scholarly journals Detailed Overview of the Buildout and Integration of an Automated High-Throughput CLIA Laboratory for SARS-CoV-2 Testing on a Large Urban Campus

Author(s):  
Lena Landaverde ◽  
David McIntyre ◽  
James Robson ◽  
Dany Fu ◽  
Luis Ortiz ◽  
...  

In 2019, the first cases of SARS-CoV-2 were detected in Wuhan, China, and by early 2020 the cases were identified in the United States. SARS-CoV-2 infections increased in the US causing many states to implement stay-at-home orders and additional safety precautions to mitigate potential outbreaks. As policies changed throughout the pandemic and restrictions lifted, there was an increase in demand for Covid-19 testing which was costly, difficult to obtain, or had long turn-around times. Some academic institutions, including Boston University, created an on-campus Covid-19 screening protocol as part of planning for the safe return of students, faculty, and staff to campus with the option for in-person classes. At BU, we stood up an automated high-throughput clinical testing lab with the capacity to run 45,000 individual tests weekly by fall of 2020, with a purpose-built clinical testing laboratory, a multiplexed RT-PCR test, robotic instrumentation, and trained CLIA certified staff. There were challenges to overcome, including the supply chain issues for PPE testing materials, and equipment that were in high demand. The Boston University Clinical Testing Laboratory was operational at the start of the fall 2020 academic year. The lab performed over 1 million SARS-CoV-2 RT-PCR tests during the 2020-2021 academic year.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 84-84
Author(s):  
Danielle Potter ◽  
Mark Riffon ◽  
Sirisha Kakamada ◽  
Robert S. Miller ◽  
George Anthony Komatsoulis

84 Background: Patients with cancer may face difficult care decisions during the COVID-19 outbreak in the US. Understanding COVID-19 risk factors may help patients and oncologists identify high-risk patients and plan for the best cancer treatment in a timely fashion. This analysis provides an assessment of racial and ethnic risk factors for COVID-19 disease within the CancerLinQ (CLQ) Discovery database. Methods: CLQ is a health technology platform developed by ASCO, which collects and aggregates longitudinal electronic health record (EHR) data from oncology practices throughout the United States. Patients with a diagnosis of a malignant neoplasm and at least two encounters in the past year at a reporting CLQ practice were defined as the underlying cancer patient population at risk for SARS-CoV-2 infection. COVID-19 cases were identified via a positive RT-PCR test for SARS-CoV-2 RNA and/or an ICD-10 code for coronavirus (e.g., B97.29, U07.1, or U07.2). Relative risks and 95% CI were calculated using SAS. Results: We identified 232,428 patients with cancer. From 1/1/2020-4/30/2020, we identified 223 COVID-19 cases in patients with cancer. Of these, 203 had a positive RT-PCR, 26 had an ICD-10 diagnosis code for SARS-CoV-2, and 6 had both. SARS-CoV-2 cases were identified from 19 of the 35 CLQ practices (52.8%) reporting data during the study period. Compared to white patients, African Americans were approximately 2 times more likely to have COVID-19 disease (RR = 1.95; 95% CI = 1.40-2.71), and Hispanics were more than 4 times more likely (RR = 4.65; 95% CI = 3.36-6.43). Patients with hematologic cancers were 1.5 times as likely to be diagnosed with COVID-19 (RR = 1.53; 95% CI = 1.09-2.16) compared to patients with solid tumors. At the time of this abstract, 10 patients (4.5%) died. Conclusions: These results are based on data from a sample of CLQ practices and represent an initial analysis of COVID-19 in the CLQ population. The elevated risk for COVID-19 among African Americans and Hispanics with cancer is noteworthy, particularly since these patients often suffer poorer cancer outcomes. The elevated risk among patients with hematologic cancers is also worth noting because these patients often have compromised immune systems and are already susceptible to many other types of infection. Because the US is in the midst of an active outbreak, we are continuing to analyze new cases and additional risk factors, such as geographical location, anti-cancer treatments, and other cancer variables (e.g. stage).


2015 ◽  
Vol 5 (3) ◽  
pp. 317-318 ◽  
Author(s):  
Neete Saha

Institutions in the United States have been popular among Saudi students seeking post-secondary degrees. In fact, Saudi Arabia is one of the highest represented home countries of international students in the US. 44,566 Saudi students enrolled in US colleges and universities for the 2012-2013 academic year, and enrollment numbers for Saudi students have been increasing tremendously over the years (IIE, 2013). Higher education in Saudi Arabia: Achievements, challenges and opportunities (2013), edited by Larry Smith and Abdulrahman Abouammoh, provides insight into this growth. This book suggests that Saudi Arabia wants to improve its higher education system, the goal being to “…achieve ‘world-class’ standards” (p. 5). To accomplish this, Saudi Arabia has invested 160 billion USD into its budget for education.


Author(s):  
Justin D. Silverman ◽  
Nathaniel Hupert ◽  
Alex D. Washburne

AbstractDetection of SARS-CoV-2 infections to date has relied on RT-PCR testing. However, a failure to identify early cases imported to a country, bottlenecks in RT-PCR testing, and the existence of infections which are asymptomatic, sub-clinical, or with an alternative presentation than the standard cough and fever have resulted in an under-counting of the true prevalence of SARS-CoV-2. Here, we show how publicly available CDC influenza-like illness (ILI) outpatient surveillance data can be repurposed to estimate the detection rate of symptomatic SARS-CoV-2 infections. We find a surge of non-influenza ILI above the seasonal average and show that this surge is correlated with COVID case counts across states. By quantifying the number of excess ILI patients in March relative to previous years and comparing excess ILI to confirmed COVID case counts, we estimate the syndromic case detection rate of SARS-CoV-2 in the US to be less than 13%. If only 1/3 of patients infected with SARS-CoV-2 sought care, the ILI surge would correspond to more than 8.7 million new SARS-CoV-2 infections across the US during the three week period from March 8 to March 28. Combining excess ILI counts with the date of onset of community transmission in the US, we also show that the early epidemic in the US was unlikely to be doubling slower than every 4 days. Together these results suggest a conceptual model for the COVID epidemic in the US in which rapid spread across the US are combined with a large population of infected patients with presumably mild-to-moderate clinical symptoms. We emphasize the importance of testing these findings with seroprevalence data, and discuss the broader potential to use syndromic time series for early detection and understanding of emerging infectious diseases.


2022 ◽  
Vol 136 (1) ◽  
pp. 282-286

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.


Plant Disease ◽  
2020 ◽  
Vol 104 (6) ◽  
pp. 1789-1800 ◽  
Author(s):  
B. A. Hodge ◽  
P. A. Paul ◽  
L. R. Stewart

Ohio is a leading producer of soft red winter wheat in the United States. Many viruses impact wheat production, but there is a lack of contemporary information on the distribution and potential impact of wheat viruses in Ohio. To address this knowledge gap, we created a comprehensive dataset of viruses identified by high-throughput sequencing (HTS) and their incidence in field sites sampled across the state. Samples were collected from 103 field sites in surveys conducted in 2012, 2016, and 2017 and subjected to RNA HTS, reverse transcription (RT) PCR, or enzyme-linked immunosorbent assay to assess virus sequence diversity, prevalence, and incidence within fields. Partial and complete virus sequences were assembled and detection validated by RT-PCR. Assembled sequences were compared with previously known virus sequences, and novel sequences were validated by Sanger sequencing. The viruses detected most often included barley yellow dwarf virus (BYDV), cereal yellow dwarf virus (CYDV), wheat streak mosaic virus (WSMV), and wheat spindle streak mosaic virus (WSSMV). These viruses were detected at 67, 69, 55, and 28% of the field sites sampled, with mean incidences of 18, 19, 20, and 49%, respectively, within fields where they were detected. Brome mosaic virus (BMV) and cocksfoot mottle virus (CfMV) were also viruses of potential importance detected in Ohio, found in 26 and 17% of the field sites sampled, respectively. Based on results from logistic regression analyses, the presence of BYDV, CYDV, WSMV, and WSSMV was associated with the presence of volunteer wheat, BYDV and CfMV with monocots as the previous crop, and BMV with the presence of nearby corn fields (P < 0.10). For six viruses, there was evidence of spatial clustering in at least one field site and the variance of mean incidence was higher at the county level than at the regional spatial level. This finding suggests that county- and site-specific factors influenced the incidence and spatial pattern of some viruses. The results of this study provide a snapshot of viruses present in Ohio wheat and insights into their biology, potential risks to wheat production, and possible management strategies.


2021 ◽  
Author(s):  
Michelle A Waltenburg ◽  
Mary A Pomeroy ◽  
Laura Hughes ◽  
Jeremy A.W. Gold ◽  
Oren Mayer ◽  
...  

Background: In early 2020, an outbreak of coronavirus disease 2019 occurred among passengers and crew of the Diamond Princess cruise ship. During February 16 and 17, some US citizens, residents, and their partners voluntarily repatriated to the US from Japan. Methods: We conducted a retrospective, longitudinal evaluation of repatriated travelers where the outcome of interest was a positive test for SARS-CoV-2. Travelers who tested positive for SARS-CoV-2 were isolated in hospitals or at home under county isolation orders and underwent serial testing by real-time reverse transcription polymerase chain reaction (RT-PCR) approximately every other day, as contemporaneous US guidance required two consecutive negative tests collected greater than or equal to 24 hours apart and symptom improvement before release from isolation. Results: Among quarantined repatriated travelers, 14% tested positive for SARS-CoV-2. One-fifth of infected travelers initially tested negative but were identified on subsequent testing. All infected travelers remained asymptomatic or developed mild symptoms during isolation. Many travelers remained in prolonged isolation because of persistent viral detection based on contemporaneous policies. Conclusion: Our findings support testing within 3-5 days after possible SARS-CoV-2 exposure to comprehensively identify infections and mitigate transmission and lend support to symptom- and time-based isolation recommendations, rather than test-based criteria.


2000 ◽  
Vol 16 (2) ◽  
pp. 107-114 ◽  
Author(s):  
Louis M. Hsu ◽  
Judy Hayman ◽  
Judith Koch ◽  
Debbie Mandell

Summary: In the United States' normative population for the WAIS-R, differences (Ds) between persons' verbal and performance IQs (VIQs and PIQs) tend to increase with an increase in full scale IQs (FSIQs). This suggests that norm-referenced interpretations of Ds should take FSIQs into account. Two new graphs are presented to facilitate this type of interpretation. One of these graphs estimates the mean of absolute values of D (called typical D) at each FSIQ level of the US normative population. The other graph estimates the absolute value of D that is exceeded only 5% of the time (called abnormal D) at each FSIQ level of this population. A graph for the identification of conventional “statistically significant Ds” (also called “reliable Ds”) is also presented. A reliable D is defined in the context of classical true score theory as an absolute D that is unlikely (p < .05) to be exceeded by a person whose true VIQ and PIQ are equal. As conventionally defined reliable Ds do not depend on the FSIQ. The graphs of typical and abnormal Ds are based on quadratic models of the relation of sizes of Ds to FSIQs. These models are generalizations of models described in Hsu (1996) . The new graphical method of identifying Abnormal Ds is compared to the conventional Payne-Jones method of identifying these Ds. Implications of the three juxtaposed graphs for the interpretation of VIQ-PIQ differences are discussed.


2009 ◽  
Vol 2 (1) ◽  
pp. 1-27
Author(s):  
Ann Abate Michelle

This essay argues that in spite of their obvious Biblically-based subject matter, clear Christian content, and undeniable evangelical perspective, the Left Behind novels for kids are not simply religious books; they are also political ones. Co-authors Tim LaHaye and Jerry B. Jenkins may claim that their narratives are interested in sharing the good news about Jesus for the sake of the future, but they are equally concerned with offering commentary on contentious US cultural issues in the present. Given the books’ adolescent readership, they are especially preoccupied with the ongoing conservative crusade concerning school prayer. As advocates for this issue, LaHaye and Jenkins make use of a potent blend of current socio-political arguments and of past events in evangelical church history: namely, the American Sunday School Movement (ASSM). These free, open-access Sabbath schools became the model for the public education system in the United States. In drawing on this history, the Left Behind series suggests that the ASSM provides an important precedent for the presence not simply of Christianity in the nation's public school system, but of evangelical faith in particular.


Author(s):  
Steven Hurst

The United States, Iran and the Bomb provides the first comprehensive analysis of the US-Iranian nuclear relationship from its origins through to the signing of the Joint Comprehensive Plan of Action (JCPOA) in 2015. Starting with the Nixon administration in the 1970s, it analyses the policies of successive US administrations toward the Iranian nuclear programme. Emphasizing the centrality of domestic politics to decision-making on both sides, it offers both an explanation of the evolution of the relationship and a critique of successive US administrations' efforts to halt the Iranian nuclear programme, with neither coercive measures nor inducements effectively applied. The book further argues that factional politics inside Iran played a crucial role in Iranian nuclear decision-making and that American policy tended to reinforce the position of Iranian hardliners and undermine that of those who were prepared to compromise on the nuclear issue. In the final chapter it demonstrates how President Obama's alterations to American strategy, accompanied by shifts in Iranian domestic politics, finally brought about the signing of the JCPOA in 2015.


2014 ◽  
Vol 23 (3) ◽  
pp. 381-388 ◽  
Author(s):  
Euan Hague ◽  
Alan Mackie

The United States media have given rather little attention to the question of the Scottish referendum despite important economic, political and military links between the US and the UK/Scotland. For some in the US a ‘no’ vote would be greeted with relief given these ties: for others, a ‘yes’ vote would be acclaimed as an underdog escaping England's imperium, a narrative clearly echoing America's own founding story. This article explores commentary in the US press and media as well as reporting evidence from on-going interviews with the Scottish diaspora in the US. It concludes that there is as complex a picture of the 2014 referendum in the United States as there is in Scotland.


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