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Introduction Fishbone foreign body retention is one of the most common problem with various clinical manifestations from asymptomatic, abscess formation, and perforation to mediastinitis with subsequence morbidity and mortality. Accurately identifying the location of the fishbone leads to precise removal, which, in turn, prevents serious consequences. Digital radiographs have been widely used for diagnosis, but many studies show poor sensitivity. Object The present study was designed to compare the diagnostic performances of digital radiograph and low-dose computed tomography (CT) for fishbone retention and to demonstrate the radiation dose of the two modalities. Methods We collected 2 pieces of fishbone from each of the 15 species commonly eaten in Southeast Asia. We embedded each fishbone in a fresh pig's neck, then subjected the pig's neck to lateral soft tissue neck digital radiograph. The locations to embed included tonsil, base of tongue, and upper esophagus. Then, we subjected the same specimen to a CT scan. Two experienced radiologists interpreted each image. Results Visibility in the digital radiograph group was 13%, and in CT images group, it was 87% regardless of the locations. The average radiation dose from digital radiographs was 0.4 mGy (radiation dose field), while from CT images it was 8.6 mGy (CT dose index). Conclusion Most of the common fishbones in Southeast Asia could not be visualized by digital radiograph when embedded in the neck. Computed tomography scans demonstrated better diagnostic performance of fishbone retention compared to digital radiographs, regardless of the embedded location.

We aimed to investigate the diagnostic performance of new 2-D shear-wave elastography (SWE) with propagation maps and attenuation imaging (ATI) for quantification of fibrosis and steatosis in non- alcoholic fatty liver disease (NAFLD). Consecutive patients with NAFLD and healthy volunteers underwent liver stiffness measurement and steatosis quantification by means of vibration- controlled transient elastography coupled with the controlled attenuation parameter as the reference and by 2-D shear-wave elastography (2-D-SWE) with propagation maps and ATI as the investigational methods. We included 232 participants (164 in the NAFLD group and 68 in the healthy control group): 51.7%/49.3% women/men ; mean age, 54.2 +/- 15.2 y ; mean body mass index, 29.4 +/- 6.5 kg/m(2). Significant correlations were found between 2-D- SWE and vibration-controlled transient elastography (r = 0.71, p < 0.0001) and between ATI and the controlled attenuation parameter (r = 0.72, p < 0.0001). NAFLD-specific 2-D-SWE liver stiffness measurement cutoffs were as follows-F >= 2: 7.9 kPa (area under the curve [AUC] = 0.91) ; F >= 3: 10 kPa (AUC = 0.92) ; and F = 4: 11.4 kPa (AUC = 0.95). For steatosis, the best cutoffs by ATI were as follows-S1 = 0.73 dB/cm/MHz (AUC = 0.86) ; S2 = 0.76 dB/cm/MHz (AUC = 0.86) ; and S3 = 0.80 dB/cm/MHz (AUC = 0.83). According to Baveno VI criteria, the optimal 2-D-SWE liver stiffness measurement for diagnosing liver cirrhosis is 15.5 kPa (AUC = 0.94), and for ruling out compensated advanced chronic liver disease it is 9.2 kPa (AUC = 0.92). To conclude, 2-D-SWE with propagation maps and ATI is reliable for quantification of liver fibrosis and steatosis in patients with NAFLD.

Qian Ye, Junying Guo, Yansong Chen, Zhaolei Cui, Yan Chen Department of Laboratory Medicine, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou City, Fujian Province, 350014, People’s Republic of ChinaCorrespondence: Zhaolei Cui; Yan ChenDepartment of Laboratory Medicine, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, No. 420 Fuma Road, Jin’an District, Fuzhou City, Fujian Province, 350014, People’s Republic of ChinaEmail cuileidizi@163.com; chenyan220422@fjmu.edu.cnObjective: The aim of this study was to evaluate the effectiveness of Epstein–Barr virus (EBV) VCA-IgA antibody, EBV DNA and HSP90α alone or in combinations for the diagnosis and prognostic prediction of nasopharyngeal carcinoma (NPC).Methods: A total of 113 treatment-naïve patients with NPC and 40 healthy controls were enrolled. Plasma HSP90α and serum EBV VCA IgA antibody were detected using ELISA, and plasma EBV DNA was quantified using qPCR assay. The effectiveness of plasma HSP90α level, serum EBV VCA IgA antibody and plasma EBV DNA was examined in the diagnosis and prognosis prediction of NPC.Results: Higher plasma HSP90α, serum EBV VCA IgA antibody and plasma viral load of EBV DNA were detected in NPC patients than in healthy controls (P < 0.001). The plasma HSP90α levels, serum EBV VCA IgA antibody titers and plasma viral load of EBV DNA were significantly greater in NPC patients with stages III and IV than in those with stages I and II (P < 0.001), and significantly lower plasma HSP90α levels, serum EBV VCA IgA antibody titers and plasma viral load of EBV DNA were found in the good prognosis group than in the poor prognosis group post-treatment (P < 0.05). The area under representative operating curves (AUCs) of plasma HSP90α, serum EBV VCA IgA antibody and plasma EBV DNA alone and in combination were 0.884, 0.841, 0.934 and 0.954 for the diagnosis of NPC, respectively. Univariate and multivariate Cox proportional hazards regression analyses identified HSP90α as an independent prognostic factor for NPC.Conclusion: The combination of plasma HSP90α, serum EBV VCA IgA antibody and plasma EBV DNA shows high diagnostic performance for NPC, and plasma HSP90α may be a potential marker for diagnosis and prognosis prediction of NPC.Keywords: nasopharyngeal carcinoma, EBV VCA-IgA antibody, EBV DNA, HSP90α, diagnostic performance, prognosis prediction

Aim This systematic review and meta-analysis aimed to assess the diagnostic performance of commonly used methods for occlusal caries diagnostics, such as visual examination (VE), bitewing radiography (BW) and laser fluorescence (LF), in relation to their ability to detect (dentin) caries under clinical and laboratory conditions. Materials and methods A systematic search of the literature was performed to identify studies meeting the inclusion criteria using the PIRDS concept (N = 1090). A risk of bias (RoB) assessment tool was used for quality evaluation. Reports with low/moderate RoB, well-matching thresholds for index and reference tests and appropriate reporting were included in the meta-analysis (N = 37; 29 in vivo/8 in vitro). The pooled sensitivity (SE), specificity (SP), diagnostic odds ratio (DOR) and areas under ROC curves (AUCs) were computed. Results SP ranged from 0.50 (fibre-optic transillumination/caries detection level) to 0.97 (conventional BW/dentine detection level) in vitro. AUCs were typically higher for BW or LF than for VE. The highest AUC of 0.89 was observed for VE at the 1/3 dentin caries detection level; SE (0.70) was registered to be higher than SP (0.47) for VE at the caries detection level in vivo. Conclusion The number of included studies was found to be low. This underlines the need for high-quality caries diagnostic studies that further provide data in relation to multiple caries thresholds. Clinical relevance VE, BW and LF provide acceptable measures for their diagnostic performance on occlusal surfaces, but the results should be interpreted with caution due to the limited data in many categories.

OBJECTIVE: To compare the evidence on the accuracy parameters of seven commercial molecular in vitro diagnostic tests for detecting SARS-CoV-2. METHODS: Relevant articles were searched in PubMed and Scopus databases until December 2020. Studies evaluating the accuracy of seven different commercial molecular diagnostic tests for detecting SARS-CoV-2 (Cepheid Xpert Xpress SARS-CoV-2 test, Simplexa COVID-19 Direct, Abbott ID NOW COVID-19, Cobas SARS-CoV-2, Allplex 2019-nCoV Assay, Panther Fusion SARS-CoV-2, and BioFire COVID-19 Test) were included. The quality of included studies was assessed using the QUADAS-2 checklist. A bivariate random effects regression model was used for the meta-analyses. RESULTS: Meta-analysis of 12 included studies showed that the performances of commercial COVID-19 molecular in vitro diagnostic tests were high, with a summary sensitivity of 95.9% (95% CI 93.9 - 97.2%, I2 = 60.22%) and specificity of 97.2% (95% CI 95.5 - 98.3%, I2 = 56.66%). Among seven evaluated tests, the Abbott ID NOW COVID-19 and Simplexa COVID-19 Direct displayed lower sensitivity (91.6%, 95% CI 80.5 - 96.6% and 92%, 95% CI 86.2 - 95.5, respectively). CONCLUSION: In summary, all evaluated tests showed good accuracy. However, the slightly lower sensitivity observed in the Abbott ID Now COVID-19 and Simplexa COVID-19 Direct should be considered when deciding on a test platform. Moreover, diagnostic accuracy of COVID-19 commercial diagnostic tests should be weighed against its ease of use and speed.

Background Electromagnetic navigation bronchoscopy (ENB) is a navigation technology intended to improve the diagnostic yield of pulmonary nodules. However, nodule displacement due to respiratory motion may compromise the accuracy of the navigation guidance. The Veran SPiNDrive ENB system employs respiratory-gating (4D-tracking) to compensate for this motion. The aim of the present study was to evaluate the diagnostic performance and safety of the Veran SPiNDrive system for biopsy of pulmonary nodules. Methods Adult patients with pulmonary nodules of ≥1 cm were enrolled at a single center. Both conventional bronchoscopy and 4D-tracking ENB were performed in one procedure session under general anesthesia, with the procedure order being randomly assigned. Radial probe endobronchial ultrasound and fluoroscopy were used in both groups. The diagnostic performance, safety, total procedure time, and total fluoroscopy time of the ENB phase were compared to the corresponding conventional bronchoscopy phase. Results The study was terminated due to poor accrual; a total of eleven patients were enrolled. The mean size of pulmonary nodules was 2.1 cm. The sensitivity for malignancy was 67% (6/9) and 56% (5/9) with conventional bronchoscopy and with 4D-tracking ENB, respectively. Two cases developed minor bleeding after conventional bronchoscopy, while no complications were observed after 4D-tracking ENB. The mean procedure time was 16.1 and 21.7 min (P=0.090), and the mean duration time for fluoroscopy use was 77 and 44 sec (P=0.056) for the conventional bronchoscopy and the 4D-tracking ENB phases, respectively. Conclusions The diagnostic performance of the Veran SPiNDrive 4D-tracking ENB did not exceed that of conventional bronchoscopy for pulmonary nodules. No complications were seen during 4D-tracking ENB. A study with a larger number of participants is required for further assessment.

Purpose To evaluate the diagnostic performance of the RSNA structured reporting language for chest CT findings in patients with COVID-19. Material and methods Patients with suspected COVID-19 who underwent chest CT and RT-PCR tests were enrolled consecutively in this retrospective study, regardless of symptoms. Imaging findings were categorized as “typical”, “indeterminate”, “atypical”, or “negative” according to RSNA reporting language and compared to RT-PCR. “Single, round GGO” and “single, peripheral GGO,” do not fit the reporting language, were also analyzed as “indeterminate” patterns. Results Of the 1186 patients included in the analysis, the diagnosis of COVID-19 was confirmed in 388 patients. Of the 388 patients, CT findings were categorized as “typical” in 248, “indeterminate” in 77, and “negative” in 63. The sensitivity, specificity, and accuracy of “typical” findings were 63.9, 99.0, and 87.5% for COVID-19, respectively. In addition to the “typical” findings, the highest diagnostic accuracy of 92.2% was achieved when the “single, peripheral GGO” and “single, round GGO” were considered to be CT-positive. Conclusion The RSNA reporting language has significant diagnostic performance for identifying COVID-19 pneumonia. CT findings that do not exactly fit the RSNA reporting language, such as “single, round GGO” and “single, peripheral GGO” improve diagnostic performance. Supplementary Information The online version contains supplementary material available at 10.1007/s11604-021-01128-2.

Background Optimizing colonoscopy resources is challenging, and information regarding performing diagnostic quantitative faecal immunochemical test (FIT) in daily clinical practice in primary health care is still limited. This study aimed to assess the sensitivity, specificity, positive predictive value and negative predictive value of varying FIT positivity thresholds on colorectal cancer (CRC) detection in primary health care. Methods A retrospective cohort study of 38,675 asymptomatic and symptomatic patients with a FIT (OC-Sensor™) performed between 2012 and 2016 in a primary health-care setting, using a clinical laboratory database of two Spanish areas linked with the National Health System's Hospital Discharge Records Database. The primary outcome was 2-year CRC incidence. Results The mean age of the participants was 63.2 years; 17,792 (46.0%) were male. CRC prevalence was 1.7% (650/38,675). The percentage of patients with a FIT result above the threshold was 20.7% and 14.6% for 10 μg Hb/g faeces and 20 μg Hb/g faeces thresholds, respectively. Sensitivity was 90.5% (95% confidence interval 88.0%–92.5%) at a 10 μg Hb/g faeces threshold, and this decreased by 3.1% when a 20 μg Hb/g faeces threshold was used. The negative predictive value for CRC was at least 99.2% in any subgroup analysed. At a 20 μg Hb/g faeces threshold, less than one additional CRC would be missed per 1000 patients investigated, while approximately 1.3 times more colonoscopy examinations were needed to identify an incidence of CRC using the lowest threshold for any situation analysed. Conclusions In primary health care, a quantitative FIT threshold should be tailored to colonoscopy capacity and CRC prevalence in specific populations. Instituto de Salud Carlos III, España | Ref. PI17/00837

Background: Many genetic diseases are known to have distinctive facial phenotypes, which are highly informative to provide an opportunity for automated detection. However, the diagnostic performance of artificial intelligence to identify genetic diseases with facial phenotypes requires further investigation. The objectives of this systematic review and meta-analysis are to evaluate the diagnostic accuracy of artificial intelligence to identify the genetic diseases with face phenotypes and then find the best algorithm. Methods: The systematic review will be conducted in accordance with the “Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols” guidelines. The following electronic databases will be searched: PubMed, Web of Science, IEEE, Ovid, Cochrane Library, EMBASE and China National Knowledge Infrastructure. Two reviewers will screen and select the titles and abstracts of the studies retrieved independently during the database searches and perform full-text reviews and extract available data. The main outcome measures include diagnostic accuracy, as defined by accuracy, recall, specificity, and precision. The descriptive forest plot and summary receiver operating characteristic curves will be used to represent the performance of diagnostic tests. Subgroup analysis will be performed for different algorithms aided diagnosis tests. The quality of study characteristics and methodology will be assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Data will be synthesized by RevMan 5.3 and Meta-disc 1.4 software. Results: The findings of this systematic review and meta-analysis will be disseminated in a relevant peer-reviewed journal and academic presentations. Conclusion: To our knowledge, there have not been any systematic review or meta-analysis relating to diagnosis performance of artificial intelligence in identifying the genetic diseases with face phenotypes. The findings would provide evidence to formulate a comprehensive understanding of applications using artificial intelligence in identifying the genetic diseases with face phenotypes and add considerable value in the future of precision medicine. OSF Registration: DOI 10.17605/OSF.IO/P9KUH.

Purpose HRCT is the preferred imaging technique to evaluate Interstitial-Lung-Disease. Optimal Low-Dose-Computed-Tomography protocol for monitoring ILD with lowest radiation dose and optimal diagnostic accuracy and image quality unknown. Methods 28 Patients underwent HRCT. Image reconstructions with varying combinations of tube current (50mA, 20mA, 15 mA, 10mA) and image-thickness/increment (1/1mm, 2/2mm, 3/2.4mm, 5/4mm) were simulated from raw data. 448 CTs evaluated by 2 readers on image quality and ILD-specific features (ground glass opacification (ggo), honeycombing (hc), reticulation (ret)). Results Reduced dose settings with 20 mA did not show any significant difference to standard dose settings for all parameters in reader 1, while results were significantly altered in reader 2. Slice thickness did not significantly influence rating of typical ILD features like ggo, hc, ret or total disease extent. The correct differentiation between UIP and NSIP could be made on all dose settings and with all slice thickness. It was even found, that an increased slice thickness can compensate for the noise associated image quality degradation. Overall, for ggo detection a combination of 20 mA and 3 or 5 mm slice thickness was not different to the original evaluation. Conclusions Assessment of ILD specific CT features down to 20 mA and a slice thickness of 3 or 5 mm is feasible.

Objective The A6702 multisite trial confirmed that apparent diffusion coefficient (ADC) measures can improve breast MRI accuracy and reduce unnecessary biopsies, but also found that technical issues rendered many lesions non-evaluable on diffusion-weighted imaging (DWI). This secondary analysis investigated factors affecting lesion evaluability and impact on diagnostic performance. Methods The A6702 protocol was IRB-approved at 10 institutions; participants provided informed consent. In total, 103 women with 142 MRI-detected breast lesions (BI-RADS assessment category 3, 4, or 5) completed the study. DWI was acquired at 1.5T and 3T using a four b-value, echo-planar imaging sequence. Scans were reviewed for multiple quality factors (artifacts, signal-to-noise, misregistration, and fat suppression); lesions were considered non-evaluable if there was low confidence in ADC measurement. Associations of lesion evaluability with imaging and lesion characteristics were determined. Areas under the receiver operating characteristic curves (AUCs) were compared using bootstrapping. Results Thirty percent (42/142) of lesions were non-evaluable on DWI; 23% (32/142) with image quality issues, 7% (10/142) with conspicuity and/or localization issues. Misregistration was the only factor associated with non-evaluability (P = 0.001). Smaller (≤10 mm) lesions were more commonly non-evaluable than larger lesions (p Conclusion Image quality remains a technical challenge in breast DWI, particularly for smaller lesions. Protocol optimization and advanced acquisition and post-processing techniques would help to improve clinical utility.

Objective To assess the diagnostic performance of breast magnetic resonance (MR) imaging as a function of gadolinium contrast dose using a retrospective reader study. Material and Methods IRB approval was obtained prior to the start of this study and was HIPAA compliant. One‐hundred and fifty MR breast examinations were included that were acquired between January 2001 and December 2006. Seventy‐five patients received contrast doses (gadopentetate dimeglumine) by weight of 0.10 mmol/kg and 75 patients were imaged using fixed volumes of 20 ml. The images were assessed by two radiologists with performance calculated for each reader as well as a combined assessment. Dose response was measured by comparing performance between cases binned by dose: 0.10; and >0.13 mmol/kg. Statistical significance was calculated using a one‐sided Z‐test for differences in proportions with interobserver agreement calculated using Cohen's kappa statistics. Results In the combined reader assessment with equivocal lesions classified as negative, sensitivity rose from 66% (19/29) to 92% (24/26, P 0.10, >0.13 mmol/kg. With equivocal lesions classified as positive, sensitivity rose from 79% (23/29) to 92% (24/26, P

BACKGROUND: Computed tomography (CT), magnetic resonance imaging, and bone scintigraphy are second-line imaging techniques that are frequently used for the evaluation of patients with a clinically suspected scaphoid fracture. However, as a result of varying diagnostic performance results, no true reference standard exists for scaphoid fracture diagnosis. We hypothesized that the use of high-resolution peripheral quantitative CT (HR-pQCT) in patients with a clinically suspected scaphoid fracture could improve scaphoid fracture detection compared with conventional CT in the clinical setting.METHODS: The present study included 91 consecutive patients (≥18 years of age) who presented to the emergency department with a clinically suspected scaphoid fracture between December 2017 and October 2018. All patients were clinically reassessed within 14 days after first presentation, followed by CT and HR-pQCT. If a scaphoid fracture was present, the fracture type was determined according to the Herbert classification system and correlation between CT and HR-pQCT was estimated with use of the Kendall W statistic or coefficient of concordance (W) (the closer to 1, the higher the correlation).RESULTS: The cohort included 45 men and 46 women with a median age of 52 years (interquartile range, 29 to 67 years). HR-pQCT revealed a scaphoid fracture in 24 patients (26%), whereas CT revealed a scaphoid fracture in 15 patients (16%). Patients with a scaphoid fracture were younger and more often male. The correlation between CT and HR-pQCT was high for scaphoid fracture type according to the Herbert classification system (W = 0.793; 95% confidence interval [CI], 0.57 to 0.91; p < 0.001) and very high for scaphoid fracture location (W = 0.955; 95%, CI 0.90 to 0.98; p < 0.001).CONCLUSIONS: In the present study, the number of patients diagnosed with a scaphoid fracture was 60% higher when using HR-pQCT as compared with CT. These findings imply that a substantial proportion of fractures-in this study, more than one-third-will be missed by the current application of CT scanning in patients with a clinically suspected scaphoid fracture.LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Resumen Introducción: la coledocolitiasis (CLDL) puede ser difícil de diagnosticar. Su importancia radica en sus potenciales complicaciones y en que el tratamiento se realiza mediante colangiopancreatografía retrógrada endoscópica (CPRE), un procedimiento con riesgo de generar complicaciones. Se han propuesto guías para su diagnóstico y la más empleada es la de la ASGE (American Society for Gastrointestinal Endoscopy), cuyo rendimiento no es ideal. Recientemente, se ha publicado la guía británica. Este estudio se realizó para establecer el rendimiento de ambas guías. Materiales y métodos: estudio prospectivo realizado entre agosto 1 de 2017 y julio 31 de 2018. Resultados: se incluyeron 300 pacientes para el análisis. Se realizó una CPRE en 145 pacientes y se confirmó la existencia de CLDL en 124 de ellos (85,5 %). La mediana de aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) fue mayor en los que tuvieron CLDC (207 mg/dL y 290 mg/dl, respectivamente). Entre tanto, la tasa de complicaciones posteriores a la CPRE fue del 5,5 %. El análisis multivariado no encontró una asociación significativa para alguna variable predictora de CLDL. En pacientes con alta probabilidad, las guías británicas tuvieron una sensibilidad del 65 % y una especificidad del 33 %, mientras que las guías ASGE mostraron una sensibilidad del 74 % y una especificidad del 28 %. En probabilidad intermedia fueron menos eficientes. Conclusiones: los criterios de la ASGE y la BSG (British Society of Gastroenterology) no tienen un buen desempeño en la población estudiada, a fin de discriminar la existencia o no de CLDL. La guía de la ASGE mostró un mejor rendimiento en general que las guías británicas. Abstract Introduction: Choledocholithiasis (CDL) may be difficult to diagnose. The relevance of making a timely diagnosis lies in its potential negative effects and the fact that treatment requires performing endoscopic retrograde cholangiopancreatography (ERCP), which is a procedure with a high risk of complications. Several guidelines have been proposed for its diagnosis, including the ASGE Guidelines, which are the most widely used although they do not have an ideal performance, and the guidelines recently published by the BSG. The objective of this study was to compare the performance of both guidelines. Materials and methods: Prospective study carried out between August 1, 2017, and July 31, 2018. Results: 300 patients were included for analysis. 145 underwent ERCP and choledocholithiasis was confirmed in 124 of them (85.5%). Median AST and ALT levels were higher in patients with choledocholithiasis (207 mg/dL and 290 mg/dL). The rate of post-ERCP complications was 5.5%. Multivariate analysis found no significant association for any predictor of CDL. Regarding the “high probability” score, the BSG guidelines had sensitivity of 65% and specificity of 33%, while the ASGE guidelines had sensitivity of 74% and specificity of 28%. Both guidelines were less efficient for “intermediate probability”. Conclusions: The ASGE and BSG criteria do not perform well in the population studied to determine whether they had CDL. The ASGE guidelines had a better overall performance than the BSG guidelines.

OBJECTIVE To compare the utility and diagnostic performance of automated breast ultrasound system (ABUS) with that of hand-held ultrasound (HHUS) in evaluating pure non-mass enhancement (NME) lesions on breast magnetic resonance imaging (MRI). MATERIALS AND METHODS One hundred twenty-six consecutive MRI-visible pure NME lesions of 122 patients with breast cancer were assessed from April 2016 to March 2017. Two radiologists reviewed the preoperative breast MRI, ABUS, and HHUS images along with mammography (MG) findings. The NME correlation rate and diagnostic performance of ABUS were compared with that of HHUS, and the imaging features associated with ABUS visibility were analyzed. RESULTS Among 126 pure NME lesions, 100 (79.4%) were malignant and 26 (20.6%) were benign. The overall correlation rate was 87.3% (110/126) in ABUS and 92.9% (117/126) in HHUS. The sensitivity and specificity were 87% and 50% for ABUS and 92% and 42.3% for HHUS, respectively, with no significant differences (p = 0.180 and 0.727, respectively). Malignant NME was more frequently visualized than benign NME lesions on ABUS (93% vs. 65.4%, p = 0.001). Significant factors associated with the visibility of ABUS were the size of NME lesions on MRI (p < 0.001), their distribution pattern (p < 0.001), and microcalcifications on MG (p = 0.027). CONCLUSION ABUS evaluation of pure NME lesions on MRI in patients with breast cancer is a useful technique with high visibility, especially in malignant lesions. The diagnostic performance of ABUS was comparable with that of conventional HHUS in evaluating NME lesions.

Objectives. This study was conducted to compare clinicopathologic and radiologic factors between benign and malignant thyroid nodules and to evaluate the diagnostic performance of shear wave elastography (SWE) combined with B-mode ultrasonography (US) in differentiating malignant from benign thyroid nodules.Methods. This retrospective study included 92 consecutive patients with 95 thyroid nodules examined on B-mode US and SWE before US-guided fine-needle aspiration biopsy or surgical excision. B-mode US findings (composition, echogenicity, margin, shape, and calcification) and SWE elasticity parameters (maximum [Emax], mean, minimum, and nodule-to-normal parenchymal ratio of elasticity) were reviewed and compared between benign and malignant thyroid nodules. The diagnostic performance of B-mode US and SWE for predicting malignant thyroid nodules was analyzed. The optimal cutoff values of elasticity parameters for identifying malignancy were determined. Diagnostic performance was compared between B-mode US only, SWE only, and the combination of B-mode US with SWE.Results. On multivariate logistic regression analysis, age (odds ratio [OR], 0.90; P=0.028), a taller-than-wide shape (OR, 11.3; P=0.040), the presence of calcifications (OR, 15.0; P=0.021), and Emax (OR, 1.22; P=0.021) were independent predictors of malignancy in thyroid nodules. The combined use of B-mode US findings and SWE yielded improvements in sensitivity, the positive predictive value, the negative predictive value, and accuracy compared with the use of B-mode US findings only, but with no statistical significance.Conclusion. When SWE was combined with B-mode US, the diagnostic performance was better than when only B-mode US was used, although the difference was not statistically significant.

Background The prognostic value of lymph node removal in ovarian cancer varies depending on the tumor stage. While in the advanced stage the removal of clinically normal lymph nodes does not improve the prognosis, this is still unclear in the early stages. Evaluation of the lymph nodes based on preoperative imaging influences the surgical procedure. Methods This retrospective analysis was performed by analyzing data from 114 patients with ovarian cancer, treated in our university hospital in the years 2000 – 2012. Diagnostic performance of imaging by computer tomography with respect to the correct prediction of lymph node status was analyzed in terms of sensitivity, specificity, positive predictive value and negative predictive value. Results Imaging by computer tomography showed a rather limited diagnostic performance with regard to the detection of lymph node metastases in ovarian cancer, with a sensitivity of 40.7%, a specificity of 89.1%, a positive predictive value of 80.0%, and a negative predictive value of 58.3%. A separate analysis for pelvic and paraaortic lymph node involvement showed a better diagnostic performance of computer tomography for the detection of positive paraaortic lymph nodes (41.2, 93.1, 84.0, and 64.3% for sensitivity, specificity, positive predictive value and negative predictive value, respectively) as compared to the detection of positive pelvic lymph nodes (25.6, 91.8, 62.5, and 69.8%). Conclusion The preoperative prediction of lymph node status by computer tomography is limited. A decision for or against lymphadenectomy should not be made solely on the basis of this approach.

Background Neoadjuvant systemic therapy (NST) is a widely accepted initial treatment modality that can lead to pathologic downstaging of the axillary disease burden in breast cancer patients. Axillary response as well as baseline 18F-fluorodeoxyglucose (18F-FDG) uptake on positron emission tomography with computed tomography (PET/CT) differ between breast cancer subtypes. The value of baseline 18F-FDG PET/CT in predicting axillary response to NST is not yet established, possibly since breast cancer subtype was not taken into account. The purpose of this study was to investigate the value of baseline 18F-FDG PET/CT in predicting axillary response to NST with a specific emphasis on subtype. Methods PET-parameters derived from the primary tumor as well as the most FDG-avid axillary lymph node were measured on baseline 18F-FDG PET/CT. Overall imaging findings were compared with the gold standard of histopathology of the axillary surgery specimen. Analyses for ER-positive/HER2-negative were performed separately from HER2-positive and TN patients. In addition, separate analyses for clinically node-positive patients were performed. Results Sixty-six patients with 69 primary tumors were included in this study. Thirty-three axillae contained ER-positive/HER2-negative, 16 HER2-positive, and 20 TN breast cancer. No significant difference in PET-parameters between patients with axillary residual disease and axillary pathologic complete response were found for ER-positive/HER2-negative breast cancer. In the combined HER2-positive/TN subgroup, the SUVmax was significantly lower in patients without residual axillary disease in both the entire cohort and in patients with clinically node-positive disease. In this combined subgroup, a cut-off of 4.89 SUVmax measured on the most FDG-avid axillary lymph node could predict residual axillary disease with a sensitivity, specificity, PPV, and NPV of 90%, 69%, 53%, and 95%, respectively. Conclusions Predicting axillary response following NST with baseline 18F-FDG PET/CT can be performed when focusing on breast cancer subtypes. The easily computed PET-parameter SUVmax can predict axillary response in HER2-positive and TN breast cancer. This study adds to the accumulating evidence that studies investigating the value of 18F-FDG PET/CT in breast cancer should always take subtypes into account.

BackgroundMammography-based breast cancer screening has been widely implemented in many developed countries. Evidence was needed on participation and diagnostic performance of population-based breast cancer screening using ultrasound in China.MethodsWe used data from the Cancer Screening Program in Urban China in Beijing from 2014 to 2019 and was followed up until July 2020 by matching with the Beijing Cancer Registry database. Eligible women between the ages of 45 and 69 years were recruited from six districts and assessed their risk of breast cancer through an established risk scoring system. Women evaluated to be at high risk of breast cancer were invited to undergo both ultrasound and mammography. Participation rates were calculated, and their associated factors were explored. In addition, the performance of five different breast cancer screening modalities was evaluated in this study.ResultsA total of 49,161 eligible women were recruited in this study. Among them, 15,550 women were assessed as high risk for breast cancer, and 7,500 women underwent ultrasound and/or mammography as recommended, with a participation rate of 48.2%. The sensitivity of mammography alone, ultrasound alone, combined of ultrasound and mammography, ultrasound for primary screening followed by mammography for triage, and mammography for preliminary screening followed by ultrasound for triage were19.2%, 38.5%, 50.0%, 46.2%, and 19.2%, and the specificity were 96.1%, 98.6%, 94.7%, 97.6%, 95.7%, respectively. The sensitivity of combined ultrasound and mammography, ultrasound for primary screening followed by mammography for triage, was significantly higher than mammography alone (p=0.008 and p=0.039). Additionally, ultrasound alone (48,323 RMB ($7,550)) and ultrasound for primary screening followed by mammography for triage (55,927 RMB ($8,739)) were the most cost-effective methods for breast cancer screening than other modalities.ConclusionsUltrasound alone and ultrasound for primary screening and mammography are superior to mammography for breast cancer screening in high-risk Chinese women.

The performance of 2 antigenic commercial assays for enteric adenovirus (AdV) infection, bioNexia Rota-Adeno ImmunoChromatographic Tests (ICT) and LIAISON® Adenovirus ChemiLuminescence Immuno Assays (CLIA), was evaluated on 321 stools from children hospitalized for acute gastroenteritis in Palermo, Italy, using a Real time-PCR (Rt-PCR) as reference method. The CLIA showed higher sensitivity (77% vs 60%), accuracy (94.4 vs 90.9) and concordance (k: 0.81 vs 0.67) with respect to ICT, despite equivalent specificity (98.8%). Using the Ct values of the Rt-PCR as a proxy of the fecal viral load, similar Ct values (mean 9.32 vs 9.89) were observed among the true positive samples, whilst a significant difference (P < 0.05) was observed in false negative samples of CLIA (mean Ct 25.68) and ICT (mean Ct 19.87). Cross-reactivity with other enteric viruses was not observed. These results indicate that both the assays tested are suitable for diagnosis of AdV gastroenteritis.

Background Paradigm shift toward nonoperative management (NOM) of adult appendicitis has made computed tomography (CT) more important than ever, particularly in differentiating complicated from uncomplicated disease. Complete surgical and pathological data of appendicitis in a place where appendectomy at initial admission is a standard of care would allow retrospective review of preoperative CT for performance and predictive ability in identifying those that may benefit from NOM in the future. Results The study included 201 CT scans of consecutive adult patients who presented for appendectomy at initial admission with pathologically confirmed acute appendicitis. Complicated appendicitis referred to gangrene or perforation on pathological or operative findings. The overall CT sensitivity, specificity and accuracy for differentiation of complicated from uncomplicated appendicitis were 87.2%, 75.7% and 81.1%, respectively. The most sensitive CT findings of complicated appendicitis were mucosal enhancement defect (83.2%; 95% CI 74.1–90.0) and moderate-to-severe periappendiceal fat stranding (96.8%; 95% CI 91.1–99.3), both independently predictive of complicated appendicitis with adjusted odds ratios (ORs) of 4.62 (95% CI 1.86–11.51) and 4.41 (95% CI 1.06–18.29), respectively. Phlegmon, fluid collection, extraluminal appendicolith, periappendiceal air and small bowel dilatation had specificity of 98.1–100%. Intraluminal appendicoliths were found more frequently in complicated appendicitis (52.6% vs. 22.6%) but not predictive for this diagnosis. Independent clinical predictors of complicated appendicitis were lack of pain migration (OR 2.06), neutrophilia ≥ 82% (OR (2.87) and symptoms ≥ 24 h (OR 5.84). Conclusions CT findings were highly accurate in differentiating complicated from uncomplicated appendicitis among patients undergone appendectomy at initial admission.

IntroductionCurrent evaluation of patients suspected of a non-ST-elevation acute coronary syndrome (NSTE-ACS) involves the use of algorithms that incorporate clinical information, electrocardiogram (ECG) and high-sensitivity cardiac troponins (hs-troponins). While primarily designed to rule out NSTE-ACS safely, these algorithms can also be used for rule in of NSTE-ACS in some patients. Still, in a substantial number of patients, these algorithms do not provide a conclusive work-up. These patients often present with an atypical clinical profile and low-range positive hs-troponin values without a characteristic rise or fall pattern. They represent a heterogeneous group of patients with various underlying conditions; only a fraction (30%–40%) will eventually be diagnosed with a myocardial infarction. Uncertainty exists about the optimal diagnostic strategy and their management depends on the clinical perspective of the treating physician ranging from direct discharge to admission for invasive coronary angiography. Coronary CT angiography (CCTA) is a non-invasive test that has been shown to be safe, fast and reliable in the evaluation of coronary artery disease. In this study, we will determine the usefulness of CCTA in patients with acute chest pain and low-range positive hs-troponin values.Methods and analysisA prospective, double-blind, observational, multicentre study conducted in the Netherlands. Patients aged 30–80 years presenting to the emergency department with acute chest pain and a suspicion of NSTE-ACS, a normal or non-diagnostic ECG and low-range positive hs-troponins will be scheduled to undergo CCTA. The primary outcome is the diagnostic accuracy of CCTA for the diagnosis of NSTE-ACS at discharge, in terms of sensitivity and negative predictive value.Ethics and disseminationThis study was approved by the Medical Research Ethics Committee of Erasmus Medical Center in Rotterdam, the Netherlands (registration number MEC-2017-506). Written informed consent to participate will be obtained from all participants. This study’s findings will be published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov (NCT03129659).

Background: Cardiac magnetic resonance (CMR) has been shown to improve the diagnosis of myocarditis, but no systematic comparison of this technique is currently available. The purpose of this study was to compare the 2009 and 2018 Lake Louise Criteria (LLC) for the diagnosis of acute myocarditis using 3.0 T MRI with endomyocardial biopsy (EMB) as a reference and to provide the cutoff values for multiparametric CMR techniques.Methods: A total of 73 patients (32 ± 14 years, 71.2% men) with clinically suspected myocarditis undergoing EMB and CMR with 3.0 T were enrolled in the study. Patients were divided into two groups according to EMB results (EMB-positive and -negative groups). The CMR protocol consisted of cine-SSFP, T2 STIR, T2 mapping, early and late gadolinium enhancement (EGE, LGE), and pre- and post-contrast T1 mapping. Their potential diagnostic ability was assessed with receiver operating characteristic curves.Results: The myocardial T1 and T2 relaxation times were significantly higher in the EMB-positive group than in the EMB-negative group. Optimal cutoff values were 1,228 ms for T1 relaxation times and 58.5 ms for T2 relaxation times with sensitivities of 86.0 and 83.7% and specificities of 93.3 and 93.3%, respectively. The 2018 LLC had a better diagnostic performance than the 2009 LLC in terms of sensitivity, specificity, positive predictive value, and negative predictive value. T1 mapping + T2 mapping had the largest area under the curve (0.95) compared to other single or combined parameters (2018 LLC: 0.91; 2009 LLC: 0.76; T2 ratio: 0.71; EGEr: 0.67; LGE: 0.73; ). The diagnostic accuracy for the 2018 LLC was the highest (91.8%), followed by T1 mapping (89.0%) and T2 mapping (87.7%).Conclusion: Emerging technologies such as T1/ T2 mapping have significantly improved the diagnostic performance of CMR for the diagnosis of acute myocarditis. The 2018 LLC provided the overall best diagnostic performance in acute myocarditis compared to other single standard CMR parameters or combined parameters. There was no significant gain when 2018LLC is combined with the EGE sequence.

Objectives: Epstein–Barr virus is a tumorigenic virus and has been extensively studied as a causative agent for Hodgkin lymphoma. Although immunostaining of the tumor biopsy is the standard method for diagnosis of Epstein–Barr virus-driven Hodgkin lymphoma, the invasiveness of the procedure renders it difficult and less desirable for the patients. Therefore, we designed this study to evaluate the efficiency of plasma Epstein–Barr virus DNA detection as an alternative diagnostic and prognostic method for Epstein–Barr virus–associated Hodgkin lymphoma. Methods: This analytical cross-sectional study was conducted during March 2017 to December 2018 including 43 Hodgkin lymphoma patients diagnosed histopathologically followed by the latent membrane protein-1 immunohistochemistry to determine their Epstein–Barr virus association. Plasma Epstein–Barr virus DNA in these samples was measured using quantitative polymerase chain reaction (qPCR). Results: Of total, 29 (67.44%) patients tested positive for plasma Epstein–Barr virus DNA. On comparing results of latent membrane protein-1 immunohistochemistry (IHC) with plasma Epstein–Barr virus DNA, plasma Epstein–Barr virus DNA was found in 25 of 30 patients with latent membrane protein-1 expression and 4 of 13 patients without latent membrane protein-1 expression. The sensitivity and the specificity of plasma Epstein–Barr virus DNA detection with respect to latent membrane protein-1 IHC were found to be 83.33% and 69.23%, respectively ( p = 0.0014). Conclusion: Determination of plasma Epstein–Barr virus DNA was found to be highly sensitive and specific in characterizing Epstein–Barr virus–associated Hodgkin lymphoma, suggesting that this diagnostic method holds promise as an alternative and more convenient method of diagnosis compared with tissue biopsy.

International audience; Background: Serum total tryptase has been shown to increase during acute allergic reactions (acute tryptase, TA ); however, few studies have investigated the values of TA or a combination of TA and baseline tryptase (TB ) to discriminate positive from negative testing in perioperative hypersensitivity reaction (POH) allergy work-up. The aim of this study was to determine the diagnostic performance of TA in order to differentiate positive from negative allergy testing suspected POH and analyse the diagnostic performance of serial tryptase levels using several formulas.Methods: All patients from the University hospital of Montpellier and Strasbourg, France, who presented with suspected POH and underwent complete drug allergy work-up between March 2011 and December 2019 with available TA and TB were included. Four formulas, including a change in TA > 11 (F1), or >2 + 1.2 × TB (F2), or >3 + TB (F3), or >120%TB (F4), were applied.Results: One hundred and sixty-two patients were included, and 131 of them (80.8%) had Grade III or IV reactions. Ninety patients had positive allergy testing. The optimal cut-off value of TA to distinguish positive from negative allergy testing patients was 9.8 μg/L with an AUC of 0.817 (95% CI: 0.752-0.882, p < .001). The 93% PPV threshold for TA was 33 μg/L (95.8% specificity). Paired tryptase levels according to formulas F2 and F3 yielded the highest Youden index (0.54 and 0.53, respectively).Conclusion: The optimal cut-off point for TA for distinguishing positive from negative allergy testing suspected POH was 9.8 μg/L. TA value of 33 μg/L was required to achieve >90% PPV.

AIMS: CT-QFR is a novel coronary computed tomography angiography (CTA) based method for on-site evaluation of patients with suspected obstructive coronary artery disease (CAD). We compared the diagnostic performance of CT-QFR with myocardial perfusion scintigraphy (MPS) and cardiovascular magnetic resonance (CMR) as second-line tests in patients with suspected obstructive CAD after coronary CTA.METHODS AND RESULTS: Paired analysis of CT-QFR and MPS or CMR, with an invasive FFR-based classification as reference standard. Symptomatic patients with >50% diameter stenosis on coronary CTA were randomized to MPS or CMR and referred for invasive coronary angiography. The rate of coronary CTA not feasible for CT-QFR analysis was 17%. Paired patient-level data were available for 118 patients in the MPS group and 113 in the CMR group, respectively. Patient-level diagnostic accuracy was better for CT-QFR than for both MPS ((82.2% (95%CI 75.2-89.2) vs. 70.3% (95%CI 62.0-78.7), p=0.029) and CMR ((77.0% (95%CI 69.1-84.9) vs. 65.5% (95%CI 56.6-74.4), p=0.047). Following a positive coronary CTA and with the intention-to diagnose, CT-QFR, CMR and MPS were equally suitable as rule-in and rule-out modalities.CONCLUSIONS: The diagnostic performance of CT-QFR as second-line test was at least similar to MPS and CMR for the evaluation of obstructive coronary artery disease in symptomatic patients presenting with ≥50% diameter stenosis on coronary CTA.

Editorial

BackgroundGenital infection with certain types of Human papillomavirus (HPV) is a major cause of cervical cancer globally. For early detection of premalignant dysplasia, evidences are coming out on the usefulness of HPV E6/E7 mRNA test as a potential tool compared with cytology and HPV DNA testing. Taking into account shortage of compiled data on this field, the aim of this systematic review was to describe the latest diagnostic performance of HPV E6/E7 mRNA testing to detect high grade cervical lesions (CIN2+) where by histology was taken as a gold standard.MethodsArticles published in English were systematically searched using key words from PubMed/Medline and SCOPUS. In addition, Google Scholar and the Google database were searched manually for grey literature. Two reviewers independently assessed study eligibility, risk of bias and extracted the data. We performed a descriptive presentation of the performance of E6/E7 mRNA test (in terms of sensitivity, specificity, negative and positive predictive values) for the detection of CIN2 + .ResultsOut of 231 applicable citations, we have included 29 articles that included a total of 23,576 study participants (age range, 15–84 years) who had different cervical pathologies. Among the participants who had cervical histology, the proportion of CIN2+ was between 10.6 and 90.6%. Using histology as a gold standard, 11 studies evaluated the PreTect HPV Proofer, 7 studies evaluated the APTIMA HPV assay (Gen-Probe) and 6 studies evaluated the Quantivirus® HPV assay. The diagnostic performance of these three most common mRNA testing tools to detect CIN2+ was; 1) PreTect Proofer; median sensitivity 83%, specificity 73%, PPV 70 and NPV 88.9%. 2) APTIMA assay; median sensitivity 91.4%, specificity 46.2%, PPV 34.3% and NPV 96.3%. 3) Quantivirus®: median sensitivity 86.1%, specificity 54.6%, PPV 54.3% and NPV was at 89.3%. Further, the area under the receiver operating characteristics (AU-ROC) curve varied between 63.8 and 90.9%.ConclusionsThe reported diagnostic accuracy implies that HPV mRNA based tests possess diagnostic relevance to detect CIN2+ and could potentially be considered in areas where there is no histology facility. Further studies including its cost should be considered.

Background Papillary thyroid carcinoma (PTC) is an indolent tumor that is exploding with increasing thyroid nodules (TN). Environmental carcinogens, lifestyle changes increased the incidence of thyroid carcinoma. With the development of B-ultrasound imaging, more and more thyroid cancer has been found. There has been a debate about whether thyroid cancer is overtreated. Methods The expression of T cell subsets and plasma cytokines in 191 patients, including 79 patients with PTC (PTC group), 58 patients with thyroid nodules (TN group) and 54 healthy individuals (HP group) were analyzed by flow cytometry. Results High levels of natural killer cells (NK) were detected in PTC and TN groups than in HP group. High activities of CD8+HLA-DR+ and CD8+CD38+ showed a gradual upward trend from HP group to PTC group. The rise in the levels of TNF-α in PTC patients’ was evident when compared with HP group. CD8+CD38+ showed a significant correlation with lymph node metastasis. CD8+CD38+ co-expression was higher in Nx stage than N0 stage, while the proportion of IL-10 was dramatically decreased in the Nx stage. Conclusions These results indicated that CD8+CD38+ might act as a biomarker of PTC lymph node metastasis. The combination of CD8+HLA-DR+, CD8+CD38+ and TNF-α can be used as useful biomarkers for the early-warning indicator of PTC.

Background The sensitivity of rapid diagnostic tests (RDTs) for malaria is inadequate for detecting low-density, often asymptomatic infections, such as those that can occur when screening pregnant women for malaria. The performance of the Alere™ Ultra-sensitive Malaria Ag Plasmodium falciparum RDT (uRDT) was assessed retrospectively in pregnant women in Indonesia. Methods The diagnostic performance of the uRDT and the CareStart™ Malaria HRP2/pLDH VOM (Plasmodium vivax, Plasmodium ovale and Plasmodium malariae) Combo RDT (csRDT) were assessed using 270 stored red blood cell pellets and plasma samples from asymptomatic pregnant women. These included 112 P. falciparum negative and 158 P. falciparum positive samples detected by a composite test (qPCR, LAMP, nPCR) as reference standard. Diagnostic indicators: sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), diagnostic odds ratio (DOR) and the level of agreement (kappa) were calculated for comparison. Results Compared with the reference test, the uRDT had a sensitivity of 19.6% (95% CI 13.9–26.8) and specificity of 98.2% (93.1–99.7%). The csRDT was 22.8% (16.7–30.3) sensitive and 95.5% (89.4–98.3) specific for P. falciparum infections. Performance of the uRDT was non-significantly different to the csRDT (p = 0.169). RDT outcome was stratified by qPCR cycling threshold (Ct), and performance of the RDTs was found to be comparable across parasite loads. Conclusion The uRDT performed similarly to the currently used csRDTs in detecting P. falciparum infections in asymptomatic pregnant women. In these settings, molecular diagnostics are currently the most sensitive for malaria.

Introduction: Various options for axillary staging after neoadjuvant systemic therapy (NST) are available for breast cancer patients with a clinically positive axillary node (cN+). This survey assessed current practices amongst breast cancer specialists.Materials and methods: A survey was performed amongst members of the European Society of Surgical Oncology and two UK-based Associations: the Association of Breast Surgery and the British Association of Surgical Oncology. The survey included 3 parts: 1. general information, 2, diagnostic work-up and 3. axillary staging after NST.Results: A total of 310 responses were collected: parts 1, 2 and 3 were fully completed by 282 (91%), 270 (87.1%) and 225 (72.6%) respondents respectively. After NST, 153/267 (57.3%) respondents currently perform ALND routinely and 114 (42.7%) respondents perform less invasive restaging of the axilla with possible omission of ALND. In the latter group, 85% does and 15% does not use nodal response seen on imaging to guide the axillary restaging procedure. Regarding respondents that do use imaging: 95% would perform a less invasive staging procedure in case of complete nodal response on imaging (63% sentinel lymph node biopsy (SLNB), excision of a previously marked positive node with SLNB (21%) and without SLNB (11%)). In case of no nodal response on imaging 77% would perform ALND.Conclusion: Current axillary staging and management practices in cN + patients after NST vary widely. To determine optimal axillary staging and management in terms of quality of life and oncologic safety, breast specialists are encouraged to include patients in clinical trials prospective registries. (C) 2019 Elsevier Ltd, BASO - The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Background: To prospectively establish and validate new diagnostic criterion (DC) for liver-specific contrast agents and further compared the diagnostic sensitivity and specificity with conventional DC. Methods: Institutional Review Board approved and written informed consent were obtained for this prospective study. Two board-certified reviewers established the reference standard as hepatocellular carcinoma (HCC), non-HCC lesions by using marks on all cross-sectional MR images. Another 2 abdominal radiologists independently performed the marked lesion observations using 5 different DCs, including DC-1: arterial phase hyperenhancement (APHE) and portal venous phase washout; DC-2: APHE and hepatobiliary phase (HBP) hypointensity; DC-3: APHE and diffusion-weighted imaging (DWI) hyperintensity; DC-4: HBP hypointensity and DWI hyperintensity; DC-5: HBP hypointensity, DWI hyperintensity and excluded these markedly T2 hyperintensity. Diagnostic performance of sensitivity, specificity, and accuracy for each imaging DC was calculated, per-lesion diagnostic sensitivity and specificity of imaging criteria were compared by using McNemars test. Results: A total of 215 patients were included (mean age 53.82 ± 11.24 years; range 24–82 years) with 265 hepatic nodules (175 HCCs and 90 non-HCCs). The DC-4 (93.71%; 164/175) and DC-5 (92.57%; 162/175) yielded the highest diagnostic sensitivity and was better than DC-1 (72.57%; 127/175), DC-2 (82.86%; 145/175), and DC-3 (82.29%; 144/175) (all p < 0.001). The specificity of DC-1 (94.44%; 85/90) was significantly higher than that with DC-2 (83.33%; 75/90), DC-3 (84.44%; 76/90), DC-4 (74.44%; 67/90), and DC-5 (82.22%; 74/90) (all p < 0.05). Additionally, the DC-4 and DC-5 achieved the highest area under curve value of 0.841 (95% CI 0.783–0.899) and 0.874 (95% CI 0.822–0.925). Conclusions: The combined use of HBP hypointensity and DWI hyperintensity as a new DC for HCC enables a high diagnostic sensitivity and comparable specificity.

Background Microsatellite instability (MSI) analysis is becoming increasingly important in many types of tumor including colorectal cancer (CRC). The commonly used MSI tests are either time-consuming or labor-intensive. A fully automated MSI test, the Idylla MSI assay, has recently been introduced. However, its diagnostic performance has not been extensively validated in clinical CRC samples. Methods We evaluated 133 samples whose MSI status had been rigorously validated by standard polymerase chain reaction (PCR), clinical nextgeneration sequencing (NGS) cancer panel test, or both. We evaluated the diagnostic performance of the Idylla MSI assay in terms of sensitivity, specificity, and positive and negative predictive values, as well as various sample requirements, such as minimum tumor purity and the quality of paraffin blocks. Results Compared with the gold standard results confirmed through both PCR MSI test and NGS, the Idylla MSI assay showed 99.05% accuracy (104/105), 100% sensitivity (11/11), 98.94% specificity (93/94), 91.67% positive predictive value (11/12), and 100% negative predictive value (93/93). In addition, the Idylla MSI assay did not require macro-dissection in most samples and reliably detected MSI-high in samples with approximately 10% tumor purity. The total turnaround time was about 150 minutes and the hands-on time was less than 2 minutes. Conclusions The Idylla MSI assay shows good diagnostic performance that is sufficient for its implementation in the clinic to determine the MSI status of at least the CRC samples. In addition, the fully automated procedure requires only a few slices of formalin-fixed paraffin-embedded tissue and might greatly save time and labor.

Background Bovine tuberculosis (bTB) is prevalent in dairy cattle in Ethiopia. Currently used diagnostic tools such as the single intradermal comparative tuberculin test (SICTT) are time consuming and labor intensive. A rapid, easy-to-use and cost-effective diagnostic test would greatly contribute to the control of bTB in developing countries like Ethiopia. In the present study, two point-of-care diagnostic tests were evaluated for the detection of bTB: LIONEX® Animal TB Rapid test, a membrane-based test for the detection of antibodies to Mycobacterium bovis in blood and ALERE® Determine TB Lipoarabinomannan (LAM) Ag, an immunoassay for the detection of lipoarabinomannan (LAM) antigen (Ag) of mycobacteria in urine. A combination of the SICTT and gamma interferon (IFN-γ) test was used as the gold standard for the validation of these point-of-care tests, as it was not feasible to slaughter the study animals to carry out the historical gold standard of mycobacterial culture. A total of 175 heads of cattle having three different bTB infection categories (positive SICTT, negative SICTT, and unknown SICTT status) were used for this study. Result The sensitivity and specificity of TB LAM Ag were 72.2% (95% CI = 62.2, 80.4) and 98.8% (95% CI = 93.6, 99.7), respectively, while the sensitivity and specificity of the LIONEX Animal TB rapid test assay were 54% (95% CI = 44.1 64.3) and 98.8% (95% CI = 93.6, 99.7) respectively. The agreement between TB LAM Ag and SICTT was higher (κ = 0.85; 95% CI = 0.65–0.94) than between TB LAM Ag and IFN-γ (κ = 0.67; 95% CI = 0.52–0.81). The agreement between LIONEX Animals TB Rapid blood test and SICTT was substantial, (κ = 0.63; 95% CI = 0.49–0.77) while the agreement between LIONEX Animal TB rapid blood test and IFN-γ test was moderate (κ = 0.53; 95% CI = 0.40–0.67). Analysis of receiver operating curve (ROC) indicated that the area under the ROC curve (AUC) for TB LAM Ag was 0.85 (95% CI = 0.79–0.91) while it was 0.76 (95% CI; =0.69–0.83) for LIONEX Animal TB rapid test assay. Conclusion This study showed that TB LAM Ag had a better diagnostic performance and could potentially be used as ancillary either to SICTT or IFN-γ test for diagnosis of bTB.

Five years have passed since the Japan Narrow Band Imaging Expert Team (JNET) classification was proposed in 2014. However, the diagnostic performance of this classification has not yet been established. We conducted a retrospective study and a systematic search of Medical Literature Analysis and Retrieval System On-Line. There were three retrospective single center studies about the diagnostic performance of this classification. In order to clarify this issue, we reviewed our study and three previous studies. This review revealed the diagnostic performance in regards to three important differentiations. (1) Neoplasia from non-neoplasia; (2) malignant neoplasia from benign neoplasia; and (3) deep submucosal invasive cancer (D-SMC) from other neoplasia. The sensitivity in differentiating neoplasia from non-neoplasia was 98.1%-99.8%. The specificity in differentiating malignant neoplasia from benign neoplasia was 84.7%-98.2% and the specificity in the differentiation D-SMC from other neoplasia was 99.8%-100.0%. This classification would enable endoscopists to identify almost all neoplasia, to appropriately determine whether to perform en bloc resection or not, and to avoid unnecessary surgery. This article is the first review about the diagnostic performance of the JNET classification. Previous reports about the diagnostic performance have all been retrospective single center studies. A large-scale prospective multicenter evaluation study is awaited for the validation.

Objectives : To investigated the diagnostic performance of circumpubertal eruption stages which identify skeletal maturity stages using the cervical vertebral maturation (CVM) method in a Saudi population. Methods : This is a retrospective cross-sectional study. Lateral cephalograms, panoramic radiographs, and intraoral pictures of 600 orthodontic patients (284 boys, 316 girls) who met inclusion criteria were assessed. Records were retrieved between January 2016 and April 2018. The diagnostic performance of eruption stages for identifying skeletal maturity was tested with positive likelihood ratios (LHR+). Results : Prevalence of each CVM stage in the eruption stages was reported. For every eruption stage, LHR+ was reported in order to identify every CVM stage. The majority of the LHR+ values were ≤3.5, with a significant value of ≥10 for the identification of the post-pubertal growth stage. The other eruptions stages did not strongly predict skeletal maturity. Conclusion : In treatment planning for cases that require identifying the growth peak, the use of eruption stages is not recommended as an indicator of skeletal maturity except for the early permanent dentition stage where strong diagnostic performance for identifying post-pubertal skeletal growth stage has been shown.

Background As an early recognition of neonatal sepsis is important for triggering the initiation of treatment, this study was thus designed to assess the diagnostic performance and discrimination value of procalcitonin (PCT) in neonatal sepsis cases. Methods This cross-sectional study, which was carried out at the Paediatric Intensive Care Unit of Hospital Universiti Sains Malaysia (HUSM) in Kelantan, Malaysia, had involved 60 neonates admitted for suspected sepsis. Sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and the area under receiver operating characteristics curve (AUC) for PCT were determined at initial presentation (0 h) as well as 12 h and 24 h after presentation in comparison to blood culture as the gold standard. Results The study consisted of 27 (45.0%) male and 33 (55.0%) female neonates with a mean (SD) age of 76.8 (48.25) h. At cut-off PCT value of > 2 ng/mL, the sensitivity, specificity, PPV and NPV were 66.7%, 66.7%, 33.3% and 88.9% at 0 h. The respective parameters were 83.3%. 56.3%, 32.3% and 93.1% at 12 h and 83.3%, 52.1%, 30.3% and 92.6% at 24 h. AUC was 71.6%, 76.6% and 71.7% at 0 h, 12 h and 24 h. Conclusions Diagnostic performance and discrimination values of PCT for diagnosis of neonatal sepsis varied with time of obtaining the blood samples. The PCT result at 12 h demonstrates the most optimal diagnostic performance and discrimination values.

Case presentation: 77-year-old former smoker admitted because of fatigue and abdominal distention. Past medical history positive for two previous hospitalizations for pericardial and pleural effusions (no diagnosis achieved). At admission erythrocyte sedimentation rate was 122 mm per hour. Baseline investigations revealed ascitic, pleural and pericardial effusion. Effusions were tapped: neoplastic cells and acid-fast bacilli (AFB) were not identified, aerobic and mycobacterial culture resulted negative. QuantiFERON TB-Gold test was negative. Total body PET-CT and autoimmunity panel were negative. A neoplastic process was considered the most likely explanation. Before signing off the patient to comfort care, a reassessment was performed and an exposure to tuberculosis during childhood was documented. Because of constrictive pericarditis, pericardiectomy was performed: histologic examination showed chronic pericardial inflammation without granulomas, but Ziehl-Neelsen stain identified AFB and PCR was positive for Mycobacterium tuberculosis complex. Patient was started on anti-TB therapy with resolution of the effusions in the following months. Genes associated with defects in innate immunity were sequences and dentritic cells were studied, but no alterations were identified. Discussion: A Bayesian approach to clinical decision making should be recommended. Interpretation of diagnostic tests should take into account the imperfect diagnostic performance of the majority of these tests. Further studies to investigate genetic susceptibility to tuberculosis are needed. Keywords: Tuberculosis, Diagnostic performance, Bayes

Introduction: Imaging findings can be affected by histopathological characteristics, such as breast cancer subtypes. The aim was to determine whether the diagnostic performance, in particular negative predictive value (NPV), of axillary US differs per subtype of breast cancer.Methods: All patients diagnosed between 2008 and 2016 in our hospital with primary invasive breast cancer and an axillary US prior to axillary surgery were included. Histopathology of axillary surgery specimens served as gold standard. The NPV, sensitivity, specificity, positive predictive value (PPV) and accuracy of the axillary US were determined for the overall population and for each subtype (ER+/PR+HER2-,HER2+, triple negative tumors). The Chi-square test was used to determine the difference in diagnostic performance parameters between the subtypes.Results: A total of 1094 breast cancer patients were included. Of these, 35 were diagnosed with bilateral breast cancer, resulting in 1129 cancer cases. Most common subtype was ER+/PR+HER2- in 858 cases (76.0%), followed by 150 cases of HER2+ tumors (13.3%) and 121 cases of triple negative tumors (10.7%). Sensitivity, specificity and accuracy of axillary US did not significantly differ between the subtypes. There was a significant difference for NPV between triple negative tumors and HER2+ tumors (90.3% vs. 80.2%, p = 0.05) and between HER2+ and ER/PR+HER2- tumors (80.2% vs. 87.2%, p = 0.04).Conclusion: There was no significant difference in the diagnostic performance of axillary US between the subtypes, except for NPV. This was highest in triple negative subtype and lowest in HER2+ tumors. This can be explained by the difference in prevalence of axillary lymph node metastases in our cohort. (C) 2019 Published by Elsevier Ltd.

Idiopathic inflammatory myopathies (IIM) are a group of diseases characterized by immune-mediated muscular lesions that may be associated with extra-muscular manifestations involving skin, lungs, heart or joints. Four main groups of IIM can be distinguished: dermatomyositis (DM), overlap myositis including mainly anti-synthetase syndrome (ASS), immune mediated necrotizing myopathy (IMNM), and inclusion body myositis (IBM). Myositis-specific autoantibodies (MSA) are increasingly recognized as valuable tools for diagnosis, classification and prognosis of IIM. For example, ASS is associated with anti-aminoacyl tRNA synthetase antibodies (anti-Jo-1, PL-7, PL-12, …), IMNM with anti-SRP and anti-HMGCR; IBM with anti-cytosolic 5'nucleotidase 1A (cN1A), and DM with anti-Mi-2, anti-MDA-5, anti-TIF-1γ, anti-NXP-2 and anti-SAE. Moreover, anti-MDA-5 is associated with amyopathic myositis and interstitial lung disease and anti-TIF-1γ and anti-NXP-2 with juvenile DM as well as malignancy in patients >40 years. Most MSA have initially been discovered by immunoprecipitation. In routine laboratories, however, MSA are screened for by indirect immunofluorescence and identified by (automated) monospecific immunoassays or by multispecific immunoassays (mainly line/dot immunoassays). Validation of these (multispecific) assays is a challenge as the antibodies are rare and the assays diverse. In this review, we give an overview of the (clinical) performance characteristics of monospecific assays as well as of multispecific assays for detection of MSA. Although most assays are clinically useful, there are differences between techniques and between manufacturers. We discuss that efforts are needed to harmonize and standardize detection of MSA. ispartof: AUTOIMMUNITY REVIEWS vol:18 issue:3 pages:293-305 ispartof: location:Netherlands status: published

BACKGROUND: The Belgian Reference Laboratory for Plasmodium offers a free-of-charge reference testing of malaria-positive or doubtful samples to clinical laboratories. METHODS: The final malaria diagnosis from the Reference Laboratory (microscopy, rapid diagnostic tests (RDTs) and Plasmodium species-specific PCR) were compared with the final diagnosis from peripheral Belgian laboratories. The Reference Laboratory reports were analysed for all samples submitted between 2013 and 2017. Criteria assessed included the diagnosis of malaria, Plasmodium species identification including mixed infections, and in case of Plasmodium falciparum, the parasite density and the presence of sexual and asexual stages. RESULTS: A total of 947 non-duplicate samples were included. Reference testing confirmed 96.3% (893/927) and 90.0% (18/20) samples submitted as positive and negative, respectively, the two missed diagnoses were samples with Plasmodium ovale and Plasmodium malariae. Submitting laboratories had correctly identified P. falciparum in 95.1% (508/534) samples with P. falciparum single infection. They had correctly diagnosed the species in 62.9% (95/151) single non-falciparum samples and had reported 'non-falciparum' in another 26 (17.2%) samples; most errors occurred among P. malariae (n = 8/21, 38.1%) and P. ovale (n = 14/51, 27.5%). Only one of the 21 mixed Plasmodium species infections had been diagnosed as such by the submitting laboratories; in three of them, P. falciparum had been overlooked. Taken single and mixed infections together, P. falciparum was diagnosed in 98.6% (546/554) samples. Among 471 single P. falciparum samples available for comparison, laboratories had correctly reported parasite densities above 2% in 87.5% (70/80) samples; they had incorrectly reported parasite densities > 2% in an extra 52 (8.9%) samples. Laboratories had correctly reported P. falciparum schizonts and gametocytes in 25.6% (11/43) and 56.7% (17/30) samples, respectively. CONCLUSION: Diagnostic laboratories in a malaria non-endemic setting provided excellent diagnosis of malaria and P. falciparum, reasonably good diagnosis of non-falciparum infections and acceptable calculation of P. falciparum parasite density. ispartof: MALARIA JOURNAL vol:18 issue:1 ispartof: location:England status: published

PurposeTo build and evaluate a radiomics-based nomogram that improves the predictive performance of the LVSI in cervical cancer non-invasively before the operation.MethodThis study involved 149 patients who underwent surgery with cervical cancer from February 2017 to October 2019. Radiomics features were extracted from T2 weighted imaging (T2WI). The radiomic features were selected by logistic regression with the least absolute shrinkage and selection operator (LASSO) penalty in the training cohort. Based on the selected features, support vector machine (SVM) algorithm was used to build the radiomics signature on the training cohort. Incorporating radiomics signature and clinical risk factors, the radiomics-based nomogram was developed. The sensitivity, specificity, accuracy, and area under the curve (AUC) and Receiver operating characteristic (ROC) curve were calculated to assess these models.ResultThe radiomics model performed much better than the clinical model in both training (AUCs 0.925 vs. 0.786, accuracies 87.5% vs. 70.5%, sensitivities 83.6% vs. 41.7% and specificities 90.9% vs. 94.7%) and testing (AUCs 0.911 vs. 0.706, accuracies 84.0% vs. 71.3%, sensitivities 81.1% vs. 43.4% and specificities 86.4% vs. 95.0%). The combined model based on the radiomics signature and tumor stage, tumor infiltration depth and tumor pathology yielded the best performance (training cohort, AUC = 0.943, accuracies 89.5%, sensitivities 85.4% and specificities 92.9%; testing cohort, AUC = 0.923, accuracies 84.6%, sensitivities 84.0% and specificities 85.1%).ConclusionRadiomics-based nomogram was a useful tool for predicting LVSI of cervical cancer. This would aid the selection of the optimal therapeutic strategy and clinical decision-making for individuals.

Background Noninvasive myocardial imaging modalities, such as cardiac magnetic resonance (CMR), single photon emission computed tomography (SPECT), and Positron emission tomography (PET), are well-established and extensively used to detect cardiac amyloid (CA). The purpose of this study is to directly compare CMR, SPECT, and PET scans in the diagnosis of CA, and to provide evidence for further scientific research and clinical decision-making. Methods PubMed, Embase, and Cochrane Library were searched. Studies used CMR, SPECT and/or PET for the diagnosis of CA were included. Pooled sensitivity, specificity, positive and negative likelihood ratio (LR), diagnostic odds ratio (DOR), their respective 95% confidence intervals (CIs) and the area under the summary receiver operating characteristic (SROC) curve (AUC) were calculated. Quality assessment of included studies was conducted. Results A total of 31 articles were identified for inclusion in this meta-analysis. The pooled sensitivities of CMR, SPECT and PET were 0.84, 0.98 and 0.78, respectively. Their respective overall specificities were 0.87, 0.92 and 0.95. Subgroup analysis demonstrated that 99mTc-HMDP manifested the highest sensitivity (0.99). 99mTc-PYP had the highest specificity (0.95). The AUC values of 99mTc-DPD, 99mTc-PYP, 99mTc-HMDP were 0.89, 0.99, and 0.99, respectively. PET scan with 11C-PIB demonstrated a pooled sensitivity of 0.91 and specificity of 0.97 with an AUC value of 0.98. Conclusion Our meta-analysis reveals that SEPCT scans present better diagnostic performance for the identification of CA as compared with other two modalities.

Background The urea breath test (UBT) is widely used for diagnosing Helicobacter pylori infection. In the Shenzhen Kuichong People’s Hospital, some UBT findings were contradictory to the histology outcomes, therefore this study aimed to assess and compare the diagnostic performance of both 13C- and 14C-UBT assays. Methods We recruited 484 H. pylori-treatment naïve patients, among which 217 and 267 were tested by the 13C-UBT or 14C-UBT, respectively. The cutoff value for H. pylori positivity based on manufacturer’s instruction was 4% delta over baseline (DOB) for the 13C-UBT, and 100 disintegrations per minute (DPM) for the 14C-UBT. Gastric biopsies of the antrum and corpus were obtained during endoscopy for histopathology. Results In patients who were tested using the 13C-UBT kit, histopathology was positive in 136 out of 164 UBT-positive patients (82.9% concordance), and negative in 46 out of 53 UBT-negative cases (86.8% concordance). For the 14C-UBT-tested patients, histopathology was positive for H. pylori in 186 out of 220 UBT-positive patients (84.5% concordance), and negative in 41 out of 47 UBT-negative cases (87.2% concordance). While the 13C-UBT and 14C-UBT each had a high sensitivity level of 95.1% and 96.9%, respectively, their specificity was low, at 62.2% and 54.7%, respectively. By using new optimal cutoff values and including an indeterminate range (3–10.3% DOB for 13C-UBT and 87–237 DPM for 14C-UBT), the specificity values can be improved to 76.7% and 76.9% for the 13C- and 14C-UBT, respectively. Conclusions The establishment of an indeterminate range is recommended to allow for repeated testing to confirm H. pylori infection, and thereby avoiding unnecessary antibiotic treatment. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000041570. Registered 29 December 2020- Retrospectively registered, http://www.chictr.org.cn/edit.aspx?pid=66416&htm=4

Urinary liver-type fatty acid binding protein (L-FABP) is a novel biomarker with promising performance in detecting kidney injury. Previous studies reported that L-FABP showed moderate discrimination in patients that underwent cardiac surgery, and other studies revealed that longer duration of cardiopulmonary bypass (CPB) was associated with a higher risk of postoperative acute kidney injury (AKI). This study aims to examine assessing CPB duration first, then examining L-FABP can improve the discriminatory ability of L-FABP in postoperative AKI. A total of 144 patients who received cardiovascular surgery were enrolled. Urinary L-FABP levels were examined at 4 to 6 and 16 to 18 h postoperatively. In the whole study population, the AUROC of urinary L-FABP in predicting postoperative AKI within 7 days was 0.720 at 16 to 18 h postoperatively. By assessing patients according to CPB duration, the urinary L-FABP at 16 to 18 h showed more favorable discriminating ability with AUROC of 0.742. Urinary L-FABP exhibited good performance in discriminating the onset of AKI within 7 days after cardiovascular surgery. Assessing postoperative risk of AKI through CPB duration first and then using urinary L-FABP examination can provide more accurate and satisfactory performance in predicting postoperative AKI.

Background We established age‐group‐specific reference intervals for serum anti‐Müllerian hormone (AMH) levels in a Korean population and investigated the effectiveness of AMH assay for polycystic ovary syndrome (PCOS) diagnosis. Methods We analyzed serum levels of AMH, follicle‐stimulating hormone (FSH), and luteinizing hormone (LH) from 1540 Korean women. Subjects were divided into three groups: healthy, benign gynecologic diseases, and PCOS. Age‐group‐specific reference intervals and AMH diagnostic performance were estimated. Results The PCOS group had a median AMH level of 7.0 µg/L, which was higher than for the healthy (1.8 µg/L) and the benign gynecologic diseases (2.7 µg/L) groups. The upper 97.5% reference limits for age groups 12–20 years, 21–34 years, and 35–46 years were 13.2 µg/L, 15.8 µg/L, and 6.6 µg/L, respectively. The area under the curve (AUC) values to estimate AMH ability to discriminate PCOS from healthy women for each age group were 0.741, 0.785, and 0.789, respectively. AUCs for LH/FSH were 0.719, 0.672, and 0.590. Conclusions The better diagnostic ability of AMH over LH/FSH in women of late childbearing ages indicates that age and other clinical characteristics should be considered when interpreting these test results., Receiver operating characteristic curves of anti‐Müllerian hormone (AMH) and the luteinizing hormone to follicle‐stimulating hormone ratio (LH/FSH) were drawn according to age groups and control types. The better diagnostic ability of AMH over LH/FSH in women of late childbearing ages indicates that age and other clinical characteristics should be considered when interpreting these test results.

Maternal vaginal/rectal colonization of group B streptococcus (GBS) is a main risk for neonatal invasive infection. Efficient determination of GBS colonization in pregnant women is crucial. This study aimed to investigate the prevalence of GBS carriage and evaluate the diagnostic performance of six methodologies for GBS screening conducted in China, including blood agar plate, liquid chromogenic medium, and loop-mediated isothermal amplification (LAMP) without pre-enrichment, chromogenic agar plate with pre-enrichment, and GBS antigen detection without and with pre-enrichment in comparison with the standard reference method (Lim broth-enriched subculture with plating on 5% sheep blood agar). Vaginal/rectal swabs were collected from 1,281 pregnant women at 35–37 weeks of gestation. Of them, 309 were taken in triplicate, one for Lim broth-enriched subculture, one for blood agar plate, and the third for GBS antigen detection (Reagent W); 177 were acquired in duplicate, one for Lim broth-enriched subculture and the other for GBS antigen detection (Reagent H); 502 were obtained in duplicate, one for Lim broth-enriched subculture and the other for liquid chromogenic medium; 158 were collected in duplicate, one for Lim broth-enriched subculture and the other for LAMP; and 135 were inoculated in Lim broth-enriched for GBS antigen detection (Reagent W) and subculture with chromogenic agar plate and 5% blood agar plate. The overall prevalence of GBS carriage was 10.1% (130/1,281, 95% CI: 8.5–12.1%) according to the standard reference method. Compared with the standard reference method, the LAMP had excellent performance of sensitivity (100%, 95%CI: 83.4–100%), specificity (94%, 95%CI: 88.1–97.1%), and Yoden index (0.940); as well as the blood agar plate with sensitivity (81.5%, 95%CI: 61.3–93.0%), specificity (100%, 95%CI: 98.3–100.0%), and Yoden index (0.815). The other four methods were not sufficient to reach the threshold in terms of sensitivity or specificity compared to the standard reference method. Furthermore, for LAMP, results can be obtained within 0.5–1 h, while for blood agar plate, which needed 24–48 h, and further identification was required. Our data suggested that the performance of LAMP was highly comparable to the standard Lim broth-enriched subculture and LAMP is considered as an alternative for fast and accurate GBS screening.

Background As a new noninvasive diagnostic technique, computed tomography (CT)-based fraction flow reserve (FFR) has been used to identify hemodynamically significant coronary artery stenosis. This meta-analysis used invasive FFR as the standard to evaluate the diagnostic performance of FFRCT. Methods We searched the PubMed, Cochrane library, and EMBASE for articles published between January 2009 and January 2021. The synthesized sensitivity and specificity of invasive FFR and FFRCT were analyzed at both the patient and vessel levels. We generated a summary receiver operating characteristic curve (SROC) and then calculated the area under the curve (AUC). Results We included a total of 23 studies, including 2,178 patients and 3,029 vessels or lesions. Analysis at each patient level demonstrated a synthesized sensitivity of 88%, specificity of 79%, LR+ of 4.16, LR-of 0.15, and AUC of 0.89 for FFRCT. Analysis at the level of each vessel or lesion showed a synthesized sensitivity of 85%, specificity of 81%, LR+ of 4.44, LR-of 0.19, and AUC of 0.87 for FFRCT. Conclusion Our research reveals that FFRCT has high diagnostic performance in patients with coronary artery stenosis, regardless of whether it is at the patient level or the vessel level.

Exosomes show diagnostic and therapeutic promise as carriers of ncRNAs in diseases. LncRNAs in exosomes have been identified as being stable and avoided degradation by nucleolytic enzymes. Although lncRNAs have been confirmed to be important in cancers, no studies for exo-lncRNAs have been reported in LAA stroke. High-throughput sequencing was performed to detect the differential expression profiles of lncRNAs in five paired plasma-derived exosome samples from patients with LAA stroke and controls (matched on vascular risk factors). Exo-lncRNA-associated networks were predicted with a combination of multiple databases. The expression of the selected genes in the networks was confirmed by qRT-PCR in a validation set (LAA vs. controls = 30:30). Furthermore, ROC analysis was used to evaluate the diagnostic performance of the lncRNA-related networks. A total of 1,020 differentially expressed lncRNAs were identified in LAA stroke patients. GO and KEGG pathway analyses indicated that their target genes are involved in atherosclerosis-related pathways, including inflammation, cell adhesion, and cell migration. qRT-PCR confirmed that the expression trend of differential expressed genes was consistent with RNA-seq. Furthermore, the AUCs of the lnc_002015-related network and lnc_001350-related network were 0.959 and 0.97, respectively, in LAA stroke. Our study showed the differential expression of lncRNAs in plasma exosomes and presented related diagnostic networks for LAA stroke for the first time. The results suggested that exosomal lncRNA-related networks could be potential diagnostic tools in LAA stroke.

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.