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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.

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.

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.

Introduction: Leucine-rich alpha-2-glycoprotein 1(LRG-1) is a human protein that has shown potential usefulness as a biomarker for diagnosing pediatric acute appendicitis (PAA). This study aims to validate the diagnostic performance of serum LRG-1 in PAA. Material and Methods: This work is a subgroup analysis from BIDIAP (BIomarkers for DIagnosing Appendicitis in Pediatrics), a prospective single-center observational cohort, to validate serum LRG-1 as a diagnostic tool in PAA. This analysis included 200 patients, divided into three groups: (1) healthy patients undergoing major outpatient surgery (n = 56), (2) patients with non-surgical abdominal pain (n = 52), and (3) patients with a confirmed diagnosis of PAA (n = 92). Patients in group 3 were divided into complicated and uncomplicated PAA. In all patients, a serum sample was obtained during recruitment, and LRG-1 concentration was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA). Comparative statistical analyses were performed using the Mann–Whitney U, Kruskal–Wallis, and Fisher’s exact tests. The area under the receiver operating characteristic curves (AUC) was calculated for all pertinent analyses. Results: Serum LRG-1 values, expressed as median (interquartile range) were 23,145 (18,246–27,453) ng/mL in group 1, 27,655 (21,151–38,795) ng/mL in group 2 and 40,409 (32,631–53,655) ng/mL in group 3 (p < 0.0001). Concerning the type of appendicitis, the serum LRG-1 values obtained were 38,686 (31,804–48,816) ng/mL in the uncomplicated PAA group and 51,857 (34,013–64,202) ng/mL in the complicated PAA group (p = 0.02). The area under the curve (AUC) obtained (group 2 vs. 3) was 0.75 (95% CI 0.67–0.84). For the discrimination between complicated and uncomplicated PAA, the AUC obtained was 0.66 (95% CI 0.52–0.79). Conclusions: This work establishes normative health ranges for serum LRG-1 values in the pediatric population and shows that serum LRG-1 could be a potentially helpful tool for diagnosing PAA in the future. Future prospective multicenter studies, with the parallel evaluation of urinary and salivary LRG-1, are necessary to assess the implementability of this molecule in actual clinical practice.

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.

A fungal polymerase chain reaction (PCR) amplifies conserved genes across diverse species, combined with the subsequent hybridization of amplicons using a specific oligonucleotide microarray, allowing for the rapid detection of pathogens at the species level. However, the performance of microarrays in diagnosing invasive mold infections (IMI) from infected tissue samples is rarely reported. During the 4-year study period, all biopsied tissue samples from patients with a suspected IMI sent for microarray assays were analyzed. A partial segment of the internal transcribed spacer (ITS) region was amplified by nested PCR after DNA extraction. Amplicons were hybridized with specific probes for a variety of mold species using an in-house oligonucleotide microarray. A total of 80 clinical samples from 74 patients were tested. A diagnosis of an IMI was made in 10 patients (4 proven, 1 probable, 3 possible, 2 clinical suspicion). The PCR/microarray test was positive for three out of four proven IMIs, one probable IMI, and one out of three possible IMIs. Two patients with positive PCR/microarray findings were considered to have clinical suspicion of an IMI, and their responsible physicians initiated antifungal therapy despite the absence of supporting microbiological and histological evidence. Clinical diagnoses were categorized into non-IMI and IMI groups (including proven, probable, possible, and clinical suspicion). The sensitivity and specificity of the microarray in diagnosing the IMIs were 70% and 95.7%, respectively, while the sensitivity and specificity of the culture and histological findings were 10%/96.3% and 40.0%/100%, respectively. PCR-based methods provide supportive microbiological evidence when culture results are inconclusive. The combination of a microarray with fungal culture and histology promotes the precise diagnosis of IMIs in difficult-to-diagnose patients.

We assessed the rapid on-line evaluation (ROLE) protocol as a modification to the conventional rapid on-site evaluation (ROSE) in the diagnostic performance improvement in endoscopic ultrasound-guided tissue acquisition (EUS-TA) for solid pancreatic lesions. This single-center, retrospective study involved consecutive patients with solid pancreatic lesions undergoing EUS-TA at Peking University First Hospital between October 2017 and March 2021. Among 137 patients enrolled, 75 were in the ROLE group and 62 were in the non-ROSE group. The diagnostic yield (97.3% vs. 85.5%, p = 0.023), accuracy (94.7% vs. 82.3%, p = 0.027), and sensitivity (95.7% vs. 81.1%, p = 0.011) were significantly higher in the ROLE group compared to the non-ROSE group. However, specificity, positive predictive value, negative predictive value, and area under the curve (AUC) showed no significant differences (all p-values > 0.05). Additionally, there was a noteworthy reduction in the number of needle passes required in the ROLE group compared to the non-ROSE group (two vs. three, p < 0.001). In a subgroup analysis, fine needle biopsy (FNB) combined with ROLE demonstrated superior diagnostic accuracy compared to FNB with non-ROSE (100% vs. 93.1%, p = 0.025). Compared with the non-ROSE protocol, the ROLE protocol might improve the diagnostic performance of EUS-TA for solid pancreatic lesions, and potentially reduce the number of needle passes requirement.

Until 2020, Djiboutian health authorities relied on histidine-rich protein-2 (HRP2)-based rapid diagnostic tests (RDTs) to establish the diagnosis of Plasmodium falciparum. The rapid spread of P. falciparum histidine-rich protein-2 and -3 (pfhrp2/3) gene-deleted parasite strains in Djibouti has led the authorities to switch from HRP2-based RDTs to lactate dehydrogenase (LDH)-based RDTs targeting the plasmodial lactate dehydrogenase (pLDH) specific for P. falciparum and P. vivax (RapiGEN BIOCREDIT Malaria Ag Pf/Pv pLDH/pLDH) in 2021. This study was conducted with the primary objective of evaluating the diagnostic performance of this alternative RDT. Operational constraints related, in particular, to the implementation of this RDT during the COVID-19 pandemic were also considered. The performance of BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) RDT was also compared to our previously published data on the performance of two HRP2-based RDTs deployed in Djibouti in 2018–2020. The diagnosis of 350 febrile patients with suspected malaria in Djibouti city was established using two batches of RapiGEN BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) RDT over a two-year period (2022 and 2023) and confirmed by real-time quantitative polymerase chain reaction. The sensitivity and specificity for the detection of P. falciparum were 88.2% and 100%, respectively. For P. vivax, the sensitivity was 86.7% and the specificity was 100%. Re-training and closer supervision of the technicians between 2022 and 2023 have led to an increased sensitivity to detect P. falciparum (69.8% in 2022 versus 88.2% in 2023; p < 0.01). The receiver operating characteristic curve analysis highlighted a better performance in the diagnosis of P. falciparum with pLDH-based RDTs compared with previous HRP2-based RDTs. In Djibouti, where pfhrp2-deleted strains are rapidly gaining ground, LDH-based RDTs seem to be more suitable for diagnosing P. falciparum than HRP2-based RDTs. Awareness-raising and training for technical staff have also been beneficial.

Fluorescence confocal microscopy (FCM) represents a novel diagnostic technique able to provide real-time histological images from non-fixed specimens. As a consequence of its recent developments, FCM is gaining growing popularity in urological practice. Nevertheless, evidence is still sparse, and, at the moment, its applications are heterogeneous. We performed a narrative review of the current literature on this topic. Papers were selected from the Pubmed, Embase, and Medline archives. We focused on FCM applications in prostate cancer (PCa), urothelial carcinoma (UC), and renal cell carcinoma (RCC). Articles investigating both office and intraoperative settings were included. The review of the literature showed that FCM displays promising accuracy as compared to conventional histopathology. These results represent significant steps along the path of FCM’s formal validation as an innovative ready-to-use diagnostic support in urological practice. Instant access to a reliable histological evaluation may indeed significantly influence physicians’ decision-making process. In this regard, FCM addresses this still unmet clinical need and introduces intriguing perspectives into future diagnostic pathways. Further studies are required to thoroughly assess the whole potential of this technique.

Background and Aims Coinfection of hepatitis delta virus (HDV) with hepatitis B virus (HBV) causes the most severe form of viral hepatitis, and the global prevalence of HDV infection is underestimated. Although serological testing of anti-HDV antibodies is widely used in the diagnosis of HDV, its diagnostic efficacy remains unclear. This study aimed to evaluate the diagnostic efficacy of HDV serological tests, the results of which may assist in the diagnosis of HDV. Methods Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. The PubMed, Web of Science and Cochrane Library databases were searched from the beginning to 31 May 2023. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. STATA SE was used for the meta-analysis of the sensitivity, specificity, positive likelihood ratio and negative likelihood ratio. Results Among a total of 1376 initially identified studies, only 12 articles met the final inclusion criteria. The pooled sensitivity and specificity were 1.00 (95% CI: 0.00–1.00) and 0.71 (95% CI: 0.50–0.78) for HDV total antibodies, 0.96 (95% CI: 0.83–0.99) and 0.98 (95% CI: 0.82–1.00) for anti-HDV IgM and 0.95 (95% CI: 0.86–0.98) and 0.96 (95% CI: 0.67–1.00) for anti-HDV IgG. The pooled sensitivity and specificity for HDV serological tests were 0.99 (95% CI: 0.96–1.00) and 0.90 (95% CI: 0.79–0.96). Conclusions This meta-analysis suggests that serological tests have high diagnostic performance in detecting antibodies against HDV, especially in HDV IgM and IgG. However, this conclusion is based on studies of a limited number and quality, and the development of new diagnostic tools with higher precision and reliability is still necessary.

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.

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.

Obesity is known to be one of the most significant risk factors for essential hypertension in childhood. However, whether obesity cut-offs may predict hypertension screening in adolescents remains controversial. This study investigated the performance of obesity cut-off values for the screening of hypertension in a South African adolescent population. In this cross-sectional study, 1144 adolescents aged between 11 and 17 years were recruited from the Eastern Cape Province of South Africa. Anthropometric and blood pressure (BP) parameters including diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR) were measured. Assessment of the sensitivity and specific of obesity cut-off values in predicting hypertension was performed using receiver operating characteristic (ROC) analysis. Obesity was positively associated (p < 0.01) with hypertension. Obese individuals, based on the predicted obesity using BMI percentile cut-off (pBMI85.2%), were more likely to develop hypertension (odds ratio: 2.070; p < 0.001) than their counterparts based on the observed obesity cut-off (pBMI95%) (Odd ratio: 1.748 p = 0.004). The area under the curve (AUC) of BMI percentile and WHtR for screening SBP percentile, and DBP percentile and HR as per ROC analysis, was low (

Background: CRB-65 (Confusion; Respiratory rate ≥ 30/min; Blood pressure ≤ 90/60 mmHg; age ≥ 65 years) is a risk score for prognosticating patients with COVID-19 pneumonia. However, a significant proportion of COVID-19 patients have normal chest X-rays (CXRs). The influence of CXR abnormalities on the prognostic value of CRB-65 is unknown, limiting its wider applicability. Methods: We assessed the influence of CXR abnormalities on the prognostic value of CRB-65 in COVID-19. Results: In 589 study patients (71 years (IQR: 57–83); 57% males), 186 (32%) had normal CXRs. On ROC analysis, CRB-65 performed similarly in patients with normal vs. abnormal CXRs for predicting inpatient mortality (AUC 0.67 ± 0.05 vs. 0.69 ± 0.03). In patients with normal CXRs, a CRB-65 of 0 ruled out mortality, NIV requirement and critical illness (intubation and/or ICU admission) with negative predictive values (NPVs) of 94%, 98% and 99%, respectively. In patients with abnormal CXRs, a CRB-65 of 0 ruled out the same endpoints with NPVs of 91%, 83% and 86%, respectively. Patients with low CRB-65 scores had better inpatient survival than patients with high CRB-65 scores, irrespective of CXR abnormalities (all p < 0.05). Conclusions: CRB-65, CXR and CRP are independent predictors of mortality in COVID-19. Adding CXR findings (dichotomised to either normal or abnormal) to CRB-65 does not improve its prognostic accuracy. A low CRB-65 score of 0 may be a good rule-out test for adverse clinical outcomes in COVID-19 patients with normal or abnormal CXRs, which deserves prospective validation.

Background and Objectives: Intervertebral disc degeneration (IDD) is a common cause of symptomatic axial low back pain. Magnetic resonance imaging (MRI) is currently the standard for the investigation and diagnosis of IDD. Deep learning artificial intelligence models represent a potential tool for rapidly and automatically detecting and visualizing IDD. This study investigated the use of deep convolutional neural networks (CNNs) for the detection, classification, and grading of IDD. Methods: Sagittal images of 1000 IDD T2-weighted MRI images from 515 adult patients with symptomatic low back pain were separated into 800 MRI images using annotation techniques to create a training dataset (80%) and 200 MRI images to create a test dataset (20%). The training dataset was cleaned, labeled, and annotated by a radiologist. All lumbar discs were classified for disc degeneration based on the Pfirrmann grading system. The deep learning CNN model was used for training in detecting and grading IDD. The results of the training with the CNN model were verified by testing the grading of the dataset using an automatic model. Results: The training dataset of the sagittal intervertebral disc lumbar MRI images found 220 IDDs of grade I, 530 of grade II, 170 of grade III, 160 of grade IV, and 20 of grade V. The deep CNN model was able to detect and classify lumbar IDD with an accuracy of more than 95%. Conclusion: The deep CNN model can reliably automatically grade routine T2-weighted MRIs using the Pfirrmann grading system, providing a quick and efficient method for lumbar IDD classification.

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.

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.

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.

Introduction: Leucine-rich alpha-2-glycoprotein 1(LRG-1) is a human protein that has shown potential usefulness as a biomarker for diagnosing pediatric acute appendicitis (PAA). This study aims to validate the diagnostic performance of serum LRG-1 in PAA. Material and Methods: This work is a subgroup analysis from BIDIAP (BIomarkers for DIagnosing Appendicitis in Pediatrics), a prospective single-center observational cohort, to validate serum LRG-1 as a diagnostic tool in PAA. This analysis included 200 patients, divided into three groups: (1) healthy patients undergoing major outpatient surgery ( n = 56), (2) patients with non-surgical abdominal pain ( n = 52), and (3) patients with a confirmed diagnosis of PAA ( n = 92). Patients in group 3 were divided into complicated and uncomplicated PAA. In all patients, a serum sample was obtained during recruitment, and LRG-1 concentration was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA). Comparative statistical analyses were performed using the Mann-Whitney U, Kruskal-Wallis, and Fisher's exact tests. The area under the receiver operating characteristic curves (AUC) was calculated for all pertinent analyses. Results: Serum LRG-1 values, expressed as median (interquartile range) were 23,145 (18,246-27,453) ng/mL in group 1, 27,655 (21,151-38,795) ng/mL in group 2 and 40,409 (32,631-53,655) ng/mL in group 3 ( p < 0.0001). Concerning the type of appendicitis, the serum LRG-1 values obtained were 38,686 (31,804-48,816) ng/mL in the uncomplicated PAA group and 51,857 (34,013-64,202) ng/mL in the complicated PAA group ( p = 0.02). The area under the curve (AUC) obtained (group 2 vs. 3) was 0.75 (95% CI 0.67-0.84). For the discrimination between complicated and uncomplicated PAA, the AUC obtained was 0.66 (95% CI 0.52-0.79). Conclusions: This work establishes normative health ranges for serum LRG-1 values in the pediatric population and shows that serum LRG-1 could be a potentially helpful tool for diagnosing PAA in the future. Future prospective multicenter studies, with the parallel evaluation of urinary and salivary LRG-1, are necessary to assess the implementability of this molecule in actual clinical practice.

A fungal polymerase chain reaction (PCR) amplifies conserved genes across diverse species, combined with the subsequent hybridization of amplicons using a specific oligonucleotide microarray, allowing for the rapid detection of pathogens at the species level. However, the performance of microarrays in diagnosing invasive mold infections (IMI) from infected tissue samples is rarely reported. During the 4-year study period, all biopsied tissue samples from patients with a suspected IMI sent for microarray assays were analyzed. A partial segment of the internal transcribed spacer (ITS) region was amplified by nested PCR after DNA extraction. Amplicons were hybridized with specific probes for a variety of mold species using an in-house oligonucleotide microarray. A total of 80 clinical samples from 74 patients were tested. A diagnosis of an IMI was made in 10 patients (4 proven, 1 probable, 3 possible, 2 clinical suspicion). The PCR/microarray test was positive for three out of four proven IMIs, one probable IMI, and one out of three possible IMIs. Two patients with positive PCR/microarray findings were considered to have clinical suspicion of an IMI, and their responsible physicians initiated antifungal therapy despite the absence of supporting microbiological and histological evidence. Clinical diagnoses were categorized into non-IMI and IMI groups (including proven, probable, possible, and clinical suspicion). The sensitivity and specificity of the microarray in diagnosing the IMIs were 70% and 95.7%, respectively, while the sensitivity and specificity of the culture and histological findings were 10%/96.3% and 40.0%/100%, respectively. PCR-based methods provide supportive microbiological evidence when culture results are inconclusive. The combination of a microarray with fungal culture and histology promotes the precise diagnosis of IMIs in difficult-to-diagnose patients.

The early diagnosis of biliary atresia (BA) in cholestatic infants is critical to the success of the treatment. Intraoperative cholangiography (IOC), an invasive imaging technique, is the current strategy for the diagnosis of BA. Ultrasonography has advanced over recent years and emerging techniques such as shear wave elastography (SWE) have the potential to improve BA diagnosis. This review sought to evaluate the diagnostic efficacy of advanced ultrasonography techniques in the diagnosis of BA. Six databases (CINAHL, Medline, PubMed, Google Scholar, Web of Science (core collection), and Embase) were searched for studies assessing the diagnostic performance of advanced ultrasonography techniques in differentiating BA from non-BA causes of infantile cholestasis. The meta-analysis was performed using Meta-DiSc 1.4 and Comprehensive Meta-analysis v3 software. Quality Assessment of Diagnostic Accuracy Studies tool version 2 (QUADAS-2) assessed the risk of bias. Fifteen studies consisting of 2185 patients (BA = 1105; non-BA = 1080) met the inclusion criteria. SWE was the only advanced ultrasonography technique reported and had a good pooled diagnostic performance (sensitivity = 83%; specificity = 77%; AUC = 0.896). Liver stiffness indicators were significantly higher in BA compared to non-BA patients (p < 0.000). SWE could be a useful tool in differentiating BA from non-BA causes of infantile cholestasis. Future studies to assess the utility of other advanced ultrasonography techniques are recommended.

Purpose: To evaluate a commercially available mobile device for the highly specialized task of detection of intracranial arterial aneurysm in telemedicine. Methods: Six radiologists with three different levels of experience retrospectively interpreted 60 computed tomography (CT) angiographies for the presence of intracranial arterial aneurysm, among them 30 cases with confirmed positive findings. Each radiologist reviewed the angiography datasets twice: once on a dedicated medical-grade workstation and on a commercially available mobile consumer-grade tablet with an interval of 3 months. Diagnostic performance, reading efficiency and subjective scorings including diagnostic confidence were analyzed and compared. Results: Diagnostic performance was comparable on both devices regardless of readers’ experience, and no significant differences in sensitivity (66–87.5%) and specificity (79.4–87%) were found. Results obtained with tablets and medical workstations were also comparable in terms of subjective assessment across all reader groups. Conclusions: There was no significant difference between tablet and workstation readings of angiography datasets for the presence of intracranial arterial aneurysm. Sensitivity, specificity, efficiency and subjective scorings were similar with the two devices for all three reader groups. While medical workstations are 10 times more expensive, tablets allow higher mobility especially for radiologists on call.

The early diagnosis of hepatic steatosis is important. No study has assessed hepatic fat quantification by using low-dose dual-energy computed tomography (CT). We assessed the accuracy of hepatic fat quantification using the multi-material decomposition (MMD) algorithm with low-dose non-contrast material-enhanced dual-energy CT. We retrospectively reviewed 33 prospectively enrolled patients who had undergone low-dose non-contrast material-enhanced dual-energy CT and magnetic resonance image (MRI) proton density fat fraction (PDFF) on the same day. Percentage fat volume fraction (FVF) images were generated using the MMD algorithm on the low-dose dual-energy CT data. We assessed the correlation between FVFs and MRI-PDFFs by using Spearman’s rank correlation. With a 5% cutoff value of MRI-PDFF for fatty liver, a receiver operating characteristic (ROC) curve analysis was performed to identify the optimal criteria of FVF for diagnosing fatty liver. CTDIvol of CT was 2.94 mGy. FVF showed a strong correlation with MRI-PDFF (r = 0.756). The ROC curve analysis demonstrated that FVF ≥ 4.61% was the optimal cutoff for fatty liver. With this cutoff value for diagnosing the fatty liver on low-dose dual-energy CT, the sensitivity, specificity, and area under the curve were 90%, 100%, and 0.987, respectively. The MMD algorithm using low-dose non-contrast material-enhanced dual-energy CT is feasible for quantifying hepatic fat.

The analytical and diagnostic performances of methods for detecting red sea bream iridovirus (RSIV), which infects marine fish, have not been evaluated. As disease management and transmission control depend on early and reliable pathogen detection, rapid virus detection techniques are crucial. Herein, we evaluated the diagnostic performance of a TaqMan-based real-time polymerase chain reaction (PCR) assay that detects RSIV rapidly and accurately. The assay amplified the RSIV, infectious spleen and kidney necrosis virus, and turbot reddish body iridovirus genotypes of Megalocytivirus and the detection limit was 10.96 copies/reaction. The assay’s performance remained uncompromised even in the presence of nine potential PCR inhibitors, including compounds commonly used in aquaculture. The variation of the cycle threshold values between assays performed by three technicians was evaluated using a plasmid DNA containing the major capsid protein gene sequence. The variation between replicates was low. The diagnostic sensitivity and specificity of the developed assay were evaluated using fish samples (n = 510) and were found to be 100% and 99.60%, respectively. Two technicians evaluated the reproducibility of the assay using fish samples (n = 90), finding a high correlation of 0.998 (p < 0.0001). Therefore, the newly developed real-time PCR assay detects RSIV both accurately and rapidly.

Introduction: There is a pressing demand for the development of cancer-specific diagnostic imaging tools, particularly for staging of pancreatic-, gastric- or cholangiocarcinoma, as current diagnostic imaging techniques, including CT, MRI and PET using FDG, are not fully adequate. The novel PET-tracer “FAPI” has the potential to visualize even small tumour deposits employing the tumour-specific expression of fibroblast-activating protein (FAP) in malignant cells. Methods: We performed a systematic review to select studies investigating the use of FAPI PET for staging pancreatic-, gastric- and cholangiocarcinoma (PROSPERO CRD42022329512). Patient-wise and lesion-wise comparisons were performed for primary tumour (T), lymph nodes (N), organ metastases (M) and peritoneal carcinomatosis (PC). Maximum standardized uptake values (SUVmax) and tumour-to-background ratios (TBR) were compared between PET using FAPI versus FDG (if reported). Results: Ten articles met the inclusion criteria. In all studies, FAPI PET showed superiority over FDG-PET/CT/MRI for the detection of T, N, M and PC, both in the patient-wise and in lesion-wise comparisons (when performed). Additionally, higher SUVmax and TBRmax values were reported for use of FAPI compared to FDG. Conclusions: The positive results of this review warrant prospective clinical studies to investigate the accuracy and clinical value of FAPI PET for diagnosing and staging patients with pancreatic-, gastric- and cholangiocarcinoma.

Background: The utility of contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) alone in the biliopancreatic region appears to be limited because it is highly dependent on the experience and skill of the endoscopist. Therefore, the present study aimed to validate the efficacy of CH-EUS in clinical practice. Methods: Between January 2018 and March 2019, 301 consecutive patients who underwent CH-EUS were prospectively enrolled in this study. The diagnostic performance of CH-EUS was compared with that of dynamic computed tomography (CT), magnetic resonance imaging (MRI), and all combinations (i.e., CH-EUS, dynamic CT, and MRI) using a Bonferroni correction. A multiple logistic regression analysis was performed to extract each disease that allowed the CH-EUS diagnosis to be consistent with the final diagnosis. Results: In multiple comparisons of diagnostic performance, no significant differences were observed among dynamic CT, MRI, and CH-EUS (p = 1.00), but the diagnostic performance was significantly higher when all modalities were combined (p < 0.001). Moreover, only intraductal papillary mucinous neoplasm comprising adenoma or carcinoma (IPMN, n = 161) showed significance with respect to the agreement with the final diagnosis (p = 0.006). Conclusions: Our results showed that CH-EUS-based diagnosis of IPMN may be possible in clinical practice. On the contrary, to accurately diagnose biliopancreatic diseases other than IPMN, comprehensive diagnosis using multiple modalities may be necessary, rather than relying on CH-EUS alone.

We aimed to evaluate and compare the diagnostic performances of ultrasonography (US) and magnetic resonance enterography (MRE) in assessing active bowel lesions in patients with Crohn’s disease (CD). Materials and Methods: We searched PubMed and EMBASE for studies in which US and MRE were used to assess active bowel lesions in CD patients. Bivariate random effect meta-analytic methods were used to estimate pooled sensitivity, specificity, and hierarchical summary receiver operating characteristic (HSROC) curves. We performed a meta-regression analysis to explore the source of study heterogeneity. Results: Eleven studies involving 752 patients were included. US exhibited a pooled sensitivity of 86% (95% confidence interval (CI) 72–94), pooled specificity of 88% (95% CI 78–94), and HSROC of 0.93 in 10 studies. MRE exhibited a pooled sensitivity of 88% (95% CI 76–95), pooled specificity of 87% (95% CI 73–95), and an HSROC of 0.94 in eight studies. In seven studies comparing the diagnostic performances of US and MRE, the summary sensitivity of US and MRE were 86% (95% CI 65–96, I2 = 92.1) and 86% (95% CI 72–93, I2 = 88.1) (p = 0.841), respectively. The summary specificity of US and MRE were 87% (95% CI 78–93, I2 = 79.8%) and 84% (72–90, I2 = 72.5%) (p = 0.431), respectively, which showed no statistical differences. On meta-regression analysis, studies from Europe (p = 0.002), those that used linear US probes (p = 0.012), those on small bowel lesions (p = 0.01), and those with outcomes as combined features (active inflammation) reported higher US sensitivity than those from other regions, those that used both linear and convex US probes, those on small and large bowels, and those with outcome as one feature (bowel wall thickening or ulcer). Studies with pediatric patients (p = 0.001), those with reference standards including US (p = 0.001), and outcomes as combined features (p = 0.01) reported higher MRE specificity than those with adult populations, reference standards other than the US, and outcomes as one feature. Conclusions: In spite of considerable heterogeneity in the included studies, both US and MRE can diagnose active bowel lesions with comparable diagnostic accuracy in patients with CD. The study region, type of US probe, lesion location, investigated outcome for US sensitivity and study population, reference standards, and investigated outcomes for MRE specificity were potential sources of heterogeneity.

Porcine deltacoronavirus (PDCoV), belonging to family Coronaviridae and genus Deltacoronavirus, is a major enteric pathogen in swine. Accurate PDCoV diagnosis relying on laboratory testing and antibody detection is an important approach. This study evaluated the potential of the receptor-binding subunit of the PDCoV spike protein (S1), generated using a mammalian expression system, for specific antibody detection via indirect enzyme-linked immunosorbent assay (ELISA). Serum samples were collected at day post-inoculation (DPI) −7 to 42, from pigs (n = 83) experimentally inoculated with different porcine coronaviruses (PorCoV). The diagnostic sensitivity of the PDCoV S1-based ELISA was evaluated using serum samples (n = 72) from PDCoV-inoculated animals. The diagnostic specificity and potential cross-reactivity of the assay was evaluated on PorCoV-negative samples (n = 345) and samples collected from pigs experimentally inoculated with other PorCoVs (n = 472). The overall diagnostic performance, time of detection, and detection rate over time varied across different S/P cut-offs, estimated by Receiver Operating Characteristic (ROC) curve analysis. The higher detection rate in the PDCoV group was observed after DPI 21. An S/P cut-off of 0.25 provided 100% specificity with no serological cross-reactivity against other PorCoV. These results support the use of S1 protein-based ELISA for accurate detection of PDCoV infections, transference of maternal antibodies, or active surveillance.

At type 1 diabetes mellitus (T1DM) onset, acute kidney injury (AKI) is very common. To diagnose AKI, the availability of a baseline serum creatinine (bSCr) is pivotal. However, in most hospitalized children the bSCr is unknown. We aimed to test whether the bSCr estimated on the basis of height (ebSCr) could be a reliable surrogate for AKI diagnosis compared with the measured bSCr (mbSCr). As the mbSCr, we considered the creatinine measured 14 days after T1DM onset while ebSCr (mg/dL) = (k × height [cm])/120 mL/min/1.73 m2, where k = 0.55 for children and adolescent girls and k = 0.7 for adolescent boys. AKI was defined as serum creatinine values >1.5 times the baseline creatinine. Kappa statistics and the percentage of agreement in AKI classification by ebSCr–AKI versus mbSCr–AKI definition methods were calculated. Bland–Altman plots were used to show the agreement between the creatinine ratio (highest/baseline creatinine; HC/BC) calculated with mbSCr and ebSCr. The number of 163 patients with T1DM onset were included. On the basis of mbSCr, 66/163 (40.5%) presented AKI while, on the basis of ebSCr, 50/163 (30.7%) accomplished AKI definition. ebSCr showed good correlation with mbSCr using both the Spearman test (rho = 0.67; p < 0.001) and regression analysis (r = 0.68; p < 0.001). Moreover, at the Bland–Altman plots, the bias of the highest/baseline creatinine ratio calculated on the basis of the mbSCr compared to ebSCr was minimal (bias = −0.08 mg/dL; 95% limits of agreement = −0.23/0.39). AKI determined using ebSCr showed 90% agreement with AKI determined using mbSCr (kappa = 0.66; p < 0.001). Finally, we compared the area under a receiver–operating characteristic curve (AUROC) of HC/BC ratio calculated on the basis of ebSCr with AUROC of the gold standard HC/BC ratio calculated on the basis of mbSCr. As expected, the gold standard had an AUROC = 1.00 with a 95% confidence interval (CI) between 0.98 and 1.00, p < 0.001. The HC/BC ratio calculated on the basis of ebSCr also had significant AUROC (AUROC = 0.94; 95% CI: 0.90–0.97; p < 0.001). The comparison of the two ROC curves showed a p < 0.001. In conclusion, when mbSCr is unknown in patients with T1DM onset, the ebSCr calculated on the basis of height could be an alternative to orientate clinicians toward AKI diagnosis.

Coronavirus disease 2019 (COVID-19) initiated global health care challenges such as the necessity for new diagnostic tests. Diagnosis by real-time PCR remains the gold-standard method, yet economical and technical issues prohibit its use in points of care (POC) or for repetitive tests in populations. A lot of effort has been exerted in developing, using, and validating antigen-based tests (ATs). Since individual studies focus on few methodological aspects of ATs, a comparison of different tests is needed. Herein, we perform a systematic review and meta-analysis of data from articles in PubMed, medRxiv and bioRxiv. The bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities was used. Most of the AT types for SARS-CoV-2 were lateral flow immunoassays (LFIA), fluorescence immunoassays (FIA), and chemiluminescence enzyme immunoassays (CLEIA). We identified 235 articles containing data from 220,049 individuals. All ATs using nasopharyngeal samples show better performance than those with throat saliva (72% compared to 40%). Moreover, the rapid methods LFIA and FIA show about 10% lower sensitivity compared to the laboratory-based CLEIA method (72% compared to 82%). In addition, rapid ATs show higher sensitivity in symptomatic patients compared to asymptomatic patients, suggesting that viral load is a crucial parameter for ATs performed in POCs. Finally, all methods perform with very high specificity, reaching around 99%. LFIA tests, though with moderate sensitivity, appear as the most attractive method for use in POCs and for performing seroprevalence studies.

Background: Analysis of serum biomarkers for the assessment of atrophic gastritis (AG), a gastric precancerous lesion, is of growing interest for identification of patients at increased risk of gastric cancer. The aim was to analyze the diagnostic performance of serum pepsinogen testing using another method, chemiluminescent enzyme immunoassay (CLEIA), as well as of other new potential biomarkers. Material and Methods: The sera of patients considered at increased risk of gastric cancer and undergoing upper endoscopy collected in our previous prospective, multicenter study were tested for pepsinogen I (PGI) and II (PGII), interleukin-6 (IL-6), human epididymal protein 4 (HE-4), adiponectin, ferritin and Krebs von den Lungen (KL-6) using the CLEIA. The diagnostic performance for the detection of AG was calculated by taking histology as the reference. Results: In total, 356 patients (162 men (46%); mean age 58.6 (±14.2) years), including 152 with AG, were included. For the detection of moderate to severe corpus AG, sensitivity and specificity of the pepsinogen I/II ratio were of 75.0% (95%CI 57.8–87.9) and 92.6% (88.2–95.8), respectively. For the detection of moderate to severe antrum AG, sensitivity of IL-6 was of 72.2% (95%CI 46.5–90.3). Combination of pepsinogen I/II ratio or HE-4 showed a sensitivity of 85.2% (95%CI 72.9–93.4) for the detection of moderate to severe AG at any location. Conclusion: This study shows that PG testing by CLEIA represents an accurate assay for the detection of corpus AG. Additionally, IL-6 and HE-4 may be of interest for the detection of antrum AG. Mini-abstract: Pepsinogens testing by chemiluminescent enzyme immunoassay is accurate for the detection of corpus atrophic gastritis. IL-6 and HE-4 maybe of interest for the detection of antrum atrophic gastritis.

The fast and accurate detection of susceptibility in drugs is a major challenge for a successful tuberculosis (TB) control programme. This study evaluated the performance of WHO-endorsed rapid diagnostic tools, such as BACTEC MGIT 960 SIRE (MGIT SIRE), GenoType MTBDRplus (MTBDRplus) and Xpert MTB/RIF (Xpert), for detecting susceptibility to first-line anti-TB drugs among pulmonary TB patients in Bangladesh. A total of 825 sputum samples with results from drug susceptibility testing (DST) against first-line anti-TB drugs in the MGIT SIRE, MTBDRplus and Xpert assays were evaluated and compared with the gold standard proportion susceptibility method of the Lowenstein–Jensen (LJ) medium. The overall sensitivities of MGIT SIRE were 97.6%, 90.0%, 61.3% and 44.9%, while specificities were 89.9%, 94.5%, 91.3% and 92.2% for detection of susceptibility to isoniazid (INH), rifampicin (RIF), streptomycin (STR) and ethambutol (EMB), respectively. For MTBDRplus, the sensitivities were 88.0% and 88.7%, and the specificities were 97.4% and 97.8% for the detection of susceptibility to INH and RIF, respectively. Xpert demonstrated a sensitivity and specificity of 94.8% and 99.5%, respectively, for the detection of RIF susceptibility. All tests performed significantly better in retreated TB patients compared with primary TB cases. For detection of RIF and INH susceptibility, all three assays showed almost perfect agreement with the LJ method, although MGIT SIRE exhibited low agreement for STR and EMB. Considering the high performance, shorter turnaround time and ease of use, molecular-based approaches Xpert and MTBDRplus can be widely implemented throughout the country for the rapid detection of drug-resistant TB.

Purpose: Intracranial vertebral artery dissection (VAD) is being increasingly recognized as a leading cause of Wallenberg syndrome and subarachnoid hemorrhage. Conventional angiography is considered the standard diagnostic modality, but the diagnosis of VAD remains challenging. This study aimed to compare the diagnostic performance of high-resolution vessel wall imaging (HR-VWI) with digital subtraction angiography (DSA) for intracranial VAD. Materials and methods: Twenty-four patients with 27 VADs, who underwent both HR-VWI and DSA within 2 weeks, were consecutively enrolled in the study from March 2016 to September 2020. HR-VWI and DSA were performed to diagnose VAD and to categorize its angiographic features as either definite dissection or suspicious dissection. Features of HR-VWI were used to evaluate direct arterial wall imaging. The reference standard was set from the clinicoradiologic diagnosis. Two independent raters evaluated the angiographic features, dissection signs, and interrater agreement. Each subject was also dichotomized into two groups (suspicious or definite VAD) in each modality, and diagnosis from HR-VWI and DSA was compared with the final diagnosis by consensus. Results: HR-VWI had higher agreement (90.6% vs. 53.1%) with the final diagnosis and better interrater reliability (kappa value (κ) = 0.91; 95% confidence interval (CI) = 0.64–1.00) compared with DSA (κ = 0.58; 95% CI = 0.35–1.00). HR-VWI provided a more detailed identification of dissection signs (77.7% vs. 22.2%) and better reliability (κ = 0.88; 95% CI = 0.58–1.00 vs. κ = 0.75; 95% CI = 0.36–1.00), compared to DSA. HR-VWI was comparable to DSA for the depiction of angiographic features for VAD. Conclusions: HR-VWI may be useful to evaluate VAD, with better diagnostic confidence compared to DSA.

The banana mild mosaic virus (BanMMV) (Betaflexiviridae, Quinvirinae, unassigned species) is a filamentous virus that infects Musa spp. and has a very wide geographical distribution. The current BanMMV indexing process for an accession requires the testing of no less than four plants cultivated in a greenhouse for at least 6 months and causes a significant delay for the distribution of the germplasm. We evaluated the sensitivity of different protocols for BanMMV detection from in vitro plants to accelerate the testing process. We first used corm tissues from 137 in vitro plants and obtained a diagnostic sensitivity (DSE) of only 61% when testing four plants per accession. After thermotherapy was carried out to eliminate BanMMV infection, the meristem was recovered and further grown in vitro. The same protocol was evaluated in parallel on the corm tissue surrounding the meristem, as a rapid screening to evaluate virus therapy success, and was compared to the results obtained following the standard protocol. The obtained results showed 28% false negatives when conducting testing from corm tissues, making this protocol unsuitable in routine processes. Furthermore, RT-PCR and high-throughput sequencing (HTS) tests were applied on tissues from the base (n = 39) and the leaves (n = 36). For RT-PCR, the average DSE per sample reached 65% from either the base or leaves. HTS was applied on 36 samples and yielded 100% diagnostic specificity (DSP) and 100% DSE, whatever the sampled tissue, allowing the identification of a new Betaflexiviridae species infecting Musa. These results suggest that a reliable diagnostic of BanMMV from in vitro plants using RT-PCR or HTS technologies might represent an efficient alternative for testing after greenhouse cultivation.

We assessed the rapid on-line evaluation (ROLE) protocol as a modification to the conventional rapid on-site evaluation (ROSE) in the diagnostic performance improvement in endoscopic ultrasound-guided tissue acquisition (EUS-TA) for solid pancreatic lesions. This single-center, retrospective study involved consecutive patients with solid pancreatic lesions undergoing EUS-TA at Peking University First Hospital between October 2017 and March 2021. Among 137 patients enrolled, 75 were in the ROLE group and 62 were in the non-ROSE group. The diagnostic yield (97.3% vs. 85.5%, p = 0.023), accuracy (94.7% vs. 82.3%, p = 0.027), and sensitivity (95.7% vs. 81.1%, p = 0.011) were significantly higher in the ROLE group compared to the non-ROSE group. However, specificity, positive predictive value, negative predictive value, and area under the curve (AUC) showed no significant differences (all p -values > 0.05). Additionally, there was a noteworthy reduction in the number of needle passes required in the ROLE group compared to the non-ROSE group (two vs. three, p < 0.001). In a subgroup analysis, fine needle biopsy (FNB) combined with ROLE demonstrated superior diagnostic accuracy compared to FNB with non-ROSE (100% vs. 93.1%, p = 0.025). Compared with the non-ROSE protocol, the ROLE protocol might improve the diagnostic performance of EUS-TA for solid pancreatic lesions, and potentially reduce the number of needle passes requirement.

Until 2020, Djiboutian health authorities relied on histidine-rich protein-2 (HRP2)-based rapid diagnostic tests (RDTs) to establish the diagnosis of Plasmodium falciparum . The rapid spread of P. falciparum histidine-rich protein-2 and -3 ( pfhrp2/3 ) gene-deleted parasite strains in Djibouti has led the authorities to switch from HRP2-based RDTs to lactate dehydrogenase (LDH)-based RDTs targeting the plasmodial lactate dehydrogenase (pLDH) specific for P. falciparum and P. vivax (RapiGEN BIOCREDIT Malaria Ag Pf/Pv pLDH/pLDH) in 2021. This study was conducted with the primary objective of evaluating the diagnostic performance of this alternative RDT. Operational constraints related, in particular, to the implementation of this RDT during the COVID-19 pandemic were also considered. The performance of BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) RDT was also compared to our previously published data on the performance of two HRP2-based RDTs deployed in Djibouti in 2018-2020. The diagnosis of 350 febrile patients with suspected malaria in Djibouti city was established using two batches of RapiGEN BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) RDT over a two-year period (2022 and 2023) and confirmed by real-time quantitative polymerase chain reaction. The sensitivity and specificity for the detection of P. falciparum were 88.2% and 100%, respectively. For P. vivax , the sensitivity was 86.7% and the specificity was 100%. Re-training and closer supervision of the technicians between 2022 and 2023 have led to an increased sensitivity to detect P. falciparum (69.8% in 2022 versus 88.2% in 2023; p < 0.01). The receiver operating characteristic curve analysis highlighted a better performance in the diagnosis of P. falciparum with pLDH-based RDTs compared with previous HRP2-based RDTs. In Djibouti, where pfhrp2 -deleted strains are rapidly gaining ground, LDH-based RDTs seem to be more suitable for diagnosing P. falciparum than HRP2-based RDTs. Awareness-raising and training for technical staff have also been beneficial.

Our objective was to evaluate the diagnostic performance of a convolutional neural network (CNN) trained on multiple MR imaging features of the lumbar spine, to detect a variety of different degenerative changes of the lumbar spine. One hundred and forty-six consecutive patients underwent routine clinical MRI of the lumbar spine including T2-weighted imaging and were retrospectively analyzed using a CNN for detection and labeling of vertebrae, disc segments, as well as presence of disc herniation, disc bulging, spinal canal stenosis, nerve root compression, and spondylolisthesis. The assessment of a radiologist served as the diagnostic reference standard. We assessed the CNN’s diagnostic accuracy and consistency using confusion matrices and McNemar’s test. In our data, 77 disc herniations (thereof 46 further classified as extrusions), 133 disc bulgings, 35 spinal canal stenoses, 59 nerve root compressions, and 20 segments with spondylolisthesis were present in a total of 888 lumbar spine segments. The CNN yielded a perfect accuracy score for intervertebral disc detection and labeling (100%), and moderate to high diagnostic accuracy for the detection of disc herniations (87%; 95% CI: 0.84, 0.89), extrusions (86%; 95% CI: 0.84, 0.89), bulgings (76%; 95% CI: 0.73, 0.78), spinal canal stenoses (98%; 95% CI: 0.97, 0.99), nerve root compressions (91%; 95% CI: 0.89, 0.92), and spondylolisthesis (87.61%; 95% CI: 85.26, 89.21), respectively. Our data suggest that automatic diagnosis of multiple different degenerative changes of the lumbar spine is feasible using a single comprehensive CNN. The CNN provides high diagnostic accuracy for intervertebral disc labeling and detection of clinically relevant degenerative changes such as spinal canal stenosis and disc extrusion of the lumbar spine.

Background: The diphtheria toxoid antigen is a major component in pediatric and booster combination vaccines and is known to raise a protective humoral immune response upon vaccination. Although antibodies are considered critical for diphtheria protection, little is known about the antigenic determinants that maintain humoral immunity. Methods: One-hundred and twelve 15 mer peptides covering the entire sequence of diphtheria toxin (DTx) protein were prepared by SPOT synthesis. The immunoreactivity of membrane-bound peptides with sera from mice immunized with a triple DTP vaccine allowed mapping of continuous B-cell epitopes, topological studies, multiantigen peptide (MAP) synthesis, and Enzyme-Linked Immunosorbent Assay (ELISA) development. Results: Twenty epitopes were identified, with two being in the signal peptide, five in the catalytic domain (CD), seven in the HBFT domain, and five in the receptor-binding domain (RBD). Two 17 mer (CB/Tx-2/12 and CB/DTx-4–13) derived biepitope peptides linked by a Gly-Gly spacer were chemically synthesized. The peptides were used as antigens to coat ELISA plates and assayed with human (huVS) and mice vaccinated sera (miVS) for in vitro diagnosis of diphtheria. The assay proved to be highly sensitive (99.96%) and specific (100%) for huVS and miVS and, when compared with a commercial ELISA test, demonstrated a high performance. Conclusions: Our work displayed the complete picture of the linear B cell IgG response epitope of the DTx responsible for the protective effect and demonstrated sufficient specificity and eligibility for phase IIB studies of some epitopes to develop new and fast diagnostic assays.

Background: Infectious endocarditis is a life-threatening disease, requiring prompt and accurate diagnosis. The aim of this article is to perform a systematic review and meta-analysis of the literature to estimate the performance of fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for the diagnosis of native valve endocarditis (NVE). Methods: Selected articles evaluating the diagnostic accuracy of 18F-FDG PET/CT in patients with suspected NVE, resulting from a comprehensive literature search through the PubMed/MEDLINE and Cochrane library databases until April 2020, were included for the systematic review and meta-analysis. Results: Seven studies (351 episodes of suspected NVE) were included. 18F-FDG PET/CT yielded a pooled sensitivity of 36.3% and a pooled specificity of 99.1% for the diagnosis of NVE. The pooled positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio were 8.3, 0.6, and 15.3, respectively. The sensitivity increased using contemporary PET/CT device with state-of-the-art patient preparation as well as innovative image acquisitions or adding the results of 18F-FDG PET/CT in a multimodality strategy. Conclusions: In our systematic review and meta-analysis, 18F-FDG PET/CT yielded a poor pooled sensitivity with an otherwise excellent pooled specificity for the diagnosis of NVE; however, several factors may increase the sensitivity without affecting the specificity and these factors should be better evaluated in future studies.

Fluorescence confocal microscopy (FCM) represents a novel diagnostic technique able to provide real-time histological images from non-fixed specimens. As a consequence of its recent developments, FCM is gaining growing popularity in urological practice. Nevertheless, evidence is still sparse, and, at the moment, its applications are heterogeneous. We performed a narrative review of the current literature on this topic. Papers were selected from the Pubmed, Embase, and Medline archives. We focused on FCM applications in prostate cancer (PCa), urothelial carcinoma (UC), and renal cell carcinoma (RCC). Articles investigating both office and intraoperative settings were included. The review of the literature showed that FCM displays promising accuracy as compared to conventional histopathology. These results represent significant steps along the path of FCM's formal validation as an innovative ready-to-use diagnostic support in urological practice. Instant access to a reliable histological evaluation may indeed significantly influence physicians' decision-making process. In this regard, FCM addresses this still unmet clinical need and introduces intriguing perspectives into future diagnostic pathways. Further studies are required to thoroughly assess the whole potential of this technique.

Filovirus serological diagnosis and epidemiological investigations are hampered due to the unavailability of validated immunoassays. Diagnostic performance of three indirect enzyme-linked immunosorbent assays (I-ELISA) was evaluated for the detection of IgG antibody to Ebola virus (EBOV) in human sera. One I-ELISA was based on a whole EBOV antigen (WAg) and two utilized recombinant nucleocapsid (NP) and glycoproteins (GP), respectively. Validation data sets derived from individual sera collected in South Africa (SA), representing an EBOV non-endemic country, and from sera collected during an Ebola disease (EBOD) outbreak in Sierra Leone (SL), were categorized according to the compounded results of the three I-ELISAs and real time reverse-transcription polymerase chain reaction (RT-PCR). At the cut-off values selected at 95% accuracy level by the two-graph receiver operating characteristic analysis, specificity in the SA EBOV negative serum panel (n = 273) ranged from 98.17% (GP ELISA) to 99.27% (WAg ELISA). Diagnostic specificity in the SL EBOV negative panel (n = 676) was 100% by the three ELISAs. The diagnostic sensitivity in 423 RT-PCR confirmed EBOD patients was dependent on the time when the serum was collected after onset of disease. It significantly increased 2 weeks post-onset, reaching 100% sensitivity by WAg and NP and 98.1% by GP I-ELISA.

Obesity is known to be one of the most significant risk factors for essential hypertension in childhood. However, whether obesity cut-offs may predict hypertension screening in adolescents remains controversial. This study investigated the performance of obesity cut-off values for the screening of hypertension in a South African adolescent population. In this cross-sectional study, 1144 adolescents aged between 11 and 17 years were recruited from the Eastern Cape Province of South Africa. Anthropometric and blood pressure (BP) parameters including diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR) were measured. Assessment of the sensitivity and specific of obesity cut-off values in predicting hypertension was performed using receiver operating characteristic (ROC) analysis. Obesity was positively associated ( p < 0.01) with hypertension. Obese individuals, based on the predicted obesity using BMI percentile cut-off (pBMI85.2%), were more likely to develop hypertension (odds ratio: 2.070; p < 0.001) than their counterparts based on the observed obesity cut-off (pBMI95%) (Odd ratio: 1.748 p = 0.004). The area under the curve (AUC) of BMI percentile and WHtR for screening SBP percentile, and DBP percentile and HR as per ROC analysis, was low (<0.65). Equally, the sensitivity and specificity were low (<0.6) for all BP measures (SBP, DBP, and HR). Furthermore, the cut-off values for blood pressure measures, as established by ROC analysis using anthropometric measures, were far below the recommended cut-off values for hypertension screening. The obesity cut-offs for BMI percentile and WHtR established in this populations showed poor performance in diagnosing hypertension even though they were strong predictors of hypertension.

Background: CRB-65 ( C onfusion; R espiratory rate ≥ 30/min; B lood pressure ≤ 90/60 mmHg; age ≥ 65 years) is a risk score for prognosticating patients with COVID-19 pneumonia. However, a significant proportion of COVID-19 patients have normal chest X-rays (CXRs). The influence of CXR abnormalities on the prognostic value of CRB-65 is unknown, limiting its wider applicability. Methods: We assessed the influence of CXR abnormalities on the prognostic value of CRB-65 in COVID-19. Results: In 589 study patients (71 years (IQR: 57-83); 57% males), 186 (32%) had normal CXRs. On ROC analysis, CRB-65 performed similarly in patients with normal vs. abnormal CXRs for predicting inpatient mortality (AUC 0.67 ± 0.05 vs. 0.69 ± 0.03). In patients with normal CXRs, a CRB-65 of 0 ruled out mortality, NIV requirement and critical illness (intubation and/or ICU admission) with negative predictive values (NPVs) of 94%, 98% and 99%, respectively. In patients with abnormal CXRs, a CRB-65 of 0 ruled out the same endpoints with NPVs of 91%, 83% and 86%, respectively. Patients with low CRB-65 scores had better inpatient survival than patients with high CRB-65 scores, irrespective of CXR abnormalities (all p < 0.05). Conclusions: CRB-65, CXR and CRP are independent predictors of mortality in COVID-19. Adding CXR findings (dichotomised to either normal or abnormal) to CRB-65 does not improve its prognostic accuracy. A low CRB-65 score of 0 may be a good rule-out test for adverse clinical outcomes in COVID-19 patients with normal or abnormal CXRs, which deserves prospective validation.

Background and Objectives: Intervertebral disc degeneration (IDD) is a common cause of symptomatic axial low back pain. Magnetic resonance imaging (MRI) is currently the standard for the investigation and diagnosis of IDD. Deep learning artificial intelligence models represent a potential tool for rapidly and automatically detecting and visualizing IDD. This study investigated the use of deep convolutional neural networks (CNNs) for the detection, classification, and grading of IDD., Methods: Sagittal images of 1000 IDD T2-weighted MRI images from 515 adult patients with symptomatic low back pain were separated into 800 MRI images using annotation techniques to create a training dataset (80%) and 200 MRI images to create a test dataset (20%). The training dataset was cleaned, labeled, and annotated by a radiologist. All lumbar discs were classified for disc degeneration based on the Pfirrmann grading system. The deep learning CNN model was used for training in detecting and grading IDD. The results of the training with the CNN model were verified by testing the grading of the dataset using an automatic model., Results: The training dataset of the sagittal intervertebral disc lumbar MRI images found 220 IDDs of grade I, 530 of grade II, 170 of grade III, 160 of grade IV, and 20 of grade V. The deep CNN model was able to detect and classify lumbar IDD with an accuracy of more than 95%., Conclusion: The deep CNN model can reliably automatically grade routine T2-weighted MRIs using the Pfirrmann grading system, providing a quick and efficient method for lumbar IDD classification.

The early diagnosis of biliary atresia (BA) in cholestatic infants is critical to the success of the treatment. Intraoperative cholangiography (IOC), an invasive imaging technique, is the current strategy for the diagnosis of BA. Ultrasonography has advanced over recent years and emerging techniques such as shear wave elastography (SWE) have the potential to improve BA diagnosis. This review sought to evaluate the diagnostic efficacy of advanced ultrasonography techniques in the diagnosis of BA. Six databases (CINAHL, Medline, PubMed, Google Scholar, Web of Science (core collection), and Embase) were searched for studies assessing the diagnostic performance of advanced ultrasonography techniques in differentiating BA from non-BA causes of infantile cholestasis. The meta-analysis was performed using Meta-DiSc 1.4 and Comprehensive Meta-analysis v3 software. Quality Assessment of Diagnostic Accuracy Studies tool version 2 (QUADAS-2) assessed the risk of bias. Fifteen studies consisting of 2185 patients (BA = 1105; non-BA = 1080) met the inclusion criteria. SWE was the only advanced ultrasonography technique reported and had a good pooled diagnostic performance (sensitivity = 83%; specificity = 77%; AUC = 0.896). Liver stiffness indicators were significantly higher in BA compared to non-BA patients (p < 0.000). SWE could be a useful tool in differentiating BA from non-BA causes of infantile cholestasis. Future studies to assess the utility of other advanced ultrasonography techniques are recommended.