scholarly journals Development of dried tube specimens for Xpert MTB/RIF proficiency testing

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Kyle DeGruy ◽  
Katherine Klein ◽  
Zilma Rey ◽  
Patricia Hall ◽  
Andrea Kim ◽  
...  

Background: Proficiency testing (PT) is part of a comprehensive quality assurance programme, which is critical to ensuring patients receive accurate and reliable diagnostic testing. Implementation of the Cepheid Xpert® MTB/RIF assay to aid in the diagnosis of tuberculosis has expanded rapidly in recent years; however, PT material for Xpert MTB/RIF is not readily available in many resource-limited settings.Objective: To develop an accurate and precise PT material based on the dried tube specimen (DTS) method, using supplies and reagents available in most tuberculosis culture laboratories.Methods: Dried tube specimens were produced at the United States Centers for Disease Control and Prevention from 2013 to 2015 by inactivating liquid cultures of well-characterised mycobacterial strains. Ten percent of DTS produced were tested with Xpert MTB/RIF and evaluated for accuracy and precision.Results: Validation testing across eight rounds of PT demonstrated that DTS are highly accurate, achieving an average of 96.8% concordance with the Xpert MTB/RIF results from the original mycobacterial strains. Dried tube specimen testing was also precise, with cycle threshold standard deviations below two cycles when inherent test cartridge variability was low.Conclusion: Dried tube specimens can be produced using equipment already present in tuberculosis culture laboratories, making Xpert MTB/RIF PT scale-up more feasible in resource-limited settings. Use of DTS may fill the gap in tuberculosis laboratory access to external quality assessment, which is an essential component of a comprehensive continuous quality improvement programme.

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Katherine Klein ◽  
Kyle DeGruy ◽  
Zilma Rey ◽  
Patricia Hall ◽  
Andrea Kim ◽  
...  

Background: Proficiency testing (PT) is an important quality assurance measure toward ensuring accurate and reliable diagnostic test results from clinical and public health laboratories. Despite the rapid expansion of the Xpert® MTB/RIF assay for the detection of tuberculosis in resource-limited settings (RLS), low-cost PT materials for Xpert MTB/RIF external quality assessment (EQA) are not widely available.Objective: We sought to determine whether a dried tube specimen (DTS)-based PT programme would be a feasible option to support Xpert MTB/RIF EQA in RLS.Methods: Between 2013 and 2015, the United States Centers for Disease Control and Prevention developed and conducted a voluntary EQA programme using DTS-based PT material. Eight rounds of PT, each comprising five DTS samples, were provided to enrolled testing sites. After each round, participant results were compared to expected results, scored as satisfactory or unsatisfactory, and sites were provided with performance reports.Results: Programme enrolment increased from 102 testing sites in seven countries to 441 testing sites in 14 countries over the course of three years. In each PT round, approximately 90% of participating sites demonstrated satisfactory performance. In seven of the 14 enrolled countries, the proportion of sites with a satisfactory score increased between the first round of participation and the most recent round of participation.Conclusion: This programme demonstrated that it is possible to implement an Xpert MTB/RIF PT programme for RLS using DTS, that substantial demand for Xpert MTB/RIF PT material exists in RLS, and that country performance can improve in a DTS-based PT programme.


2006 ◽  
Vol 11 (11) ◽  
pp. 3-4 ◽  
Author(s):  
G Krause

Surveillance systems have been described as the nerve cells of public health with afferent arms receiving information, cell bodies analysing the information and efferent arms initiating appropriate action or further distribution of information [1]. Increasing numbers of scientific publications on the methodology and evaluation of surveillance systems seem to underline the importance of surveillance systems in public health. The most often cited references in these publications appear to be the definition of public health surveillance by Thacker and Berkelman [2] and variations thereof, and the recommendations for evaluating surveillance systems from 1988 [3] and its update from 2002 written by working groups at the Centers for Disease Control and Prevention (CDC) in the United States[4].


2020 ◽  
Vol 119 (820) ◽  
pp. 303-309
Author(s):  
J. Nicholas Ziegler

Comparing the virus responses in Germany, the United Kingdom, and the United States shows that in order for scientific expertise to result in effective policy, rational political leadership is required. Each of these three countries is known for advanced biomedical research, yet their experiences in the COVID-19 pandemic diverged widely. Germany’s political leadership carefully followed scientific advice and organized public–private partnerships to scale up testing, resulting in relatively low infection levels. The UK and US political responses were far more erratic and less informed by scientific advice—and proved much less effective.


Author(s):  
Gilles Duruflé ◽  
Thomas Hellmann ◽  
Karen Wilson

This chapter examines the challenge for entrepreneurial companies of going beyond the start-up phase and growing into large successful companies. We examine the long-term financing of these so-called scale-up companies, focusing on the United States, Europe, and Canada. The chapter first provides a conceptual framework for understanding the challenges of financing scale-ups. It emphasizes the need for investors with deep pockets, for smart money, for investor networks, and for patient money. It then shows some data about the various aspects of financing scale-ups in the United States, Europe, and Canada, showing how Europe and Canada are lagging behind the US relatively more at the scale-up than the start-up stage. Finally, the chapter raises the question of long-term public policies for supporting the creation of a better scale-up environment.


2021 ◽  
pp. 109019812110144
Author(s):  
Soon Guan Tan ◽  
Aravind Sesagiri Raamkumar ◽  
Hwee Lin Wee

This study aims to describe Facebook users’ beliefs toward physical distancing measures implemented during the Coronavirus disease (COVID-19) pandemic using the key constructs of the health belief model. A combination of rule-based filtering and manual classification methods was used to classify user comments on COVID-19 Facebook posts of three public health authorities: Centers for Disease Control and Prevention of the United States, Public Health England, and Ministry of Health, Singapore. A total of 104,304 comments were analyzed for posts published between 1 January, 2020, and 31 March, 2020, along with COVID-19 cases and deaths count data from the three countries. Findings indicate that the perceived benefits of physical distancing measures ( n = 3,463; 3.3%) was three times higher than perceived barriers ( n = 1,062; 1.0%). Perceived susceptibility to COVID-19 ( n = 2,934; 2.8%) was higher compared with perceived severity ( n = 2,081; 2.0%). Although susceptibility aspects of physical distancing were discussed more often at the start of the year, mentions on the benefits of intervention emerged stronger toward the end of the analysis period, highlighting the shift in beliefs. The health belief model is useful for understanding Facebook users’ beliefs at a basic level, and it provides a scope for further improvement.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S279-S279
Author(s):  
Eimear Kitt ◽  
Julia S Sammons ◽  
Kathleen Chiotos ◽  
Susan E Coffin ◽  
Susan E Coffin ◽  
...  

Abstract Background The Centers for Disease Control and Prevention (CDC) recommends upper respiratory tract (URT) polymerase chain reaction (PCR) testing as the initial diagnostic test for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Lower respiratory tract (LRT) testing for patients requiring mechanical ventilation is also recommended. The goal of this study was to evaluate concordance between paired URT and LRT specimens in children undergoing pre-admission/procedure screening or diagnostic testing. We hypothesized that < 10% of paired tests would have discordant results. Methods Single center cross-sectional study including children with artificial airways who had paired URT and LRT SARS-CoV-2 PCR testing between 4/1/2020 and 6/8/2020. URT specimens included nasopharyngeal (NP) swabs and aspirates. LRT specimens included tracheal aspirates and bronchoalveolar lavages. URT and LRT specimens were classified as paired if the two specimens were collected within 24 hours. Artificial airways included tracheostomies and endotracheal tubes. Tests were classified as diagnostic versus screening based on the indication selected in the order. Results 102 paired specimens were obtained during the study period. Fifty-nine were performed for screening and 43 were performed for diagnosis of suspected SARS-CoV-2. Overall, 94 specimens (92%) were concordant, including 89 negative from both sources and 5 positive from both sources. Eight specimens (8%) were discordant, all of which were positive from the URT and negative from the LRT (Figure 1). Among patients undergoing screening, 3 of 4 positive tests were discordant and among symptomatic patients, 5 of 9 positive tests were discordant. There were no instances of a positive LRT specimen with a negative URT specimen. Figure 1. Performance of upper and lower respiratory tract SARS-CoV-2 PCR testing in children with artificial airways Conclusion Overall, most paired samples from the URT and LRT yielded concordant results with no pairs positive from the LRT and negative from the URT. These data support the CDC recommendation that URT specimens are the preferred initial SARS-CoV-2 test, while LRT specimens should be collected only from mechanically ventilated with suspected SARS-CoV-2. Disclosures All Authors: No reported disclosures


Biosensors ◽  
2020 ◽  
Vol 11 (1) ◽  
pp. 14
Author(s):  
Priya Dave ◽  
Roberto Rojas-Cessa ◽  
Ziqian Dong ◽  
Vatcharapan Umpaichitra

The United States Centers for Disease Control and Prevention considers saliva contact the lead transmission mean of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the coronavirus disease 2019 (COVID-19). Saliva droplets or aerosols expelled by sneezing, coughing, breathing, and talking may carry this virus. People in close distance may be exposed directly to these droplets or indirectly when touching the droplets that fall on surrounding surfaces and ending up contracting COVID-19 after touching the mucosa tissue of their faces. It is of great interest to quickly and effectively detect the presence of SARS-CoV-2 in an environment, but the existing methods only work in laboratory settings, to the best of our knowledge. However, it may be possible to detect the presence of saliva in the environment and proceed with prevention measures. However, detecting saliva itself has not been documented in the literature. On the other hand, many sensors that detect different organic components in saliva to monitor a person’s health and diagnose different diseases, ranging from diabetes to dental health, have been proposed and they may be used to detect the presence of saliva. This paper surveys sensors that detect organic and inorganic components of human saliva. Humidity sensors are also considered in the detection of saliva because a large portion of saliva is water. Moreover, sensors that detect infectious viruses are also included as they may also be embedded into saliva sensors for a confirmation of the presence of the virus. A classification of sensors by their working principles and the substances they detect is presented, including the sensors’ specifications, sample size, and sensitivity. Indications of which sensors are portable and suitable for field application are presented. This paper also discusses future research and challenges that must be resolved to realize practical saliva sensors. Such sensors may help minimize the spread of not only COVID-19 but also other infectious diseases.


2021 ◽  
pp. 192536212110224
Author(s):  
Melissa C. Mercado ◽  
Deborah M. Stone ◽  
Caroline W. Kokubun ◽  
Aimée-Rika T. Trudeau ◽  
Elizabeth Gaylor ◽  
...  

Introduction: It is widely accepted that suicides—which account for more than 47 500 deaths per year in the United States—are undercounted by 10% to 30%, partially due to incomplete death scene investigations (DSI) and varying burden-of-proof standards across jurisdictions. This may result in the misclassification of overdose-related suicides as accidents or undetermined intent. Methods: Virtual and in-person meetings were held with suicidologists and DSI experts from five states (Spring-Summer 2017) to explore how features of a hypothetical electronic DSI tool may help address these challenges. Results: Participants envisioned a mobile DSI application for cell phones, tablets, or laptop computers. Features for systematic information collection, scene description, and guiding key informant interviews were perceived as useful for less-experienced investigators. Discussion: Wide adoption may be challenging due to differences in DSI standards, practices, costs, data privacy and security, and system integration needs. However, technological tools that support consistent and complete DSIs could strengthen the information needed to accurately identify overdose suicides.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tobias M. Holden ◽  
Reese A. K. Richardson ◽  
Philip Arevalo ◽  
Wayne A. Duffus ◽  
Manuela Runge ◽  
...  

Abstract Background Availability of SARS-CoV-2 testing in the United States (U.S.) has fluctuated through the course of the COVID-19 pandemic, including in the U.S. state of Illinois. Despite substantial ramp-up in test volume, access to SARS-CoV-2 testing remains limited, heterogeneous, and insufficient to control spread. Methods We compared SARS-CoV-2 testing rates across geographic regions, over time, and by demographic characteristics (i.e., age and racial/ethnic groups) in Illinois during March through December 2020. We compared age-matched case fatality ratios and infection fatality ratios through time to estimate the fraction of SARS-CoV-2 infections that have been detected through diagnostic testing. Results By the end of 2020, initial geographic differences in testing rates had closed substantially. Case fatality ratios were higher in non-Hispanic Black and Hispanic/Latino populations in Illinois relative to non-Hispanic White populations, suggesting that tests were insufficient to accurately capture the true burden of COVID-19 disease in the minority populations during the initial epidemic wave. While testing disparities decreased during 2020, Hispanic/Latino populations consistently remained the least tested at 1.87 tests per 1000 population per day compared with 2.58 and 2.87 for non-Hispanic Black and non-Hispanic White populations, respectively, at the end of 2020. Despite a large expansion in testing since the beginning of the first wave of the epidemic, we estimated that over half (50–80%) of all SARS-CoV-2 infections were not detected by diagnostic testing and continued to evade surveillance. Conclusions Systematic methods for identifying relatively under-tested geographic regions and demographic groups may enable policymakers to regularly monitor and evaluate the shifting landscape of diagnostic testing, allowing officials to prioritize allocation of testing resources to reduce disparities in COVID-19 burden and eventually reduce SARS-CoV-2 transmission.


Author(s):  
Jennifer A. Jones ◽  
Zishan K. Siddiqui ◽  
Charles Callahan ◽  
Surbhi Leekha ◽  
Sharon Smyth ◽  
...  

Abstract The state of Maryland identified its first case of COVID-19 on March 5, 2020. The Baltimore Convention Center (BCCFH) quickly became a selected location to set up a 250-bed inpatient Field Hospital and Alternate Care Site. In contrast to other field hospitals throughout the United States, the BCCFH remained open throughout the pandemic and took on additional COVID-19 missions, including community SARS-CoV-2 diagnostic testing, monoclonal antibody infusions for COVID-19 outpatients, and community COVID-19 vaccinations. At the time of publication, the BCCFH had cared for 1,478 COVID-19 inpatients, performed 108,155 COVID-19 tests, infused 2,166 COVID-19 patients, and administered 115,169 doses of COVID-19 vaccine. To prevent the spread of pathogens during operations, infection prevention and control guidelines were essential to ensure the safety of staff and patients. Through multi-agency collaboration, utilization of infection prevention best practices, and answering what we describe as “PPE-ESP”, an operational framework was established to reduce infection risks for those providing or receiving care at the BCCFH during the COVID-19 pandemic.


Sign in / Sign up

Export Citation Format

Share Document