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ABSTRACT Red sea bream iridovirus (RSIV) occurs mainly at high water temperatures and infects more than 30 different species of fish. In Asia, infected fish cause mass mortality every year. Molecular diagnostics is a technology that efficiently detects and identifies a wide range of fish pathogens through rapid and sensitive analysis of their genetic material. Rapid viral detection is essential for effective disease control. In this study, we developed and validated a cross‐priming amplification‐based lateral flow assay (CPA‐LFA) suitable for field diagnosis owing to its short diagnostic time and simple diagnostic process. The CPA‐LFA achieved optimal performance with concentrations of 4 mM MgSO4, 1.2 mM dNTPs and 0.7 M betaine, with the reaction conducted at 60°C for 60 min. The developed CPA‐LFA could specifically identify RSIV without cross‐reactivity with several pathogens commonly reported in various fish cell lines and fish. The 95% limit of detection (LOD95%) of CPA‐LFA was 385.76 copies/μL, which was comparable to that of conventional polymerase chain reaction (PCR). Quantitative PCR (qPCR) was used to identify true‐positive and true‐negative samples from 210 fish samples (160 from cultured fish and 50 from artificially infected fish). Compared with qPCR, CPA‐LFA classified six positive samples as false positives. The viral load of these samples was determined to be less than 195.1 copies/μL. The diagnostic sensitivity and specificity of CPA‐LFA were 94.34% and 100%, respectively. Furthermore, inter‐operator reproducibility testing yielded a kappa value of 1.0, indicating perfect agreement. Therefore, the novel CPA‐LFA is especially well‐suited for field diagnostics owing to its straightforward diagnostic procedure and capability to quickly and accurately detect RSIV. [ABSTRACT FROM AUTHOR]

During periods of high-power operation, proton exchange membrane fuel cell (PEMFC) produce water, which gradually accumulates at the cathode. It causes flooding faults and significantly impacts on PEMFC safety. The data collected by the sensors is a fundamental prerequisite for the flooding faults diagnosis in PEMFC. Consequently, it is critical to select sensors. However, the conventional methods for selecting sensors consider sensitivity and noise immunity, the number of sensors selected and the flood diagnostic performance are not optimized. To solve the above problems, this paper proposes a sensor preference method that combines the Mantel test and Spearman coefficient (MS method). This method first uses the Mantel test to analyze the correlation between two flooding evaluation indicators and the sensors, it identifies suitable sensors for diagnosing flooding faults. Subsequently, the Spearman coefficient eliminates redundant sensors. Additionally, a one-dimensional convolutional neural network is employed to construct a flooding diagnosis model. The MS method is contrasted with two traditional sensor selection methods. The results show that the MS method selected sensors yield superior model training and enhanced accuracy in diagnosing flooding, thereby ensuring PEMFC safety. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to assess the efficacy of innovative Chemiluminescence Immunoassay (CLIA) in testing Cryptococcal Antigen (CrAg) across two medical centers, employing the FDA-approved CrAg Lateral Flow Assay (LFA) by IMMY as a reference standard. Methods: The study encompassed patients diagnosed with cryptococcosis at West China Hospital of Sichuan University (HX) between July 2022 and May 2023, and Suzhou Fifth People's Hospital (SZ) from September 2020 to September 2023. All specimens underwent simultaneous detection using the LFA (IMMY, Norman, USA) and CLIA (Chuanglan, Suzhou, China). Results: A total of 628 patients were enrolled, revealing a remarkable 99.20% concordance between LFA and CLIA (623/628, 99.20%). The LFA exhibited a sensitivity of 96.83% (244/252) and specificity of 98.35% (179/182). Among the 42 patients with unaltered CrAg titers, the changes of Signal-to-Cut-Off ratio (ΔS/CO) results exhibited a noteworthy discrepancy, with 71.43% (30/42) demonstrating a decreasing trend in ΔS/CO of at least 10%. Conclusions: The CLIA method demonstrated commendable specificity and sensitivity, exhibiting a high level of agreement with the FDA-approved LFA method. Additionally, CLIA demonstrated superior utility for treatment monitoring compared to LFA, offering continuous insight into the fluctuation of CrAg concentrations. [ABSTRACT FROM AUTHOR]

Background: The current diagnostic strategy for hepatitis C virus (HCV) infection involves a two-step approach: antibody HCV screening followed by confirmatory nucleic acid testing. This study aimed to evaluate the diagnostic performance of the Abbott ARCHITECT HCV Ag assay in serum/plasma samples as a potential one-step alternative for diagnosing active HCV infection in people living with hepatitis B virus (PLWHB) through a systematic review and meta-analysis. Methods: A systematic review and meta-analysis were conducted following PRISMA-DTA guidelines. This protocol was registered on PROSPERO (CRD42023402093). A comprehensive search of electronic databases identified studies published up to 1 November 2024, comparing the ARCHITECT HCV Ag assay to an HCV-RNA reference standard. Sensitivity, specificity, and likelihood ratios were pooled using a random-effects model within the MIDAS module of Stata software. Study quality was assessed using QUADAS-2. Heterogeneity was evaluated using the Q statistic, quantified using the I², and further explored through meta-regression. Results: Ten studies (n = 494 participants) met inclusion criteria. The Abbott ARCHITECT HCV Ag assay demonstrated high sensitivity [91%, 95% confidence interval (CI): 76–97%] and specificity (99%, 95% CI: 99–100%). The positive likelihood ratio (PLR) was 81.20 (95% CI: 12.34–534.36), and the negative likelihood ratio (NLR) was 0.09 (95% CI: 0.03–0.27). The area under the summary receiver operating characteristic curve (AUC-SROC) was 99% (95% CI 98–100%). In regions with high HCV prevalence (≥ 10%), the test accurately confirmed active HCV infection in over 90% of cases. However, confirmatory testing remains necessary in low-prevalence settings (≤ 5%). The assay demonstrated an excellent ability to identify individuals without HCV infection, with a low false-negative rate (≤ 2%) regardless of HCV prevalence. Heterogeneity analysis revealed moderate to substantial variation in test performance (I² = 72.09% for sensitivity, 35.47% for PLR, and 78.33% for NLR). QUADAS-2 applicability concerns predicted heterogeneity, but differences were likely insignificant due to minimal variations and limited studies. Conclusions: The Abbott ARCHITECT HCV Ag assay exhibited promising accuracy in detecting active HCV infection among PLWHB. This test might help diagnose active HCV infection in high-prevalence scenarios (≥ 10%) but needs further confirmation in low-prevalence settings (≤ 5%). [ABSTRACT FROM AUTHOR]

Objective: To investigate the clinical application value of microfluidic-based in vitro diagnostic (IVD) technology in pathogenic detection of respiratory tract infections. Methods: A total of 300 clinical samples, including blood, bronchoalveolar lavage fluid, and pleural effusion, were collected from patients with respiratory tract infections. The samples were randomly divided into three groups: A, B, and C, with 100 cases in each group. Group A used traditional microbiological detection methods, Group B used metagenomic next-generation sequencing (mNGS) technology, and Group C used both microfluidic-based IVD technology and traditional microbiological detection methods to detect pathogenic microorganisms in the clinical samples. The positive detection rate, detection time, and detection cost were compared among the groups. The diagnostic performance of each group was compared using the Receiver Operating Characteristic (ROC) curve. Results: Traditional microbiological detection identified 38 positive samples (38%), including 45 pathogens; mNGS technology identified 95 positive samples (95%), including 210 pathogens; microfluidic-based IVD technology identified 96 positive samples (96%), including 158 pathogens. Microfluidic-based IVD technology had a significantly higher positive detection rate for pathogenic microorganisms compared to traditional culture techniques (96% vs 38%, χ2 = 122.0, P < 0.01), and it was also faster and cheaper than mNGS technology. ROC analysis showed that compared to traditional microbiological culture results, microfluidic-based IVD technology had significantly increased sensitivity and specificity, similar to mNGS technology. Conclusion: In respiratory infectious diseases, microfluidic-based IVD technology had a higher detection rate for pathogenic microorganisms than traditional culture methods, and it had advantages in detection time and cost compared to mNGS technology. It could also detect critical drug-resistant genes of pathogens. Hence, microfluidic-based IVD technology can be a viable option for diagnosis and treatment of respiratory infectious diseases. [ABSTRACT FROM AUTHOR]

Objectives. The aim of the present study was to assess the performance of radiolabeled-PSMA PET/CT in a cohort of intermediate-risk prostate cancer (PCa) patients for initial staging. Methods. This is a retrospective, multicenter analysis of patients diagnosed with intermediate-risk PCa who were staged using radiolabeled PSMA PET/CT to evaluate the extent of the disease before initiating appropriate treatment. The study included patients from the Nuclear Medicine Units of the Humanitas group between 2021 and 2024. The change in management due to the PSMA PET/CT examination was assessed. Results. A total of 181 patients were enrolled across all three centers. Histopathological assessment from biopsy revealed that 51.4% of patients had favorable PCa, while 48.6% had unfavorable disease. PET/CT was positive for the primary lesions in all patients, but it revealed a positivity rate in 23 (12.7%) patients for nodes and distant organs, with a positivity rate of 0.21 in the unfavorable group and 0.05 in the favorable group (p < 0.005). Based on follow-up data, diagnostic accuracy was higher than 90% in both the favorable and unfavorable groups for lymph node and distant metastases. The inclusion of PSMA PET/CT in the diagnostic algorithm for patients with intermediate-risk PCa impacted patient management in 24 (13.3%) cases, based on the multidisciplinary team decision. Conclusions. PSMA PET/CT can affect the management of patients with intermediate-risk PCa in up to 13% of cases, mainly for unfavorable diseases. New imaging techniques as a first-line imaging procedure can help to plan the correct therapeutic approach in the intermediate-risk PCa group. [ABSTRACT FROM AUTHOR]

Purpose: The aim of our study was to assess the diagnostic performance of commercially available AI software for intracranial aneurysm detection and to determine if the AI system enhances the radiologist's accuracy in identifying aneurysms and reduces image analysis time. Methods: TOF-MRA clinical brain examinations were analyzed using commercially available software and by an consultant neuroradiologist for the presence of intracranial aneurysms. The results were compared with the reference standard, to measure the sensitivity and specificity of the software and the consultant neuroradiologist. Furthermore, we examined the time required for the neuroradiologist to analyze the TOF-MRA image set, both with and without use of the AI software. Results: In 500 TOF-MRI brain studies, 106 aneurysms were detected in 85 examinations by combining AI software with neuroradiologist readings. The neuroradiologist identified 98 aneurysms (92.5% sensitivity), while AI detected 77 aneurysms (72.6% sensitivity). Specificity and sensitivity were calculated from the combined effort as reference. Combining AI and neuroradiologist readings significantly improves detection reliability. Additionally, AI integration reduced TOF-MRA analysis time by 19 s (23% reduction). Conclusions: Our findings indicate that the AI-based software can support neuroradiologists in interpreting brain TOF-MRA. A combined reading of the AI-based software and the neuroradiologist demonstrated higher reliability in identifying intracranial aneurysms as compared to reading by either neuroradiologist or software, thus improving diagnostic accuracy of the neuroradiologist. Simultaneously, reading time for the neuroradiologist was reduced by approximately one quarter. [ABSTRACT FROM AUTHOR]

Pediatric bone injuries are traditionally diagnosed using radiography. However, ultrasonography is emerging as an alternative due to its speed and minimal invasiveness. This study assessed the diagnostic capabilities of ultrasound before radiography in a group of 186 children with suspected long bone fractures at Saint Etienne University Hospital (Saint-Priest-en-Jarez, France). Patients with open trauma and severe deformity were excluded. Ultrasonography demonstrated 88.2% sensitivity and 86.4% specificity, with better results for forearm injuries. Of the 186 cases, 162 were consistent with radiography and 24 varied. Factors influencing an accurate diagnosis included the presence of indirect signs, operator experience, and examination duration, while indirect signs often led to misinterpretation. Although ultrasound cannot completely replace radiography due to its limitations in identifying deeper fractures, this study revealed its substantial efficacy and ease, supporting its potential utility in pediatric trauma emergencies. [ABSTRACT FROM AUTHOR]

Background: Exploring a biomarker with enhanced sensitivity and specificity for tissue perfusion may facilitate the timely identification of circulatory collapse, and enable more precise resuscitation efforts. Objective: The objective of this study was to ascertain the correlation between whole blood lactate versus plasma renin concentration being a biomarker of tissue perfusion and predictor of mortality among hypotensive critically ill patients. Methods: This prospective, observational cohort study enrolled 84 hypotensive critically ill patients. Plasma renin concentration and blood lactate were measured at enrollment, 24, 48, and 72 hours. The primary outcome is the correlation between the recorded renin, lactate concentrations and mortality rate during hospitalization. Results: The mean plasma renin concentration at enrollment was 61.95 pg/ml in survivors, and 104.45 pg/ml in non-survivors (p = <0.001). The non-survivors exhibited a significant boost in plasma renin concentration after 48 and 72 hours, opposed to the survivors (112 vs 40.89, and 106.64 vs 28.85 pg/ml) respectively. There was a significant positive correlation between plasma renin, blood lactate concentrations and patient mortality (r = 0.389 & 0.601) respectively. Conclusion: Plasma renin and whole blood lactate had positive correlation to mortality, yet plasma renin revealed superior diagnostic accuracy over blood lactate for mortality prediction in hypotensive critically-ill patients. Trial registration: The protocol of this study can be obtained on ClinicalTrials.gov with the id NCT05810415. [ABSTRACT FROM AUTHOR]

Acute kidney injury (AKI) constitutes a common complication associated with liver or kidney transplantation, which may significantly impact the graft condition and perioperative mortality. Current AKI diagnostic criteria based on serum creatinine (sCr) and urine output alterations are widely utilized in routine clinical practice. However, the diagnostic value of sCr may be limited by various confounding factors, including age, sex, reduced or increased muscle mass, and pre-existing chronic kidney disease (CKD). Furthermore, sCr is rather a late indicator of AKI, as its concentration tends to increase only when the severity of the injury is enough to decrease the estimated glomerular filtration rate (eGFR). Recent expertise highlights the need for novel biomarkers in post-transplantation AKI diagnosis, prediction of event-associated mortality, or evaluation of indications for renal replacement treatment (RRT). Over the last decade, the diagnostic performance of various AKI biomarkers has been assessed, among which some showed the potential to outperform sCr in AKI diagnosis. Identifying susceptible individuals, early diagnosis, and prompt intervention are crucial for successful transplantation, undisturbed graft function in long-term follow-up, and decreased mortality. However, the research on AKI biomarkers in transplantation still needs to be explored. The field lacks consistent results, rigorous study designs, and external validation. Considering the rapidly growing prevalence of CKD and cirrhosis that are associated with the transplantation at their end-stage, as well as the existing knowledge gap, the aim of this article was to provide the most up-to-date review of the studies on novel biomarkers in the diagnosis of post-transplantation AKI. [ABSTRACT FROM AUTHOR]

This study aimed to validate the DFS (direct fast scarlet) staining in the diagnosis of EC (eosinophilic colitis). The study included 50 patients with EC and 60 with control colons. Among the 60 control samples, 39 and 21 were collected from the ascending and descending colons, respectively. We compared the median number of eosinophils and frequency of eosinophil degranulation by HE (hematoxylin and eosin) and DFS staining between the EC and control groups. In the right hemi‐colon, eosinophil count by HE was useful in distinguishing between EC and control (41.5 vs. 26.0 cells/HPF, p < 0.001), but the ideal cutoff value is 27.5 cells/HPF (high‐power field). However, this method is not useful in the left hemi‐colon (12.5 vs. 13.0 cells/HPF, p = 0.990). The presence of degranulation by DFS allows us to distinguish between the groups even in the left hemi‐colon (58% vs. 5%, p < 0.001). DFS staining also enabled a more accurate determination of degranulation than HE. According to the current standard to diagnose EC (count by HE staining ≥20 cells/HPF), mucosal sampling from left hemi‐colon is problematic since the number of eosinophils could not be increased even in EC. Determination of degranulated eosinophils by DFS may potentiate the diagnostic performance even in such conditions. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess the diagnostic performance of contrast-enhanced ultrasound (CEUS) in characterizing small renal masses (SRMs) measuring less than 3 cm and in distinguishing between malignant and benign SRMs. Methods: A retrospective study was conducted between January 2022 and January 2023 at the Radiology Department of (Anonymized data), with a total of 43 patients assessed via CT and MRI scans, which were subsequently studied by experienced radiologists who were blinded to the pathology results. The CEUS findings were then compared with histopathological examination outcomes or follow-up imaging results. Results: The study results revealed a notably high level of diagnostic accuracy, with sensitivity at 0.875, specificity at 0.94, positive predictive value at 0.95, and negative predictive value at 0.86 for characterizing SRMs. Spearman rank correlation analysis substantiated a robust positive linear correlation between the CEUS findings and biopsy results (r = 0.972). Conclusions: These findings underscore the potential utility of CEUS as a valuable tool for discriminating between malignant and benign SRMs, carrying significant implications for clinical decision-making and leading to improved patient outcomes. However, larger validation studies are imperative to establish its role in routine clinical practice and to address potential limitations. [ABSTRACT FROM AUTHOR]

Objective The Berlin algorithm was developed to help diagnose axial SpA (axSpA), but new studies suggest some features typical of SpA are less specific than previously assumed. Furthermore, evidence is lacking for other SpA subtypes (e.g. peripheral SpA). We aimed to review the evidence on the performance of SpA features for diagnosing each SpA subtype. Methods We conducted a systematic literature review of studies reporting the diagnostic performance of one or more SpA features in patients with suspected SpA. The external reference was the rheumatologist's diagnosis of SpA. Meta-analysis was performed, separately for each SpA subtype, to estimate pooled sensitivity, specificity and positive and negative likelihood ratios (LR+ and LR−, respectively). Meta-regression assessed the effect of covariates (e.g. feature's prevalence) on each feature's performance. Results Of 13 844 articles screened, 46 were included. Sacroiliitis on MRI, damage on pelvic radiographs and elevated CRP had the best balance between LR+ and LR− (LR+ 3.9–17.0, LR− 0.5–0.7) for diagnosing axSpA. HLA-B27 had an LR+ lower than anticipated (LR+ 3.1). Inflammatory back pain (IBP) had a low LR+ (LR+ ≈1), but substantially decreased the likelihood of axSpA when absent (LR− 0.3). Conversely, peripheral features and extramusculoskeletal manifestations showed a high LR+ (LR+ 1.6–5.0), but were as common in axSpA as non-axSpA (LR− ≈1). The specificity of most features was reduced in settings when these were highly prevalent. Limited data precluded a detailed analysis on diagnosing other SpA subtypes. Conclusion Imaging features and CRP have good diagnostic value for axSpA. However, the specificity of other features, especially HLA-B27 and IBP, is lower than previously known. [ABSTRACT FROM AUTHOR]

Purpose: While sedation is routinely used in pediatric PET examinations to preserve diagnostic quality, it may result in side effects and may affect the radiotracer's biodistribution. This study aims to investigate the feasibility of sedation-free pediatric PET imaging using ultra-fast total-body (TB) PET scanners and deep learning (DL)-based attenuation and scatter correction (ASC). Methods: This retrospective study included TB PET (uExplorer) imaging of 35 sedated pediatric patients under four years old to determine the minimum effective scanning time. A DL-based ASC method was applied to enhance PET quantification. Both quantitative and qualitative assessments were conducted to evaluate the image quality of ultra-fast DL-ASC PET. Five non-sedated pediatric patients were subsequently used to validate the proposed approach. Results: Comparisons between standard 300-second and ultra-fast 15-second imaging, CT-ASC and DL-ASC ultra-fast 15-second images, as well as DL-ASC ultra-fast 15-second images in non-sedated and sedated patients, showed no significant differences in qualitative scoring, lesion detectability, and quantitative Standard Uptake Value (SUV) (P = ns). Conclusions: This study demonstrates that pediatric PET imaging can be effectively performed without sedation by combining ultra-fast imaging techniques with a DL-based ASC. This advancement in sedation-free ultra-fast PET imaging holds potential for broader clinical adoption. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate deep learning reconstruction (DLR)-based accelerated rectal magnetic resonance imaging (MRI) compared with standard MRI. Materials and methods: Patients with biopsy-confirmed rectal adenocarcinoma between November/2022 and May/2023 in a single centre were prospectively enrolled for an intra-individual comparison between standard fast spin-echo (FSEstandard) and DLR-based FSE (FSEDL) sequences. Quantitative and qualitative image quality metrics of the pre-therapeutic MRIs were evaluated in all patients; diagnostic performance and evaluating time for T-staging, N-staging, extramural vascular invasion (EMVI), and mesorectal fascia (MRF) status was further analysed in patients undergoing curative surgery, with histopathologic results as the diagnostic gold standard. Results: A total of 117 patients were enrolled, with 60 patients undergoing curative surgery. FSEDL reduced the acquisition time by 65% than FSEstandard. FSEDL exhibited higher signal-to-noise ratios, contrast-to-noise ratio, and subjective scores (noise, tumour margin clarity, visualisation of bowel wall layering and MRF, overall image quality, and diagnostic confidence) than FSEstandard (p < 0.001). Reduced artefacts were observed in FSEDL for patients without spasmolytics (p < 0.05). FSEDL provided higher T-staging accuracy by junior readers than FSEstandard (reader 1, 58.33% vs 70.00%, p = 0.016; reader 3, 60.00% vs 76.67%, p = 0.021), with similar N-staging, EMVI, and MRF performance. No significant difference was observed for senior readers. FSEDL exhibited shorter diagnostic time in all readers' T-staging and overall evaluation, and junior readers' EMVI and MRF (p < 0.05). Conclusion: FSEDL provided improved image quality, reading time, and junior radiologists' T-staging accuracy than FSEstandard, while reducing the acquisition time by 65%. Clinical relevance statement: DLR is clinically applicable for rectal MRI, providing improved image quality with shorter scanning time, which may ease the examination burden. It is beneficial for diagnostic optimisation in improving junior radiologists' T-staging accuracy and reading time. Key Points: The rising incidence of rectal cancer has demanded enhanced efficiency and quality in imaging examinations. FSEDLdemonstrated superior image quality and had a 65% reduced acquisition time. FSEDLcan improve the diagnostic accuracy of T-staging and reduce the reading time for assessing rectal cancer. [ABSTRACT FROM AUTHOR]

Microvascular invasion (MVI) is a key prognostic factor for hepatocellular carcinoma (HCC). The predictive models for solitary HCC could potentially integrate more comprehensive tumor information. Owing to the diverse findings across studies, we aimed to compare radiomic and non-radiomic methods for preoperative MVI detection in solitary HCC. Articles were reviewed from databases including PubMed, Embase, Web of Science, and the Cochrane Library until April 7, 2023. The pooled sensitivity, specificity, positive likelihood ratio (PLR), and negative likelihood ratio (NLR) were calculated using a random-effects model within a 95% confidence interval (CI). Diagnostic accuracy was assessed using summary receiver-operating characteristic curves and the area under the curve (AUC). Meta-regression and Z-tests identified heterogeneity and compared the predictive accuracy. Subgroup analyses were performed to compare the AUC of two methods according to study type, study design, tumor size, modeling methods, and imaging modality. The analysis incorporated 26 studies involving 3539 patients with solitary HCC. The radiomics models showed a pooled sensitivity and specificity of 0.79 (95%CI: 0.72–0.85) and 0.78 (95%CI: 0.73–0.82), with an AUC at 0.85 (95%CI: 0.82–0.88). Conversely, the non-radiomics models had sensitivity and specificity of 0.74 (95%CI: 0.65–0.81) and 0.88 (95%CI: 0.82–0.92) and an AUC of 0.88 (95%CI: 0.85–0.91). Subgroups with preoperative MRI, larger tumors, and functional imaging had higher accuracy than those using preoperative CT, smaller tumors, and conventional imaging. Non-radiomic methods outperformed radiomic methods, but high heterogeneity calls across studies for cautious interpretation. [ABSTRACT FROM AUTHOR]

Background: Diagnosing periprosthetic joint infection (PJI) remains a significant challenge for healthcare professionals. Commonly utilized inflammatory markers include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and white blood cells (WBC). Human β-defensin 1 (β-defensin) is an antimicrobial peptide elevated in infection, yet its diagnostic value for PJI has not been explored. The purpose of this study was to evaluate the efficacy of synovial β-defensin as a diagnostic marker for PJI and to compare its performance with ESR, serum CRP, and WBC. Methods: We conducted a single-center retrospective study from October 2022 to June 2023. A total of 105 joint fluid samples from revision patients at the Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra were collected intraoperatively (71 hips, 34 knees) and frozen. According to MSIS criteria, 64 patients were defined as positive for PJI and the remaining 41 were negative. Synovial β-defensin levels were quantified using ELISA, serum CRP levels by immunoturbidimetry, and blood ESR and WBC were analyzed. Sensitivity and specificity were determined using ROC curves, and diagnostic performance was compared using the area under the curve (AUC). Cut-off values for diagnosing PJI were established. Results: Levels of synovial β-defensin, ESR, serum CRP, and WBC were significantly higher in the PJI group compared to the non-PJI (P < 0.0001). The AUCs were 0.948 for β-defensin, 0.884 for ESR, 0.902 for CRP, and 0.767 for WBC, with a combined AUC of 0.994. Sensitivity/specificity for β-defensin, ESR, CRP, and WBC were 0.966/0.830, 0.887/0.791, 0.930/0.771, and 0.820/0.682, respectively. Optimal predictive cut-off values were 1105.8 pg/mL for β-defensin, 11.5 mm/h for ESR, 5.55 mg/L for CRP, and 7.3 × 103/mm3 for WBC. Conclusion: The synovial β-defensin assay demonstrated greater sensitivity and specificity for the diagnosis of PJI compared to ESR, serum CRP and WBC. Therefore, β-defensin shows promise as a diagnostic marker for PJI. Simultaneous determination of all markers may increase diagnostic confidence. [ABSTRACT FROM AUTHOR]

Background/Objectives: Periprosthetic joint infection (PJI) is a disastrous complication after joint replacement procedures as the diagnosis remains a significant challenge. The objective of this study is to assess the accuracy and test the interdependency of the proposed compound serum biomarkers for the diagnosis of PJI after total hip arthroplasties (THA). Methods: From January 2019 to December 2023, 77 consecutive cases that underwent revision total hip arthroplasties (rTHA) were included in a single−retrospective, observational cohort study. A total of 32 arthroplasties were classified as having septic complications using the European Bone and Joint Infection Society (EBJIS) definition from 2021, while the other 45 cases were assigned as aseptic failures (AF). Results: In the univariate analysis between the two groups created, statistically significant differences (p < 0.005) were found for the following variables: time from primary arthroplasty to symptom onset (Time PA−SO), neutrophil count, Lymphocyte count, haematocrit level (HCT) and haemoglobin level (HGB), C−reactive protein (CRP), the neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), monocyte lymphocyte ratio (MLR), systemic inflammation index (SII), systemic inflammation response index (SIRI), and aggregate inflammation systemic index (AISI). The ROC curve analysis showed that the SII (sensitivity 90.6% and specificity 62.2%) and the NLR (sensitivity 84.4% and specificity 64.4%) are the most accurate biomarkers. The multivariate analysis confirmed that NLR > 2.63 (p = 0.006), PLR > 147 (p = 0.021), MLR > 0.31 (p = 0.028), SII > 605.31 (p = 0.002), SIRI > 83.34 (p = 0.024), and AISI > 834.86 (p = 0.011) are all closely related to PJI diagnosis independently. Conclusions: The proposed serum biomarkers can be correlated with PJI diagnosis with the reserve of relatively low specificities. [ABSTRACT FROM AUTHOR]

Background: Mobile health (mHealth) has an emerging potential for remote assessment of traumatic dental injuries (TDI) and support of emergency care. This study aimed to determine the diagnostic accuracy of TDI detection from smartphone-acquired photographs. Methods: The upper and lower anterior teeth of 153 individuals aged ≥ 6 years were photographed using a smartphone camera app. The photos of 148 eligible participants were reviewed independently by a dental specialist, two general dentists, and two dental therapists, using predetermined TDI classification and criteria. The sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and inter-rater reliability were estimated to evaluate the diagnostic performance of the photographic method relative to the reference standard established by the dental specialist. Results: Of the 1,870 teeth screened, one-third showed TDI; and one-seventh of the participants had primary or mixed dentitions. Compared between the specialist's reference standard and four dental professionals' reviews, the diagnostic sensitivity and specificity for TDI versus non-TDI were 59–95% and 47–93%, respectively, with better performance for urgent types of TDI (78–89% and 99–100%, separately). The diagnostic consistency was also better for the primary/mixed dentitions than the permanent dentition. Conclusion: This study suggested a valid mHealth practice for remote assessment of TDI. A better diagnostic performance in the detection of urgent types of TDI and examination of the primary/mixed dentition was also reported. Future directions include professional development activities involving dental photography and photographic assessment, incorporation of a machine learning technology to aid photographic reviews, and randomized controlled trials in multiple clinical settings. [ABSTRACT FROM AUTHOR]

The enteric protozoan parasites Giardia duodenalis and Cryptosporidium spp. are common cause of diarrhea in pet dogs and cats, affecting primarily young animals. This comparative study evaluates the diagnostic performance of conventional and molecular methods for the detection of G. duodenalis and Cryptosporidium spp. infection in dogs and cats. The compared diagnostic assays included merthiolate-iodine-formalin (MIF) method, lateral flow immunochromatography rapid test (ICT) and real-time PCR; using direct immunofluorescence assay (DFA) as golden standard. The study included the analysis of 328 fecal samples from different dog (n = 225) and cat (n = 103) populations. According to DFA, the overall prevalence of G. duodenalis was 24.4% (80/328, 95% CI: 19.8–29.4), varying from 11.6% (12/103, 95% CI: 6.2–19.5) in cats to 30.2% (68/225, 95% CI: 24.3–36.7) in dogs. The overall prevalence of Cryptosporidium spp. was 4.0% (13/328, 95% CI: 2.1–6.7), varying from 2.9% (3/103, 95% CI: 0.6–8.3) in cats to 4.4% (10/225, 95% CI: 2.1–8.0) in dogs. MIF was only used for the detection of G. duodenalis, which was identified by this method in 22.7% of dogs and 7.8% of cats, respectively. DFA was the most sensitive technique for detecting G. duodenalis in samples from dogs and cats (p-value: < 0.001), followed by real-time PCR. Identification of Cryptosporidium infections was most effectively accomplished by the combination of DFA and PCR technique (p-value: < 0.001). In addition, epidemiological (sex, age, origin) and clinical (fecal consistency) variables were collected to assess their potential associations with an increased likelihood of infection by G. duodenalis and/or Cryptosporidium spp. Breeder dogs were more likely to harbor G. duodenalis infection (p-value: 0.004), whereas female cats were significantly more infected with Cryptosporidium (p-value: 0.003). In conclusion, DFA (alone or in combination with PCR) has been identified as the most accurate and cost-effective method for detecting G. duodenalis and Cryptosporidium spp. in fecal samples from pet dogs and cats. This highlights their importance in both veterinary and clinical settings for enabling prompt treatment and preventing potential transmission to humans. [ABSTRACT FROM AUTHOR]

Introduction: Our objective was to determine whether the educational game SonoQz can improve diagnostic performance in ultrasound assessment of ovarian tumors. Material and Methods: The SonoQz mobile application was developed as an educational tool for medical doctors to practice ultrasound assessment, based on still images of ovarian tumors. The game comprises images from 324 ovarian tumors, examined by an ultrasound expert prior to surgery. A training phase, where the participants assessed at least 200 cases in the SonoQz app, was preceded by a pretraining test, and followed by a posttraining test. Two equal tests (A and B), each consisting of 20 cases, were used as pre‐ and posttraining tests. Half the users took test A first, B second, and the remaining took the tests in the opposite order. Users were asked to classify the tumors (1) according to International Ovarian Tumor Analysis (IOTA) Simple Rules, (2) as benign or malignant, and (3) suggest a specific histological diagnosis. Logistic mixed models with fixed effects for pre‐ and posttraining tests, and crossed random effects for participants and cases, were used to determine any improvement in test scores, sensitivity, and specificity. Results: Fifty‐eight doctors from 19 medical centers participated. Comparing the pre‐ and posttraining test, the median of correctly classified cases, in Simple Rules assessment increased from 72% to 83%, p < 0.001; in classifying the lesion as benign or malignant tumors from 86% to 95%, p < 0.001; and in making a specific diagnosis from 43% to 63%, p < 0.001. When classifying tumors as benign or malignant, at an unchanged level of sensitivity (98% vs. 97%, p = 0.157), the specificity increased from 70% to 89%, p < 0.001. Conclusions: Our results indicate that the educational game SonoQz is an effective tool that may improve diagnostic performance in assessing ovarian tumors, specifically by reducing the number of false positives while maintaining high sensitivity. [ABSTRACT FROM AUTHOR]

Diagnosing perioperative anaphylaxis (POA) is often challenging. Although a guideline recommends measuring tryptase rather than histamine, there is little evidence for this. We aimed to examine the diagnostic performance and appropriate timing of tryptase and histamine measurements for diagnosing anaphylaxis, and the association between Hypersensitivity Clinical Scoring Scheme (HCSS) scores and elevated biomarkers. We measured tryptase and histamine levels thrice: 30 min, 2 h, and at least 24 h after an anaphylactic event for patients with suspected anaphylaxis, and at the induction of general anesthesia and 30 min and 2 h after the start of surgery for control patients without a reaction. Absolute values and the magnitude and rate of change from baseline were evaluated. We determined the thresholds of tryptase and histamine levels with the best diagnostic performance and compared their performance. Forty-five patients with perioperative anaphylaxis were included in this study. The control group included 30 patients with uneventful general anesthesia and 12 patients with a suspected but unconfirmed diagnosis of perioperative anaphylaxis. Comparison at the same measurement timings showed that tryptase generally had better diagnostic performance than histamine. Both showed better diagnostic performance when assessed using multiple measurements rather than a single measurement. The best diagnostic performance was seen with the percentage change in the higher tryptase value, whether measured at 30 min or 2 h after anaphylaxis onset, as compared to baseline. However, neither tryptase nor histamine levels correlated with HCSS scores. Overall, tryptase showed better diagnostic performance than histamine. When multiple tryptase measurements are possible, parameters calculated using two acute phase measurements and the baseline level have better diagnostic performance. [Display omitted] [ABSTRACT FROM AUTHOR]

Purpose: The current diagnostic methods for leptospirosis diagnosis are technically complex and expensive, with limited applicability to specialized laboratories. Furthermore, they lack diagnostic accuracy in the acute stage of the disease, which coincides with a period when antibiotics are highly effective. New simple and accurate tests are mandatory to decentralize and improve diagnosis. Here, we introduced a new lateral flow immunoassay (Lepto-LF) for human leptospirosis. Methods: We conducted a double-blinded assay using 104 serum samples from patients with confirmed or discarded diagnosis for leptospirosis. The diagnostic performance of Lepto-LF was estimated across different ranges of days from onset of symptoms (dpo), considering the diagnostic algorithm as reference standard. Additionally, it was compared with the screening methods enzyme-linked immunosorbent assay (IgM-ELISA) and the slide agglutination test using temperature-resistant antigen (SATR). Results: Lepto-LF exhibited perfect diagnostic performance with a Youden´s index J = 1 from 6 dpo in the acute phase. IgM-ELISA gave slightly lower accuracy with J = 0.91 and 95.5% of both sensitivity and specificity; while SATR showed a markedly inferior yield (J = 0.41, sensitivity = 95.5%, specificity = 45.5%). The performances remained consistent in the convalescence phase of the disease (> 10 dpo). Conclusion: Lepto-LF was found to be a reliable test for simple, rapid and early diagnosis of leptospirosis, resulting a promising tool for decentralizing leptospirosis diagnosis and enabling timely treatment of patients. In addition, Lepto-LF may be employed as confirmatory test, especially in remote areas and vulnerable contexts where the standard MAT is not available. [ABSTRACT FROM AUTHOR]

Background: Evaluation of liver fibrosis played a monumental role in the diagnosis and monitoring of chronic hepatitis B (CHB). We aimed to explore the value of serum N-glycan markers in liver fibrosis. Methods: This multi-center (33 hospitals) study recruited 760 treatment-naïve CHB patients who underwent liver biopsy. Serum N-glycan markers were analyzed by DNA sequencer-assisted fluorophore-assisted with capillary electrophoresis (DSA-FACE) technology. First, we explore the relationship between 12 serum N-glycan markers and the fibrosis stage. Then, we developed a Px score for diagnosing significant fibrosis using the LASSO regression. Next, we compared the diagnostic performances between Px, LSM, APRI, and FIB-4. Finally, we explored the relationships between glycosyltransferase gene and liver fibrosis with RNA-transcriptome sequencing. Results: We included 622 CHB participants: male-dominated (69.6%); median age 42.0 (IQR 34.0–50.0); 287 with normal ALT; 73.0% with significant fibrosis. P5(NA2), P8(NA3), and P10(NA4) were opposite to the degree of fibrosis, while other profiles (except for P0[NGA2]) increased with the degree of fibrosis. Seven profiles (P1[NGA2F], P2[NGA2FB], P3[NG1A2F], P4[NG1A2F], P7[NA2FB], P8[NA3], and P9[NA3Fb]) were selected into Px score. Px score was associated with an increased risk of significant fibrosis (for per Px score increase, the risk of significant fibrosis was increased by 3.54 times (OR = 4.54 [2.63–7.82]) in the fully-adjusted generalized linear model. p for trend was <0.001. The diagnostic performance of the Px score was superior to others. Glycosyltransferase genes were overexpressed in liver fibrosis, and glycosylation and glycosyltransferase-related pathways were significantly enriched. Conclusions: Serum N-glycan markers were positively correlated with liver fibrosis. Px score had good performance in distinguishing significant fibrosis. [ABSTRACT FROM AUTHOR]

Dried blood spot (DBS) sampling is increasingly used for hepatitis C virus (HCV) screening. HCVcAg testing offers a faster and more streamlined approach to diagnosing HCV infection. We conducted a systematic review and meta‐analysis to assess the diagnostic performance of the Abbott ARCHITECT HCV Ag assay for screening active HCV infection using DBS samples. Eight studies (n = 1229) were selected among all published studies available up to October 4, 2024, in different databases with a search strategy registered (PROSPERO: CRD42022363975). The gold standard method was the HCV PCR test. Data were analyzed using the MIDAS module in STATA with a random effects model. Combined diagnostic accuracy measures were as follows: sensitivity 85%, specificity 100%, positive likelihood ratio (PLR) 233.1, negative likelihood ratio (NLR) 0.15, and summary receiver operating characteristic (SROC) 0.99. Likelihood ratios and Fagan's nomogram suggested that the HCVcAg assay with DBS samples can confirm or rule out active HCV infection with over 92% accuracy in high‐prevalence settings (≥5%). However, in low‐prevalence settings (≤1%), a confirmatory test must be required for positive results. The ability of the test to identify people without HCV infection was high regardless of HCV prevalence, with an error rate of less than 3%. This meta‐analysis is subject to limitations, particularly due to the number of included studies and significant heterogeneity among them. HCV screening using the Abbott ARCHITECT HCV Ag assay with DBS samples showed excellent diagnostic performance, but its external validity may be limited when HCV prevalence is low (≤1%). [ABSTRACT FROM AUTHOR]

Background: Vesical Imaging‐Reporting and Data System (VI‐RADS) has been developed for assessing bladder cancer from multiparametric (mp) MRI but its performance in diagnosing muscle‐invasive bladder cancer (MIBC) is suboptimal. Purpose: To investigate associations between normalized apparent diffusion coefficient (NADC) and clinicopathological characteristics and to determine whether the inclusion of NADC can improve the performance of VI‐RADS in diagnosing MIBC. Study Type: Retrospective. Population: Two hundred seventy‐five patients with pathologically confirmed bladder cancer (101 MIBC and 174 non‐MIBC [NMIBC]) underwent preoperative mpMRI (233 male, 42 female). Field Strength/Sequence: 3‐T, T2‐weighted imaging (turbo spin‐echo), diffusion‐weighted imaging (free‐breathing spin‐echo), and dynamic contrast‐enhanced imaging (gradient‐echo). Assessment: NADC was the mean ADC of tumor divided by that of the iliopsoas muscles in trans caput femoris plane. Associations between NADC and clinicopathological characteristics were evaluated. Models were established for differentiating MIBC and NMIBC: VI‐RADS model; VN model (VI‐RADS and NADC), Images model (significant variables from imaging associated with MIBC), LN model (Images model without NADC), and Full model (all significant variables associated with MIBC). Statistical Tests: Variables for model development were based on logistic regression. Models were evaluated by receiver operating characteristic (ROC) curve. Comparison of the area under the curves (AUCs) for the models used DeLong's test. A P value <0.05 was considered statistically significant. Results: NADC was significantly lower in lesions with diameter ≥ 3 cm, MIBC, histological high grade, lymph node metastasis, and lymphovascular invasion. Compared with VI‐RADS model, the AUCs for VN model (VI‐RADS score and NADC), Images model (VI‐RADS score, NADC and tumor size) and Full model (VI‐RADS score, NADC, tumor size and histological grade) were significantly higher. No significant differences were observed between the AUCs for VN model and Images model (P = 0.051). Data Conclusion: NADC reflects information about the aggressiveness of bladder cancer. Combining VI‐RADS with NADC can improve performance in diagnosing MIBC. Evidence Level: 4 Technical Efficacy: Stage 2 [ABSTRACT FROM AUTHOR]

Abstract Objective To investigate the clinical application value of microfluidic-based in vitro diagnostic (IVD) technology in pathogenic detection of respiratory tract infections. Methods A total of 300 clinical samples, including blood, bronchoalveolar lavage fluid, and pleural effusion, were collected from patients with respiratory tract infections. The samples were randomly divided into three groups: A, B, and C, with 100 cases in each group. Group A used traditional microbiological detection methods, Group B used metagenomic next-generation sequencing (mNGS) technology, and Group C used both microfluidic-based IVD technology and traditional microbiological detection methods to detect pathogenic microorganisms in the clinical samples. The positive detection rate, detection time, and detection cost were compared among the groups. The diagnostic performance of each group was compared using the Receiver Operating Characteristic (ROC) curve. Results Traditional microbiological detection identified 38 positive samples (38%), including 45 pathogens; mNGS technology identified 95 positive samples (95%), including 210 pathogens; microfluidic-based IVD technology identified 96 positive samples (96%), including 158 pathogens. Microfluidic-based IVD technology had a significantly higher positive detection rate for pathogenic microorganisms compared to traditional culture techniques (96% vs 38%, χ2 = 122.0, P

Abstract Background The current diagnostic strategy for hepatitis C virus (HCV) infection involves a two-step approach: antibody HCV screening followed by confirmatory nucleic acid testing. This study aimed to evaluate the diagnostic performance of the Abbott ARCHITECT HCV Ag assay in serum/plasma samples as a potential one-step alternative for diagnosing active HCV infection in people living with hepatitis B virus (PLWHB) through a systematic review and meta-analysis. Methods A systematic review and meta-analysis were conducted following PRISMA-DTA guidelines. This protocol was registered on PROSPERO (CRD42023402093). A comprehensive search of electronic databases identified studies published up to 1 November 2024, comparing the ARCHITECT HCV Ag assay to an HCV-RNA reference standard. Sensitivity, specificity, and likelihood ratios were pooled using a random-effects model within the MIDAS module of Stata software. Study quality was assessed using QUADAS-2. Heterogeneity was evaluated using the Q statistic, quantified using the I², and further explored through meta-regression. Results Ten studies (n = 494 participants) met inclusion criteria. The Abbott ARCHITECT HCV Ag assay demonstrated high sensitivity [91%, 95% confidence interval (CI): 76–97%] and specificity (99%, 95% CI: 99–100%). The positive likelihood ratio (PLR) was 81.20 (95% CI: 12.34–534.36), and the negative likelihood ratio (NLR) was 0.09 (95% CI: 0.03–0.27). The area under the summary receiver operating characteristic curve (AUC-SROC) was 99% (95% CI 98–100%). In regions with high HCV prevalence (≥ 10%), the test accurately confirmed active HCV infection in over 90% of cases. However, confirmatory testing remains necessary in low-prevalence settings (≤ 5%). The assay demonstrated an excellent ability to identify individuals without HCV infection, with a low false-negative rate (≤ 2%) regardless of HCV prevalence. Heterogeneity analysis revealed moderate to substantial variation in test performance (I² = 72.09% for sensitivity, 35.47% for PLR, and 78.33% for NLR). QUADAS-2 applicability concerns predicted heterogeneity, but differences were likely insignificant due to minimal variations and limited studies. Conclusions The Abbott ARCHITECT HCV Ag assay exhibited promising accuracy in detecting active HCV infection among PLWHB. This test might help diagnose active HCV infection in high-prevalence scenarios (≥ 10%) but needs further confirmation in low-prevalence settings (≤ 5%). Graphical Abstract

Haemophilia presents challenges in joint pathology assessment, prompting exploration of point-of-care ultrasonography (POC-US) as a diagnostic tool. Aims: The study aimed to assess the diagnostic performance of point-of-care ultrasonography (POC-US) compared to magnetic resonance imaging (MRI) in detecting synovial hypertrophy, cartilage abnormality, and bony abnormality among people with haemophilia (PWH) treated at Assam Medical College Hospital.

Abstract Background The contrast-enhanced US (CEUS) Bosniak classification, proposed by the European Federation for Ultrasound in Medicine and Biology (EFSUMB) in 2020, predicts malignancy in cystic renal masses (CRMs). However, intra- and inter-rater reproducibility for CEUS features has not been well investigated. Purpose To explore intra- and inter-rater agreement for US features, identify confounding features, and assess the diagnostic performance of CEUS Bosniak classification. Materials and methods This retrospective study included patients with complex CRMs who underwent CEUS examination from January 2013 to August 2023. Radiologists (3 experts and 3 novices) evaluated calcification, echogenic content, wall, septa, and internal nodules of CRMs using CEUS Bosniak classification. Intra- and inter-rater agreements were assessed using the Gwet agreement coefficient (Gwet’s AC). Linear regression identified features associated with discrepancies in Bosniak category assignment. Diagnostic performance was evaluated using the area under the receiver operating characteristic curve (AUC). Results A total of 103 complex CRMs were analyzed in 103 patients (mean age, 50 ± 15 years; 66 males). Intra-rater agreement for the Bosniak category was substantial to almost perfect (Gwet’s AC 0.73–0.87). Inter-rater agreement was substantial for the Bosniak category (Gwet’s AC 0.75) and moderate to almost perfect for US features (Gwet’s AC 0.44–0.94). Nodule variation (i.e., absence vs. obtuse margin vs. acute margin) explained 84% of the variability in the Bosniak category assignment. CEUS Bosniak classification showed good diagnostic performance, with AUCs ranging from 0.78 to 0.90 for each rater. Conclusions CEUS Bosniak classification demonstrated substantial intra- and inter-rater reproducibility and good diagnostic performance in predicting the malignancy potential of CRMs. Nodule variations significantly predicted differences in Bosniak category assignments. Critical relevance statement Contrast-enhanced US Bosniak classification reliably predicts malignancy in cystic renal masses, demonstrating substantial reproducibility and diagnostic accuracy. This improves clinical decision-making and patient management. Key Points Intra- and inter-rater reproducibility for contrast-enhance US features for Bosniak classification have not been well investigated. Substantial inter-rater agreements for the Bosniak category and variable agreements for determining imaging features were found. Contrast-enhanced US Bosniak classification is reproducible and has good diagnostic performance for predicting malignancy in cystic renal masses. Graphical Abstract

Background: Diagnosing perioperative anaphylaxis (POA) is often challenging. Although a guideline recommends measuring tryptase rather than histamine, there is little evidence for this. We aimed to examine the diagnostic performance and appropriate timing of tryptase and histamine measurements for diagnosing anaphylaxis, and the association between Hypersensitivity Clinical Scoring Scheme (HCSS) scores and elevated biomarkers. Methods: We measured tryptase and histamine levels thrice: 30 min, 2 h, and at least 24 h after an anaphylactic event for patients with suspected anaphylaxis, and at the induction of general anesthesia and 30 min and 2 h after the start of surgery for control patients without a reaction. Absolute values and the magnitude and rate of change from baseline were evaluated. We determined the thresholds of tryptase and histamine levels with the best diagnostic performance and compared their performance. Results: Forty-five patients with perioperative anaphylaxis were included in this study. The control group included 30 patients with uneventful general anesthesia and 12 patients with a suspected but unconfirmed diagnosis of perioperative anaphylaxis. Comparison at the same measurement timings showed that tryptase generally had better diagnostic performance than histamine. Both showed better diagnostic performance when assessed using multiple measurements rather than a single measurement. The best diagnostic performance was seen with the percentage change in the higher tryptase value, whether measured at 30 min or 2 h after anaphylaxis onset, as compared to baseline. However, neither tryptase nor histamine levels correlated with HCSS scores. Conclusions: Overall, tryptase showed better diagnostic performance than histamine. When multiple tryptase measurements are possible, parameters calculated using two acute phase measurements and the baseline level have better diagnostic performance.

To explore the differences between SonoVue and Sonazoid contrast-enhanced ultrasound (CEUS) in evaluating enhancement features of renal masses and determine the diagnostic value of CEUS in clear cell renal cell carcinoma (ccRCC). A total of 57 eligible patients were enrolled and divided into the ccRCC, papillary renal cell carcinoma (pRCC), non-ccRCC and non-pRCC malignancy groups, and benign mass groups based on their postsurgical histopathologic diagnosis. The enhancement features of renal masses following SonoVue and Sonazoid CEUS in each group were analyzed. Diagnostic efficiencies of SonoVue and Sonazoid CEUS for ccRCC and non-ccRCC were determined. There were no significant differences in the enhancement features of renal masses with SonoVue and Sonazoid imaging in the four groups (p >.05). Both SonoVue CEUS and Sonazoid CEUS showed good diagnostic performance for the differential diagnosis of ccRCC and non-ccRCC, with sensitivities of 88.6% and 85.7%, specificities of 76.5% and 88.2%, accuracies of 84.6% and 86.5%, positive predictive values of 88.6% and 93.8%, and negative predictive values of 76.5% and 75%, respectively. There were no statistically significant differences in any of the diagnostic performance indices between the two methods (p >.05). The CEUS features of SonoVue and Sonazoid in evaluating renal masses were similar in the vascular phase. Both SonoVue and Sonazoid CEUS showed good diagnostic performance for the differential diagnosis of ccRCC and non-ccRCC. [ABSTRACT FROM AUTHOR]

Abstract Background A new pathogen detection tool, metagenomic next-generation sequencing (mNGS), has been widely used for infection diagnosis, but the clinical and diagnostic value of mNGS in urinary tract infection (UTI) remains inconclusive. This systematic review with meta-analysis aimed to investigate the efficacy of mNGS in treating UTIs. Methods A comprehensive literature search was performed in PubMed, Web of Science, Embase, and the Cochrane Library, and eligible studies were selected based on the predetermined criteria. The quality of the included studies was assessed via the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool, and the certainty of evidence (CoE) was measured by the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) score. Then, the positive detection rate (PDR), pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under the curve of the summary receiver operating characteristic curve (AUROC) was estimated in Review Manager, Stata, and MetaDisc. Subgroup analysis, meta-regression, and sensitivity analysis were performed to reveal the potential factors that influence internal heterogeneity. Results A total of 17 studies were selected for further analysis. The PDR of mNGS was markedly greater than that of culture (odds ratio (OR) = 2.87, 95% confidence interval [CI]: 1.72–4.81, p

Abstract Background Prostate cancer is one of the most common malignant tumors in middle-aged and elderly men and carries significant prognostic implications, and recent studies suggest that dual-energy computed tomography (DECT) utilizing new virtual monoenergetic images can enhance cancer detection rates. This study aimed to assess the impact of virtual monoenergetic images reconstructed from DECT arterial phase scans on the image quality of prostate lesions and their diagnostic performance for prostate cancer. Methods We conducted a retrospective analysis of 83 patients with prostate cancer or prostatic hyperplasia who underwent DECT scans at Meizhou People’s Hospital between July 2019 and December 2023. The variables analyzed included age, tumor diameter and serum prostate-specific antigen (PSA) levels, among others. We also compared CT values, signal-to-noise ratio (SNR), subjective image quality ratings, and contrast-to-noise ratio (CNR) between virtual monoenergetic images (40–100 keV) and conventional linear blending images. Receiver operating characteristic (ROC) curve analyses were performed to evaluate the diagnostic efficacy of virtual monoenergetic images (40 keV and 50 keV) compared to conventional images. Results Virtual monoenergetic images at 40 keV showed significantly higher CT values (168.19 ± 57.14) compared to conventional linear blending images (66.66 ± 15.5) for prostate cancer (P

Abstract Background The accuracy of traditional knee MR imaging in diagnosing anterior cruciate ligament tears, especially partial tears, is relatively low, which may lead to misdiagnosis and missed diagnosis. This study aimed to assess the diagnostic performance of a novel imaging method, high-resolution oblique coronal MRI at an optimal flexed-knee Angle, for ACL tears. Methods 50 healthy volunteers were scanned with a scan-assisted device for the optimal flexion angle of ACL. For 92 knee trauma patients selected strictly according to inclusion and exclusion criteria, conventional extended-knee scans (control group) and high-resolution oblique coronal scans based on the optimal flexed-knee angle (experimental group) were conducted. Two observers rated ACL visibility blindly on a 5-point scale. Arthroscopy-defined outcomes determined diagnostic metrics for each method and sensitivity, specificity, positive predictive value, negative predictive value and accuracy were calculated. Results The average optimal flexion angle for healthy volunteers was approximately 30° (30.3° ± 5.0°). Imaging demonstrated complete visualization of the ACL in 96.7% of images in the experimental group versus 12.0% in the control group. The diagnostic indicators of the experimental group surpassed those of the control group: sensitivity (94.9% vs. 76.3%), specificity (97.0% vs. 81.8%), positive predictive value (98.2% vs. 88.2%), negative predictive value(91.4% vs. 65.9%), and accuracy (95.7% vs. 78.3%). ROC analysis indicated superior diagnostic performance in the experimental group, with an AUC of 0.945 compared with 0.776 for the control group (p

Background: The available evidence suggests that urinary calprotectin may be a potential biomarker in distinguishing between intrinsic acute kidney injury (AKI) and prerenal AKI. Objectives: The aim of this study was to determine the diagnostic value of calprotectin in identifying pediatric acute renal impairment. Methods: A search of the Medline, Embase, Scopus and Web of Science electronic databases was conducted on April 27, 2024. Diagnostic studies conducted on the value of urinary calprotectin in AKI were included. Two independent reviewers assessed the search records and any disagreements were resolved by discussion. The risk of bias was assessed using quality assessment of diagnostic accuracy studies (QUADAS-2) guidelines. The performance of urinary calprotectin in diagnosing AKI and its discriminatory ability between intrinsic and prerenal AKI were evaluated by calculating the pooled standardized mean difference (SMD) and 95% confidence interval (CI), as well as sensitivity, specificity and area under the curve (AUC). Results: Seven studies were included. The mean urinary levels of calprotectin in AKI were significantly higher than those in the non-AKI group (SMD=0.73; 95% CI, 0.50%, 0.97%; I2=0.00%). The mean urinary levels of calprotectin in pediatrics with intrinsic AKI were significantly higher than in those with prerenal AKI (SMD=0.76; 95% CI, 0.48%, 1.05%; 95% CI, 0%). Urinary calprotectin exhibited a sensitivity of 0.937 (95% CI, 0.829%, 0.978%) and a specificity of 0.252 (95% CI, 0.126%, 0.442%) for distinguishing intrinsic AKI from prerenal AKI. Additionally, the AUC of urinary calprotectin in differentiating intrinsic AKI from prerenal AKI was 0.691 (95% CI, 0.541%, 0.809%). Conclusions: Urinary calprotectin demonstrates fair screening performance characteristics for differentiating intrinsic from prerenal AKI in children. However, the low specificity necessitates additional diagnostic testing in cases with positive results.

Abstract Background Chagas disease (CD), a neglected parasitic disease caused by Trypanosoma cruzi, poses a significant health threat in Latin America and has emerged globally because of human migration. Trypanosoma cruzi infects humans and over 100 other mammalian species, including dogs, which are important sentinels for assessing the risk of human infection. Nonetheless, the serodiagnosis of T. cruzi in dogs is still impaired by the absence of commercial tests. In this study, we investigated the diagnostic accuracy of four chimeric recombinant T. cruzi IBMP antigens (IBMP-8.1, IBMP-8.2, IBMP-8.3, and IBMP-8.4) for detecting anti-T. cruzi antibodies in dogs, using latent class analysis (LCA). Methods We examined 663 canine serum samples, employing indirect ELISA with the chimeric antigens. LCA was utilized to establish a latent variable as a gold standard for T. cruzi infection, revealing distinct response patterns for each antigen. Results The IBMP (Portuguese acronym for the Molecular Biology Institute of Paraná) antigens achieved area under the ROC curve (AUC) values ranging from 90.9% to 97.3%. The highest sensitivity was attributed to IBMP-8.2 (89.8%), while IBMP-8.1, IBMP-8.3, and IBMP-8.4 achieved 73.5%, 79.6%, and 85.7%, respectively. The highest specificity was observed for IBMP-8.4 (98.6%), followed by IBMP-8.2, IBMP-8.3, and IBMP-8.1 with specificities of 98.3%, 94.4%, and 92.7%, respectively. Predictive values varied according to prevalence, indicating higher effectiveness in endemic settings. Conclusions Our findings underscore the remarkable diagnostic performance of IBMP-8.2 and IBMP-8.4 for the serodiagnosis of Trypanosoma cruzi in dogs, representing a promising tool for the diagnosis of CD in dogs. These chimeric recombinant antigens may not only enhance CD surveillance strategies but also hold broader implications for public health, contributing to the global fight against this neglected tropical disease. Graphical Abstract

Abstract The objective of this study was to evaluate semi-quantitatively the diagnostic performance of PET/CT metabolic parameters in differentiating benign or malignant cardiac or pericardial masses. A total of forty-one patients with newly diagnosed cardiac/pericardial masses who underwent 18F-FDG PET/CT were recruited. PET/CT metabolic parameters including the maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), total lesion glycolysis (TLG), tumor metabolic volume (MTV), the maximum tumor-to-mediastinal background ratio (TMR) and the maximum tumor-to-liver background ratio (TLR) is measured or calculated to evaluate the benign or malignant nature of cardiac/pericardial masses. Compared with benign cardiac/pericardial lesions, cardiac/pericardial malignancies had higher SUVmax, SUVmean, TLG, MTV, TMR, and TLR. All these PET/CT metabolic parameters showed high diagnostic performance in semi-quantitative evaluation of benign or malignant cardiac or pericardial masses, and SUVmean and MTV had the highest diagnostic accuracy. Therefore, PET/CT metabolic parameters can semi-quantitatively evaluate the benign or malignant cardiac/pericardial masses.

Abstract The purpose of the present study is to evaluate whether an online reference system (ORS, STATdx Elsevier, Amsterdam, Netherlands) impacts finding the histologically confirmed diagnosis of rare or atypical abdominal tumors and lesions in radiologic imaging. In total, 101 patients with rare tumor entities or lesions and atypical manifestations of common tumors were enrolled retrospectively. Blinded readings were performed by four radiologists with varying levels of experience, who reported on: (a) correct diagnosis (CD), (b) time needed to find the diagnosis, and (c) diagnostic confidence, initially without followed by the assistance of the ORS. The experienced reader (3 years of experience post-residency, CD 49.5%), as well as the advanced reader with 1 year of experience post-residency (CD 43.6%), and a resident with 5 years of experience (CD 46.5%) made the correct diagnosis more frequently compared to the less experienced reader (CD 25.7%). A significant improvement in making the correct diagnosis was only achieved by the advanced reader, the resident with 5 years of experience (CD with ORS 58.4%; p

Background: A new pathogen detection tool, metagenomic next-generation sequencing (mNGS), has been widely used for infection diagnosis, but the clinical and diagnostic value of mNGS in urinary tract infection (UTI) remains inconclusive. This systematic review with meta-analysis aimed to investigate the efficacy of mNGS in treating UTIs. Methods: A comprehensive literature search was performed in PubMed, Web of Science, Embase, and the Cochrane Library, and eligible studies were selected based on the predetermined criteria. The quality of the included studies was assessed via the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool, and the certainty of evidence (CoE) was measured by the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) score. Then, the positive detection rate (PDR), pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under the curve of the summary receiver operating characteristic curve (AUROC) was estimated in Review Manager, Stata, and MetaDisc. Subgroup analysis, meta-regression, and sensitivity analysis were performed to reveal the potential factors that influence internal heterogeneity. Results: A total of 17 studies were selected for further analysis. The PDR of mNGS was markedly greater than that of culture (odds ratio (OR) = 2.87, 95% confidence interval [CI]: 1.72–4.81, p < 0.001, I2 = 90%). The GRADE score presented a very low CoE. Then, the pooled sensitivity was 0.89 (95% CI: 0.86–0.91, I2 = 39.65%, p = 0.06), and the pooled specificity was 0.75 (95% CI: 0.51–0.90, I2 = 88.64%, p < 0.001). The AUROC of the studies analyzed was 0.89 (95% CI: 0.86–0.92). The GRADE score indicated a low CoE. Conclusion: The current evidence shows that mNGS has favorable diagnostic performance for UTIs. More high-quality prospective randomized controlled trials (RCTs) are expected to verify these findings and provide more information about mNGS in UTI treatment and prognosis. [ABSTRACT FROM AUTHOR]

A growing number of studies have shown that microRNAs (miRNAs) can exert oncogenic or tumor suppressor activities in a variety of cancers, including lung cancer. Given their presence in exosome preparations, microRNA molecules may in fact participate in exosomal intercellular transfers and signaling. In the present study, we examined the profile of 25 circulating exosomal microRNAs in ostensibly healthy controls compared to patients with squamous cell lung cancers (SQCLC) or lung adenocarcinomas (LUAD). Eight miRNAs, namely, miR-21-5p, miR-126-3p, miR-210-3p, miR-221-3p, Let-7b-5p, miR-146a-5p, miR-222-3p, and miR-9-5p, were highly enriched in the cohort and selected for further analyses. All miRNAs were readily detected in non-small cell lung cancer (NSCLC) patients of both sexes at all cancer stages, and their levels in exosomes correlated with the clinicopathological characteristics of tumors. Thus, the presence of these miRNAs in circulating exosomes may contribute to the regulation of oncogenic activity in patients with NSCLC. [ABSTRACT FROM AUTHOR]

The emergence and spread of highly pathogenic avian influenza virus A subtype H5N1 (HP H5N1-IAV), particularly clade H5N1 2.3.4.4b, pose a severe global health threat, affecting various species, including mammals. Historically, cattle have been considered less susceptible to IAV, but recent outbreaks of H5N1-IAV 2.3.4.4b in dairy farms suggest a shift in host tropism, underscoring the urgency of expanded surveillance and the need for adaptable diagnostic tools in outbreak management. This study investigated the presence of anti-nucleoprotein (NP) antibodies in serum and milk and viral RNA in milk on dairy farms affected by outbreaks in Texas, Kansas, and Michigan using a multi-species IAV ELISA and RT-qPCR. The analysis of ELISA results from a Michigan dairy farm outbreak demonstrated a positive correlation between paired serum and milk sample results, confirming the reliability of both specimen types. Our findings also revealed high diagnostic performance during the convalescent phase (up to 96%), further improving sensitivity through serial sampling. Additionally, the evaluation of diagnostic specificity using serum and milk samples from IAV-free farms showed an excellent performance (99.6%). This study underscores the efficacy of the IAV NP-blocking ELISA for detecting and monitoring H5N1-IAV 2.3.4.4b circulation in dairy farms, whose recent emergence raises significant animal welfare and zoonotic concerns, necessitating expanded surveillance efforts. [ABSTRACT FROM AUTHOR]

The rising incidence and mortality of early-onset colorectal cancer (EOCRC) emphasize the urgent need for effective non-invasive screening. Circulating microRNAs (miRNAs) have emerged as promising biomarkers for cancer detection. This systematic review aims to evaluate the diagnostic performance of circulating miRNAs in detecting colorectal cancer (CRC). A literature search was conducted in PubMed and Scopus. Studies that report sensitivity, specificity, or area under the curve (AUC) for CRC detection by miRNA were included. The miRNA miR-21 was the most frequently studied biomarker, with a varying range of AUC from 0.55 to 0.973 attributed to differences in study populations and methodologies. The miRNAs miR-210 and miR-1246 showed potential diagnostic capacity with miR-1246 achieving an AUC of 0.924, 100% sensitivity, and 80% specificity. The miRNA panels offer improved diagnostic performance compared to individual miRNA. The best performing panel for CRC patients below 50 is miR-211 + miR-25 + TGF-β1 with AUC 0.99 and 100 specificity and 97 sensitivity. Circulating miRNAs hold significant promise as non-invasive biomarkers for CRC screening. However, the variability in diagnostic performance highlights the need for a standardized method and robust validation studies. Future research should focus on large-scale, ethnically diverse cohorts to establish clinically relevant miRNA biomarkers for CRC, particularly in younger populations. [ABSTRACT FROM AUTHOR]

This study aims to enhance breast cancer detection accuracy through an AI-driven ultrasound tool, Vis-BUS, developed by Barreleye Inc., Seoul, South Korea. Vis-BUS incorporates Lesion Detection AI (LD-AI) and Lesion Analysis AI (LA-AI), along with a Cancer Probability Score (CPS), to differentiate between benign and malignant breast lesions. A retrospective analysis was conducted on 258 breast ultrasound examinations to evaluate Vis-BUS's performance. The primary methods included the application of LD-AI and LA-AI to b-mode ultrasound images and the generation of CPS for each lesion. Diagnostic accuracy was assessed using metrics such as the Area Under the Receiver Operating Characteristic curve (AUROC) and the Area Under the Precision-Recall curve (AUPRC). The study found that Vis-BUS achieved high diagnostic accuracy, with an AUROC of 0.964 and an AUPRC of 0.967, indicating its effectiveness in distinguishing between benign and malignant lesions. Logistic regression analysis identified that 'Fatty' lesion density had an extremely high odds ratio (OR) of 27.7781, suggesting potential convergence issues. The 'Unknown' density category had an OR of 0.3185, indicating a lower likelihood of correct classification. Medium and large lesion sizes were associated with lower likelihoods of correct classification, with ORs of 0.7891 and 0.8014, respectively. The presence of microcalcifications showed an OR of 1.360. Among Breast Imaging-Reporting and Data System categories, category C5 had a significantly higher OR of 10.173, reflecting a higher likelihood of correct classification. Vis-BUS significantly improves diagnostic precision and supports clinical decision-making in breast cancer screening. However, further refinement is needed in areas like lesion density characterization and calcification detection to optimize its performance. [ABSTRACT FROM AUTHOR]

This article will provide a perspective review of the most extensively investigated deep learning (DL) applications for musculoskeletal disease detection that have the best potential to translate into routine clinical practice over the next decade. Deep learning methods for detecting fractures, estimating pediatric bone age, calculating bone measurements such as lower extremity alignment and Cobb angle, and grading osteoarthritis on radiographs have been shown to have high diagnostic performance with many of these applications now commercially available for use in clinical practice. Many studies have also documented the feasibility of using DL methods for detecting joint pathology and characterizing bone tumors on magnetic resonance imaging (MRI). However, musculoskeletal disease detection on MRI is difficult as it requires multi-task, multi-class detection of complex abnormalities on multiple image slices with different tissue contrasts. The generalizability of DL methods for musculoskeletal disease detection on MRI is also challenging due to fluctuations in image quality caused by the wide variety of scanners and pulse sequences used in routine MRI protocols. The diagnostic performance of current DL methods for musculoskeletal disease detection must be further evaluated in well-designed prospective studies using large image datasets acquired at different institutions with different imaging parameters and imaging hardware before they can be fully implemented in clinical practice. Future studies must also investigate the true clinical benefits of current DL methods and determine whether they could enhance quality, reduce error rates, improve workflow, and decrease radiologist fatigue and burnout with all of this weighed against the costs. [ABSTRACT FROM AUTHOR]

Background: Patients who were infected by the Human Immunodeficiency Virus (HIV) could have weakened immunity that is complicated by opportunistic infections, especially for Mycobacterium tuberculosis (MTB). Notably, the HIV-MTB co-infection will accelerate the course of disease progress and greatly increase the mortality of patients. Since the traditional diagnostic methods are time-consuming and have low sensitivity, we aim to investigate the performance of mNGS (metagenomic Next-Generation Sequencing) and mNPS (metagenomic NanoPore Sequencing) for the rapid diagnosis of tuberculosis in HIV-infected patients. Methods: The 122 HIV-infected patients were enrolled for the retrospective analysis. All of the patients underwent traditional microbiological tests, mNGS, and (or) mNPS tests. The clinical comprehensive diagnosis was used as the reference standard to compare the diagnostic performance of culture, mNGS, and mNPS on tuberculosis. We also investigate the diagnostic value of mNGS and mNPS on mixed-infection. Furthermore, the treatment adjustment directed by mNGS and mNPS was analyzed. Results: Compared with the composite reference standard, the culture showed 42.6% clinical sensitivity and 100% specificity, and the OMT(other microbiological testing) had 38.9% sensitivity and 100% specificity. The mNGS had 58.6% clinical sensitivity and 96.8% specificity, and the mNPS had 68.0% clinical sensitivity and 100% specificity. The proportion of mixed-infection cases (88.9%) in the TB group was higher than those in the non-TB group (54.8%) and the mNGS and mNPS are more competitive on mixed-infection diagnosis compared with the traditional methods. Furthermore, there are 63 patients (69.2%) and 36 patients (63.2%) achieved effective treatment after receiving the detection of mNPS and mNGS, respectively. Conclusion: Our study indicated that mNPS and mNGS have high sensitivity and specificity for TB diagnosis compared with the traditional methods, and mNPS seems to have better diagnostic performance than mNGS. Moreover, mNGS and mNPS showed apparent advantages in detecting mixed infection. The mNPS and mNGS-directed medication adjustment have effective treatment outcomes for HIV-infected patients who have lower immunity. [ABSTRACT FROM AUTHOR]

Medullary thyroid cancer (MTC) shows a relatively poor prognosis among thyroid cancers. Though calcitonin has been used as a diagnostic marker for MTC, it has disadvantages including poor sample stability and discrepancies among results by assay. This study aimed to compare the usefulness of preoperative calcitonin and procalcitonin (PCT) in the diagnosis of MTC. Serum calcitonin and PCT levels were measured before thyroidectomy from MTC (n = 23) and other types of thyroid cancers in patients (n = 1308). Diagnostic performances of calcitonin and PCT for discerning MTC were estimated. In a multivariate analysis, preoperative calcitonin level was independently associated with the diagnosis of MTC, whereas PCT was not. Calcitonin and PCT, respectively, exhibited area under the curve values of 0.997 and 0.979 for the diagnosis of MTC, without significant differences. For calcitonin, the sensitivity, specificity, and positive and negative predictive values were 0.957, 0.992, 0.688, and 0.999, respectively, at a cut-off of 7.2 pg/mL. The corresponding values for PCT were 0.913, 0.995, 0.778, and 0.998 at a cut-off of 0.19 ng/mL. Preoperative calcitonin and PCT showed similar diagnostic utility for MTC. Depending on the patient's clinical status and laboratory environment, these tests can be used as complementary methods for detecting MTC. [ABSTRACT FROM AUTHOR]