scholarly journals NeuMoDx random access molecular diagnostic system for detection and quantification of hepatitis B virus in clinical samples

2020 ◽  
Vol 14 (10) ◽  
pp. 1197-1203
Author(s):  
Ayse Arikan ◽  
Murat Sayan ◽  
Osman Doluca
Keyword(s):  
Statistical Significance ◽  
Random Access ◽  
Absolute Error ◽  
Hbv Dna ◽  
Molecular Diagnostic ◽  
Clinical Samples ◽  
External Quality ◽  
Chi Square ◽  
Deming Regression ◽  
The Mean

Introduction: Currently, several molecular assays are available to detect and quantify HBV DNA in clinical samples. We aimed to characterize and compare the clinical performance of newly designed NeuMoDx PCR to the existing artus PCR. Methodology: The plasma HBV DNA levels of 96 clinical and 5 external quality control samples were measured by NeuMoDx and artus assays simultaneously in Kocaeli University, Turkey. The linearity, agreement and the correlation between two assays were determined by Deming regression analysis, Bland-Altman plotting, the chi-square and the relative absolute error statistical analyzes. For all statistical analyzes, the XLSTAT statistical program was used. Results: The mean (standard deviation; SD) age was 45.07 ± 12.29. HBsAg S/Co median (range) was 4,273.4 ± 1,138.1 and ALT U/L median (range) was 27 ± 16. The mean (SD) of HBV DNA was 1.46+E6 ± 1.0+E4 for NeuMoDx and 1.54+E5 ± 4.7 + E4 for artus assays. The Deming regression indicates a linear correlation (95% confidence). The chi-square test indicates strong correlation (p < 0.001). Bland-Altman analysis confirms that the measurement difference is acceptable. The relative absolute error analysis for artus showed relatively less and more consistent error rate. With 5 external quality check samples, the statistical significance was low (p = 0.566). Conclusions: The NeuMoDx HBV assay showed an excellent analytical performance by providing a rapid, high throughput technology in a random-access testing system in clinical samples and may be a new solution for viral load quantification in the management of HBV infections.

scholarly journals Agreement between Impression of Stroke in the Emergency Department and Diagnosis at the Neurology Department

2019 ◽  
Vol 7 (3) ◽  
pp. 7
Author(s):  
Samad Shams-Vahdati ◽  
Alireza Ala ◽  
Eliar Sadeghi-Hokmabad ◽  
Neda Parnianfard ◽  
Maedeh Gheybi ◽  
...  
Keyword(s):  
Emergency Department ◽  
Ischemic Stroke ◽  
Statistical Significance ◽  
Retrospective Chart Review ◽  
Chi Square ◽  
Prevention Therapy ◽  
Significant Difference ◽  
Chi Square Test ◽  
Academic Teaching Hospital ◽  
The Mean

Background: Missing to detect an ischemic stroke in the emergency department leads to miss acute interventions and treatment with secondary prevention therapy. Our study examined the diagnosis of stroke in the emergency department (ED) and neurology department of an academic teaching hospital. Methods and Materials: A retrospective chart review was performed from March 2017 to March 2018. ED medical document (chart) were reviewed by a stroke neurologist to collect the clinical diagnosis and characteristics of ischemic stroke patients. For determining the cases of misdiagnosed and over diagnosed data, the administrative data codes were compared with the chart adjudicated diagnosis. The adjusted estimate of effect was estimated through testing the significant variables in a multivariable model. The comparisons were done with chi square test. Statistical significance was considered at P < 0.05. Results: Of 861 patients of the study, 54% were males and 43% were females; and the mean age of them was 66.51 ± 15.70. We find no statically significant difference between patient’s Glasgow Coma Scale (GCS) in the emergency department (12.87±3.25) and patients GCS in the neurology department (11.77±5.15). There were 18 (2.2%) overdiagnosed of ischemic stroke, 8 (0.9%) misdiagnosed of ischemic stroke and 36 (4.1%) misdiagnosed of hemorrhagic strokes in the emergency department. Conclusion: There was no significant difference between impression of stroke in the emergency department and diagnosis at the neurology department.

scholarly journals Caregiver Burden and Disability in Somatoform Disorder: An Exploratory Study

2020 ◽  
pp. 025371762095756
Author(s):  
Esther Chinneimawi ◽  
Padmavathi Nagarajan ◽  
Vikas Menon
Keyword(s):  
Caregiver Burden ◽  
Somatoform Disorders ◽  
Statistical Significance ◽  
International Classification Of Diseases ◽  
Somatoform Disorder ◽  
Chi Square ◽  
Disability Score ◽  
Chi Square Test ◽  
The Mean ◽  
Student’S T

Background: Very few Indian studies have explored disability among patients with somatoform disorder and the burden experienced by their caregivers. We aimed to assess the levels of disability among patients with somatoform disorder and the levels of burden among their caregivers and compare these parameters against patients with schizophrenia. Methods: Participants included adults with a diagnosis of somatoform disorders (F45.0–F 45.9) ( n = 28) or schizophrenia (F20.0–F20.9) ( n = 28) diagnosed as per the International Classification of Diseases, Tenth Revision ( ICD-10), clinical descriptions, and diagnostic guidelines, as well as their caregivers. The WHO Disability Assessment Schedule 2.0 and Family Burden Interview Schedule were used to assess patient disability and caregiver burden, respectively. Independent Student’s t-test or chi-square test was used to compare relevant sociodemographic and clinical parameters. Results: Out of 56 patients, the mean (±SD) age of the sample was 38.6 (±10.5) years. Females constituted a slender majority of the sample ( n = 29, 51.8%). The mean disability score of patients with somatoform disorders was slightly higher (83.6 ±20.9) than that of patients with schizophrenia (82.3 ±16.7). Similarly, the mean burden score of caregivers of patients with somatoform disorders was nominally higher (18.96 ±9.9) than that of caregivers of patients with schizophrenia (15.7 ±9.7). Neither of these differences approached statistical significance (P > 0.05). Conclusion: Patients with somatoform disorders experience considerable levels of disability, and their caregivers go through various levels of burden in their daily life that is comparable to schizophrenia.

Five Year Analysis Assessing the Trend in Prescribing and Expenditures of Oral Oncolytics for Medicare Part D: 2013-2017

2021 ◽  
pp. 089719002110002
Author(s):  
Eric P. Borrelli ◽  
Conor G. McGladrigan
Keyword(s):  
Statistical Significance ◽  
Medicare Part D ◽  
Medicare Part ◽  
First Line ◽  
Chi Square ◽  
Part D ◽  
Medication Costs ◽  
The Mean ◽  
The Cost ◽  
Oral Oncolytics

Introduction: Oral oncolytics are becoming a mainstay in oncology, representing first-line therapies for numerous different malignancies. In addition, the cost of oncology drugs has increased dramatically in recent years. Given the increasing number of oral oncolytics available, as well as the increase in medication costs in recent years, it is important to assess the trend in prescriptions and expenditures of these agents. Methods: A descriptive retrospective analysis of the Medicare Part D Provider Utilization and Payment Data Public Use File (PUF) was conducted for the years 2013 through 2017. Outcomes of interest included total aggregate prescriptions per year, total aggregate expenditures per year, mean expenditure per prescription per year, and mean expenditure per standardized 30-day prescription per year. Chi-square tests were conducted to assess statistical significance of differences in proportions of prescriptions as well as expenditures between 2013 and 2017. Results: The number of prescriptions for oral oncolytics dispensed to Medicare Part D beneficiaries increased from 7,017,902 in 2013 to 8,164,883 in 2017. Medicare Part D expenditures for oral oncolytics increased greater than 2.5-fold from $5,631,224,307 in 2013 to $14,422,681,331 in 2017 after adjusting for inflation. The mean expenditure per prescription for oral oncolytics increased from $802 in 2013 to $1,766 in 2017. Conclusions: This study found oral oncolytic utilization has been increasing in recent years with a slight, but statistically significant increase in the proportion of oncolytics for all Medicare prescriptions from 2013 through 2017.

scholarly journals Multicenter comparison of the Cobas 6800 system with the RealStar RT-PCR kit for the detection of SARS-CoV-2

2020 ◽  
Author(s):  
Marc Wirden ◽  
Linda Feghoul ◽  
Mélanie Bertine ◽  
Marie-Laure Nere ◽  
Quentin Le Hingrat ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Linear Regression Analysis ◽  
Regression Line ◽  
Clinical Samples ◽  
Altman Analysis ◽  
Rt Pcr ◽  
Bland Altman Analysis ◽  
Deming Regression ◽  
The Mean ◽  
Pcr Assays

ABSTRACTBackgroundRT-PCR testing is crucial in the diagnostic of SARS-CoV-2 infection. The use of reliable and comparable PCR assays is a cornerstone to allow use of different PCR assays depending on the local equipment. In this work, we provide a comparison of the Cobas® (Roche) and the RealStar® assay (Altona).MethodsAssessment of the two assays was performed prospectively in three reference Parisians hospitals, using 170 clinical samples. They were tested with the Cobas® assay, selected to obtain a distribution of cycle threshold (Ct) as large as possible, and tested with the RealStar assay with three largely available extraction platforms: QIAsymphony (Qiagen), MagNAPure (Roche) and NucliSENS-easyMag (BioMérieux).ResultsOverall, the agreement (positive for at least one gene) was 76%. This rate differed considerably depending on the Cobas Ct values for gene E: below 35 (n = 91), the concordance was 99%. Regarding the positive Ct values, linear regression analysis showed a determination correlation (R2) of 0.88 and the Deming regression line revealed a strong correlation with a slope of 1.023 and an intercept of -3.9. Bland-Altman analysis showed that the mean difference (Cobas® minus RealStar®) was + 3.3 Ct, with a SD of + 2.3 Ct.ConclusionsIn this comparison, both RealStar® and Cobas® assays provided comparable qualitative results and a high correlation when both tests were positive. Discrepancies exist after 35 Ct and varied depending on the extraction system used for the RealStar® assay, probably due to a low viral load close to the detection limit of both assays.

scholarly journals Performances of NeuMoDx, a random-access system for HBV-DNA and HCV-RNA quantification

2020 ◽  
Author(s):  
Juliette Besombes ◽  
Charlotte Pronier ◽  
Charles Lefevre ◽  
Gisèle Lagathu ◽  
Anne Maillard ◽  
...  
Keyword(s):  
Internal Control ◽  
Random Access ◽  
Turnaround Time ◽  
Correlation Factor ◽  
Hbv Dna ◽  
Clinical Samples ◽  
Hcv Rna ◽  
Rna Quantification ◽  
Kappa Agreement ◽  
Serial Dilutions

AbstractViral loads (VL) monitoring for hepatitis B and C is essential to evaluate disease progression and treatment response. Automated, random-access rapid systems are becoming standard to provide reliable VL to clinicians. The aim of this study was to evaluate the analytical performances of the recently launched NeuMoDx™ for HBV-DNA and HCV-RNA quantification. Clinical samples routinely quantified on the Beckman-Veris system were either retrospectively (frozen samples; HBV n=178, HCV n=249), or in parallel (fresh primary tubes; HBV n=103, HCV n=124) tested using NeuMoDx™. Linearity range was assessed on serial dilutions of high tittered plasmas containing different genotypes for HBV (A-E, n=10) and HCV (1a-b, 2-5, n=12). Overall test failure, mostly internal control amplification failure, was 2.3% and was not influenced by matrix types. For HBV-VL, Kappa agreement was 74%, with 27 (12.6%) discrepancies. Correlation between HBV assays on 72 quantified samples by both methods was excellent (r=0.963) with a mean bias (NeuMoDx™-Veris) of 0.21 log IU/mL. For HCV-VL, Kappa agreement reached 94%, with 9 (2.8%) discrepancies. The r-correlation factor between assays on 104 samples was 0.960 with a mean bias of −0.14 log IU/mL (NeuMoDx™-Veris). Serial dilutions confirmed the claimed linear ranges for all HBV and HCV genotypes. The mean turnaround time was 72’ [55-101] for HBV and 96’ [78-133] for HCV. These results obtained on the NeuMoDx™ confirmed the overall good functionality of the system with a short turn-around-time, full traceability and easy handling. These results on HBV- and HCV-VL look promising and should be challenged with further comparisons.

scholarly journals Targeting CD33 for acute myeloid leukemia therapy

BMC Cancer ◽  
2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Jingjing Liu ◽  
Jiayin Tong ◽  
Haiping Yang
Keyword(s):  
Cox Regression ◽  
De Novo ◽  
Statistical Significance ◽  
Univariate Analysis ◽  
Normal Karyotype ◽  
Mean Value ◽  
High Ratio ◽  
Chi Square ◽  
Npm1 Mutation ◽  
The Mean

Abstract Background The aim of this study was to analyze the level of CD33 expression in patients with newly diagnosed AML and determine its correlation with clinical characteristics. Methods Samples were collected for analysis from AML patients at diagnosis. We evaluated the level of CD33 expression by flow cytometry analysis of bone marrow. Chi-square or t- tests were used to assess the association between the high and low CD33 expression groups. Survival curves were generated by the Kaplan-Meier and Cox regression model method. Results In this study we evaluated the level of CD33 expression in de novo patients diagnosed from November 2013 until January 2019. The mean value of 73.4% was used as the cutoff for the two groups. Statistical analysis revealed that 53 of the 86 (61.2%) AML patients were above the mean. Although there was no statistical significance between CD33 expression level and gene mutation, FLT3 mutation (P = 0.002) and NPM1 mutation (P = 0.001) were more likely to be seen in the high CD33 group. The overall survival (OS) was worse in the high CD33 group (39.0 m vs. 16.7 m, x2 = 13.06, P < 0.001). The Cox survival regression display that the CD33 is independent prognostic marker (HR =0.233,p = 0.008). Univariate analysis showed that the high expression of CD33 was an unfavorable prognostic factor. Of the 86 patients, CD33-high was closely related to the patients with normal karyotype (x2 = 4.891,P = 0.027), high white blood cell count (WBC, t = 2.804, P = 0.007), and a high ratio of primitive cells (t = 2.851, P = 0.005). Conclusions These findings provide a strong rationale for targeting CD33 in combination with chemotherapy, which can be considered a promising therapeutic strategy for AML.

scholarly journals Retrospective Analysis on Inferior Third Molar Position by Means of Orthopantomography or CBCT: Periapical Band-Like Radiolucent Sign

2021 ◽  
Vol 11 (14) ◽  
pp. 6389
Author(s):  
Young-Sam Kim ◽  
Young-Min Park ◽  
Saverio Cosola ◽  
Abanob Riad ◽  
Enrica Giammarinaro ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Third Molar ◽  
Cortical Plate ◽  
Third Molar Surgery ◽  
Chi Square ◽  
Dental Clinics ◽  
Tooth Roots ◽  
Root Position ◽  
Chi Square Test ◽  
The Mean

Background: Orthopantomography (OPG) is usually used as a primary diagnostic radiological exam in the planning of third molar surgery because it is deeply available in dental clinics and has lower radiation doses compared to Cone-beam computed tomography (CBCT). The OPG provides a bi-dimensional image, but several radiological signs have been proposed to study the position of the lower third molar and to predict surgical risks. Methods: Patients were divided into two groups, the OPG with a radiolucent area (D-group) and the OPG without any sign (C-group) in correspondence of inferior wisdom tooth roots. Results: The mean distance between the inferior third molar root and the lingual cortical mandibular bone was −1.09 ± 1.5 mm. The nearness of the root that is less than 1 mm was more frequent in the D-group (84.85%) compared to the C-group (14.58%) with statistical significance (Odd ratio: 32.8) using the Chi-square test. Conclusions: When the root of the impacted inferior third molar is impacted into the lingual cortical plate, a periapical band-like radiolucent sign may appear in the OPG image. It could be useful for the prediction of root position and surgical risks.

scholarly journals Targeting CD33 for Acute Myeloid Leukemia Therapy

2021 ◽  
Author(s):  
Jing jing liu ◽  
Jia Yin Tong ◽  
Hai Ping Yang
Keyword(s):  
De Novo ◽  
Statistical Significance ◽  
Normal Karyotype ◽  
Mean Value ◽  
High Ratio ◽  
Categorical Variables ◽  
Chi Square ◽  
Npm1 Mutation ◽  
Kaplan Meier ◽  
The Mean

Abstract Objective The aim of this study was to analyze the level of CD33 expression in patients with newly diagnosed AML and determine its correlation with clinical characteristics. Methods: Samples were collected for analysis from AML patients at diagnosis. We evaluated the level of CD33 expression by flow cytometry analysis of bone marrow. Chi-square or t- tests were used to assess the association of categorical variables between the high and low CD33 expression groups. Spearman’s rho was applied when appropriate. Survival curves were generated by the Kaplan–Meier method. Results ① In this study we evaluated the level of CD33 expression in de novo patients diagnosed from November 2013 until January 2019. The mean value of 73.4% was used as the cutoff for the two groups. Statistical analysis revealed that 53 of the 86 (61.2%) AML patients were above the mean.② Although there was no statistical significance between CD33 expression level and gene mutation, FLT3 mutation (P=0.002) and NPM1 mutation (P༝0.001)were more likely to be seen in the high CD33 group. ③ The overall survival (OS) was worse in the high CD33 group (39.0 m vs. 16.7 m, x2 = 7.385, P = 0.007). Multivariate analysis showed that the high expression of CD33 was an unfavorable prognostic factor. ④ Of the 86 patients, CD33-high was closely related to the patients with normal karyotype (x2 = 4.891,P = 0.027), high white blood cell count (WBC, t = 2.804, P = 0.007), and a high ratio of primitive cells (t = 2.851, P = 0.005). Conclusions These findings provide a strong rationale for targeting CD33 in combination with chemotherapy, which can be considered a promising therapeutic strategy for AML.

scholarly journals Association of Electrolyte Changes and Inflammatory Markers with Renal Involvement in Children with Febrile UTI

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Farshid Kompani ◽  
Leila Barati ◽  
Maryam Moghadam Samba
Keyword(s):  
Statistical Significance ◽  
Renal Involvement ◽  
Laboratory Data ◽  
Urine Specific Gravity ◽  
Positive Finding ◽  
Chi Square ◽  
Significance Level ◽  
Febrile Uti ◽  
Dmsa Scan ◽  
The Mean

Background: We need some simpler, cheaper, and less burdensome tools to investigate the severity of renal parenchymal involvement in children with clinical pyelonephritis. Objectives: The present study was designed to investigate the relationship between electrolyte changes with renal involvement as documented by dimercaptosuccinic acid (DMSA) scan in children with febrile urinary tract infection (UTI). Methods: This is a retrospective cohort study, involving 158 children aged two months to 14 years with febrile UTI admitted to Taleghani Hospital in Gorgan from 2018 to 2019. Their documents in hospital were analyzed. They were divided into two groups with positive or negative defects on DMSA scan. Clinical and laboratory data were studied. Statistical analysis was performed using SPSS version 18. Data were analyzed using independent t-test with normal distribution of variables, otherwise chi-square test was used. The statistical significance level of the study was considered 0.05. Results: Among the 158 children, 78 patients (49.4%) had normal DMSA scan results, and 80 patients (50.6%) had an abnormal result. The mean age in month was not different between the two groups. In patients with positive renal cortical defects on DMSA Scintigraphy (group 2), ESR was significantly higher than the first group (P < 0.05). The mean serum Na level in the second group was lower than in the first group; however, it was only slightly significant (P = 0.058). The two groups showed no difference with respect to serum potassium, urine specific gravity (SG), WBC count, and the duration of fever (P > 0.05). The frequency distribution of proteinuria was not different between the two groups (P = 0.836). Conclusions: We suggest that increased ESR, positive CRP, and the presence of reflux can predict renal parenchymal involvement in children with febrile UTI as evidenced by a positive finding on DMSA scan, and the presence of hyponatremia has a little predictive value in this regard.

Characteristics of a high-risk minority population

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21141-21141
Author(s):  
N. Jooma ◽  
R. Elledge ◽  
K. Sexton ◽  
M. Kalidas ◽  
M. Rimawi ◽  
...  
Keyword(s):  
Molecular Mechanisms ◽  
Statistical Significance ◽  
Menopausal Status ◽  
Patient Characteristics ◽  
Minority Population ◽  
Breast Cancers ◽  
Breast Cancer Patients ◽  
Chi Square ◽  
Her 2 ◽  
The Mean

21141 Background: Black and Hispanic breast cancer patients have a worse outcome when compared to Caucasians. This could be due to socioeconomic, cultural or biologic factors. We hypothesized that host and tumor biologic characteristics associated with a poor outcome may be found more often in minority women. Methods: Race/ethnicity, menopausal status, tumor histological features, and patient characteristics including age and body mass index (BMI) were reviewed from a prospective neoadjuvant trial of docetaxel vs. doxorubicin/cyclophosphamide at Baylor College of Medicine Breast Center, from September 2002 to September 2006. The data were analyzed using Chi-square and Fisher's exact tests, while the Kruskal-Wallis method was used to analyze BMI. Results: Of the 167 patients, 63% (n=105) were Caucasian, 15% (n=26) were Hispanic and 22% (n=36) were Black. The mean age was 47.6 years (range: 30–72). Fifty-nine percent were premenopausal. Overall, mean BMI was 29, with Caucasians having a mean BMI of 27.5, Hispanics with 29.8 and Blacks with a BMI of 34.6 (P<0.001). Sixty-five percent of the Caucasians and 58% of Hispanics were ER+ or PR+ versus 44% of Blacks (P=0.09). Sixteen percent of Caucasians were HER-2 positive compared to 4% of Hispanics and 9% of Blacks (p=0.25). In addition, 22% of Caucasians and 38% of Hispanics were ER-, PR-, HER-2- compared to 50% of tumors from Blacks (p=0.007). There was a trend linking BMI and triple negative status in breast cancers, which did not achieve statistical significance (p=0.21). Conclusion: In this study we found that black and Hispanic women were more likely to be obese and have ER-, PR-, HER-2- tumor phenotypes, both of which have been associated with poorer outcomes. Ongoing studies are being performed to elucidate the link between clinical and biological characteristics and understand the underlying molecular mechanisms associated with these findings. No significant financial relationships to disclose.

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