Comparison of the NeuMoDX, Diasorin Simplexa, Cepheid and Roche CDC SARS-CoV 2 EUA assays using nasopharyngeal/nasal swabs in universal transport media (UTM) and sputum and tracheal aspirates

2020 ◽  
Author(s):  
Robert Tibbetts ◽  
Kathy Callahan ◽  
Kareem Rofoo ◽  
Richard J. Zarbo ◽  
Linoj Samuel
Keyword(s):  
The United States ◽  
World Health ◽  
Molecular Testing ◽  
Additional Specimen ◽  
Significant Difference ◽  
Nasal Swabs ◽  
Henry Ford ◽  
United States Food ◽  
Health Organization ◽  
Tracheal Aspirates

AbstractIn March 2019 the outbreak of SARS-CoV 2 was officially defined as a pandemic by the World Health Organization and shortly after, the United States Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the Centers for Disease Control (CDC) for reverse transcription polymerase chain reaction (rtPCR) molecular testing for the detection of the SARS-CoV-2 virus from NP swabs. Since then, EUA with relaxed regulations were granted to numerous manufacturers and clinical microbiology laboratories to implement in-house testing assays with nasopharyngeal swabs (NP) and subsequently additional specimen types. Because of supply chain shortages leading to competition for reagents, sustaining any significant volume of testing soon became problematic. As a countermeasure, within several weeks the Henry Ford Microbiology Laboratory validated 4 different rtPCR assays and multiple specimen types using NeuMoDX, Diasorin Simplexa, Cepheid and Roche platforms. The purpose of this study was to analyze the analytic sensitivity of these rtPCR assays with NP/nasal swabs and sputum/tracheal aspirates. Qualitative analytic agreement between the 4 platforms for NP/nasal swabs ranged 95% - 100% overall with no statistically significant difference in threshold cT values. Similar results were obtained with the sputum/tracheal aspirates. These data demonstrate the high accuracy and reproducibility in detection of SARS-CoV 2 between the rtPCR assays performed on 4 different platforms with numerous specimen types.

scholarly journals Review of Quality Deficiencies Found in Active Pharmaceutical Ingredient Master Files Submitted to the WHO Prequalification of Medicines Programme

2014 ◽  
Vol 17 (2) ◽  
pp. 169 ◽  
Author(s):  
Isabel Ortega Diego ◽  
Antony Fake ◽  
Matthias Stahl ◽  
Lembit Rägo
Keyword(s):  
Technical Assistance ◽  
Active Pharmaceutical Ingredient ◽  
The United States ◽  
World Health ◽  
European Medicines Agency ◽  
United States Food ◽  
Materials Used ◽  
The Stability ◽  
Health Organization ◽  
Over Time

Purpose. The aim of this work was to determine the number and type of active pharmaceutical ingredient (API) quality deficiencies in API Master Files (APIMFs) as submitted to the World Health Organization (WHO) Prequalification of Medicines Programme (PQP). Methods. We conducted a retrospective review of API quality deficiencies identified following the assessment of new APIMFs for non-sterile APIs during a 6-year period from 1 January 2007 to 31 December 2012. All deficiencies were collected, classified and quantified according to the Common Technical Document (CTD) sections and subsections and as groups of commonly raised questions. Results. There were 5446 deficiencies collected from 159 APIMF deficiency letters by CTD section, by selected CTD subsections and by selected CTD subsections and year. More than 50% of the total number of deficiencies related to the manufacturing sections of the CTD, followed by deficiencies concerning the impurities, the API specification and the stability sections of the CTD.  A pattern of API deficiencies across the different CTD subsections and over time was identified. Conclusions. The most frequent critical deficiencies were related to how the specific manufacturing process and the key materials used, in particular the API starting material, impact the API impurities content. The number and pattern of APIMF deficiencies did not change over time. The results are compared to the findings in similar studies as reported by the United States Food and Drug Administration (USFDA), the European Directorate for the Quality of Medicines (EDQM) and the European Medicines Agency (EMA) and similarities and differences are discussed. Our findings highlight the need for greater guidance and technical assistance for API manufacturers submitting APIMFs to the PQP. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Antibiotic Resistance of Escherichia coli Isolated from Conventional, No Antibiotics, and Humane Family Owned Retail Broiler Chicken Meat

Animals ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. 2217
Author(s):  
Helen M. Sanchez ◽  
Victoria A. Whitener ◽  
Vanessa Thulsiraj ◽  
Alicia Amundson ◽  
Carolyn Collins ◽  
...  
Keyword(s):  
United States ◽  
Antibiotic Resistance ◽  
Los Angeles ◽  
The United States ◽  
World Health ◽  
United States Department ◽  
E Coli ◽  
Significant Difference ◽  
Potential Strategy ◽  
Health Organization

The use of antibiotics for therapeutic and especially non-therapeutic purposes in livestock farms promotes the development of antibiotic resistance in previously susceptible bacteria through selective pressure. In this work, we examined E. coli isolates using the standard Kirby-Bauer disk diffusion susceptibility protocol and the CLSI standards. Companies selling retail chicken products in Los Angeles, California were grouped into three production groupings—Conventional, No Antibiotics, and Humane Family Owned. Humane Family Owned is not a federally regulated category in the United States, but shows the reader that the chicken is incubated, hatched, raised, slaughtered, and packaged by one party, ensuring that the use of antibiotics in the entire production of the chicken is known and understood. We then examined the antibiotic resistance of the E. coli isolates (n = 325) by exposing them to seven common antibiotics, and resistance was seen to two of the antibiotics, ampicillin and erythromycin. As has been shown previously, it was found that for both ampicillin and erythromycin, there was no significant difference (p > 0.05) between Conventional and USDA (United States Department of Agriculture)-certified No Antibiotics chicken. Unique to this work, we additionally found that Humane Family Owned chicken had fewer (p ≤ 0.05) antibiotic-resistant E. coli isolates than both of the previous. Although not considered directly clinically relevant, we chose to test erythromycin because of its ecological significance to the environmental antibiotic resistome, which is not generally done. To our knowledge, Humane Family Owned consumer chicken has not previously been studied for its antibiotic resistance. This work contributes to a better understanding of a potential strategy of chicken production for the overall benefit of human health, giving evidentiary support to the One Health approach implemented by the World Health Organization.

Household and Population-Level Behavioural Changes Due to COVID-19 Pandemic: A Smart Thermostat Based Comparative Data Analysis

2021 ◽  
Vol 10 (1) ◽  
pp. 1-6
Author(s):  
Kirti Sundar Sahu ◽  
Arlene Oetomo ◽  
Niloofar Jalali ◽  
Plinio P. Morita
Keyword(s):  
Data Analysis ◽  
Population Level ◽  
World Health ◽  
Motion Sensors ◽  
Household Level ◽  
Work From Home ◽  
Significant Difference ◽  
Health Organization ◽  
Smart Thermostat ◽  
The Impact

The World Health Organization declared the coronavirus outbreak as a pandemic on March 11, 2020. To inhibit the spread of COVID-19, governments around the globe, including Canada, have implemented physical distancing and lockdown measures, including a work-from-home policy. Canada in 2020 has developed a 24-Hour Movement Guideline for all ages laying guidance on the ideal amount of physical activity, sedentary behaviour, and sleep (PASS) for an individual in a day. The purpose of this study was to investigate changes on the household and population-level in lifestyle behaviours (PASS) and time spent indoors at the household level, following the implementation of physical distancing protocols and stay-at-home guidelines. For this study, we used 2019 and 2020 data from ecobee, a Canadian smart Wi-Fi thermostat company, through the Donate Your Data (DYD) program. Using motion sensors data, we quantified the amount of sleep by using the absence of movement, and similarly, increased sensor activation to show a longer duration of household occupancy. The key findings of this study were; during the COVID-19 pandemic, overall household-level activity increased significantly compared to pre-pandemic times, there was no significant difference between household-level behaviours between weekdays and weekends during the pandemic, average sleep duration has not changed, but the pattern of sleep behaviour significantly changed, specifically, bedtime and wake up time delayed, indoor time spent has been increased and outdoor time significantly reduced. Our data analysis shows the feasibility of using big data to monitor the impact of the COVID-19 pandemic on the household and population-level behaviours and patterns of change.

scholarly journals Secular Trends of Underweight, Overweight, and Obesity in Children and Adolescents from Ukraine

2021 ◽  
Vol 18 (6) ◽  
pp. 3302
Author(s):  
Katarzyna Dereń ◽  
Justyna Wyszyńska ◽  
Serhiy Nyankovskyy ◽  
Olena Nyankovska ◽  
Marta Yatsula ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Age Groups ◽  
Overweight And Obesity ◽  
The Body ◽  
World Health ◽  
Public Health Issue ◽  
Significant Difference ◽  
Significant Public Health ◽  
Health Organization ◽  
Obesity In Children

Overweight and obesity, as well as underweight in children and adolescents, pose a significant public health issue. This study aimed to investigate the secular trend of the incidence of underweight, overweight, and obesity in children from Ukraine in 2013/2014 and 2018/2019. The studies were conducted in randomly selected primary and secondary schools in Ukraine. In total, 13,447 children (6468 boys and 6979 girls) participated in the study in 2013/2014 and 18,144 children (8717 boys and 9427 girls) participated in 2018/2019. Measurements of body weight and height were performed in triplicate. Underweight, overweight, and obesity were diagnosed according to the standards of the World Health Organization (WHO). In the group of girls, a significant difference between 2013/2014 and 2018/2019 measurements was found only among 7-year-olds. The percentage of girls at this age exceeding the body mass index (BMI) norm was lower in the 2018/2019 study. In boys, a significant difference was also found in 7-year-olds, and, as in girls, a lower share of overweight and obesity was found in 2018/2019. But for the ages of 12, 13, and 15, the significant differences had a different character—more overweight or obese boys were found in the 2018/2019 study. The proportion of underweight children was similar for the majority of age groups in both genders and did not differ in a statistically significant way.

scholarly journals Malaria continues to select for sickle cell trait in Central Africa

2015 ◽  
Vol 112 (22) ◽  
pp. 7051-7054 ◽  
Author(s):  
Eric Elguero ◽  
Lucrèce M. Délicat-Loembet ◽  
Virginie Rougeron ◽  
Céline Arnathau ◽  
Benjamin Roche ◽  
...  
Keyword(s):  
Sickle Cell ◽  
Sickle Cell Trait ◽  
Genetic Disorder ◽  
Central Africa ◽  
The United States ◽  
Malaria Prevalence ◽  
Current Data ◽  
World Health ◽  
Human Populations ◽  
Health Organization

Sickle cell disease (SCD) is a genetic disorder that poses a serious health threat in tropical Africa, which the World Health Organization has declared a public health priority. Its persistence in human populations has been attributed to the resistance it provides to Plasmodium falciparum malaria in its heterozygous state, called sickle cell trait (SCT). Because of migration, SCT is becoming common outside tropical countries: It is now the most important genetic disorder in France, affecting one birth for every 2,400, and one of the most common in the United States. We assess the strength of the association between SCT and malaria, using current data for both SCT and malaria infections. A total of 3,959 blood samples from 195 villages distributed over the entire Republic of Gabon were analyzed. Hemoglobin variants were identified by using HPLCy (HPLC). Infections by three species of Plasmodium were detected by PCR followed by sequencing of a 201-bp fragment of cytochrome b. An increase of 10% in P. falciparum malaria prevalence is associated with an increase by 4.3% of SCT carriers. An increase of 10 y of age is associated with an increase by 5.5% of SCT carriers. Sex is not associated with SCT. These strong associations show that malaria remains a selective factor in current human populations, despite the progress of medicine and the actions undertaken to fight this disease. Our results provide evidence that evolution is still present in humans, although this is sometimes questioned by scientific, political, or religious personalities.

PUBLIC HEALTH, NURSING AND MEDICAL SOCIAL WORK

PEDIATRICS ◽  
1951 ◽  
Vol 8 (4) ◽  
pp. 570-572
Keyword(s):  
Premature Infants ◽  
The United States ◽  
World Health ◽  
Multiple Birth ◽  
Expert Committee ◽  
Medical Social Work ◽  
Incidence And Mortality ◽  
Health Nursing ◽  
Health Organization ◽  
Intrinsic Variable

IN THE summary of the report of the Expert Committee on Prematurity of the World Health Organization, published in this column in February 1951, Dr. Ethel Dunham indicated the concern of the Expert Committee in regard to uniformity of information on the incidence and mortality of prematurity. The need for uniformity is particularly urgent in a field where there are so many intrinsic variable factors. It has been shown time and again that the ability of a premature infant to survive, under the best of care, is closely correlated with the birth weight, which in itself reflects the stage of maturity. In turn, the stage of maturity at a given weight is affected by sex, race, and whether the child is a single or one of a multiple birth. Uniformly, at a particular stage of maturity, male infants are larger than female, single births are larger than multiple births and, in the United States, white babies are larger than Negro babies. These considerations underline the danger of misinterpretation of so-called over-all rates for the incidence of prematurity and for the mortality of premature infants. For example, at any given weight, Negro premature infants are probably more mature and consequently have a better chance of surviving.

The Ethics of COVID-19 Vaccine Passports

2021 ◽  
Vol 46 (4) ◽  
pp. 1-2
Author(s):  
Joseph Meaney ◽  
Keyword(s):  
United States ◽  
World Health Organization ◽  
The United States ◽  
Scientific Data ◽  
World Health ◽  
Medical Decisions ◽  
The Poor ◽  
Divided Society ◽  
The World ◽  
Health Organization

COVID-19 vaccine passports run the risk of creating a divided society where social privileges or restrictions based on “fitness” lead to discrimination based on immunization status. Individuals have a strong right to be free of coercion to take a COVID-19 vaccine, and we should be very leery of further invasion of private medical decisions. These concerns are shared both internationally and in the United States, and the World Health Organization, the Biden administration, and many US governors oppose COVID-19 vaccine credentials. In addition, regulations for COVID-19 vaccine credentials face practical barriers, including lack of access globally, especially among the poor; and lack of scientific data on the efficacy of these vaccines.

Accounting for the Rising Caesarean Section Rate in Canada: What Are the Roles of Changing Needs, Practices, and Incentives?

2021 ◽  
Author(s):  
Michael Baker ◽  
Maripier Isabelle ◽  
Mark Stabile ◽  
Sara Allin
Keyword(s):  
Caesarean Section ◽  
Financial Incentives ◽  
Health Care Systems ◽  
Caesarean Section Rate ◽  
The United States ◽  
World Health ◽  
Strong Increase ◽  
Primary Determinant ◽  
Care Systems ◽  
Health Organization

In most high-income countries, including Canada, the share of births by Caesarean section (C‑section) has risen over the past decades to far exceed World Health Organization recommendations of the proportion justified on medical grounds (15 percent). Although unnecessary C-sections represent an important cost for health care systems, they are not associated with clear benefits for the mother and the child and can sometimes represent additional risks. Drawing on administrative records of nearly four million births in Canada, as well as macro data from the United States and Australia, we provide a comprehensive account of rising C-section rates. We explicitly consider the contributions of the main factors brought forward in the policy literature, including changing characteristics of mothers, births, and physicians as well as changing financial incentives for C-section deliveries. These factors account for at most one-half of the increase in C-section rates. The majority of the remaining increase in C-sections over the period 1994–2011 occurred in the early 2000s. We suggest that some event or shock in the early 2000s is likely the primary determinant of the recent strong increase in the C-section rate in Canada.

(Mis)Information on Digital Platforms: Lessons from Twitter and Sina Weibo in the COVID-19 Pandemic (Preprint)

2021 ◽  
Author(s):  
Sarah Kreps
Keyword(s):  
Public Health ◽  
World Health Organization ◽  
Public Discourse ◽  
The United States ◽  
World Health ◽  
Sina Weibo ◽  
Digital Platforms ◽  
The World ◽  
Health Organization ◽  
Relative Prevalence

BACKGROUND Misinformation about COVID-19 has presented challenges to public health authorities during pandemics. Understanding the prevalence and type of misinformation across contexts offers a way to understand the discourse around COVID-19 while informing potential countermeasures. OBJECTIVE The aim of the study was to study COVID-19 content on two prominent microblogging platform, Twitter, based in the United States, and Sina Weibo, based in China, and compare the content and relative prevalence of misinformation to better understand public discourse of public health issues across social media and cultural contexts. METHODS A total of 3,579,575 posts were scraped from both Weibo and Twitter, focusing on content from January 30th, 2020, when the World Health Organization (WHO) declared COVID-19 a “Public Health Emergency of International Concern” and February 6th, 2020. A 1% random sample of tweets that contained both the English keywords “coronavirus” and “covid-19” and the equivalent Chinese characters was extracted and analyzed based on changes in the frequencies of keywords and hashtags. Misinformation on each platform was compared by manually coding and comparing posts using the World Health Organization fact-check page to adjudicate accuracy of content. RESULTS Both platforms posted about the outbreak and transmission but posts on Sina Weibo were less likely to reference controversial topics such as the World Health Organization and death and more likely to cite themes of resisting, fighting, and cheering against the coronavirus. Misinformation constituted 1.1% of Twitter content and 0.3% of Weibo content. CONCLUSIONS Quantitative and qualitative analysis of content on both platforms points to cross-platform differences in public discourse surrounding the pandemic and informs potential countermeasures for online misinformation.

scholarly journals Water Quality of the Trstionica River (Bosnia and Herzegovina)

2020 ◽  
Vol 69 (7-8) ◽  
pp. 371-376
Author(s):  
Šuhreta Delibašić ◽  
Jasna Huremović ◽  
Sabina Žero ◽  
Sabina Gojak-Salimović
Keyword(s):  
Water Quality ◽  
Bosnia And Herzegovina ◽  
Limit Of Detection ◽  
Weather Conditions ◽  
Ion Exchange Resin ◽  
World Health ◽  
Mean Values ◽  
Significant Difference ◽  
Health Organization

The present study was conducted to investigate the water quality of the Trstionica River, Bosnia and Herzegovina. The physicochemical properties (temperature, pH, conductivity, total solids after evaporation at 105 °C), content of metals (calcium (Ca), cadmium (Cd), chromium (Cr), copper (Cu), iron (Fe), magnesium (Mg), manganese (Mn), sodium (Na), nickel (Ni), lead (Pb) and zinc (Zn)), and anions (chloride (Cl–), and phosphate (PO43–)) were determined in water samples collected at seven locations during two sampling periods: unstable weather conditions (precipitation), and stable weather conditions (without precipitation). There was a significant difference in the content of individual parameters in the river water depending on the sampling time. For determination of metals concentrations, which were below the limit of detection, a preconcentration method using an ion-exchange resin was applied. The metals concentrations during the rainy day were in the order Ca > Mg > Na > Fe > Cu > Zn > Pb > Mn with mean values of 343, 6.03, 1.94, 0.18, 0.20, 0.03, 0.02, 0.01 mg dm–3, respectively, and during stable weather conditions: Ca > Mg > Na > Cu > Fe > Mn > Zn with mean values of 288, 7.62, 2.38, 0.11, 0.10, 0.01, 0.01 mg dm–3, respectively. Cd, Cr, and Ni concentrations were below limit of detection in both cases. Obtained values were compared with World Health Organization (WHO) regulations. The results showed that the Trstionica River in the investigated part of the stream meets most of the parameters required by the regulations. The correlation between analysed parameters was assessed, as well. Based on the calculated water quality index values, the water of Trstionica River falls into the category of excellent water.

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