiologic background. Logistic regression was used to examine factors associated with documented prenatal suspicion and in-hospital mortality, and annual hospital-based CGIM admission rates were modelled with Poisson regression, using the number of paediatric surgical admission as the offset. Results: Among the 231 children (58.9% male), the most frequent diagnoses were persistent omphalomesenteric duct remnants (16%), oesophageal atresia with or without tracheoesophageal fistula (15.6%), and anorectal malformations (13.9%). Documented prenatal ultrasound suspicion was present in 17.7% of pregnancies (41/231) and was likely underestimated because antenatal documentation was unavailable for 17.7% of the cohort. The highest proportions of documented prenatal suspicion were observed in jejuno-ileal and duodenal atresia. Foregut malformations were the most common by embryological grouping (93/231, 40.3%). Most cases were diagnosed during the neonatal period (n = 161, 69.7%). CGIM admission rates per 1000 surgical admissions ranged from 20.8 to 38.2. An exploratory Poisson model yielded a hospital-based rate ratio per calendar year of 0.88 (95% CI 0.81–0.97; p = 0.008). However, given the limited number of annual observations and increasing total surgical admissions, this finding should be considered exploratory and hypothesis-generating only. Complex cases accounted for 8.2% and associated extra-intestinal anomalies were present in 70.1%. In-hospital mortality was 13.0% and occurred predominantly in patients with complex or foregut malformations. In the primary complete-case multivariable model, prematurity remained independently associated with mortality, whereas complex CGIMs were not independently associated with mortality after adjustment. A prespecified multiple-imputation sensitivity analysis yielded a stronger estimate for complex CGIMs, but this finding was interpreted cautiously and not treated as a primary result. Conclusions: In this tertiary referral cohort, documented prenatal suspicion of CGIM was low and strongly diagnosis-dependent, while most cases were identified in the neonatal period. Mortality was concentrated in foregut and clinically complex presentations in the descriptive analysis, while prematurity remained independently associated with death in the primary multivariable model. These findings highlight the need to strengthen prenatal referral pathways and coordinated national surveillance. Full article

(This article belongs to the Special Issue Clinical Diagnosis and Management in Pediatric Surgery)

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14 pages, 517 KB

Open AccessArticle

Estimating the Post-Mortem Interval Under Extreme Heat Environments: A Climate-Adaptive Case Series Based on Artificial Intelligence-Supported Diagnostics

by Francesco Sessa, Clelia Grippaldi, Massimiliano Esposito, Carlos A. Gutierrez, Emina Dervišević, Efehan Ulas, Federica Ministeri, Lucio Di Mauro, Matteo Bolcato, Cristoforo Pomara and Monica Salerno

Diagnostics 2026, 16(9), 1407; https://doi.org/10.3390/diagnostics16091407 - 6 May 2026

Cited by 1 | Viewed by 747

Abstract

Background/Objectives: Accurate post-mortem interval (PMI) estimation becomes increasingly difficult when bodies decompose under extreme heat. Hyperthermal Mediterranean environments accelerate soft-tissue degradation, induce early mummification, and distort classical thanatological indicators, often resulting in substantial PMI overestimation. This study analyzes three forensic cases affected [...] Read more.

Background/Objectives: Accurate post-mortem interval (PMI) estimation becomes increasingly difficult when bodies decompose under extreme heat. Hyperthermal Mediterranean environments accelerate soft-tissue degradation, induce early mummification, and distort classical thanatological indicators, often resulting in substantial PMI overestimation. This study analyzes three forensic cases affected by climate-driven decomposition anomalies and presents a climate-adaptive, AI-assisted diagnostic framework applied uniformly across all cases to improve PMI interpretation. Methods: A retrospective case series analysis was conducted on three individuals recovered during summer heatwaves. Crime scene investigation, post-mortem computed tomography (PMCT), autopsy, and genetic identification were integrated with 5–15-year meteorological datasets. Classical PMI estimations were compared with circumstantial data. A multimodal AI model, incorporating environmental features, decomposition morphology, and microenvironmental modifiers, was operationalized for each case using a hybrid Random Forest–LSTM architecture. Engineered indices included Accumulated Degree Days (ADD), a Decomposition Index, and climate-stress metrics (Thermal Load Index, Desiccation Pressure Factor, Microenvironmental Distortion Coefficient). Quantile regression provided calibrated prediction intervals. Results: Morphological assessments overestimated PMI in every case, suggesting intervals of 1–6 months despite true PMIs of approximately 20 days (Cases 1–2) or 36–48 h (Case 3). The AI model yielded conceptual outputs more consistent with verified PMIs, ~21 days (Case 1), ~23 days (Case 2), and ~42 h (Case 3), each accompanied by 50% and 90% prediction intervals. Explainability analyses identified thermal load, desiccation pressure, and microenvironmental distortion, particularly insulation in Case 3, as dominant drivers. Conclusions: Extreme heat fundamentally alters decomposition trajectories, rendering classical PMI methods unreliable. Applying a climate-aware, AI-assisted diagnostic framework across all three cases improved interpretability, providing uncertainty-aware estimates aligned with true PMIs. The AI framework is presented as a conceptual, non-trained, proof-of-concept system, and reported outputs represent operational demonstrations rather than validated predictions, offering a promising foundation for next-generation PMI diagnostics in hyperthermal forensic settings. Full article

(This article belongs to the Section Machine Learning and Artificial Intelligence in Diagnostics)

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13 pages, 6104 KB

Open AccessArticle

Evaluation of Splenic Volume and Surface Area According to Age and Gender: A Three-Dimensional Slicer Computed Tomography Study—Imaging

by Busra Pirinc, Ayse Gamze Ozcan, Ekrem Solmaz, Betul Sevindik, Emine Uysal and Zeliha Fazliogullari

Diagnostics 2026, 16(9), 1406; https://doi.org/10.3390/diagnostics16091406 - 6 May 2026

Viewed by 551

Abstract

Background: The spleen is an important organ in the evaluation of systemic diseases due to its hematologic and immunologic functions. Changes in splenic volume and surface area have diagnostic significance in various clinical conditions. This study aimed to evaluate age- and sex-related changes [...] Read more.

Background: The spleen is an important organ in the evaluation of systemic diseases due to its hematologic and immunologic functions. Changes in splenic volume and surface area have diagnostic significance in various clinical conditions. This study aimed to evaluate age- and sex-related changes in splenic volume and surface area in an adult population. Material: A total of 304 abdominal CT scans (153 females, 151 males) were retrospectively evaluated. Participants aged 19–89 years were stratified by decades. Changes in splenic surface area and volume were analyzed according to age and sex using measurements obtained from these images with the 3D Slicer software package. Results: Splenic volume showed significant differences across age groups in females, whereas no statistically significant age-related difference was observed in males. Splenic surface area differed significantly according to age groups in both sexes. The highest mean splenic volume and surface area were observed in the 19–29 age group in both sexes. The lowest mean values were detected in the 80–89 age group in females and in the 70–79 age group in males. Conclusions: Splenic volume is higher in males than in females. A statistically significant decrease in splenic volume with advancing age was observed in females, whereas only a non-significant decreasing trend was noted in males. A marked reduction in splenic volume and surface area was observed particularly after the age of 70 years. This finding is associated with age-related immune decline and functional hyposplenism and carries clinical significance in terms of increased susceptibility to infections and diminished immune response in elderly individuals. Furthermore, splenic shrinkage should be considered in the assessment of hematological reserve and in the differentiation of changes related to chronic diseases. Full article

(This article belongs to the Section Medical Imaging and Theranostics)

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14 pages, 5780 KB

Open AccessArticle

Contrast Enhancement Is Associated with a Higher DSC MRI-Derived Cerebral Metabolic Rate of Oxygen Index in Untreated Glioblastoma

by Jonas Reis, Marco Öchsner, Chiara Adam, Thomas D. Fischer, Thomas Liebig and Robert Forbrig

Diagnostics 2026, 16(9), 1405; https://doi.org/10.3390/diagnostics16091405 - 6 May 2026

Viewed by 1035

Abstract

Background/Objectives: Contrast enhancement (CE) on T1-weighted MRI is routinely used to guide therapy in the management of glioblastoma, although adjacent non-contrast-enhancing (non-CE) T2/FLAIR abnormalities can also harbor viable tumor tissue. The differences between these radiographic compartments remain incompletely characterized beyond conventional structural imaging. [...] Read more.

Background/Objectives: Contrast enhancement (CE) on T1-weighted MRI is routinely used to guide therapy in the management of glioblastoma, although adjacent non-contrast-enhancing (non-CE) T2/FLAIR abnormalities can also harbor viable tumor tissue. The differences between these radiographic compartments remain incompletely characterized beyond conventional structural imaging. We therefore compared CE and non-CE compartments in untreated IDH-wildtype glioblastoma using dynamic susceptibility contrast (DSC) and diffusion-weighted MRI derived indices. Methods: Adults with untreated glioblastoma imaged preoperatively between January 2021 and September 2024 on multi-vendor 1.5 T and 3 T scanners were retrospectively included. Regions of interest were placed in CE tumor, adjacent non-CE T2/FLAIR hyperintense tissue, and contralateral normal-appearing white matter (NAWM). Mean apparent diffusion coefficient (rADC), cerebral blood volume (rCBV), capillary transit time heterogeneity (rCTH), oxygen extraction fraction (rOEF), and a cerebral metabolic rate of oxygen index (rCMRO₂) were extracted and harmonized for scanner effects and normalized to NAWM. Paired CE–non-CE differences were tested using Wilcoxon signed-rank tests and summarized by Hodges–Lehmann differences with bootstrap 95% confidence intervals. Spearman correlations were used to assess coupling within contrast-enhancing tumor regions. Results: Seventy-two participants were analyzed (median age 67 years; 34 women); 66 had paired CE and non-CE data. rCMRO₂ and rCBV were higher in CE than non-CE (both p < 0.001), while rADC was lower (p = 0.003). rOEF (p = 0.12) and rCTH (p = 0.52) did not differ significantly between compartments. Conclusions: CE in untreated IDH-wildtype glioblastoma predominantly reflects higher perfusion capacity (rCBV) along with a higher model-derived rCMRO₂ index, while capillary-function indices (rCTH and rOEF) are not consistently compartment-restricted. These findings may refine the physiological interpretation of CE in glioblastoma and support further validation of DSC-derived indices. Full article

(This article belongs to the Special Issue Brain/Neuroimaging 2025–2026)

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11 pages, 1087 KB

Open AccessProtocol

Establishment of Local Diagnostic Reference Levels for Adult CT Brain in Johannesburg, South Africa: A Retrospective Protocol Study

by Khahliso Genious Seekoei, Nape Matheko Phahlamohlaka, Jeanette Du Plessis and Setlhapelo Edward Mokhure

Diagnostics 2026, 16(9), 1404; https://doi.org/10.3390/diagnostics16091404 - 6 May 2026

Viewed by 854

Abstract

Introduction: Computed Tomography (CT) brain imaging provides high-resolution anatomical detail but involves relatively higher radiation doses, necessitating dose monitoring and optimisation. Diagnostic reference levels (DRLs) are recommended dose indicators for optimising radiation exposure without compromising diagnostic image quality; however, national DRLs for [...] Read more.

Introduction: Computed Tomography (CT) brain imaging provides high-resolution anatomical detail but involves relatively higher radiation doses, necessitating dose monitoring and optimisation. Diagnostic reference levels (DRLs) are recommended dose indicators for optimising radiation exposure without compromising diagnostic image quality; however, national DRLs for CT brain imaging have not yet been established in South Africa. This article presents a protocol for establishing local DRLs for non-contrast- (non-CE) and contrast-enhanced (CE) adult CT brain examinations at an academic hospital in Johannesburg, South Africa. Materials and Methods: The research site is at a single hospital in Johannesburg, South Africa. The research design for this study is retrospective. A sample of 197 adult CT brain examinations (63 non-CE, 34 CE, and 100 combined non-CE and CE examinations) performed between 1 January and 31 December 2024 will be used to develop local DRLs. The 64-slice CT scanner of choice for data collection is the Siemens SOMATOM Definition AS. The population defined for this study is individuals aged 18–70 years. The preferred contrast media used for CT brain examination at the research site is 40 mL of Omnipaque 350. The scan range for CT brain is from the base of the skull (foramen magnum) to the vertex, ensuring full coverage of intracranial structures. Dose metrics, including the volumetric CT dose index (CTDIvol) and dose–length product (DLP), will be extracted from archived dose reports. Local DRLs will be established as the 75th percentile values of CTDIvol and DLP for each protocol group. Descriptive statistics (mean, median, and interquartile range) will be used to summarise the data demographics. The effective dose will be estimated by applying a head-specific conversion coefficient to the DLP values. Results: As this is a study protocol, results are not yet available. Local DRLs will be reported as the mean, median, and 75th percentile values of the DLP and CTDIvol for non-CE, CE, and for both non-CE and CE CT brain examinations. The effective dose will be estimated by applying a head-specific dose conversion coefficient (k-factor) to the mean DLP values. Expected Outcomes: This study is expected to establish local DRLs for adult CT brain examinations, providing baseline data for dose optimisation and supporting the future development of national DRLs in South Africa. Conclusions: Establishing local DRLs will support the optimisation of the radiation dose in CT brain imaging to keep the dose as low as reasonably achievable. The DRLs developed for this study will contribute to national and international efforts toward optimising radiation dose during diagnostic X-ray imaging investigations. Full article

(This article belongs to the Special Issue Advances in Computed Tomography Imaging for Clinical Diagnosis—2nd Edition)

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12 pages, 3556 KB

Open AccessArticle

Microbiological Profiling of Menstrual Blood Aspirated from the Uterus in Patients Undergoing Frozen Embryo Transfer

by Mark Jain, Elena Mladova, Pavel Zalepaev, Margarita Gundobina, Alexander Klimov, Liya Shcherbakova, Larisa Samokhodskaya and Olga Panina

Diagnostics 2026, 16(9), 1403; https://doi.org/10.3390/diagnostics16091403 - 6 May 2026

Viewed by 508

Abstract

Background: There is growing evidence that uterine microbiota might be linked to endometrial receptivity (ER) and affect the outcome of assisted reproductive technology (ART) procedures. Owing to the invasive nature of endometrial sampling, the evaluation of microbiota in this biomaterial is only [...] Read more.

Background: There is growing evidence that uterine microbiota might be linked to endometrial receptivity (ER) and affect the outcome of assisted reproductive technology (ART) procedures. Owing to the invasive nature of endometrial sampling, the evaluation of microbiota in this biomaterial is only possible outside the embryo transfer (ET) cycle. However, menstrual blood might be the key to overcoming this challenge as it can be safely aspirated from the uterine cavity at the beginning of the target ET cycle. This study aimed to evaluate the association of the microbiological profiles of menstrual blood with ER in patients undergoing frozen ET. Methods: Menstrual blood was obtained from 98 individuals scheduled for frozen ET in a private ART clinic (ET success rate–50%). DNA was isolated from menstrual sediment and analyzed using a multiplex quantitative PCR assay designed to identify 28 relevant microbial taxa and 3 Herpesviridae viruses. Results: Bacterial DNA was detected in 75.5% of samples. There were no associations between the abundance of individual microbial taxa and the outcome of ET, and the same was true for Shannon’s α-diversity indices (p > 0.05). However, Candida spp. and Enterobacteriaceae were detected exclusively in patients with negative ET outcomes (p = 0.028). Individuals with recurrent implantation failure had a significantly lower abundance of Lactobacillus spp. than the rest (0.0 [0.0; 7.4] vs. 2.8 [0.0; 91.9] %, p = 0.024). Conclusions: Menstrual blood aspirated directly from the uterus is a promising biomaterial for endometrial microbiological profiling. Upon further investigation, its analysis might become a useful tool in managing infertile patients scheduled for ART treatment. Full article

(This article belongs to the Special Issue Microbiology Laboratory: Sample Collection and Diagnosis Advances, 2nd Edition)

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12 pages, 1116 KB

Open AccessArticle

Gestational Age-Specific Biometric and Estimated Fetal Weight Curves in Gastroschisis: A Brazilian Multicenter Cohort Study

by Karina Felippe Monezi Pontes, Liliam Cristine Rolo, Gustavo Yano Callado, Alberto Borges Peixoto, Manoel Sarno, Alex Sandro Rolland Souza, Francisco Herlânio Costa Carvalho, Antonio Braga and Edward Araujo Júnior

Diagnostics 2026, 16(9), 1402; https://doi.org/10.3390/diagnostics16091402 - 6 May 2026

Viewed by 553

Abstract

Objective: This study aimed to describe gestational age-specific biometric and estimated fetal weight (EFW) patterns derived from a multicenter cohort of fetuses with gastroschisis and to evaluate the agreement between prenatal EFW and birth weight. Methods: This retrospective study included singleton [...] Read more.

Objective: This study aimed to describe gestational age-specific biometric and estimated fetal weight (EFW) patterns derived from a multicenter cohort of fetuses with gastroschisis and to evaluate the agreement between prenatal EFW and birth weight. Methods: This retrospective study included singleton pregnancies with a prenatal diagnosis of gastroschisis and at least two ultrasound evaluations between 20 and 37 weeks. Data were collected from four Brazilian tertiary centers between 2010 and 2024. Biometric parameters (biparietal diameter, head circumference [HC], abdominal circumference, and femur length) and EFW were recorded. EFW was calculated using Hadlock IV and Siemer formulas. Polynomial regression models were applied to generate gestational age-specific curves for HC, femur length (FL), and EFW. Agreement between prenatal EFW and birth weight (in cases assessed within 14 days of delivery) was analyzed using Bland–Altman plots and the concordance correlation coefficient (CCC). Results: A total of 116 pregnancies and 355 ultrasound tests were included. Polynomial models showed a strong association between gestational age and EFW (R² = 0.837 for Siemer; R² = 0.728 for Hadlock), HC (R² = 0.849), and FL (R² = 0.877). The 50th percentile curves for gastroschisis were consistently lower than those from standard growth charts. In the birthweight concordance analysis (n = 46), the Siemer formula showed low agreement (CCC = 0.55), while the Hadlock formula showed even lower concordance (CCC = 0.44), with both formulas underestimating actual birth weight. Conclusions: Fetuses with gastroschisis have distinct growth patterns not captured by standard references. Tailored growth curves and careful interpretation of EFW are essential to improve prenatal assessment in this population. Full article

(This article belongs to the Section Clinical Diagnosis and Prognosis)

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19 pages, 8071 KB

Open AccessSystematic Review

Oculomotor Nerve Palsy—Etiologies, Symptoms and Diagnosis: A Systematic Review with Meta-Analysis

by Konstantina Bolou, George Triantafyllou, Nikolaos-Achilleas Arkoudis, Panagiotis Papadopoulos-Manolarakis, Irini Chatziralli, Vasileios Papadopoulos, Georgios Velonakis and Maria Piagkou

Diagnostics 2026, 16(9), 1401; https://doi.org/10.3390/diagnostics16091401 - 6 May 2026

Cited by 1 | Viewed by 11781

Abstract

Background/Objectives: Oculomotor nerve palsy (OMNP) is a clinically significant condition that may represent the earliest manifestation of life-threatening intracranial pathology, particularly aneurysmal compression or neoplasia. Despite its neurosurgical relevance, comprehensive meta-analytic evidence synthesizing OMNP etiologies, clinical presentation, and contemporary diagnostic pathways remains limited. [...] Read more.

Background/Objectives: Oculomotor nerve palsy (OMNP) is a clinically significant condition that may represent the earliest manifestation of life-threatening intracranial pathology, particularly aneurysmal compression or neoplasia. Despite its neurosurgical relevance, comprehensive meta-analytic evidence synthesizing OMNP etiologies, clinical presentation, and contemporary diagnostic pathways remains limited. Methods: Following PRISMA 2020 guidelines, MEDLINE, Scopus, and Web of Science were systematically searched for studies reporting quantitative data on OMNP. Pooled prevalence estimates were calculated using random-effects models for causes and symptoms, while a structured narrative synthesis was performed for diagnostic modalities because outcome reporting was heterogeneous and unsuitable for meta-analysis. Risk of bias was assessed using the Joanna Briggs Institute (JBI) risk of bias tool. Results: Twenty-four studies involving 5541 patients were included. Using a multivariate multilevel model to account for within-study dependence, the most common etiological category was vascular disorders (35.62%), followed by idiopathic (16.47%) and neoplastic (12.10%). Head trauma and aneurysms accounted for 11.26% and 10.08% of cases, respectively. Diplopia (60.63%) and ptosis (54.12%) remained the predominant clinical symptoms, while pupil involvement was identified in 40.62% of the pooled population. Diagnostic paradigms have shifted decisively toward non-invasive neuroimaging, with magnetic resonance imaging reported in 66% of included studies and magnetic resonance or computed tomographic angiography increasingly employed to identify surgically relevant vascular lesions. Conclusions: Although vascular disorders represented the most common etiological category, the notable prevalence of aneurysmal and neoplastic causes underscores the importance of prompt high-resolution neuroimaging and early neurosurgical assessment. Early recognition and etiological stratification remain essential to optimize management and prevent irreversible neurological morbidity. Full article

(This article belongs to the Special Issue Diagnostic Imaging in Neurological Diseases: 2nd Edition)

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9 pages, 1230 KB

Open AccessArticle

Acute Ischemic Stroke Lesion Characterization: Comparative Analysis of Cortical and Basal Ganglia Lesions Using Time-Histogram Metrics

by Hon-Man Liu and Wei-Lung Tseng

Diagnostics 2026, 16(9), 1400; https://doi.org/10.3390/diagnostics16091400 - 6 May 2026

Viewed by 441

Abstract

Background and Purpose: Understanding regional differences in acute ischemic stroke (AIS) lesions, particularly between cortical and basal ganglia (BG) regions, is crucial for enhancing diagnostic precision and therapeutic strategies. This study builds upon prior research in CT-based stroke imaging by introducing entropy [...] Read more.

Background and Purpose: Understanding regional differences in acute ischemic stroke (AIS) lesions, particularly between cortical and basal ganglia (BG) regions, is crucial for enhancing diagnostic precision and therapeutic strategies. This study builds upon prior research in CT-based stroke imaging by introducing entropy and SD as novel biomarkers for lesion differentiation and focuses on their temporal evolution to identify critical diagnostic windows for clinical management. Methods: We retrospectively analyzed imaging data from 45 AIS patients (27 cortical, 18 BG lesions). Time-histogram metrics—standard deviation (SD), skewness, kurtosis, and entropy—were computed for lesions in both regions across multiple time points post-stroke. Statistical comparisons utilized one-way ANOVA and post hoc t-tests (p < 0.05). Results: Cortical lesions exhibited significantly higher entropy (4.34 vs. 3.99, p = 0.000034) and SD (5.16 vs. 3.94, p = 0.000144) compared to BG lesions, reflecting greater heterogeneity. No significant differences were found in skewness or kurtosis. Peak diagnostic sensitivity occurred at 76–87 min post-stroke (p < 0.001). Temporal trends revealed increasing divergence in entropy and SD between cortical and BG lesions during this window. The identification of the 76–87-min diagnostic window offers critical insights into the hyperacute phase, where early ischemic changes are often subtle on NCCT. Conclusions: SD and entropy are robust biomarkers for distinguishing cortical and BG lesions in AIS, offering insights into regional tissue responses and temporal evolution, with potential for personalized stroke care. These metrics could serve as standalone biomarkers or be integrated into AI-based NCCT triage systems to enhance lesion characterization and therapeutic decision-making. Full article

(This article belongs to the Special Issue Advanced Imaging and Theranostics in Neurological Diseases)

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1 pages, 654 KB

Open AccessCorrection

Correction: Edris et al. Temporal Bone Fractures on High-Resolution CT: Bridging Radiologic Detail with Otologic Anatomy and Surgical Implications. Diagnostics 2026, 16, 718

by Osama M. K. Edris, Abdulgaffar Bashir Adam, Emad Ali Albadawi, Ahmad Mahroos ALGhabban, Razan Saad M. Alqarni, Wejdan Hussain Owaydhah, Omar A. Alharthi, Eyad Khattab, Fahd Alharbi and Yasir Hassan Elhassan

Diagnostics 2026, 16(9), 1399; https://doi.org/10.3390/diagnostics16091399 - 6 May 2026

Viewed by 340

Abstract

In the original publication [...] Full article

(This article belongs to the Section Medical Imaging and Theranostics)

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18 pages, 794 KB

Open AccessArticle

Integrating Patient-Reported Outcomes into Clinical Pathways in Atrial Fibrillation: A Framework Aligned with the AF-CARE Model

by Emma Sokolova, Olav Goetz, Ketija Grīnberga, Sevinc Elif Sen, Kaspars Kupics, Aija Mača-Kalēja, Ainārs Rudzītis, Daiga Behmane and Oskars Kalējs

Diagnostics 2026, 16(9), 1398; https://doi.org/10.3390/diagnostics16091398 - 6 May 2026

Cited by 1 | Viewed by 982

Abstract

Background: Atrial fibrillation (AF) significantly impacts the clinical and financial burden of healthcare systems worldwide. Patient-reported outcomes (PROMs) are considered a core element of patient-centered care. However, the integration of PROMs into AF clinical pathways remains limited. Objectives: In this study, [...] Read more.

Background: Atrial fibrillation (AF) significantly impacts the clinical and financial burden of healthcare systems worldwide. Patient-reported outcomes (PROMs) are considered a core element of patient-centered care. However, the integration of PROMs into AF clinical pathways remains limited. Objectives: In this study, we aimed to develop a policy-oriented framework for integrating PROMs into AF management, building on QoL assessment and the AF-CARE pathway. Methods: We compared the selected instruments (AFEQT, SF-36, EQ-5D, and AFSS) to examine how different QoL domains are represented. We then considered how the missing domains relate to routine care and healthcare delivery. On this basis, we constructed a conceptual framework linking PROM domains with clinical and policy decisions, as well as with diagnostic and follow-up strategies in AF. Results: Existing PROMs capture symptom burden reasonably well, but they do not fully reflect several domains that shape the daily experience of patients with AF, including cognition, sleep quality, sexual health, and economic burden. The proposed framework places PROMs within the AF-CARE components and illustrates how they can be used in routine practice—not only for long-term monitoring, but also to improve clinical decision-making, and better align with value-based healthcare strategies at both the clinical and system levels. It also outlines a practical approach to incorporating PROMs into everyday care and into broader health-system decision-making. Conclusions: Integrating PROMs into AF-CARE requires a system-level redesign rather than isolated tool implementation. Within the proposed framework, the question is no longer whether PROMs should be used in AF care, but how to integrate them in a way that meaningfully influences clinical decisions and patient outcomes. Full article

(This article belongs to the Special Issue Clinical Diagnosis and Management in Cardiology)

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12 pages, 1176 KB

Open AccessArticle

Do Computed Tomography Findings Affect Operating Time in Bi-Lateral Sagittal Split Osteotomy? A Pilot Study

by Kazuyuki Yusa, Nobuyuki Sasahara, Tomoharu Hemmi, Satoshi Kasuya, Kenta Kagami, Kotaro Taniguchi and Shigeo Ishikawa

Diagnostics 2026, 16(9), 1397; https://doi.org/10.3390/diagnostics16091397 - 6 May 2026

Viewed by 452

Abstract

Background/Objectives: The aim of this study was to investigate the association between patient demographics and overall operating time during bilateral sagittal split osteotomy (BSSO). Methods: For this retrospective study, data were collected from patients who had undergone BSSO in our hospital [...] Read more.

Background/Objectives: The aim of this study was to investigate the association between patient demographics and overall operating time during bilateral sagittal split osteotomy (BSSO). Methods: For this retrospective study, data were collected from patients who had undergone BSSO in our hospital between 2016 and 2023. The mandibular body and mandibular ramus were evaluated from preoperative computed tomography (CT), and CT attenuation values of cortical and cancellous bone in the mandibular ramus were obtained from standardized preoperative CT images. Patient demographics (age, sex, occlusal class, and body weight) before surgery were also collected from the medical record. Results: Forty-six patients were included in this study. Weight and CT attenuation of the mandibular ramus (both cortical and cancellous bone) correlated with operating time (weight: rs = 0.304, p = 0.04; CT attenuation of mandibular ramus: rs = 0.323, p = 0.029). In addition, the Mann–Whitney U test revealed significantly greater operating time in males (p < 0.05). Effects of each variable were estimated after adjusting for other variables, and CT attenuation of the mandibular ramus (both cortical and cancellous bone) (B = 0.088, p = 0.008) was identified as having an effect on operating time. Higher CT attenuation, reflecting greater cortical and cancellous bone density, may increase resistance during osteotomy and consequently prolong operating time. Conclusions: This pilot study observed a possible association between CT attenuation of the mandibular ramus and operating time in BSSO. However, these findings are preliminary and do not imply any causal relationships. Thus, further studies with larger cohorts are required to confirm these observations. Full article

(This article belongs to the Special Issue Recent Advances in Oral and Maxillofacial Surgery: Diagnosis and Management)

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14 pages, 7051 KB

Open AccessArticle

Variation in Manifest Subjective Refraction in a Population Screened for Refractive Surgery

by Achim Langenbucher, Jascha Wendelstein, Nóra Szentmáry, Alan Cayless, Anika Förster, Peter Hoffmann and Suphi Taneri

Diagnostics 2026, 16(9), 1396; https://doi.org/10.3390/diagnostics16091396 - 5 May 2026

Viewed by 569

Abstract

Background/Objectives: The purpose of this study was to investigate the variation in subjective manifest refraction measures in a patient cohort screened for myopic refractive surgery. Methods: In this retrospective non-randomised cross-sectional single-centre study, we evaluated a dataset containing sequences of three [...] Read more.

Background/Objectives: The purpose of this study was to investigate the variation in subjective manifest refraction measures in a patient cohort screened for myopic refractive surgery. Methods: In this retrospective non-randomised cross-sectional single-centre study, we evaluated a dataset containing sequences of three refraction measurements performed by four experienced optometrists in 175 eyes screened for refractive corneal or lens surgery for myopia or myopic astigmatism. Refraction was converted from sphere (SPH), cylinder (CYL) and axis to power vector components (spherical equivalent SEQ and cylinder projections C0 and C45). The mean power vectors of the three repeat measurements (MEAN) and the deviations (DEV) of the repeat measurements from the MEAN were evaluated. Results: MEAN values for SPH/CYL/SEQ/C0/C45 were −5.93/0.99/−5.44/−0.47/0.02 D and the corresponding standard deviations were 0.20/0.16/0.17/0.17/0.16 D. DEV of both SEQ and CYL correlated significantly with patient age (Spearman R = 0.16 and 0.20). DEV of CYL correlated with mean (myopic) SEQ (R = −0.22) and CYL (R = 0.27) whereas DEV of SEQ showed no significant correlation with mean SEQ or CYL. Conclusions: The variation in subjective manifest refraction with repeat measurements is in a range of ±0.16 to ±0.20 D for SPH, CYL and the power vector components SEQ, C0 and C45. If reliable subjective refraction measurements are mandatory, e.g., for planning refractive surgery procedures or for formula constant optimisation, repeat refractometry measures could help to ensure representative data and to estimate the intraindividual variations. Full article

(This article belongs to the Special Issue Diagnosis and Management of Ophthalmic Disorders)

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12 pages, 539 KB

Open AccessArticle

Exploratory Analysis of Dental Age Differences in Children with Type 1 Diabetes Using the Demirjian Method

by Maria Simona Dămășaru, Eugen Bud, Sorana Maria Bucur, Mariana Păcurar, Manuela Chibelean, Silvia-Izabella Pop, Alexandru Ștefan Zalana, Irina Elena Muntean, Lucian Cristian Petcu and Mariana Cornelia Tilinca

Diagnostics 2026, 16(9), 1395; https://doi.org/10.3390/diagnostics16091395 - 5 May 2026

Viewed by 513

Abstract

Background: Chronological age does not always accurately reflect biological maturation in children, particularly in the presence of systemic conditions. Dental age is widely used as a biological maturity indicator; however, the impact of Type 1 diabetes mellitus on dental development remains unclear and [...] Read more.

Background: Chronological age does not always accurately reflect biological maturation in children, particularly in the presence of systemic conditions. Dental age is widely used as a biological maturity indicator; however, the impact of Type 1 diabetes mellitus on dental development remains unclear and inconsistently reported. Objective: This paper aims to explore differences between dental age (DA) and chronological age (CA) in children with Type 1 diabetes compared to healthy controls, and to assess the association between glycemic control (HbA1c) and dental maturation. Materials and Methods: This observational comparative study included 90 children aged 8–15 years: 45 with Type 1 diabetes and 45 age- and sex-matched healthy controls. Dental age was estimated using the Demirjian method and compared with chronological age. Group comparisons were performed using independent t-tests, while paired t-tests assessed within-group differences. Linear regression analysis evaluated the association between HbA1c and dental age. Effect sizes and 95% confidence intervals were reported. Results: In the diabetes group, dental age was significantly higher than chronological age (mean difference = 1.56 years, p < 0.001), indicating advanced dental maturation. No significant difference between dental and chronological age was observed in the control group. Dental age was also significantly higher in the diabetes group compared to controls (mean difference = 1.61 years, p < 0.001; Cohen’s d = 0.93). HbA1c levels were positively associated with dental age (R² = 0.409, p < 0.01), suggesting that metabolic control may contribute to variability in dental maturation. Conclusions: Children with Type 1 diabetes appear to exhibit advanced dental maturation compared to healthy peers. Glycemic control may be associated with this variation, although the findings should be interpreted within the exploratory framework of the study. Dental age assessment should be used cautiously and in conjunction with other maturity indicators, particularly in children with systemic conditions. Full article

(This article belongs to the Special Issue Focus on Children's Oral Health: Advances in Pediatric Dentistry and Imaging Assessments)

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12 pages, 491 KB

Open AccessArticle

Edema as a Key Presentation of Acrodermatitis Chronica Atrophicans: A Retrospective Cohort Study from a Tertiary Setting in Denmark 2017–2025

by Otto Scharff El-Nasser, Helene Mens, Nanna Skaarup Andersen, Christoffer Valdemar Nissen and Anne-Mette Lebech

Diagnostics 2026, 16(9), 1394; https://doi.org/10.3390/diagnostics16091394 - 5 May 2026

Viewed by 761

Abstract

Background/Objectives: Acrodermatitis chronica atrophicans (ACA), a late cutaneous manifestation of Lyme borreliosis, presents with a broad clinical spectrum. Most commonly, a characteristic bluish-red patchy rash, but it can also appear as unilateral limb swelling. This study aimed to characterize the clinical manifestations, diagnostic [...] Read more.

Background/Objectives: Acrodermatitis chronica atrophicans (ACA), a late cutaneous manifestation of Lyme borreliosis, presents with a broad clinical spectrum. Most commonly, a characteristic bluish-red patchy rash, but it can also appear as unilateral limb swelling. This study aimed to characterize the clinical manifestations, diagnostic workup, and outcomes of patients with ACA in a tertiary setting in Denmark. Methods: Retrospective cohort study including all patients diagnosed with ACA at Copenhagen University Hospital-Rigshospitalet between 2017 and 2025. Results: Forty patients were included (median age 57 years; 63% female), with a median BMI of 24.5 [range 15.6–36.3]. Symptom duration was long (median 1 year). All patients presented with a skin rash. The most common location was the lower extremity, 26/40 (65%). Local edema and neuropathic pain were common (20/40) 50% and (23/40) 55%, respectively. A total of 13/40 patients underwent lymphoscintigraphy, which was deemed pathological in 7/13 (54%). The patients presenting with edema underwent significantly more imaging procedures, median 3 (range 1–5) vs. 0 (range 0–2), p < 0.005; they were younger, median age 49 years (range 17–76) vs. median 65 (range 30–81), p = 0.03; but did not differ in BMI, median 26.6 (range 19.0–36.2) versus median 23.8 (range 15.6–36.3), p = 0.48. All patients were Borrelia burgdorferi (Bb) IgG seropositive. Borrelia-specific PCR was positive in 6/13 (46%). Histopathology supported the diagnosis in 19/20 (95%). Clinical evaluation of the treatment response at 3 months was good in 33/40 (83%). Conclusions: Edema/swelling due to lymphatic obstruction is a common presentation of ACA in the tertiary setting, resulting in extensive diagnostic workup. The condition is associated with younger age but not BMI, sex, or immunodeficiency. Raised awareness and earlier testing for Bb IgG in serum seem warranted. Full article

(This article belongs to the Section Clinical Diagnosis and Prognosis)

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Open AccessArticle

Vascular Features of Gallbladder Lesions Using Microvascular Flow Imaging on Transabdominal Ultrasonography: A Retrospective Study

by Haruo Miwa, Ritsuko Oishi, Nene Sakai, Ryo Soma, Kozue Shibasaki, Yugo Ishino, Shotaro Tsunoda, Kazuki Endo, Akihiro Funaoka, Yuichi Suzuki, Hiromi Tsuchiya, Satoshi Komiyama, Manabu Morimoto and Shin Maeda

Diagnostics 2026, 16(9), 1393; https://doi.org/10.3390/diagnostics16091393 - 5 May 2026

Viewed by 698

Abstract

Background/Objectives: Transabdominal ultrasonography (TUS) is widely used for the detection of gallbladder lesions (GBLs), but differentiating malignant lesions from non-malignant lesions remains challenging. Microvascular flow imaging (MVFI), including superb microvascular imaging, detective flow imaging, and B-flow, enables visualization of low-flow vessels without contrast [...] Read more.

Background/Objectives: Transabdominal ultrasonography (TUS) is widely used for the detection of gallbladder lesions (GBLs), but differentiating malignant lesions from non-malignant lesions remains challenging. Microvascular flow imaging (MVFI), including superb microvascular imaging, detective flow imaging, and B-flow, enables visualization of low-flow vessels without contrast agents. This study aimed to characterize MVFI vascular features of GBLs and evaluate their reproducibility. Methods: We retrospectively analyzed 42 patients with GBLs who underwent TUS between March 2022 and December 2025. Two blinded readers independently assessed B-mode and MVFI findings. The evaluated MVFI findings included vascular flow detection, number of basal vessels, vessel shape, vessel thickness, and vessel irregularity. Interobserver agreement was assessed using Cohen’s kappa coefficient, and imaging findings were compared between invasive malignant and non-malignant lesions. Results: Of the 42 lesions, 10 were invasive malignant and 32 were non-malignant. Vascular signals were detected in all invasive malignant lesions and in 21 of 32 non-malignant lesions. Multiple basal vessels and vessel dilation were more frequently observed in invasive malignant lesions. Interobserver agreement was excellent for the number of basal vessels (κ = 0.91) and good for vessel thickness (κ = 0.72), indicating that these findings were more reproducible than other MVFI features. Conclusions: MVFI enables visualization of intralesional vascular features in GBLs. Multiple basal vessels and vessel dilation were associated with invasive malignancy and showed favorable reproducibility. These findings may serve as candidate imaging markers for future prospective validation. Full article

(This article belongs to the Special Issue Abdominal Ultrasound: A Left Behind Area—2nd Edition)

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16 pages, 1289 KB

Open AccessArticle

Comparative Outcomes of Left Bundle Branch Pacing and Biventricular Pacing for Cardiac Resynchronization Therapy in Heart Failure with Reduced Ejection Fraction

by Fedan Hacizade, Mert Dogan, Kudret Aytemir and Ugur Canpolat

Diagnostics 2026, 16(9), 1392; https://doi.org/10.3390/diagnostics16091392 - 4 May 2026

Viewed by 753

Abstract

Background: Left bundle branch area pacing (LBBaP) has emerged as a physiological alternative to conventional biventricular pacing (BiVP) for cardiac resynchronization therapy (CRT). We aimed to compare long-term clinical, electrical, and echocardiographic outcomes of LBBaP versus BiVP in patients with heart failure with [...] Read more.

Background: Left bundle branch area pacing (LBBaP) has emerged as a physiological alternative to conventional biventricular pacing (BiVP) for cardiac resynchronization therapy (CRT). We aimed to compare long-term clinical, electrical, and echocardiographic outcomes of LBBaP versus BiVP in patients with heart failure with reduced ejection fraction (HFrEF). Methods: In this single-center retrospective study, 271 consecutive patients undergoing CRT implantation were included (LBBaP, n = 68; BiVP, n = 203). Outcomes included electrical resynchronization parameters, echocardiographic reverse remodeling, heart failure hospitalization, and all-cause mortality during a median follow-up of 41 months. Results: LBBaP achieved greater electrical resynchronization, with shorter postprocedural QRS duration (144 vs. 153 ms; p = 0.005) and shorter left ventricular activation time compared with BiVP. LBBaP was associated with lower radiation exposure (124 vs. 244 mGy; p < 0.001) and lower pacing thresholds. At 6 months, LVEF was higher in the LBBaP group (37.7% vs. 33.0%; p = 0.005), and heart failure hospitalization occurred less frequently (22.6% vs. 36.7%; p = 0.042). Long-term all-cause mortality did not differ between groups (p = 0.289). In multivariable analysis, baseline renal dysfunction and heart failure hospitalization within 6 months independently predicted mortality. Conclusions: In patients with HFrEF undergoing CRT, LBBaP provides superior electrical resynchronization and greater reverse remodeling compared with BiVP. Although associated with improved short-term clinical outcomes, long-term survival appears primarily determined by comorbid conditions rather than pacing modality. Full article

(This article belongs to the Section Clinical Diagnosis and Prognosis)

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13 pages, 2150 KB

Open AccessArticle

Bowel Bubble Formation with Oral Sulfate Solution for Colonoscopy Bowel Preparation Using Same-Day and Split-Day Regimens: The B-BOSS Study

by Naohisa Yoshida, Ken Inoue, Reo Kobayashi, Yoshikazu Inagaki, Yuri Tomita, Hikaru Hashimoto, Yutaka Inada, Ryohei Hirose, Takeshi Yasuda, Naoto Iwai, Osamu Dohi, Kazuhiko Uchiyama, Hardesh Dhillon and Tomohisa Takagi

Diagnostics 2026, 16(9), 1391; https://doi.org/10.3390/diagnostics16091391 - 4 May 2026

Viewed by 649

Abstract

Background and Objectives: Bowel bubble formation during colonoscopy can impair mucosal visualization and reduce procedural efficiency. However, its clinical significance remains incompletely characterized. This study aimed to evaluate the prevalence of severe bowel bubbles in the proximal colon and their impact on colonoscopic [...] Read more.

Background and Objectives: Bowel bubble formation during colonoscopy can impair mucosal visualization and reduce procedural efficiency. However, its clinical significance remains incompletely characterized. This study aimed to evaluate the prevalence of severe bowel bubbles in the proximal colon and their impact on colonoscopic quality in patients undergoing bowel preparation with oral sulfate solution (OSS), using either a same-day regimen (SAR) with 480 mL OSS or a split-day regimen (SPR) with 960 mL OSS. Methods: This retrospective study was conducted between October 2024 and December 2025 across two affiliated institutions. Patients who underwent colonoscopy with OSS-based bowel preparation were included. SAR was used for screening, symptomatic evaluation, and surveillance colonoscopy. SPR was applied exclusively to patients with a prior history of sodium picosulfate-related abdominal pain or inadequate bowel preparation with SAR. Sodium picosulfate was prescribed on the day before colonoscopy in the SAR group and a low-residual diet was administered in both the SAR and SPR groups. The prevalence of severe bubbles in the proximal colon was evaluated, and their impact on colonoscopic quality was examined. Results: A total of 176 SAR cases and 51 SPR cases were analyzed. The rate of severe bubbles in the proximal colon was identical between both regimens (17.6%). Compared with cases without severe bubbles, those with severe bubbles had significantly longer cecal insertion times (median [IQR]: 7.0 [5.0–10.0] vs. 9.0 [7.0–13.0] min, p = 0.018) and total procedure time (20.0 [16.0–25.0] vs. 24.0 [19.0–30.0] min, p = 0.024). Preparation-to-colonoscopy time was also longer in cases with severe bubbles (5.0 [4.0–5.5] vs. 5.0 [5.0–6.0] h, p = 0.041). Adenoma detection rates were 73.2% in cases without severe bubbles and 67.5% in those with severe bubbles (p = 0.571). Conclusions: Severe bowel bubble formation tended to be associated with longer cecal insertion and total procedure times, and was more frequently observed with a longer preparation-to-colonoscopy interval. Full article

(This article belongs to the Special Issue Global Advances in EGD and Colonoscopy: The Convergence of Advanced Imaging and AI)

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11 pages, 4453 KB

Open AccessArticle

Histopathological Analysis of Thrombi in Acute Ischemic Stroke: An Exploratory Study of Thrombus Composition and CD34-Positive Endothelial Cells

by Sena Aksoy, Atay Vural, İbrahim Kulaç, Hatem Hakan Selçuk, Ali Burak Kızılırmak, Yasemin Gürsoy Özdemir and Bayram Yılmaz

Diagnostics 2026, 16(9), 1390; https://doi.org/10.3390/diagnostics16091390 - 3 May 2026

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Abstract

Background/Objectives: Mechanical thrombectomy (MT) enables direct examination of the retrieved thrombus in acute ischemic stroke. Thrombus composition may influence treatment outcomes and reflect underlying stroke mechanisms. This study aimed to analyze thrombus histological composition and CD34-positive endothelial cells and evaluate their association with [...] Read more.

Background/Objectives: Mechanical thrombectomy (MT) enables direct examination of the retrieved thrombus in acute ischemic stroke. Thrombus composition may influence treatment outcomes and reflect underlying stroke mechanisms. This study aimed to analyze thrombus histological composition and CD34-positive endothelial cells and evaluate their association with clinical and radiological characteristics. Methods: Fifty-six patients with acute ischemic stroke who underwent MT were included. Thrombi were classified as fibrin-dominant or red blood cell (RBC)-dominant using hematoxylin–eosin staining (H&E). Endothelial cells were identified via CD34 immunostaining. Associations between thrombus composition, procedural variables, imaging findings, and clinical outcomes were analyzed. Results: Forty-one (73.2%) thrombi were fibrin-dominant, and 15 (26.8%) were RBC-dominant. Fibrin-dominant thrombi were significantly associated with more distal occlusions (p = 0.027) and with the use of stent-retrievers (p = 0.045). RBC-dominant thrombi were more frequently associated with the hyperdense artery sign (HAS) (p = 0.015). CD34-positive staining correlated with shorter symptom-to-door (p = 0.017) and symptom-to-puncture times (p < 0.001). Endothelial ingrowth was more common in thrombi from proximal occlusions (p = 0.017). No significant associations were observed between thrombus composition and recanalization success, number of passes, or functional outcomes. The association between RBC-dominant thrombi and HAS supports the potential role of imaging markers in predicting thrombus composition prior to intervention. In addition, the presence and distribution of CD34-positive endothelial cells in relation to time intervals and occlusion location may reflect dynamic processes such as thrombus organization and vessel wall interaction. Conclusions: These findings highlight the heterogeneous nature of thrombus in acute ischemic stroke. Further studies are needed to clarify the biological and clinical implications of these observations. Full article

(This article belongs to the Section Pathology and Molecular Diagnostics)

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18 pages, 6268 KB

Open AccessArticle

Deep Learning-Based Full-Process Automatic CPAK Classification System and Its Application in the Analysis of Alignment Outcomes Before and After Knee Arthroplasty

by Kun Wu, Xiao Geng, Xinguang Wang, Jiazheng Chen and Hua Tian

Diagnostics 2026, 16(9), 1389; https://doi.org/10.3390/diagnostics16091389 - 3 May 2026

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Abstract

Background/Objectives: Coronal Plane Alignment of the Knee (CPAK) classification enables individualized alignment assessment in total knee arthroplasty (TKA), yet manual evaluation is time-consuming and lacks preoperative-to-postoperative transition analysis. Methods: This retrospective, single-center study aimed to develop and validate a fully automated [...] Read more.

Background/Objectives: Coronal Plane Alignment of the Knee (CPAK) classification enables individualized alignment assessment in total knee arthroplasty (TKA), yet manual evaluation is time-consuming and lacks preoperative-to-postoperative transition analysis. Methods: This retrospective, single-center study aimed to develop and validate a fully automated deep learning-based CPAK classification system using internal validation on a held-out test set (n = 92) and to investigate individual-level transition patterns and their association with short-term clinical outcomes using paired radiographic data from a large Chinese cohort. A total of 919 KOA patients undergoing TKA were analyzed. A keypoint detection model (HRNet-W32) was developed to automatically calculate the medial proximal tibial angle, lateral distal femoral angle, arithmetic hip-knee-ankle angle, and joint line obliquity, from which CPAK types were derived. Results: On the validation set (92 cases), the model achieved a Mean Radial Error of 1.22 ± 0.43 mm for keypoint detection; mean absolute errors for MPTA and LDFA were ≤0.74°, while for aHKA and JLO they were 0.91° and 1.12°, respectively, with intraclass correlation coefficients ≥0.96 compared to manual annotations. Automatic CPAK classification accuracy was 80.98% (kappa = 0.767). Transition matrix analysis showed that only 9.36% of all patients maintained their original type postoperatively, with most shifting to types IV, V, or VII. After inverse probability weighting, no significant differences in clinical outcomes were observed among transition groups (all adjusted p > 0.05). Conclusions: These results demonstrate that the proposed automated system enables efficient CPAK assessment, revealing substantial postoperative alignment transitions that were not associated with differential short-term outcomes, thereby supporting AI-assisted individualized alignment planning in TKA. Full article

(This article belongs to the Section Machine Learning and Artificial Intelligence in Diagnostics)

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23 pages, 870 KB

Open AccessArticle

Admission Biomarkers as Predictors of Mortality in Comatose Patients in the Intensive Care Unit: A Retrospective Pilot Study

by Pompiliu Mircea Bogdan, Roxana Elena Bogdan-Goroftei, Alina Plesea-Condratovici, Adina Oana Armencia, Letitia Doina Duceac, Camer Salim, Cristian Gutu, Manuela Arbune, Lavinia-Alexandra Moroianu, Constantin Marinel Vlase, Monica Mihaela Scutariu and Alina Mihaela Calin

Diagnostics 2026, 16(9), 1388; https://doi.org/10.3390/diagnostics16091388 - 3 May 2026

Viewed by 584

Abstract

Background: Intensive care units (ICUs) provide management of critically ill patients requiring continuous monitoring and complex therapeutic interventions. The aim of this study was to analyze the clinical and biological characteristics associated with mortality in patients admitted to the intensive care unit. [...] Read more.

Background: Intensive care units (ICUs) provide management of critically ill patients requiring continuous monitoring and complex therapeutic interventions. The aim of this study was to analyze the clinical and biological characteristics associated with mortality in patients admitted to the intensive care unit. Methods: This retrospective observational study included 108 adult patients admitted to the Anesthesia and Intensive Care Unit of the “Sf. Apostol Andrei” Emergency County Clinical Hospital in Galați, who were in a coma at the time of admission. Demographic data, comorbidities, clinical parameters and biological biomarkers determined at admission were analyzed. Statistical analysis was performed using the SPSS program and included non-parametric tests (Mann–Whitney U), Spearman correlation analysis, multivariate logistic regression and ROC curve analysis to evaluate the predictive performance of biomarkers. Results: Hypertension (60.2%) and diabetes mellitus (35.2%) were the most common comorbidities. Comparative analysis revealed significant differences between deceased and surviving patients for several biological parameters, including leukocytes, C-reactive protein, LDH, D-dimers, INR and APTT. In multivariate analysis, LDH (OR = 0.998; p < 0.001) and APTT (OR = 0.951; p = 0.033) remained independently associated with mortality. ROC analysis revealed good discrimination capacity for LDH (AUC ≈ 0.805) and moderate performance for APTT. Conclusions: Determination of LDH and APTT at the time of admission to the ICU may provide useful information for assessing the prognosis of critically ill patients and for early stratification of mortality risk. Full article

(This article belongs to the Section Clinical Diagnosis and Prognosis)

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17 pages, 2496 KB

Open AccessArticle

Vaginal Microbiota Composition and HPV Genotype-Specific CIN2+ Risk: A Cross-Sectional Study

by Alexandru Hamod, Razvan Popovici, Mihaela Oancea, Mihaela Grigore, Tudor Lazăr, Ingrid-Andrada Vasilache, Anda Pristavu, Dumitru Gafițanu, Alexandra Cristofor, Adina Tănase, Cristina Mandici, Ana-Maria Grigore, Liliana Strat, Cristian Bucșineanu and Manuela Ciocoiu

Diagnostics 2026, 16(9), 1387; https://doi.org/10.3390/diagnostics16091387 - 2 May 2026

Viewed by 675

Abstract

Background/Objectives: Emerging evidence links vaginal microbiome dysbiosis with HPV persistence and CIN progression, but whether microbiome markers provide incremental prognostic value beyond molecular triage assays remains unclear. This study aimed to evaluate whether Lactobacillus depletion and Shannon diversity improve prediction of biopsy-confirmed [...] Read more.

Background/Objectives: Emerging evidence links vaginal microbiome dysbiosis with HPV persistence and CIN progression, but whether microbiome markers provide incremental prognostic value beyond molecular triage assays remains unclear. This study aimed to evaluate whether Lactobacillus depletion and Shannon diversity improve prediction of biopsy-confirmed CIN2+ and CIN3+ outcomes beyond CINtec and HPV-16 genotyping. Methods: This was a secondary analysis of a cross-sectional study including 82 women undergoing cervical screening or follow-up for abnormal cytology. Associations with CIN2+, CIN3+, and CINtec positivity were estimated using modified Poisson regression. Multiplicative interaction between HPV-16 and Lactobacillus depletion was formally tested. Incremental discriminative performance was assessed using area under the receiver operating characteristic curve (AUC), DeLong’s test, net reclassification improvement (NRI), and integrated discrimination improvement (IDI). Results: HPV-16 was the strongest predictor of CIN2+ (PR = 6.08, p < 0.001) and CIN3+ (PR = 5.53, p = 0.001). A significant sub-multiplicative interaction indicated that Lactobacillus depletion carried its strongest prognostic signal in HPV-16-negative women (CIN3+: PR_interaction = 0.04, p = 0.003). Adding microbiome markers to CINtec + HPV-16 significantly improved CIN2+ discrimination (ΔAUC = 0.034, p = 0.031), driven by correct downward reclassification of non-events (NRI_non-events = 0.833). When added to HPV-16 + age, IDI for CIN2+ reached 0.092 (p = 0.004). Conclusions: Vaginal microbiome markers, particularly Lactobacillus depletion, provide statistically significant incremental discriminative value for CIN2+ beyond CINtec p16/Ki-67 dual staining and HPV-16 genotyping. Microbiome-based triage may be most impactful in HPV-16-negative women. Full article

(This article belongs to the Special Issue Recent Advances in the Diagnosis and Management of Gynecological Cancers)

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18 pages, 747 KB

Open AccessArticle

Cumulative Reproductive Outcomes Across Three Embryo Transfer Cycles After Hysteroscopic Endometrial Polypectomy Using a Tissue Removal System in Infertile Women: A Single-Center Retrospective Cohort Study

by Yurie Nako, Kiyotaka Kawai, Shoko Katsumata, Yuko Takayanagi, Shogo Nishii, Tatsuyuki Ogawa, Makiko Tajima and Osamu Hiraike

Diagnostics 2026, 16(9), 1386; https://doi.org/10.3390/diagnostics16091386 - 2 May 2026

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Abstract

Background/Objectives: This study aimed to describe cumulative reproductive outcomes across three embryo transfer (ET) cycles after hysteroscopic endometrial polypectomy using a hysteroscopic tissue removal system (HTRS) and to identify determinants of cumulative and per-cycle pregnancy. Methods: In this single-center retrospective cohort study, we [...] Read more.

Background/Objectives: This study aimed to describe cumulative reproductive outcomes across three embryo transfer (ET) cycles after hysteroscopic endometrial polypectomy using a hysteroscopic tissue removal system (HTRS) and to identify determinants of cumulative and per-cycle pregnancy. Methods: In this single-center retrospective cohort study, we included infertile women who underwent HTRS-based endometrial polypectomy between January 2023 and December 2024 and subsequently initiated at least one ET cycle. Patients were followed from ET1 through ET3. The primary endpoint was the cumulative clinical pregnancy rate (CCPR) within three ET cycles. In the observed cumulative analysis, treatment discontinuation was considered as non-pregnancy. Kaplan–Meier (KM) analysis was used to estimate the cumulative pregnancy probability, with treatment discontinuation considered as censoring. Multivariate logistic regression and generalized estimating equations were used to identify patient-level and cycle-level predictors. Results: Among 100 patients, 79 achieved clinical pregnancy within three ET cycles (CCPR 79.0%). The KM estimate at ET3 was 87.4%, and the cumulative live birth rate was 65.0%. Pregnancy rates declined with advancing maternal age (≤34 years, 91.9%; 35–39 years, 78.3%; ≥40 years, 52.9%). Maternal age independently predicted lower cumulative pregnancy and lower per-cycle pregnancy probability, whereas blastocyst transfer was associated with a higher probability of pregnancy per cycle. Conclusions: In women who underwent ET after HTRS polypectomy, cumulative pregnancy across three ET cycles was relatively high; however progression to live birth declined with advancing maternal age. As no non-surgical comparison group was included, these findings should be interpreted as descriptive rather than causal. Full article

(This article belongs to the Topic Development of Diagnosis and Treatment Modalities in Obstetrics and Gynecology)

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11 pages, 1208 KB

Open AccessArticle

Evaluation of Presacral Vascular Anatomy Using Contrast-Enhanced 3D-CT for Surgical Planning in Endoscopic Sacrocolpopexy

by Akiko Abe, Yasushi Kotani, Chiharu Wada, Takaya Sakamoto, Yoko Kashima, Kosuke Murakami, Hisamitsu Takaya and Noriomi Matsumura

Diagnostics 2026, 16(9), 1385; https://doi.org/10.3390/diagnostics16091385 - 2 May 2026

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Abstract

Background: Endoscopic sacrocolpopexy (ESC) is a widely performed procedure for pelvic organ prolapse, with laparoscopic sacrocolpopexy (LSC) and robotic-assisted sacrocolpopexy (RSC) approaches. However, suturing to the anterior longitudinal ligament at the sacral promontory carries a risk of massive hemorrhage due to presacral [...] Read more.

Background: Endoscopic sacrocolpopexy (ESC) is a widely performed procedure for pelvic organ prolapse, with laparoscopic sacrocolpopexy (LSC) and robotic-assisted sacrocolpopexy (RSC) approaches. However, suturing to the anterior longitudinal ligament at the sacral promontory carries a risk of massive hemorrhage due to presacral vascular injury. This study aimed to determine the frequency of presacral venous variations considered clinically relevant during suturing at the promontory and to explore their association with perioperative outcomes using contrast-enhanced three-dimensional computed tomography (3D-CT). Methods: Among 319 consecutive ESC cases performed between 2014 and 2025, 265 patients who underwent preoperative contrast-enhanced CT were retrospectively analyzed in this single-center cohort study. Two vascular findings were defined as clinically significant: (1) anomalous drainage of the internal iliac vein into the contralateral common iliac vein and (2) a clearly visualized median sacral vein on 3D reconstruction. The clinical impact of vascular abnormalities was evaluated using surgical time, blood loss, and perioperative complication rates as indicators. Student’s t-test was used for comparing continuous variables, and the chi-squared test was used for comparing categorical variables. The data for this study were retrospectively collected from electronic medical records, anonymized, and then analyzed. Results: Anomalous internal iliac vein drainage was observed in 11.3% (30/265), and a visible median sacral vein was observed in 10.2% (27/265). Overall, 17.7% (47/265, CI: 13.2–22.2%) of patients had at least one clinically significant variation. There were no significant differences between the groups in terms of age, parity, BMI, operative time, blood loss, or perioperative complication rates. No cases required transfusion. Conclusions: Clinically significant presacral vein mutations were present in approximately 1 in 6 patients. The main findings of this study are that clinically significant presacral vascular mutations are relatively frequent (17.7%) in ESC and that there was no significant difference in perioperative outcomes between patients with and without vascular mutations. Clinically relevant presacral vascular variations are relatively common in ESC. Preoperative contrast-enhanced 3D-CT may support risk assessment and surgical planning. Full article

(This article belongs to the Special Issue Diagnosis and Management of Gynecological Disorders)

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13 pages, 881 KB

Open AccessReview

Advances in the Diagnosis of Invasive Pulmonary Mold Infections: Focus on Diagnostic Performance and Cost-Effectiveness of Diagnostic Tests

by Spyridon Papadimatos, Andreas Tziotis, Panos Arvanitis, Audrey Le-Mahajan and Dimitrios Farmakiotis

Diagnostics 2026, 16(9), 1384; https://doi.org/10.3390/diagnostics16091384 - 2 May 2026

Viewed by 1303

Abstract

Invasive pulmonary mold infections (IPMIs) are critical complications in immunocompromised patients, contributing significantly to morbidity and mortality. Diagnosing pathogens like Aspergillus species (spp.) and the Mucorales remains challenging due to non-specific clinical presentations and the limitations of traditional culture methods. This review provides [...] Read more.

Invasive pulmonary mold infections (IPMIs) are critical complications in immunocompromised patients, contributing significantly to morbidity and mortality. Diagnosing pathogens like Aspergillus species (spp.) and the Mucorales remains challenging due to non-specific clinical presentations and the limitations of traditional culture methods. This review provides an up-to-date synopsis of IPMI diagnostic tools, focusing on their diagnostic performance, turnaround time (TAT), and cost-effectiveness. We conducted a narrative review of the current literature regarding clinical evaluation, radiographic findings, invasive diagnostics, and non-invasive assays, including next-generation sequencing (NGS) and volatile organic compounds (VOCs). Chest computerized tomography (CT) remains a vital first step, though classic signs like the “halo” or “reverse halo” are neither sensitive nor specific. Traditional diagnostics are limited by low sensitivity and delayed results. While plasma microbial cell-free DNA (mcfDNA) NGS offers rapid TAT (24–48 h) and high specificity, its suboptimal sensitivity for Aspergillus spp. (<50%) and high cost remain significant barriers. Investigational VOC “breath tests” show promising sensitivity (77–96%) but lack standardization. Future research must prioritize the standardization of non-invasive microbiologic testing modalities, particularly those with rapid TAT such as bedside “breath tests” and high-throughput mcfDNA NGS. Development of clinical algorithms that balance cost-effectiveness with timely pathogen diagnosis based on the patient’s degree of immunosuppression is essential to improve survival in high-risk populations. Full article

(This article belongs to the Special Issue Advances in Diagnostic and Therapeutic Strategies for Infectious Diseases)

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16 pages, 3675 KB

Open AccessArticle

Performance of New Roche Cobas Pulse Glucose Meter Against Potential Interfering Substances and Hematocrit Variations

by Mokarrameh Pudineh Moarref, Wanda Black and Yu Chen

Diagnostics 2026, 16(9), 1383; https://doi.org/10.3390/diagnostics16091383 - 1 May 2026

Viewed by 3594

Abstract

Background: Point-of-care (POC) glucometers are essential for rapid blood glucose monitoring but are subject to interference and hematocrit variations. This study evaluated the analytical performance of the new Cobas Pulse glucometer against the Accu-Chek Inform II meter in the presence of N-acetylcysteine [...] Read more.

Background: Point-of-care (POC) glucometers are essential for rapid blood glucose monitoring but are subject to interference and hematocrit variations. This study evaluated the analytical performance of the new Cobas Pulse glucometer against the Accu-Chek Inform II meter in the presence of N-acetylcysteine (NAC, 0.32–2.5 mmol/L), ascorbic acid (0.28–2.84 mmol/L), D-galactose (5.5–27 mmol/L), hemolysis (0.5–5 g/L hemoglobin), icterus (200–1600 μmol/L bilirubin), lipemia (2.5–15 g/L Intralipid), and hematocrit variations (20–60%). Methods: Interference testing followed CLSI EP07 guidelines using three whole blood pools with low (2.0–2.7 mmol/L), medium (4.5–7.4 mmol/L), and high (16.3–23 mmol/L) glucose levels. Interferents were spiked into these whole blood pools. Duplicate glucose levels were measured by 2 Pulse meters and 2 Inform II meters. The results were then assessed using the international standards, e.g., ISO 15197:2017 criteria (±15% or ±0.83 mmol/L). Results: Accu-Chek Inform II showed severe positive interference from galactose (up to 446.3%, p < 0.001), ascorbic acid (up to 98.8%, p = 0.002), and NAC (up to 61.4%, p = 0.001), exceeding ISO limits. Cobas Pulse demonstrated minimal interference (maximum biases: −3.7% for galactose, −4.4% for ascorbic acid, 7.7% for NAC, all p > 0.05). Both meters showed similar hematocrit-dependent bias (positive at 20–30%, negative at 50–60%) and acceptable performance for hemolysis, icterus (≤800 μmol/L), and lipemia. Conclusions: Compared to the Accu-Chek Inform II, the Cobas Pulse demonstrated greater resilience to interferences. Cobas Pulse meets strict accuracy standards (±10% for hospital use) with low interference, which makes it suitable for care of critically ill patients. The Cobas Pulse is more dependable for POCT across various clinical situations, supporting its role in critical care. Full article

(This article belongs to the Special Issue Recent Advances in Clinical Biochemistry, 2nd Edition)

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Diagnostics, Volume 16, Issue 9 (May-1 2026) – 165 articles

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