Search

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

The RU_SATED scale is increasingly used across the globe to measure sleep health. However, there is a lack of consensus around its psychometric and diagnostic performance. We conducted an empirical investigation into the psychometrics of the Chinese version of the RU_SATED (RU_SATED-C) scale, with a focus on structural validity and diagnostic performance. 1171 adults were enrolled from three communities in Hangzhou, China in July 2022. The dataset was spilt in half, and we ran a bootstrapped exploratory graph analysis (bootEGA) in one half and a confirmatory factor analysis (CFA) in the other half to assess structural validity. Correlations with insomnia, wellness, anxiety, and depression symptoms were examined in order to assess concurrent validity; and Cronbach's α and McDonald's ω were calculated to assess internal consistency. Additionally, a Receiver Operating Characteristic (ROC) analysis established and externally validated the optimal score for identifying insomnia symptoms. A one-dimensional structure, as identified by bootEGA, was corroborated in the CFA [comparative fit index = 0.934, root mean square error of approximation = 0.088, standardized root mean square residual = 0.051]. A moderate correlation was shown with insomnia symptoms, while weak correlations were observed with wellness, anxiety, and depression symptoms. The RU_SATED-C scale displayed sub-optimal internal consistency where coefficients dropped if any item was removed. A recommended cutoff score of ≤13 was derived for probable insomnia with a satisfactory diagnostic performance. The RU_SATED-C scale displayed a one-dimensional model, along with adequate concurrent validity, internal consistency, and diagnostic performance. Further work necessitates multi-scenario testing and additional validation using objective sleep assessments. • The RU_SATED scale exhibited adequate psychometrics in a Chinese community cohort. • Integration of exploratory graph analysis and confirmatory factor analysis. • A unidimensional factor structure of sleep health was measured by the RU_SATED scale. • ROC analysis identified the optimal cutoff for potential insomnia identification. [ABSTRACT FROM AUTHOR]

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

[Display omitted] • Ascaris suum is the most widespread and common nematode in pigs. • Ascaris suum eggs were detected in 18% of the alternative farms included in the study. • At least 20% of pigs over 22 weeks of age were seropositive for A. suum on 80% of farms. • The coprological test has very good specificity but very low sensitivity. • The serological diagnostic test seems better suited to defining a farm's status. Coprological and serological diagnostic tests were compared to define the status of a pig farm with regard to Ascaris suum. On each of the 100 farms in France visited for the study, 10 blood samples were taken from pigs at the end of fattening (at least 22 weeks old) and 20 to 30 faecal samples were taken, depending on the category of animals present on the farm (10 sows, 10 piglets aged 10 to 12 weeks and 10 pigs at the end of fattening, aged at least 22 weeks). A SERASCA® ELISA test (Laboratory of Parasitology, Ghent University) was performed on each blood sample (cut-off 0.5) and a coprological analysis on each faecal sample. A Bayesian approach was used to estimate the sensitivity and specificity of the coprological and serological tests. A farm was considered positive if at least one A. suum egg was observed in the faecal samples. With regard to the serological test, various hypotheses were tested in order to define the number of seropositive animals required to consider a farm positive for A. suum. The coprological test has very good specificity in the search for A. suum , whether 20 or 30 samples are taken per farm. However, even with an increase in the number of samples, the sensitivity of this diagnostic approach is very low (less than 30%). On the other hand, the serological diagnostic method, which consists of taking blood samples from 10 animals at the end of fattening, has good sensitivity and seems better suited to defining the status of a farm with regard to A. suum , provided that a farm is considered seropositive only if two out of 10 samples are positive. [ABSTRACT FROM AUTHOR]

To compare the differences in apparent diffusion coefficient (ADC) and synthetic magnetic resonance (MR) measurements of four region of interest (ROI) placement methods for breast tumor and to investigate their diagnostic performance. 110 (70 malignant, 40 benign) newly diagnosed breast tumors were evaluated. The patients underwent 3.0 T MR examinations including diffusion-weighted imaging and synthetic MR. Two radiologists independently measured ADCs, T 1 relaxation time (T 1), T 2 relaxation time (T 2), and proton density (PD) using four ROI methods: round, square, freehand, and whole-tumor volume (WTV). The interclass correlation coefficient (ICC) was used to assess their measurement reliability. Diagnostic performance was evaluated using multivariate logistic regression analysis and the receiver operating characteristic (ROC) curves. The mean values of all ROI methods showed good or excellent interobserver reproducibility (0.79–0.99) and showed the best diagnostic performance compared to the minimum and maximum values. The square ROI exhibited superior performance in differentiating between benign from malignant breast lesions, followed by the freehand ROI. T 2 , PD, and ADC values were significantly lower in malignant breast lesions compared to benign ones for all ROI methods (p < 0.05). Multiparameters of T 2 + ADC demonstrated the highest AUC values (0.82–0.95), surpassing the diagnostic efficacy of ADC or T 2 alone (p < 0.05). ROI placement significantly influences ADC and synthetic MR values measured in breast tumors. Square ROI and mean values showed superior performance in differentiating benign and malignant breast lesions. The multiparameters of T 2 + ADC surpassed the diagnostic efficacy of a single parameter. [ABSTRACT FROM AUTHOR]

The diagnosis of rotator cuff tears (RCTs) using radiographs alone is clinically challenging; thus, the utility of deep learning algorithms based on convolutional neural networks has been remarkable in the field of medical imaging recognition. We aimed to evaluate the diagnostic performance of artificial intelligence (a deep learning algorithm; a convolutional neural network) to detect and classify RCTs using shoulder radiographs, and compare its diagnostic performance with that of orthopedic surgeons. A total of 1169 plain shoulder anteroposterior radiographs (1 image per shoulder) were included in the total dataset and divided into four groups: intact, small, medium, and large to massive tear groups. The sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and area under the receiver operating curve were measured for the detection of RCTs through binary classification. The average accuracy, recall, precision, and F1-score were divided into four groups by cuff tear size for multiclass classification. The convolutional neural network demonstrated a high performance, with 92% sensitivity, 69% specificity, 86% accuracy, and an area under the receiver operating curve of 0.88 for the detection of RCTs. The average accuracy, recall, precision, and F1-score of the convolutional neural network for classification were 60%, 0.42, 0.49, and 0.45, respectively. The accuracy of the convolutional neural network for the detection and classification of RCTs was significantly better than that of orthopedic surgeons. The convolutional neural network demonstrated the diagnostic ability to detect and classify RCTs using plain shoulder radiographs, and the diagnostic performance exhibited equal to superior accuracy when compared with those of shoulder experts. [ABSTRACT FROM AUTHOR]

Breast imaging plays a crucial role in the early detection and management of breast cancer, with visual quality, modality innovation and diagnostic performance being key factors in achieving accurate diagnoses and optimal patient outcomes. This paper presents a comprehensive bibliometric analysis of the literature on the three above elements focusing on breast imaging, aiming to uncover publication trends, identify influential works and authors, and highlight future research directions. We employed a methodical bibliometric approach, making use of Scopus and Web of Science (WoS) databases for gathering literatures. We planned our search strategy, concentrating on terms linked to "breast imaging," "image quality," and "diagnostic accuracy" to ensure a systematic examination of the subject. The enhanced search functions in these databases enabled us to narrow down and improve our findings, choosing only the articles, conference papers, and book sections that are most relevant. After conducting a thorough screening process to remove duplicates and evaluate significance, we utilized ScientoPy and VOSviewer software for an in-depth bibliometric analysis. This helped to explore trends in publications, patterns of citations, and thematic groups, giving us a better understanding of how the field has changed and where it currently stands. Our approach prioritized assessing methodological quality and bias in the studies we included, guaranteeing the reliability of our findings. We reviewed 2984 relevant publications, revealing a consistent annual growth rate of 2.8% in breast imaging research, with the United States and Europe leading in contributions. The study found that advancements in radiological technologies and international collaboration are driving forces behind the field's expansion. Key subject areas such as 'Radiology, Nuclear Medicine, and Medical Imaging' dominated, underscoring their impact on diagnostic quality. Notable authors and institutions have been identified for their influential research, characterized by high citation metrics and significant scholarly impact. The study shows a continuous increase in research on breast imaging, considered by new technologies and teamwork defining the present time. The assessment highlights a key move towards utilizing digital imaging methods and computational analysis, affecting the improvement of future diagnostic procedures and patients' results. The study highlights the importance of continued international collaborations to tackle the new barriers in breast imaging and make the most of technological progress. This study shows a focus on using interdisciplinary methods and cutting-edge technology in breast imaging to help healthcare professionals improve their performance and accuracy in diagnosis. Recognizing vital research and emerging trends should guide clinical guidelines, radiology training, and patient care plans to encourage the use of effective techniques and stimulate innovation in diagnostic approaches. [ABSTRACT FROM AUTHOR]

To assess the diagnostic performance of MRI to predict ovarian malignancy alone and compared with other diagnostic studies. A retrospective analysis was conducted of patients aged 2-21 years who underwent ovarian mass resection between 2009 and 2021 at 11 pediatric hospitals. Sociodemographic information, clinical and imaging findings, tumor markers, and operative and pathology details were collected. Diagnostic performance for detecting malignancy was assessed by calculating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for MRI with other diagnostic modalities. One thousand and fifty-three patients, with a median age of 14.6 years, underwent resection of an ovarian mass; 10% (110/1053) had malignant disease on pathology, and 13% (136/1053) underwent preoperative MRI. MRI sensitivity, specificity, PPV, and NPV were 60%, 94%, 60%, and 94%. Ultrasound sensitivity, specificity, PPV, and NPV were 31%, 99%, 73%, and 95%. Tumor marker sensitivity, specificity, PPV, and NPV were 90%, 46%, 22%, and 96%. MRI and ultrasound concordance was 88%, with sensitivity, specificity, PPV, and NPV of 33%, 99%, 75%, and 94%. MRI sensitivity in ultrasound-discordant cases was 100%. MRI and tumor marker concordance was 88% with sensitivity, specificity, PPV, and NPV of 100%, 86%, 64%, and 100%. MRI specificity in tumor marker-discordant cases was 100%. Diagnostic modalities used to assess ovarian neoplasms in pediatric patients typically agree. In cases of disagreement, MRI is more sensitive for malignancy than ultrasound and more specific than tumor markers. Selective use of MRI with preoperative ultrasound and tumor markers may be beneficial when the risk of malignancy is uncertain. This retrospective review of 1053 patients aged 2-21 years who underwent ovarian mass resection between 2009 and 2021 at 11 pediatric hospitals found that ultrasound, tumor markers, and MRI tend to agree on benign vs malignant, but in cases of disagreement, MRI is more sensitive for malignancy than ultrasound. [ABSTRACT FROM AUTHOR]

Sonography is a beneficial imaging modality for detecting elbow fractures in children, considering the lack of radiation exposure and time efficiency. This systematic review aims to determine the diagnostic value and clinical applicability of sonography and each sonographic finding in detecting pediatric elbow fractures. Pubmed, Scopus, and WOS databases were searched for related original articles until February 25, 2023, and data related to diagnostic performance were extracted. We used the Bivariate model and hierarchic summary receiver operating characteristic (HSROC) approach to calculate pooled diagnostic values. Cochrane Q test and I-squared were performed to evaluate heterogeneity. We assessed heterogeneity with meta-regression. Eight studies were included, which involved a total number of 880 patients. According to meta-analysis, sonography demonstrated a pooled sensitivity of 97% (91–99%) and specificity of 90% (80–95%), positive likelihood ratio(LR+) of 9.82 (4.59–20.97), and negative likelihood ratio (LR–) of 0.03 (0.01–0.10). For the sonographic posterior fat pad sign as a sole diagnostic sign, we calculated a Pooled Sensitivity of 80% (70–88%), Specificity of 97% (87–99%), LR+ of 28.8 (6–139.3), and LR– of 0.2 (0.13–0.31). Also, lipohemarthrosis demonstrated a pooled sensitivity of 80% (70–88%), specificity of 97% (87–99%), LR+ of 28.8 (6–139.3), and LR– of 0.2 (0.13–0.31). The sensitivity of detecting fractures with cortical line disruption was significantly higher in studies that utilized a comprehensive technique compared to a conventional technique. Sonography is a valuable diagnostic tool for the assessment of pediatric elbow injuries, and it can be capable of confirmation or exclusion of the diagnosis. [ABSTRACT FROM AUTHOR]

To assess and compare the diagnostic performance of Clinical Prediction Rules (CPRs) developed to detect group A Beta-haemolytic streptococci in people with acute pharyngitis (or sore throat). A systematic review. We searched PubMed, Embase and Web of Science (inception–September 2022) for studies deriving and/or validating CPRs comprised of ≥2 predictors from an individual's history or physical examination. Two authors independently screened articles, extracted data and assessed risk of bias in included studies. A meta-analysis was not possible due to heterogeneity. Instead we compared the performance of CPRs when they were validated in the same study population (head-to-head comparisons). We used a modified grading of recommendations, assessment, development, and evaluations (GRADE) approach to assess certainty of the evidence. We included 63 studies, all judged at high risk of bias. Of 24 derived CPRs, 7 were externally validated (in 46 external validations). Five validation studies provided data for head-to-head comparison of four pairs of CPRs. Very low certainty evidence favoured the Centor CPR over the McIsaac (2 studies) and FeverPain CPRs (1 study) and found the Centor CPR was equivalent to the Walsh CPR (1 study). The AbuReesh and Steinhoff 2005 CPRs had a similar poor discriminative ability (1 study). Within and between study comparisons suggested the performance of the Centor CPR may be better in adults (>18 years). Very low certainty evidence suggests a better performance of the Centor CPR. When deciding about antibiotic prescribing for pharyngitis patients, involving patients in a shared decision making discussion about the likely benefits and harms, including antibiotic resistance, is recommended. Further research of higher rigour, which compares CPRs across multiple settings, is needed. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the diagnostic performance of radiologists following the utilization of artificial intelligence (AI)-based computer-aided detection software (CAD) in detecting suspicious lesions in automated breast ultrasounds (ABUS). ABUS-detected 262 breast lesions (histopathological verification; January 2020 to December 2022) were included. Two radiologists reviewed the images and assigned a Breast Imaging Reporting and Data System (BI-RADS) category. ABUS images were classified as positive or negative using AI-CAD. The BI-RADS category was readjusted in four ways: the radiologists modified the BI-RADS category using the AI results (AI-aided 1), upgraded or downgraded based on AI results (AI-aided 2), only upgraded for positive results (AI-aided 3), or only downgraded for negative results (AI-aided 4). The AI-aided diagnostic performances were compared to radiologists. The AI-CAD-positive and AI-CAD-negative cancer characteristics were compared. For 262 lesions (145 malignant and 117 benign) in 231 women (mean age, 52.2 years), the area under the receiver operator characteristic curve (AUC) of radiologists was 0.870 (95% confidence interval [CI], 0.832–0.908). The AUC significantly improved to 0.919 (95% CI, 0.890–0.947; P = 0.001) using AI-aided 1, whereas it improved without significance to 0.884 (95% CI, 0.844–0.923), 0.890 (95% CI, 0.852–0.929), and 0.890 (95% CI, 0.853–0.928) using AI-aided 2, 3, and 4, respectively. AI-CAD-negative cancers were smaller, less frequently exhibited retraction phenomenon, and had lower BI-RADS category. Among nonmass lesions, AI-CAD-negative cancers showed no posterior shadowing. AI-CAD implementation significantly improved the radiologists' diagnostic performance and may serve as a valuable diagnostic tool. [ABSTRACT FROM AUTHOR]

Exosomal long noncoding RNAs (lncRNAs) are the key to diagnosing and treating various diseases. This study aimed to investigate the diagnostic value of plasma exosomal lncRNAs in white matter hyperintensities (WMH). We used high-throughput sequencing to determine the differential expression (DE) profiles of lncRNAs in plasma exosomes from WMH patients and controls. The sequencing results were verified in a validation cohort using qRT-PCR. The diagnostic potential of candidate exosomal lncRNAs was proven by binary logistic analysis and receiver operating characteristic (ROC) curves. The diagnostic value of DE exo-lncRNAs was determined by the area under the curve (AUC). The WMH group was then divided into subgroups according to the Fazekas scale and white matter lesion site, and the correlation of DE exo-lncRNAs in the subgroup was evaluated. In our results, four DE exo-lncRNAs were identified, and ROC curve analysis revealed that exo-lnc_011797 and exo-lnc_004326 exhibited diagnostic efficacy for WMH. Furthermore, WMH subgroup analysis showed exo-lnc_011797 expression was significantly increased in Fazekas 3 patients and was significantly elevated in patients with paraventricular matter hyperintensities. Plasma exosomal lncRNAs have potential diagnostic value in WMH. Moreover, exo-lnc_011797 is considered to be a predictor of the severity and location of WMH. [ABSTRACT FROM AUTHOR]

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Depuis leur découverte en 2013, les anticorps anti-5'nucléotidase 1A (anti-cN1A) ont fait l'objet de nombreuses publications pour évaluer leur sensibilité et leur spécificité diagnostique. Actuellement utilisés comme une aide au diagnostic de la myosite à inclusions pour laquelle leur spécificité est bonne, ils peuvent être cependant détectés au cours d'autres maladies auto-immunes et en particulier au cours du syndrome de Gougerot-Sjögren (SGS). Leur prévalence, importante au cours de cette maladie, diminue leur performance diagnostique chez des patients présentant à la fois une myosite et un SGS. Les anticorps anti-cN1A pourraient également avoir un rôle pronostique au cours d'un SGS. Since their discovery in 2013, anti-5'nucleotidase 1A (anti-cN1A) antibodies have been the subject of numerous publications to assess their sensitivity and diagnostic specificity. Currently used as an aid in the diagnosis of inclusion body myositis for which their specificity is good, they can be detected in other autoimmune diseases and in particular in Sjögren's Syndrome. Their prevalence, which is significant during this disease, decreases diagnostic performance in patients with both myositis and Sjögren's Syndrome. Anti-cN1A antibodies may also have a prognostic role during SGS. [ABSTRACT FROM AUTHOR]

Background: The clinical application of coronary MR angiography (MRA) combining diastole and systole imaging has never been described comprehensively in coronary artery disease (CAD) patients. We aimed to design an optimal non-contrast coronary MRA scan protocol combining diastolic and systolic imaging and to (1) evaluate its diagnostic performance for detecting significant coronary stenosis; (2) evaluate the feasibility of this protocol to noninvasively measure the coronary distensibility index (CDI). Methods: From June 2021 to May 2022, 33 healthy volunteers and 91 suspected CAD patients scheduled for X-ray coronary angiography (CAG) were prospectively enrolled. 3T non-contrast water-fat coronary MRA was carried out twice at diastole and systole. Significant coronary stenosis was defined as a luminal diameter reduction of ≥ 50% using CAG as the reference and was evaluated as follows: (1) by coronary MRA in diastole alone; (2) by coronary MRA in systole alone; (3) by combined coronary MRA in diastole and systole. According to CAG, the patients were divided into significant CAD patients and non-significant CAD patients. The difference in CDI among participants was evaluated. Results: Combined coronary MRA was completed in 31 volunteers and 76 patients. The per-patient sensitivity, specificity, and accuracy of combined coronary MRA were 97.5%, 83.3%, and 90.8%, respectively. Compared with single diastolic mode, combined coronary MRA showed equally high sensitivity but improved specificity on a per-patient basis (83.3% vs. 63.9%, adjusted P = 0.013). The CDI tested by coronary MRA decreased incrementally from healthy volunteers to non-significant and significant CAD patients. Conclusion: Compared with single-phase mode, 3 T non-contrast combined coronary MRA significantly improved specificity and may have potential to be a simple noninvasive method to measure CDI. [ABSTRACT FROM AUTHOR]

We aimed to evaluate the performance of fast and straightforward Murray law-based quantitative flow ratio (μQFR) computation in cerebrovascular stenosis. A total of 30 patients with symptomatic stenosis of 50%–70% luminal stenosis and underwent fractional pressure ratio (FPR) assessment at our hospital were included in the present study. μQFR was applied to the interrogated vessel. An artificial intelligence algorithm was proposed for automatic delineation of lumen contours of cerebrovascular stenosis. We used invasive FPRs as a reference standard. Pearson's correlation coefficient (r) was used to assess the correlation strength between the μQFR and FPR, and Bland-Altman plots were used to evaluate the agreement between the μQFR and FPR. An analysis of the receiver operating characteristic was used to evaluate the performance of μQFR. Our results displayed a strong positive correlations (r = 0.92; P < 0.001) between the μQFR and pressure wire FPR. Excellent agreement was observed between the μQFR and FPR with a mean difference of 0.01 ± 0.08 (range, −0.16 to 0.14; P = 0.263). The overall accuracy for identifying an FPR of ≤0.7 was 92% (95% confidence interval [CI], 85%–100%). The area under the receiver operating characteristic curve was higher for the μQFR (0.92; 95% CI, 0.81–0.98) than for diameter stenosis (0.88; 95% CI, 0.75–0.95). The positive likelihood ratio was 3.9 for the μQFR with a negative likelihood ratio of 0. The μQFR computation has a strong correlation and agrees with the FPR calculated from the pressure wire. Therefore, the μQFR might provide an essential therapeutic aid for patients with symptomatic stenosis. [ABSTRACT FROM AUTHOR]

Software to compute angiography-derived fractional flow reserve (angio-FFR) have been validated against pressure wire–derived fractional flow reserve (PW-FFR) with an area under the receiver-operating characteristic curve (AUC) of 0.93 to 0.97. The aim of this study was to investigate diagnostic accuracies of 5 angio-FFR software/methods by an independent core lab in a prospective cohort of 390 vessels with carefully documented sites of PW-FFR and pressure wire–derived instantaneous wave-free ratio. One "matcher investigator" colocalized on angiography the sites of pressure wire measurement with angio-FFR measurements and provided the same 2 optimal angiographic views and frame selection to independent analysts who were blinded to invasive physiological results and results from other software. The results were anonymized and randomly presented. The AUC of each angio-FFR was compared with 2-dimensional quantitative coronary angiography (QCA) percent diameter stenosis (%DS) using a 2-tailed paired comparison of AUC. All 5 software/methods yielded a high proportion of analyzable vessels (A: 100%, B: 100%, C: 92.1%, D: 99.5%, and E: 92.1%). The AUCs for predicting fractional flow reserve ≤0.8 for software A, B, C, D, E, and 2-dimensional QCA %DS were 0.75, 0.74, 0.74, 0.73, 0.73, and 0.65, respectively. The AUC for each angio-FFR was significantly greater than that for 2-dimensional QCA %DS. This head-to-head comparison by an independent core lab demonstrated that the diagnostic accuracy of various angio-FFR software for predicting PW-FFR ≤0.80 was useful, with a higher discrimination compared with 2-dimensional QCA %DS; however, it did not reach the diagnostic accuracy previously reported in validation studies of various vendors. Therefore, the intrinsic clinical value of "angiography-derived fractional flow reserve" requires confirmation in large clinical trials. [Display omitted] [ABSTRACT FROM AUTHOR]

To explore the diagnostic performance of routine magnetic resonance imaging (MRI) for the cross-sectional assessment of osteophytes (OPs) in all three knee compartments using computed tomography (CT) as a reference standard. The Strontium Ranelate Efficacy in Knee Osteoarthritis (SEKOIA) trial explored the effect of 3 years of treatment with strontium ranelate in patients with primary knee OA. OPs were scored for the baseline visit only using a modified MRI Osteoarthritis Knee Score (MOAKS) scoring system in the patellofemoral (PFJ), the medial tibiofemoral (TFJ) and the lateral TFJ. Size was assessed from 0 to 3 in 18 locations. Descriptive statistics were used to describe differences in ordinal grading between CT and MRI. In addition, weighted-kappa statistics were employed to assess agreement between scoring using the two methods. Sensitivity, specificity, positive predictive value and negative predictive value as well as area under the curve (AUC) measures of diagnostic performance were employed using CT as the reference standard. Included were 74 patients with available MRI and CT data. Mean age was 62.9 ± 7.5 years. Altogether 1,332 locations were evaluated. For the PFJ, MRI detected 141 (72%) of 197 CT-defined OPs with a w-kappa of 0.58 (95% CI [0.52–0.65]). In the medial TFJ, MRI detected 178 (81%) of 219 CT-OPs with a w-kappa of 0.58 (95% CI [0.51–0.64]). For the lateral compartment these numbers were 84 (70%) of 120 CT-OPs with a w-kappa of 0.58 (95% CI [0.50–0.66]). MRI underestimates presence of osteophytes in all three knee compartments. CT may be helpful particularly regarding assessment of small osteophytes particularly in early disease. [ABSTRACT FROM AUTHOR]

• Diagnosing of health problems with e-devices is an effective means among the elderly. • The overall diagnostic performance of ECG-based index tests was better than VS-based ones. • Multiple signals detection system (combining ECG, VS or PA) was a better and more promising way for diagnosing different kinds of health problems. The aim of this review was to evaluate the overall diagnostic performance of e-devices for detection of health problems in older adults at home. A systematic review was conducted following the PRISMA-DTA guidelines. 31 studies were included with 24 studies included in meta-analysis. The included studies were divided into four categories according to the signals detected: physical activity (PA), vital signs (VS), electrocardiography (ECG) and other. The meta-analysis showed the pooled estimates of sensitivity and specificity were 0.94 and 0.98 respectively in the 'VS' group. The pooled sensitivity and specificity were 0.97 and 0.98 respectively in the 'ECG' group. All kinds of e-devices perform well in diagnosing the common health problems. While ECG-based health problems detection system is more reliable than VS-based ones. For sole signal detection system has limitation in diagnosing specific health problems, more researches should focus on developing new systems combined of multiple signals. [ABSTRACT FROM AUTHOR]

To assess and compare reader performance in interpreting digital periapical (PA) radiography and cone beam computed tomography (CBCT) in endodontic disease detection, using a free-response, factorial model. A reader performance study of 2 image test sets was undertaken using a factorial, free-response design, accounting for the independent variables: case type, case severity, reader type, and imaging modality. Twenty-two readers interpreted 60 PA and 60 CBCT images divided into 5 categories: diseased–subtle, diseased–moderate, diseased–obvious, nondiseased–subtle, and nondiseased–obvious. Lesion localization fraction, specificity, false positive (FP) marks, and the weighted alternative free-response receiver operating characteristic figure of merit were calculated. CBCT had greater specificity than PA in the obvious nondiseased cases (P =.01) and no significant difference in the subtle nondiseased category. Weighted alternative free-response receiver operating characteristic values were higher for PA than CBCT in the subtle diseased (P =.02) and moderate diseased (P =.01) groups with no significant difference between in the obvious diseased groups. CBCT had higher mean FPs than PA (P <.05) in subtle diseased cases. Mean lesion localization fraction in the moderate diseased group was higher in PA than CBCT (P =.003). No relationships were found between clinical experience and all diagnostic performance measures, except for in the obvious diseased CBCT group, where increasing experience was associated mean FP marks (P =.04). Reader performance in the detection of endodontic disease is better with PA radiography than CBCT. Clinical experience does not impact upon the accuracy of interpretation of both PA radiography and CBCT. [ABSTRACT FROM AUTHOR]

To assess the diagnostic performances of prostate specific antigen (PSA) and PSA with prostate magnetic resonance imaging (MRI) to predict prostate cancer in patients with PSA ≤ 20 ng/mL. Patients suspected of prostate cancer with a PSA test and prebiopsy MRI were included (n = 881). Prostate biopsy results or follow-up clinical data for 2 years were used to determine the presence of prostate cancer. The diagnostic performance of PSA, MRI, and PSA with MRI (referred to as the protocol) was evaluated. The positive predictive value (PPV) and negative predictive value (NPV) of the MRI were calculated in subgroups of patients with specific ranges of PSA level. Prostate cancer and CSC were diagnosed in 220 and 162 patients, respectively. Adding MRI to PSA could greatly improve specificity and PPV (0.833 and 0.567) for detecting CSC, compared to PSA ≥ 4 ng/mL alone (0.248 and 0.0219). Even though the sensitivity of the protocol (0.679) was lower than PSA (0.938), the NPV of the protocol was comparable to PSA (0.929 vs. 0.924). The protocol consistently showed the superior PPV and NVP to PSA only in not only patients within the gray zone of PSA, but also in patients with higher PSA. In conclusion, this longitudinal observational study confirmed that adding prebiopsy MRI to PSA was consistently beneficial in patients with PSA ≤ 20 ng/mL for avoiding unnecessary biopsy despite decrease in the sensitivity. [ABSTRACT FROM AUTHOR]

We conducted a systematic review and meta-analysis of studies and reports comparing the performance of antigen rapid diagnostic tests (Ag RDT) for diagnosing Ebola disease (EVD). We searched PubMed, EMBASE, and Web of Science for diagnostic studies published between 1976 and 2023, evaluating them with QUADAS-2. Using a bivariate random-effects model, we estimated the pooled sensitivity and specificity of Ag RDTs. Of 64 eligible full studies and reports, 16 met the inclusion criteria. Pooled sensitivity and specificity were 82.1% (95%CI: 75.2 – 88.0) and 97.0% (95%CI: 95.1-98.2), respectively. We conducted subgroup analysis on 4 Ag RDTs, 3 RT-PCR tests, and 4 sample types, showing varied performance. The high specificity and positive predictive value of Ag RDTs support their use to "rule-in" patients with EVD. However, high-sensitivity RDTs suitable for field settings and capable of detecting multiple ebolavirus species are needed. [ABSTRACT FROM AUTHOR]

Although the STOP-Bang questionnaire has been validated for its efficacy and diagnostic performance in various settings, there is no review that summarizes the pertinent evidence of the STOP-Bang questionnaire in the different populations. We aimed to review the evidence of the diagnostic performance of the STOP-Bang questionnaire, correlation between STOP-Bang scores and the probability of obstructive sleep apnea (OSA), and its clinical application in various populations. This review guides healthcare providers in the sleep medicine and perioperative medicine disciplines to be better informed when using the STOP-Bang questionnaire in the different populations. It provides a greater understanding for both patients and clinicians when making decisions regarding OSA screening for each population. [ABSTRACT FROM AUTHOR]

• Selecting proper lipoarabinomannan-testing assays is the key to enhance the detection rate. • Electrochemiluminescence was recommended for tuberculosis/HIV patients, especially taking urine as a sample. • Enzyme-linked immune sorbent assay was recommended as a reliable detection for smear-positive Africans. How to choose proper lipoarabinomannan-testing assays for diagnosing tuberculosis (TB) in different populations baffles clinicians. This work assessed all reported lipoarabinomannan assays' performance and aimed to identify the eligibility of each assay and offer guidance for clinicians. We searched PubMed, Embase, and Web of Science until August 23, 2020. The risk of bias was evaluated by QADAS-2. Heterogeneity was evaluated by the Cochran Q test and I2. Sensitivity and specificity were pooled by a bivariate mixed model (register number: CRD42021270506). A total of 97 articles, covering 144 trials, 16 assays, 45,679 participants, and eight sample types, were divided into five groups. Electrochemiluminescence (ECL) had a sensitivity of 65%, specificity of 92%, and an area under curve (AUC) of 0.85 in diagnosing pulmonary TB in adults. ECL showed a promising diagnostic ability (sensitivity: 78%; specificity: 88%; AUC: 0.88) in patients with HIV, especially for urine detection (sensitivity: 90%; specificity: 89%; AUC: 0.95). The enzyme-linked immune assay showed a preference for diagnosing TB in Asians and Africans, especially in Africans who were smear-positive (sensitivity: 80%; specificity: 88%; AUC: 0.91). ECL was recommended for diagnosing pulmonary TB in adults, especially for TB/HIV co-infection. Taking urine as a sample further enhanced ECL's diagnostic performance. Enzyme-linked immune assay was recommended as an additional TB-related detection for smear-positive Africans. [ABSTRACT FROM AUTHOR]

Rationale and Objectives: To compare the diagnostic performance of abbreviated breast MRI (AB-MRI) and digital breast tomosynthesis (DBT) in women with a personal history (PH) of breast cancer as a postoperative screening tool.Materials and Methods: A total of 471 patients who completed both DBT and AB-MRI examinations were included in this study (median age, 54.5 years). The detected cancer characteristics were analyzed. The cancer detection rate (CDR), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the curve (AUC) were calculated by receiver operating characteristic (ROC) curve analysis.Results: Eleven malignancies were diagnosed, and most of the detected cancers were stage I (7 of 11, 63.6%). Eight were invasive ductal carcinomas (IDC), and 3 were ductal carcinoma in situ (DCIS). Of the 11 recurrences, 6 malignancies were detected by DBT, and 11 were detected by AB-MRI. AB-MRI detected all 8 IDC and 3 DCIS lesions, and DBT detected 6 of 8 IDC lesions. The CDRs for DBT and AB-MRI screenings were 12.7 and 23.4 per 1,000 women, respectively. The sensitivity, specificity, PPV, NPV, and accuracy of DBT versus AB-MRI were 54.6% versus 100%, 97.6% versus 96.5%, 35.3% versus 40.7%, 98.9% versus 100%, and 96.6% versus 96.6%, respectively. AB-MRI showed a higher AUC value (0.983) than DBT (0.761) (p = 0.0049).Conclusion: AB-MRI showed an improved CDR, especially for invasive cancer. The diagnostic performance of AB-MRI was superior to that of DBT with high sensitivity and PPV without sacrificing specificity in women with a PH of breast cancer. [ABSTRACT FROM AUTHOR]

Infectious hematopoietic necrosis virus (IHNV) severely and lethally infects salmonid fish, including Atlantic salmon (Salmo salar) and rainbow trout (Oncorhynchus mykiss) worldwide. Rapid and accurate viral detection is crucial for preventing pathogen spread and minimizing damage. Although several IHNV detection assays have been developed, their analytical and diagnostic performances have not been evaluated and field usability assessments have not been completely validated. Here, we developed a reverse-transcription cross-priming amplification-based lateral flow assay (RT-CPA-LFA) and validated its diagnostic performance. To detect the IHNV, primers were designed based on the consensus sequence of the nucleocapsid (N) gene. Notably, when combined with a lateral flow dipstick, it could visualize the IHNV amplification products within 5 min and the detection limit of the developed RT-CPA-LFA was 3.28×105 copies/μL. The diagnostic sensitivity and specificity in fish samples (n =140) were 98.88 % and 96.08 %, respectively. Moreover, the IHNV detection rate by RT-CPA-LFA in dead rainbow trout artificially injected with the virus was 100 %, consistent with to the results obtained from second conventional and real-time PCR, indicating its applicability for rapid IHNV detection and presumptive IHN diagnosis during the endemic period. • Nucleocapsid gene-derived RT-CPA primers were designed for IHNV detection. • RT-CPA-LFA exhibited high diagnostic sensitivity (98.88 %) and specificity (96.08 %). • IHNV detection rates in dead fish using RT-CPA-LFA and other molecular assays were consistent. • RT-CPA-LFA is applicable during endemic periods. [ABSTRACT FROM AUTHOR]

Influenza A virus (IAV) is an important pathogen in Brazilian swine herds, and monitoring the viral circulation is essential to control and reduce the transmission. Surveillance programs for IAV are often based on individual piglets level sampling, making the evaluation of the available diagnostic tools crucial to assessing IAV circulation in herds. Thus, two sample collection methodologies were compared in pig herds in southern Brazil to detect IAV by RT-qPCR: nasal swab (NS) and nasal wipe (NW). A Bayesian latent class model (BLCM) was set for two tests and two populations. The NW and NS used are more specific (higher than 95 % for both) than sensitive. The sensitivity for NW was lower than the NS, 84.14 % (70 % – 95 %; posterior probability interval (PPI): 95 %) and 87.15 % (73 % – 97 %; PPI: 95 %), respectively, and the specificity was 95 % (90 % – 99 %; PPI: 95 %) and 99 % (96 % – 100 %; PPI: 95 %), respectively. Although the wipe sample collection loses both sensitivity and specificity compared with nasal swab, differences in test performance were very limited and PPIs largely overlapped. Therefore NW can also be considered a valuable tool. The decision about the use of both techniques should be based on the trade-off between their performance limitations and feasibility in routine monitoring. [ABSTRACT FROM AUTHOR]

• We describe an optimization procedure to define cut-offs of quantitative AChRAb assays. • Cut-offs were derived from healthy controls and other autoimmune diseases patients. • and diagnostic performance were examined using a representative cohort of MG patients. • Raw testing values were found as optimal quantitative measures of AChRAb levels. • Agreement between ELISA and RIA for AChRAb positivity were found good. • Quantitative values are more informative than positivity in association with clinical features. This study aims to establish an optimization procedure to define the cut-offs of quantitative assays for acetylcholine receptor antibody (AChRAb), evaluate their diagnostic performance in myasthenia gravis (MG), and explore the association with clinical features. Samples from a representative cohort of 77 MG patients, 80 healthy controls (HC) and 80 other autoimmune diseases (OAD) patients were tested using competitive inhibition ELISA and RIA. Raw values (OD and cpm) and processed values (inhibition rate, binding rate and concentration) were used to define the cut-offs with statistical methods, a rough method, and receiver operating characteristic (ROC) curve. Optimal cut-offs were selected by comparing false positive rates in HC and OAD individuals. The diagnostic performance was evaluated in whole MG cohort and subgroups. Agreement between ELISA and RIA for AChRAb positivity were examined with Kappa test and McNemar test. Clinical association with AChRAb was explored by comparison among subgroups and with Spearman rank correlation. The optimal cut-offs for AChRAb positivity were determined as OD ≤ 1.79 for ELISA and cpm ≥ 1234.12 for RIA, which derived from statistical method and performed better than those derived from ROC curves. The sensitivity and specificity were 74.03%, 100% for ELISA, and 74.03%, 99.37% for RIA. There was good agreement between ELISA and RIA for AChRAb positivity in whole cohort and subgroups (weighted к ≥ 0.71, p < 0.01; McNemar test, p > 0.05). Levels of AChRAb were different in MG subgroups (p < 0.01). Correlation between Quantitative Myasthenia Gravis scores and AChRAb levels was moderate for ELISA and RIA (r s = -0.60 and 0.57, p < 0.01). The raw testing values of ELISA and RIA were found as optimal quantitative measures of AChRAb levels. There are good agreements on diagnostic performance between two assays. Quantitative values are more informative than positivity in association with clinical features. [ABSTRACT FROM AUTHOR]

Breast cancer is the most common malignancy in women. Mammography and ultrasound are commonly used in a clinical environment as the first choice for breast cancer detection. Magnetic Resonance Imaging (MRI) has been reported to reveal additional information. In the following review MRI, Ultrasound (US) and Mammography (MM) are all compared in terms of their diagnostic performance on breast cancer detection, depending on tumor type, breast density and patient's history. Evaluating each modality alone, MRI provided an overall sensitivity and specificity of 94.6% (range 85.7%–100%) and 74.2% (range 25%–100%) respectively, while mammography showed that the overall sensitivity was at 54.5% (range 27%–86.8%) and specificity was 85.5% (range 62.9%–98.8%). The overall sensitivity and specificity of ultrasound was 67.2% (range 26.9%–87.5%) and 76.8% (range 18.8%–96.9%). When combining the results of all three techniques, it resulted in a sensitivity of 97.7% (range 95%–100%) and a specificity of 63.3% (range 37.1%–87.5%). In addition, contrast-enhanced mammography (CE-MM) and MRI (CE-MRI) illustrated an overall sensitivity and specificity for CE-MM was 90.5% (range 80.9%–100%) and 52.6% (range 15%–76.1%) and for CE-MRI, the overall sensitivity and specificity was 91.5% (range 89.1%–93.8%) and 64.7% (range 43.7%–85.7%). As modalities alone, the highest sensitivity has been observed for MRI and the lowest sensitivity for mammography regardless breast type, density, and history. Sensitivity is even more increased from the combination of US + MRI or MM + MRI or MRI + MM + US. The specificity seems to be affected by the size, type of the tumor and patient's history, however based on breast density, the highest specificity was observed by US alone. Breast cancer screening is of outmost importance and identifying the best technique will improve cancer management. Combining techniques increases diagnostic ability compared with using modalities alone. CE-MM can be a viable option in dense breast tissue when there are contraindications to MRI as it also has high sensitivity based on the type of breast cancer. [ABSTRACT FROM AUTHOR]

We evaluated the measurement feasibility and diagnostic ability of an ultrasound-guided attenuation parameter (UGAP) using a high-frequency convex transducer in children. This retrospective study included all consecutive children who underwent abdomen ultrasonography from July to December 2020. Attenuation coefficients (ACs) of the liver were measured using both 1- to 6-MHz (AC1-6) and 2- to 9-MHz (AC2-9) probes of the LOGIQ E10 system (GE Healthcare). t-Tests and Pearson's or partial correlation analyses were performed, and AC cutoff values for diagnosing fatty liver were obtained from receiver operating characteristic curve analyses. Finally, 118 patients (M:F = 83:35, mean age: 10.2 ± 4.1 y) were evaluated, and the measurement success rate was 98.3% (116/118) for AC2-9. AC1-6 was available in children with a liver depth greater than 9 cm. The ratio of interquartile range to median of the AC2-9 was lower than that of the AC1-6 (4.3 vs. 8.5, p < 0.001). In the normal group (n = 41), the AC2-9 values were not associated with age, sex or body mass index. For the evaluation of steatosis, the AC2-9 values exhibited a positive correlation with the MR fat fraction (coefficient = 0.498, p < 0.001). The cutoff value of 0.699 dB/cm/MHz had 90.2% sensitivity and 100% specificity for diagnosing fatty liver. In conclusion, measurements of ACs using a high-frequency convex transducer are feasible even in small children, with lower measurement variability. The AC2-9 values also had good diagnostic performance for pediatric fatty liver. [ABSTRACT FROM AUTHOR]

COVID-19 Reporting and Data System (CO-RADS) is a tool for standardizing the reports of patients with suspected or confirmed Sars-CoV-2 infection. We performed a study of the performance of the CO-RADS in a triage scenario of patients in Brazil. Data from 426 Computed Tomography (CT) scans from March 2020 through December 2020 were assessed in an ambidirectional, both retrospective and prospective, for the assessment in one of the six categories of the CO-RADS. We assessed sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLR) Youden's index, Positive and Negative Clinical Utility Index (UC + and UC− respectively) and diagnostic odds ratio (DOR). We also plotted Receiver Operating Characteristics (ROC) curve with Area Under the Curve (AUC) for CO-RADS of >4 (4 + 5). For CO-RADS classification > 4 (4 + 5) considered positive, the AUC obtained was of 0.89 (95% CI of 0.02), sensitivity of 78% (95% CI of 0.3), specificity of 91% (95% CI of 0.3), PPV of 0.92 (95% CI of 0.02), NPV of 0.41 (95% CI of 0.03), PLR of 0.85 (95% CI of 0.2), and NLR of 0.23 (95% CI of 0.02). CO-RADS demonstrated overall good diagnostic performance in stratifying patients with suspected Sars-CoV-2 infection, even those without confirmed laboratorial diagnosis, therefore being useful in a triage scenario with lack of resources. [ABSTRACT FROM AUTHOR]

• Polyester and FLOQSwabs perform in similar manner when testing for SARS-CoV-2. • Tests using nasal swabs by RT-PCR were more sensitive than tests using tongue swabs for SARS-CoV-2. • Self-collected nasal swabs are an accurate method for diagnosis of SARS-CoV-2. This study assesses and compares the performance of different swab types and specimen collection sites for SARS-CoV-2 testing, to reference standard real-time reverse transcriptase-polymerase chain reaction (RT-PCR) and viral culture. Symptomatic adults with COVID-19 who visited routine COVID-19 testing sites used spun polyester and FLOQSwabs to self-collect specimens from the anterior nares and tongue. We evaluated the self-collected specimen from anterior nares and tongue swabs for the nucleocapsid (N) or spike (S) antigen of SARS-CoV-2 by RT-PCR and then compared these results with results from RT-PCR and viral cultures from nurse-collected nasopharyngeal swabs. Diagnostic sensitivity was highest for RT-PCR testing conducted using specimens from the anterior nares collected on FLOQSwabs (84%; 95% CI 68-94%) and spun polyester swabs (82%; 95% CI 66-92%), compared to RT-PCR tests conducted using specimens from nasopharyngeal swabs. Relative to viral culture from nasopharyngeal swabs, diagnostic sensitivities were higher for RT-PCR and antigen testing of anterior nares swabs (91-100%) than that of tongue swabs (18-81%). Antigen testing of anterior nares swabs had higher sensitivities against viral culture (91%) than against nasopharyngeal RT-PCR (38-70%). All investigational tests had high specificity compared with nasopharyngeal RT-PCR. Spun polyester swabs are equally effective as FLOQSwabs for anterior nasal RT-PCR testing. We found that anterior nares specimens were more sensitive than tongue swab specimens or antigen testing for detecting SARS-CoV-2 by RT-PCR. Thus, self-collected anterior nares specimens may represent an alternative method for diagnostic SARS-CoV-2 testing in some settings. [ABSTRACT FROM AUTHOR]

Background: Computerized methodologies standardize the myocardial perfusion imaging (MPI) interpretation process. Methods: To develop an automated relative perfusion quantitation approach for 18F-flurpiridaz, PET MPI studies from all phase III trial participants of 18F-flurpiridaz were divided into 3 groups. Count distributions were obtained in N = 40 normal patients undergoing pharmacological or exercise stress. Then, N = 90 additional studies were selected in a derivation group. Following receiver operating characteristic curve analysis, various standard deviations below the mean normal were used as cutoffs for significant CAD, and interobserver variability determined. Finally, diagnostic performance was compared between blinded visual readers and blinded derivations of automated relative quantitation in the remaining N = 548 validation patients. Results: Both approaches yielded comparable accuracies for the detection of global CAD, reaching 71% and 72% by visual reads, and 72% and 68% by automated relative quantitation, when using CAD ≥ 70% or ≥ 50% stenosis for significance, respectively. Similar results were observed when analyzing individual coronary territories. In both pharmacological and exercise stress, automated relative quantitation demonstrated significantly more interobserver agreement than visual reads. Conclusions: Our automated method of 18F-flurpiridaz relative perfusion analysis provides a quantitative, objective, and highly reproducible assessment of PET MPI in normal and CAD subjects undergoing either pharmacological or exercise stress. [ABSTRACT FROM AUTHOR]

• KFLC can be determined in CSF samples by sensitive automated methods. • Several neuro-inflammatory conditions that can mimic MS were included as controls. • Most MS cases showed K index ≥ 7.25, including some cases with negative OCBs. • K index can provide valuable support to the analysis of OCB results. • Selecting samples for OCB detection can improve analytical workflow (K index ≥ 2.55) Automated, technically simple analytical methods offering objective results are highly valued in clinical laboratories. Kappa free light chains (KFLC) in cerebrospinal fluid (CSF) are promising multiple sclerosis (MS) biomarkers, particularly kappa (K) index. KFLC were determined in CSF and serum samples of patients diagnosed with MS, clinically/radiologically isolated syndrome (N, 39), and controls (N, 152; inflammatory and non-inflammatory neurological disorders). Diagnostic performance of several KFLC parameters, previously determined oligoclonal band (OCB) testing, and IgG index, was assessed. A K index decision threshold for sample screening was identified and reduction in performed OCB analyses estimated accordingly. Higher KFLC parameters were detected in the MS group and K index performed best among them (AUC 0.92). At a 7.25 cut-off it showed better sensitivity (85% vs. 77%) though less specificity (88% vs. 91%) than OCBs. Comparatively, IgG index's performance was inferior (AUC 0.83). A decision K index threshold of 2.55 (97% sensitivity) would reduce OCB testing by 52% in the studied population. The proposed 7.25 cut-off could assist MS diagnostics and identify some false negative cases from OCB studies. Sequential algorithms using K index for the decision to perform OCB detection would improve laboratory efficiency and substantially reduce costs. [ABSTRACT FROM AUTHOR]

Rationale and Objectives: Research on implementation of artificial intelligence (AI) in radiology workflows and its impact on reports remains scarce. In this study, we aim to assess if an AI platform would perform better than clinical radiology reports in evaluating noncontrast chest computed tomography (CT) scans.Materials and Methods: Consecutive patients who had undergone noncontrast chest CT were retrospectively identified. The radiology reports were reviewed in a binary fashion for reporting of pulmonary lesions, pulmonary emphysema, aortic dilatation, coronary artery calcifications (CAC), and vertebral compression fractures (VCF). CT scans were then processed using an AI platform. The reports' findings and the AI results were subsequently compared to a consensus read by two board-certificated radiologists as reference.Results: A total of 100 patients (mean age: 64.2 ± 14.8 years; 57% males) were included in this study. Aortic segmentation and calcium quantification failed to be processed by AI in 2 and 3 cases, respectively. AI showed superior diagnostic performance in identifying aortic dilatation (AI: sensitivity: 96.3%, specificity: 81.4%, AUC: 0.89) vs (Reports: sensitivity: 25.9%, specificity: 100%, AUC: 0.63), p <0.001; and CAC (AI: sensitivity: 89.8%, specificity: 100, AUC: 0.95) vs (Reports: sensitivity: 75.4%, specificity: 94.9%, AUC: 0.85), p = 0.005. Reports had better performance than AI in identifying pulmonary lesions (Reports: sensitivity: 97.6%, specificity: 100%, AUC: 0.99) vs (AI: sensitivity: 92.8%, specificity: 82.4%, AUC: 0.88), p = 0.024; and VCF (Reports: sensitivity:100%, specificity: 100%, AUC: 1.0) vs (AI: sensitivity: 100%, specificity: 63.7%, AUC: 0.82), p <0.001. A comparable diagnostic performance was noted in identifying pulmonary emphysema on AI (sensitivity: 80.6%, specificity: 66.7%. AUC: 0.74) and reports (sensitivity: 74.2%, specificity: 97.1%, AUC: 0.86), p = 0.064.Conclusion: Our results demonstrate that incorporating AI support platforms into radiology workflows can provide significant added value to clinical radiology reporting. [ABSTRACT FROM AUTHOR]

Rationale and Objectives: To provide updated information on the effect of clinical history on diagnostic image interpretation and to provide study methodology and design recommendations for future studies assessing the effect of clinical history on diagnostic image performance.Materials and Methods: A literature search of Medline, Embase, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases was conducted from database inception to July 21, 2020. Studies comparing diagnostic imaging performance with and without clinical history, using observers reading images under both conditions that used an independent reference standard were included.Results: Twenty-two studies met the inclusion criteria, with 15 showing clinical history improved diagnostic performance. One study reported a decrease in diagnostic performance with clinical history and the remaining six studies found no significant change in performance. Two studies used the free response paradigm with both reporting clinical history increased location sensitivity, decreased specificity and had no overall change in diagnostic performance. The disease spectrum of included cases was largely unreported and a balanced reading design was not used in 19 studies.Conclusion: Most published studies found that clinical history improved diagnostic performance. More recent studies accounting for abnormality location and multiple abnormalities showed an increase in false positives and no significant change in overall diagnostic performance with clinical history. [ABSTRACT FROM AUTHOR]

Objectives: The performance of ultrasound features from shear wave elastography (SWE) and high-frequency ultrasound imaging was evaluated independently and in combination to diagnose carpal tunnel syndrome (CTS).Materials and Methods: Twenty-five subjects were imaged in a sitting position with an arm extended and palm facing up. SWE of the medial nerve (MN) was acquired at the wrist level (site 1) and proximal to the pronator quadratus muscle (site 2). Cross-sectional area (CSA) and vascularity of the MN were assessed at the wrist using a 24 MHz probe. Color and power Doppler imaging (CDI and PDI), monochrome and color-coded Superb Microvascular Imaging (SMI) were performed for vascularity assessments. The diagnosis and severity of CTS was determined by clinical and electrodiagnostic tests. Diagnostic performance of the ultrasound features was assessed by t-tests, ANOVAs, and ROC analysis.Results: The study included 20 control hands and 27 hands with CTS. All ultrasound features except for the stiffness ratio were significantly different between the CTS and control wrists (p<0.04). The stiffness of MN at site 1 showed a higher accuracy than at site 2. The combination of CSA and MN stiffness from site 2 showed an overall accuracy of 95% with a specificity and sensitivity of 100% and 93%, respectively. The CSA, MN stiffness from site 2, and CDI combination improved the accuracy to 96% with specificity and sensitivity of 100% and 93%, respectively. However, no ultrasound features (independently or in combination) differentiated all stages of CTS severity.Conclusions: SWE with high-frequency ultrasound imaging showed potential for the diagnosis of CTS. [ABSTRACT FROM AUTHOR]

Recent guidelines suggest that biopsy may be omitted in some groups of patients with PI-RADS 3 lesions on mpMRI. In this study, we aimed to evaluate biopsy strategies involving prostate-specific antigen density (PSAd) to avoid unnecessary biopsy versus the risk of missing clinically significant prostate cancer (csPCa) in patients with PI-RADS 3 lesions. Data of 616 consecutive patients who underwent PSAd and mpMRI before prostate biopsy between January 2017 and January 2022 at a single center were retrospectively assessed. All of these patients underwent combined cognitive or fusion targeted biopsy of suspicious lesions and transrectal ultrasonography guided systematic biopsy. PI-RADS 3 based strategies with PSAd and mpMRI combination were created. For each strategy, avoided unnecessary biopsy, reduced ISUP Grade 1, and missed ISUP Grade ≥ 2 ratios were determined. Decision curve analysis (DCA) was used to statistically compare the net benefit of each strategy. DCA revealed that patients who had PI-RADS 3 lesions with PSAd ≥ 0.2, and/or patients who had PI-RADS 4 and 5 lesions had the most benefit, under the threshold probability level between 10% and 50%, which avoided 48.2% unnecessary prostate biopsies and reduced 51% of ISUP grade 1 cases, while missed 17.5% of ISUP grade ≥ 2 cases. (22.1% for ISUP grade 2 and 8.8% for ISUP grade ≥ 3). Strategy 1 (PI-RADS 4-5 and/or PSAd ≥ 0.2), 3 (PI-RADS 4-5 and/or PI-RADS 3 if PSAd ≥ 0.15), and 7 (PI-RADS 4-5 and/or PI-RADS 3 if PSAd ≥ 0.15 and/or PI-RADS 2 if PSAd ≥ 0.2) were the next three best strategies. mpMRI combined with PSAd strategies reduced biopsy attempts in PI-RADS 3 lesions. Using these strategies, the advantage of avoiding biopsy and the risk of missing the diagnosis of csPCa can be discussed with the patient, and the biopsy decision can be made afterwards. Although most studies focus on preventing unnecessary prostate biopsy, patients may not accept the rates of missing clinically significant prostate cancer and the associated clinical risks. Therefore, our risk-adapted strategies allow each patient and clinician to choose the most appropriate strategy for themselves. [ABSTRACT FROM AUTHOR]

To estimate the diagnostic value of magnetic resonance imaging (MRI)-based radiomic models in detecting the extramural venous invasion (EMVI) of rectal cancer. Appropriate studies in multiple electronic databases were systematically retrieved. The Quality Assessment of Diagnostic Accuracy Studies 2 and Radiomics Quality Score (RQS) were used to evaluate the eligible studies' methodology quality. Summary accuracy metrics were calculated, and the publication bias was detected using Deek's funnel plot. The sensitivity and meta-regression analysis were performed to investigate the causes of heterogeneity. For the seven eligible studies, which included 1175 patients, the pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio were 0.80 (95 % CI, 0.70–0.88), 0.89 (95 % CI, 0.84–0.92), 7.0 (95 % CI, 4.7, 10.4), 0.22 (95 % CI, 0.14, 0.34), and 32 (95 % CI, 16, 65), respectively. The area under the receiver operating characteristic curve (AUC) was 0.91 (95 % CI, 0.88, 0.93). Moderate heterogeneity was found due to I2 values of 38.63 % and 32.29 % in sensitivity and specificity, respectively. Meta-regression analysis suggested that the patient enrollment, number of patients, segmentation method, and RQS score were the source of the heterogeneity. The head-to-head analysis suggested that radiomics model had a higher sensitivity for detection of EMVI than subjective evaluation by radiologist (0.47 vs. 0.73, p ≤ 0.001). Our study suggests that MRI-based radiomic models have good diagnostic value in detecting EMVI for rectal cancer patients. Nevertheless, more prospective and high-quality studies with larger sample sizes are needed in the future to validate these results. • MRI-based radiomic models have good diagnostic value in detecting EMVI for rectal cancer patients • The heterogeneity among studies highlights the need for further studies to validate these results • The summary sensitivity and specificity of MRI-based radiomic models for detecting EMVI was 80% (70–88% 95% CI) and 89% (84–92%), respectively. [ABSTRACT FROM AUTHOR]

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/m2. 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. [ABSTRACT FROM AUTHOR]

Left ventricular assist devices (LVAD) are increasingly used for durable mechanical circulatory support in advanced heart failure. While LVAD therapy provides substantial improvement in mortality and quality of life, long-term therapy confers increased risk for device complications. We evaluated if cardiac computed tomography (CCT) improves the detection of cardiomechanical complications among patients with LVAD and suspected device malfunction. In this study, we compared the diagnostic performance of CCT and transthoracic echocardiography (TTE) for the identification of cardiomechanical LVAD complications, including thrombus or neointimal hyperplasia, inflow cannula malposition with dynamic obstruction, fixed outflow obstruction, device infection, and severe aortic regurgitation. Complications were confirmed with surgical evaluation, pathologic assessment, or response to therapeutic intervention. Among 58 LVAD patients, who underwent CCT and TTE for suspected LVAD dysfunction, there were 49 confirmed cardiomechanical LVAD complications among 43 (74.1%) patients. The most common LVAD complication was thrombus or neointimal hyperplasia (65.3%), followed by dynamic obstruction (26.5%). Individually, CCT identified 29 of the 49 (59.2%) confirmed LVAD cardiomechanical complications, whereas TTE alone identified a complication in 11 cases (22.4%). However, diagnostic performance was greatest when the two modalities were used in combination, yielding a sensitivity of 67%, specificity of 93%, PPV of 97%, NPV of 47% and diagnostic accuracy of 73%. The novel and complementary use of CCT with TTE for the evaluation of suspected device malfunction improves the accurate identification of cardiomechanical LVAD complication compared to either modality alone. [ABSTRACT FROM AUTHOR]

Malignant soft tissue tumors (STTs) are often mistaken for benign tumors, leading to inappropriate treatment including unplanned resection. Elastography, as a non-invasive measurement of tissue mechanical properties, makes use of the different soft tissue elasticity in diverse pathologies to generate information that can be used for diagnostic purposes. Elastography for STTs carries important information that is helpful in differentiating malignant and benign masses. The present study was undertaken to systematically review existing trials on the reliability of elastography in assessment of malignant STTs. A comprehensive literature exploration of the PubMed, EMbase and China National Knowledge Infrastructure databases was conducted for published articles involving the application of elastography in distinguishing malignant STTs. The diagnostic performance of elastography was evaluated with pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio and area under the summary receiver operating characteristic curve. Publication bias was also evaluated. This meta-analysis enrolled 18 eligible studies with a total of 1420 patients. The overall number of reported STTs was 1569, of which 478 were classified as positive and 1091 as negative at elastography. The pooled sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of elastography were 0.82 (95% confidence interval: 0.74-0.87), 0.80 (0.71-0.86), 3.99 (2.65-6.01) and 0.23 (0.15-0.34), respectively. The diagnostic odds ratio and area under the curve were 17.36 (8.28-36.38) and 0.88 (0.84-0.90), respectively (Glas et al. 2003). The results of meta-regression analysis revealed that the total number of patients and prevalence of malignant STTs were significant factors in sensitivity, and the year of publication, total number of patients and index test were significant factors affecting study heterogeneity for specificity (p < 0.05). No significant publication bias was observed. This meta-analysis indicates that ultrasound elastography achieves relatively good performance in discriminating between malignant and benign STTs. Nevertheless, further research is needed to verify this finding. [ABSTRACT FROM AUTHOR]

• Metagenomic next-generation sequencing (mNGS) improves sensitivity of Mycobacterium tuberculosis complex (MTBC) detection in bronchoalveolar lavage fluid (BALF). • MTBC detection by mNGS was affected by Vitamin D, erythrocyte sedimentation rate, TB retreatment and cavity in chest. • MTBC detection by mNGS was not affected by anti-TB therapy within 3 months. • mNGS presents potential clinical utility for the better diagnosis of coinfection. Metagenomic next-generation sequencing (mNGS) is an effective diagnostic method for infectious diseases, however, its clinical utility for tuberculosis (TB) diagnosis remains to be demonstrated. A total of 322 bronchoalveolar lavage fluid (BALF) samples were collected from 311 suspected and confirmed pulmonary TB patients and tested by mNGS, acid-fast bacillus (AFB) smear by microscopy, Xpert® MTB/RIF (Xpert), mycobacterium culture and bacterial/fungal culture. Diagnostic performance of mNGS was compared with conventional methods for detection of Mycobacterium tuberculosis complex (MTBC) and other pathogens in BALF. Underlying factors associated with positive detection in pulmonary TB patients were investigated. mNGS, Xpert and culture presented a high proportion of complete matching for MTBC detection (244/322, 75.8%). In pulmonary TB patients pre-treatment the sensitivity of MTBC detection by mNGS, Xpert, culture and smear was 59.9% (85/142), 69.0% (98/142), 59.9% (85/142) and 24.6% (35/142), respectively, and 79.6% overall; MTBC was detected by mNGS in 33.2% (5/34) Xpert and culture negative samples. Positive MTBC detection by mNGS was affected by Vitamin D, erythrocyte sedimentation rate, TB initial treatment/retreatment, and cavity in chest imaging (χ 2 = 37.42, P < 0.001), but not by prior anti-TB therapy within 3 months. mNGS was able to detect new potential pathogens in 8.7% (28/322) of samples. Combining mNGS with conventional detection methods could increase the detection rate for MTBC. Additionally, mNGS could identify pathogens in a non-targeted approach for better diagnosis of coinfection. [ABSTRACT FROM AUTHOR]

The aim of the work described here was to evaluate the diagnostic performance of ultrasound thyroid computer-aided diagnosis (CAD) software. This multicenter prospective study included 494 patients (565 thyroid nodules) who underwent surgery or biopsy after ultrasonography at four hospitals from January 2019 to September 2019. The diagnostic performance metrics of different readers were calculated and compared with the pathologic results. The sensitivity of CAD was outstanding and was equivalent to that of a senior radiologist (90.51% vs. 88.47%, p > 0.05). The area under the curve of CAD was equivalent to that of a junior radiologist (0.748 vs. 0.739, p > 0.05). However, the specificity was only 49.63%, which was lower than those of the three radiologists (75.56%, 85.93% and 90.37% for the junior, intermediate and senior radiologists, respectively). The diagnostic performance of the junior radiologist was significantly improved with the aid of CAD (junior + CAD). The sensitivity and area under the curve of junior + CAD were improved from 72.20% to 89.93% and from 0.739 to 0.816, respectively (both p values <0.05), and the positive predictive value, negative predictive value and κ coefficient improved from 76.3% to 78.6%, 82.0% to 86.8% and 0.394 to 0.511, respectively. Though specificity slightly decreased from 75.56% to 73.33%, the difference was not statistically significant (p > 0.05). In general, the clinical application value of CAD is promising, and its instrumental value for junior radiologists is significant. [ABSTRACT FROM AUTHOR]

Background Midupper arm circumference (MUAC) is used as an independent diagnostic tool to detect wasting in children aged 6–59 mo. However, little is known about the diagnostic performance of MUAC for detecting wasting among infants aged 1–6 mo. Objective The objective of this study was to evaluate the diagnostic performance of MUAC in detecting severe wasting in infants aged 1–6 mo. Methods We conducted a facility-based cross-sectional study among 467 hospitalized infants aged 1–6 mo in Ethiopia. Severe wasting was defined as having a weight for length z score (WLZ) below the cutoff value of −3 SDs from the median as per the WHO 2006 child growth standards. Receiver operating characteristic (ROC) analysis along with the calibration test was used to test the discriminatory performance of MUAC. Furthermore, we calculated the sensitivity, specificity, positive predictive value, and negative predictive value for the proposed optimal cutoffs. Results The median age, MUAC, and WLZ were 100 d (IQR: 69–145 d), 119 mm (IQR: 103–130 mm), and −1.27 (IQR: −2.66 to 0.34), respectively. The prevalence of severe and moderate wasting was n  = 101 (21.6%) and n  = 61 (13.0%), respectively. The MUAC area under the ROC curve accuracy level in identifying severe wasting was 0.86 (95% CI: 0.82, 0.89). The optimal MUAC cutoff of ≤112 mm yielded the highest Youden index of 0.61, with a sensitivity of 85.1% (95% CI: 76.7%, 91.4%) and a specificity of 76.0% (95% CI: 71.2%, 80.2%). Conclusions A MUAC cutoff of ≤112 mm performed well in detecting severe wasting among infants aged 1–6 mo. Further research is needed to evaluate the performance of MUAC for detecting wasting at community level and for predicting mortality among infants aged <6 mo. [ABSTRACT FROM AUTHOR]

Objectives: Cardiovascular disease is the leading cause of mortality and morbidity. Serial troponin tests have been endorsed as essential diagnostic steps to rule out/-in acute myocardial infarction (AMI), and hs-cTn assays have shown promise in enhancing the accuracy and efficiency of AMI diagnosis in the emergency department (ED).Methods: A systematic review and meta-analysis of diagnostic test accuracy studies were conducted to compare the diagnostic performance of various accelerated diagnostic algorithms of hs-cTn assays for patients with symptoms of AMI. Random-effects bivariate meta-analysis was conducted to estimate the summary sensitivity, specificity, likelihood ratios, and area under receiver operating characteristic curve.Results: In the systematic review consisting of 56 studies and 67,945 patients, both hs-cTnT and hs-cTnI-based 0-, 1-, 2- and 0-1 h algorithms showed a pooled sensitivity >90%. The hs-cTnI-based algorithm showed a pooled specificity >80%. The hs-cTnT-based algorithms had a specificity of 68% for the 0-h algorithm and of around 80% for the 1-, 2-, and 0-1 h algorithms. The heterogeneities of all diagnostic algorithms were mild (I2 < 50%).Conclusion: Both hs-cTnI- and hs-cTnT-based accelerated diagnostic algorithms have high sensitivities but moderate specificities for early diagnosis of AMI. Overall, hs-cTnI-based algorithms have slightly higher specificities in early diagnosis of AMI. For patients presenting ED with typical symptoms, the use of hs-cTnT or hs-cTnI assays at the 99th percentile may help identify patients with low risk for AMI and promote early discharge from the ED. [ABSTRACT FROM AUTHOR]

Rationale and Objectives: To determine the optimal keV for the visualization of gastric cancer and to investigate its value in depicting lesions and in identifying depth invasion using virtual monoenergetic images (VMIs) on a novel dual-layer spectral detector CT.Materials and Methods: Eighty-two gastric cancer patients were retrospectively enrolled, and 41 patients who did not undergo surgery were evaluated for image quality in VMIs at different keVs (40 keV-70 keV with 10 keV increments) and in conventional 120 kVp polyenergetic images (PEIs) reconstructed from the portal venous phase. Objective image quality was assessed by the contrast-to-noise ratio of the gastric cancer, while subjective performance was compared using a 5-point Likert scale. Another 41 patients who underwent surgery were examined to compare the diagnostic performance of the VMIs taken at the optimal keV and that of the 120 kVp-PEIs.Results: The contrast-to-noise ratio of gastric cancer at 40 keV (10.4 ± 4.6) was the highest among all the VMIs and was significantly superior to that of the 120 kVp-PEIs (3.5 ± 1.5, p < 0.001). Gastric-specific image quality was rated highest for the 40 keV-VMIs (4.92 ± 0.26), which was significantly superior to that of the 120 kVp-PEIs (4.15 ± 0.82, p < 0.001). In the diagnostic group, there were 13 pT1, 10 pT2, 9 pT3, and 9 pT4 gastric cancer patients. Compared with the 120 kVp-PEIs, the VMIs at 40 keV tended to have a higher detection rate of gastric cancer (82.9% vs. 92.7%, respectively, p = 0.125) and a significantly improved diagnostic accuracy in the T stage (from 41.5% to 78.11%, respectively) (p < 0.001), particularly in pT1 patients, whose diagnostic accuracy was improved by 53.8% (7.7% vs. 61.5%, respectively, p = 0.016).Conclusion: VMIs at 40 keV performed the best, both objectively and subjectively, for gastric cancer, leading to improved lesion depiction and higher T stage accuracy. [ABSTRACT FROM AUTHOR]

Epizootics of Koi herpesvirus (KHV) cause mass mortality in koi carp (Cyprinus rubrofuscus) and common carp (Cyprinus carpio) worldwide. Rapid and accurate virus detection technology is crucial for preventing pathogen spread and minimizing damage. Although several diagnostic assays have been developed for KHV, the analytical and diagnostic performance of the detection methods has not been evaluated. In this study, we developed and validated the diagnostic performance of two molecular diagnostic assays, cross-priming amplification-based lateral flow assay (CPA-LFA) and TaqMan probe-based real-time polymerase chain reaction (PCR). To detect KHV, primers and probe were designed based on the thymidine kinase (TK) genes. The detection limits of developed CPA-LFA and real-time PCR assays were determined to be 675.69 copies/μL and 8.384 copies/μL, respectively. The diagnostic sensitivity and specificity of the developed assay were determined using fish samples (n = 179). CPA-LFA was found to be 93.67% and 100%, respectively, and real-time PCR was found to be 100% and 100%, respectively. Therefore, the newly developed CPA-LFA and real-time PCR assays accurately and rapidly detect KHV. CPA-LFA is particularly suitable for point-of-care diagnosis because of its simple diagnostic process, and real-time PCR analysis is most suitable for precise diagnosis because it can detect low viral loads. • Developed and validated CPA-LFA and TaqMan probe real-time PCR for KHV detection. • Primers and probe designed from consensus sequence of enlarged TK genes in KHV Asian and European types. • Evaluation of the diagnostic sensitivity and specificity of the developed method obtained values higher than 95%. • The CPA-LFA and TaqMan probe real-time PCR facilitate the rapid and accurate detection of KHV. [ABSTRACT FROM AUTHOR]