scholarly journals Clinical evaluation of the molecular-based BD SARS-CoV-2/Flu for the BD MAX™ System

2021 ◽  
Author(s):  
Sonia Paradis ◽  
Elizabeth Lockamy ◽  
Charles K. Cooper ◽  
Stephen Young
Keyword(s):  
Differential Diagnosis ◽  
Clinical Evaluation ◽  
Diagnostic Performance ◽  
Multiplex Assay ◽  
Optimal Treatment ◽  
Acceptance Criteria ◽  
Percent Agreement ◽  
External Vendors

ABSTRACTEfficient and accurate assays for the differential diagnosis of COVID-19 and/or influenza (flu) could facilitate optimal treatment for both diseases. Diagnostic performance related to SARS-CoV-2 and Flu A/B detection was characterized for the BD SARS-CoV-2/Flu for BD MAX™ System (“MAX SARS-CoV-2/Flu”) multiplex assay in comparison with BD BioGx SARS-CoV-2 Reagents for BD MAX™ System (“BioGx SARS-CoV-2”) and the Cepheid Xpert® Xpress Flu/RSV (“Xpert Flu”). Two hundred and thirty-five nasopharyngeal specimens were obtained from external vendors. MAX SARS-CoV-2/Flu had positive percent agreement (PPA) and negative percent agreement (NPA) values for SARS-CoV-2 and Flu A/B that met FDA-EUA acceptance criteria of >95%.

Classifications and Clinical Assessment of Haemorrhoids:The Proctologist’s Corner

2020 ◽  
Vol 15 ◽  
Author(s):  
Arcangelo Picciariello ◽  
Petr Tsarkov ◽  
Vincenzo Papagni ◽  
Sergey Efetov ◽  
Daniel Markaryan ◽  
...  
Keyword(s):  
Differential Diagnosis ◽  
Clinical Evaluation ◽  
Clinical Assessment ◽  
Adult Population ◽  
Preoperative Assessment ◽  
Classification Systems ◽  
Patient Treatment ◽  
Benign Condition ◽  
Haemorrhoidal Disease ◽  
Therapeutic Choice

BACKGROUND: Haemorrhoidal disease (HD) is a benign condition affecting a considerable part of adult population. HD can be considered a social and economic burden with high impact on patient lifestyle. Several new techniques and devices have been proposed for HD treatment; however, preoperative assessment is essential and the use of classification system is recommended. METHODS: In the last two decades many studies described the preoperative assessment and several attempts of classification for HD. This review focuses on the most relevant studies found in literature where classification systems and clinical evaluation with differential diagnosis have been evaluated. RESULTS: The knowledge of classification systems and differential diagnosis for HD has been shown to play a central role in the clinical assessment and in the best treatment choice. Although there are new challenging techniques and devices for HD treatment, a preoperative assessment is always mandatory. CONCLUSION: Preoperative clinical evaluation is essential for HD patient treatment and outcome. Classification systems are useful for the therapeutic choice and for researches on new medical or surgical treatments. In fact, the international guidelines advise several therapeutic options depending on the severity of the HD.

scholarly journals Contrast-Enhanced Ultrasound in the Differential Diagnosis of Primary Thyroid Lymphoma and Nodular Hashimoto’s Thyroiditis in a Background of Heterogeneous Parenchyma

2021 ◽  
Vol 10 ◽  
Author(s):  
Lulu Yang ◽  
Haina Zhao ◽  
Yushuang He ◽  
Xianglan Zhu ◽  
Can Yue ◽  
...  
Keyword(s):  
Differential Diagnosis ◽  
Hashimoto’S Thyroiditis ◽  
Diagnostic Performance ◽  
Roc Curves ◽  
Hashimoto's Thyroiditis ◽  
Imaging Features ◽  
Contrast Enhanced Ultrasound ◽  
Thyroid Lymphoma ◽  
Contrast Enhanced ◽  
Primary Thyroid Lymphoma

ObjectiveTo investigate the diagnostic performance of contrast-enhanced ultrasound (CEUS) in the differentiation of primary thyroid lymphoma (PTL) and nodular Hashimoto’s thyroiditis (NHT) in patients with background of heterogeneous diffuse Hashimoto’s thyroiditis (HT).MethodsSixty HT patients with 64 thyroid nodules (31 PTL and 33 NHT) who had undergone CEUS examination were included in this study. With histopathological results as the reference, we evaluated the imaging features of each nodule on both conventional ultrasonography (US) and CEUS. Quantitative CEUS parameters including peak intensity (PI), time to peak (TTP), and area under the time–intensity curve (AUC) were gathered in the nodule and background parenchyma. The ratio indexes of theses parameters were calculated by the ratio of the lesion and the corresponding thyroid parenchyma. Logistic regression and receiver operating characteristic (ROC) curves analyses of valuable US indicators were further preformed to evaluate the diagnostic capability of CEUS in discrimination of PTL and NHT.ResultsAmong all the observed US imaging features and CEUS parameters, 10 indicators showed significant differences between PTL and NHT (all P < 0.05). All the significant indicators were ranked according to the odds ratios (ORs). Eight of them were CEUS associated including imaging features of enhancement pattern, degree, homogeneity, and quantification parameters of PI, AUC, ratios of PI, AUC, and TTP, while indicators on conventional US, including vascularity and size ranked the last two with ORs less than 3. The five single CEUS parameters showed good diagnostic performance in diagnosis of PTL with areas under ROC curves of 0.72–0.83 and accuracies of 70.3–75.0%. The combination of CEUS imaging features and the ratios of PI, AUC, and TTP demonstrated excellent diagnostic efficiency and achieved area under ROC curve of 0.92, which was significantly higher than any of the five single parameters (all P < 0.05), with a sensitivity of 83.9%, specificity of 87.9%, and accuracy of 85.9%.ConclusionsCEUS is an efficient diagnostic tool in the differential diagnosis of PTL and NHT for patients with diffuse HT. Conjoint analysis of CEUS imaging features and quantification parameters could improve the diagnostic values.

Differential diagnosis of parkinsonian degenerative disorders in combination manual measurements with automated volumetry of the brain

2020 ◽  
Author(s):  
Yiwei Zhang ◽  
Han Wang ◽  
Dan Xu ◽  
Bo Hou ◽  
Tianye Lin ◽  
...  
Keyword(s):  
Differential Diagnosis ◽  
Diagnostic Performance ◽  
Characteristic Curve ◽  
Brain Regions ◽  
Relative Volume ◽  
Intracranial Volume ◽  
Degenerative Disorders ◽  
Automated Measurements ◽  
Morphological Differences ◽  
The Brain

Abstract Background: To compare brain morphological differences in progressive supranuclear palsy (PSP), multiple system atrophy with the parkinsonian variant (MSA-P), Parkinson’s disease (PD) and controls by manual and automated measurements and to explore the feasibility of these measurements in disease differentiation.Methods: Ninety-five PSP patients (48 males, mean age 67.9 y), 32 MSA-P patients (18 males, mean age 63.0 y), 136 PD patients (72 males, mean age 66.6 y) and 100 controls (50 males, mean age 66 y) were included. The 12 manual measurements were acquired. Relative brain structural volumes adjusted according to the intracranial volume (ICV) of different brain regions werealsoquantified. Differences among and between groups were evaluated. Receiver operating characteristic curve analysis was used to assess diagnostic performance and define cutoff values of these measures.Results: P/M area 2.0displayed the highest diagnostic performance (AUC: 0.801) for distinguishing PSP from MSA-P or PD (sensitivity69.5%, specificity 82.1%). Furthermore, the combination of morphological features in manual parameters (P/M area 2.0, MRPI and M/P diameter) and volume atrophy in the midbrain improved the PSP discrimination (AUC: 0.870, sensitivity 76.8%, specificity 83.9%). The relative volume of the putamen can better differentiate MSA-P from PSP and PD (AUC: 0.844, sensitivity 81.3%, specificity 75.3%). Similarly, the ability to differentially diagnose MSA-P increased most significantly (AUC: 0.927, sensitivity 87.5%, specificity 87.9%) when combing volume atrophy in the putamen with the caudate and manual parameter (M/P diameter).Conclusion: Manual and automated MR variables can reveal atrophy features of the brain and be helpful in the differential diagnosis.

scholarly journals Performance and Clinical Evaluation of a Sensitive Multiplex Assay for the Rapid Detection of Common NPM1 Mutations

2010 ◽  
Vol 12 (5) ◽  
pp. 629-635 ◽  
Author(s):  
Michael Hafez ◽  
Fei Ye ◽  
Keith Jackson ◽  
Zhe Yang ◽  
Judith E. Karp ◽  
...  
Keyword(s):  
Clinical Evaluation ◽  
Rapid Detection ◽  
Multiplex Assay

scholarly journals Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2

2020 ◽  
Vol 58 (8) ◽  
Author(s):  
Wei Zhen ◽  
Elizabeth Smith ◽  
Ryhana Manji ◽  
Deborah Schron ◽  
Gregory J. Berry
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Drug Administration ◽  
Clinical Evaluation ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Molecular Diagnostic ◽  
Analytical Sensitivity ◽  
Reference Standard ◽  
Slight Improvement ◽  
Percent Agreement

ABSTRACT Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the globe. As part of the worldwide response, many molecular diagnostic platforms have been granted emergency use authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms (Cepheid Xpert Xpress SARS-CoV-2 [Xpert Xpress], Abbott ID NOW COVID-19 [ID NOW], and GenMark ePlex SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found that Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/ml), followed by ePlex (100% detection at 1,000 copies/ml), and ID NOW (20,000 copies/ml). Xpert Xpress also had highest positive percent agreement (PPA) compared to our reference standard (98.3%) followed by ePlex (91.4%) and ID NOW (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, ID NOW produced the lowest time to result per specimen (∼17 min) compared to Xpert Xpress (∼46 min) and ePlex (∼1.5 h), but what ID NOW gained in rapid results, it lost in analytical and clinical performance. ePlex had the longest time to results and showed a slight improvement in PPA over ID NOW. Information about the clinical and analytical performance of these assays, as well as workflow, will be critical in making informed and timely decisions on testing platforms.

Anal Fibroepithelial Polyp With Epithelial Vascular Pseudoinvasion

2020 ◽  
Vol 28 (7) ◽  
pp. 764-767
Author(s):  
Giovanni Fellegara ◽  
Nicoletta Di Mari
Keyword(s):  
Differential Diagnosis ◽  
Clinical Evaluation ◽  
Squamous Cell ◽  
Histological Evaluation ◽  
Fibroepithelial Polyp ◽  
Pathogenetic Mechanisms ◽  
First Case ◽  
Microscopic Evaluation

In this article, we report a case of anal fibroepithelial polyp with benign squamous cell vascular pseudoinvasion. The patient was a 38-year-old Caucasian man, who presented at our institution for recurrent episodes of anal discomfort. Clinical evaluation revealed the presence of 2 pedunculated anal polyps that were resected and submitted for histological evaluation. On microscopic evaluation, one of the polyps shows epithelial endovascular displacement associated with morphological signs of traumatism. The differential diagnosis and possible pathogenetic mechanisms explaining the presence of such findings are discussed. To the best of our knowledge, this is the first case reported of an anal fibroepithelial polyp with epithelial vascular pseudoinvasion.

scholarly journals P089: Does the use of ultrasound improve diagnosis during simulated trauma scenarios?

CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S108
Author(s):  
D. McLean ◽  
L. Hewitson ◽  
D. Lewis ◽  
J. Fraser ◽  
J. Mekwan ◽  
...  
Keyword(s):  
Differential Diagnosis ◽  
Diagnostic Performance ◽  
Statistical Tests ◽  
Correct Diagnosis ◽  
Primary Diagnosis ◽  
Point Of Care Ultrasound ◽  
Trauma Patients ◽  
Diagnostic Capabilities ◽  
Attending Physicians ◽  
The Impact

Introduction: Point of care ultrasound (US) is a key adjunct in the management of trauma patients, in the form of the extended focused assessment with sonography in trauma (E-FAST) scan. This study assessed the impact of adding an edus2 ultrasound simulator on the diagnostic capabilities of resident and attending physicians participating in simulated trauma scenarios. Methods: 12 residents and 20 attending physicians participated in 114 trauma simulations utilizing a Laerdal 3G mannequin. Participants generated a ranked differential diagnosis list after a standard assessment, and again after completing a simulated US scan for each scenario. We compared reports to determine if US improved diagnostic performance over a physical exam alone. Standard statistical tests (χ2 and Student t tests) were performed. The research team was independent of the edus2 designers. Results: Primary diagnosis improved significantly from 53 (46%) to 97 (85%) correct diagnoses with the addition of simulated US (χ2=37.7, 1df; p=<0.0001). Of the 61 scenarios where an incorrect top ranked diagnosis was given, 51 (84%) improved following US. Participants were assigned a score from 1 to 5 based on where the correct diagnosis was ranked, with a 5 indicating a correct primary diagnosis. Median scores significantly increased from 3.8 (IQR 3, 4.9) to 5 (IQR 4.7, 5; W=219, p<0.0001).Participants were significantly more confident in their diagnoses after using the US simulator, as shown by the increase in their mean confidence in the correct diagnosis from 53.1% (SD 22.8) to 83.5% (SD 19.1; t=9.0; p<0.0001)Additionally, participants significantly narrowed their differential diagnosis lists from an initial medium count of 3.5 (IQR 2.9, 4.4) possible diagnoses to 2.4 (IQR 1.9, 3; W=-378, p<0.0001) following US. The performance of residents was compared to that of attending physicians for each of the above analyses. No differences in performance were detected. Conclusion: This study showed that the addition of ultrasound to simulated trauma scenarios improved the diagnostic capabilities of resident and attending physicians. Specifically, participants improved in diagnostic accuracy, diagnostic confidence, and diagnostic precision. Additionally, we have shown that the edus2 simulator can be integrated into high fidelity simulation in a way that improves diagnostic performance.

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