scholarly journals Application, Verification, and Implementation of SARS-CoV-2 Serologic Assays with Emergency Use Authorization

2020 ◽  
Vol 59 (1) ◽  
pp. e02148-20 ◽  
Author(s):  
Elitza S. Theel ◽  
Marc Roger Couturier ◽  
Laura Filkins ◽  
Elizabeth Palavecino ◽  
Stephanie Mitchell ◽  
...  

ABSTRACTInterest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitations and reporting considerations for laboratories. Assessments concerning single-antibody and multiantibody isotype detection assays, which may provide either differentiated or nondifferentiated (i.e., total antibody) antibody class results, are addressed. Additional considerations prior to assay implementation are also discussed, including biosafety, quality control, and proficiency testing strategies. As the landscape of SARS-CoV-2 serologic testing is rapidly changing, this document provides updated guidance for laboratorians on application of these assays.

Author(s):  
Craig Allen

The first completely researched history of U.S. Spanish-language television traces the rise of two foremost, if widely unrecognized, modern American enterprises—the Spanish-language networks Univision and Telemundo. It is a standard scholarly history constructed from archives, original interviews, reportage, and other public materials. Occasioned by the public’s wakening to a “Latinization” of the U.S., the book demonstrates that the emergence of Spanish-language television as a force in mass communication is essential to understanding the increasing role of Latinos and Latino affairs in modern American society. It argues that a combination of foreign and domestic entrepreneurs and innovators who overcame large odds resolves a significant and timely question: In an English-speaking country, how could a Spanish-speaking institution have emerged? Through exploration of significant and colorful pioneers, continuing conflicts and setbacks, landmark strides, and ongoing controversies—and with revelations that include regulatory indecision, behind-the-scenes tug-of-war, and the internationalization of U.S. mass media—the rise of a Spanish-language institution in the English-speaking U.S. is explained. Nine chapters that begin with Spanish-language television’s inception in 1961 and end 2012 chronologically narrate the endeavor’s first 50 years. Events, passages, and themes are thoroughly referenced.


1995 ◽  
Vol 14 (2) ◽  
pp. 262-262
Author(s):  
Kenneth I. Berns

Members of the American Society for Microbiology (ASM) have a considerable history of bringing scientific and technical knowledge to the issue of biological weapons control and being available to serve in advisory roles to the government. ASM's involvement with the biological weapons issue began in the 1940s, when microbiologists served as advisors to the government's Biological Defense Research Program and participated in the Biological Warfare Committee of the U.S. National Academy of Sciences. In 1970, a controversy resulting from the ASM's involvement with this issue abated when the ASM Council approved a statement concerning non-secrecy and free movement in research. Simultaneously, the society affirmed support for President Richard M. Nixon's action to end the U.S.'s offensive biological weapons program. The society's code of ethics, published in 1985, contains two relevant sections that seek to discourage ASM members from participating in biological weapons development.


1991 ◽  
Vol 85 (2) ◽  
pp. 358-371 ◽  

In October 1988 the American Branch of the International Law Association and the American Society of International Law established a Joint Committee on the Role of the Legal Adviser of the Department of State. The Committee’s charge was to examine the role of the Legal Adviser in encouraging respect for international law in the U.S. government decisionmaking process, and to make suggestions and recommendations to enhance the Legal Adviser’s effectiveness in this regard. The thirty-four members of the Committee included nine former Legal Advisers, a former President’s counsel, other past and present U.S. government officials, academics and private attorneys. Collectively, the Committee reflected broad experience and a variety of perspectives as regards issues of U.S. foreign policy and international law. (The members of the Committee are listed in footnote 1.)


Author(s):  
Robert A. Burt

The Supreme Court long considered its highest mission to be the protection of individual liberty from intrusion by government, but the court shifted its focus to social and economic equality. This book explores this shift and its implications, especially for the legal protection of the vulnerable. Crucial to the author's perspective is an unconventional view of the role of judges—not simply to decide disputes, but to promote a respectful dialogue leading to a genuine understanding between parties. The U.S. Constitution, through its interpretation by the U.S. Supreme Court, deals with the protection of vulnerable people in American society. It focuses on the judge not as the sole determiner of equality or protection but as a leader who, through careful observation and guidance, promotes an interactive process among the parties in order to settle the matter in an empathic, mutually respectful way. The book points out that judges are not the only actors through whom democratic values founded on empathic mutual respect and accountability can be promoted. At the center of this study is the Civil Rights Act of 1968.


2020 ◽  
Vol 9 (3) ◽  
pp. 157-166
Author(s):  
Iordanis Petsas ◽  
Sofia M Vidalis

The U.S. infrastructure has been issued a grade of D+ from the American Society of Civil Engineers because of the low funding for new construction, maintenance, and repair. It is now reaching the end of its useful life and cost estimates have reached as high as $3.6-trillion. The public infrastructure investment is at 2.4% of GDP, which is half of what it was 50-years ago. The U.S. has explored new ways to finance its infrastructure because of funding uncertainty. Investments such as, pensions, foreign investments, and sovereign wealth funds, manage trillions in assets and are forecasted to grow. This paper presents an overview in infrastructure funding and identifies possible approaches in addressing long-term financial needs with foreign capital partnership.


2016 ◽  
Vol 54 (7) ◽  
pp. 1686-1693 ◽  
Author(s):  
Lars F. Westblade ◽  
Alex van Belkum ◽  
Adam Grundhoff ◽  
George M. Weinstock ◽  
Eric G. Pamer ◽  
...  

Clinicogenomics is the exploitation of genome sequence data for diagnostic, therapeutic, and public health purposes. Central to this field is the high-throughput DNA sequencing of genomes and metagenomes. The role of clinicogenomics in infectious disease diagnostics and public health microbiology was the topic of discussion during a recent symposium (session 161) presented at the 115th general meeting of the American Society for Microbiology that was held in New Orleans, LA. What follows is a collection of the most salient and promising aspects from each presentation at the symposium.


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