Vaccine-Induced Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection)
As new public health challenges relating to COVID-19 emerge, such as variant strains, waning vaccine efficacy over time, and decreased vaccine efficacy for special populations (immunocompromised hosts), it is important to determine a correlate of protection (CoP) to allow accurate bridging studies for special populations and against variants of concern. Large-scale phase 3 clinical trials are inefficient to rapidly assess novel vaccine candidates for variant strains or special populations, because these trials are slow and costly. Defining a practical CoP will aid in efficiently conducting future assessments to further des...
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Amy C. Sherman, Micha ël Desjardins, Lindsey R. Baden Source Type: research
Suboptimal Humoral Immunity in Severe Acute Respiratory Syndrome Coronavirus 2 Infection and Viral Variant Generation
This review describes the underlying basis for the sup-optimal humoral immune response in coronavirus disease (COVID)-19 including the absence of evidence for affinity maturation in the vast majority of patients and the absence of germinal centers even in severe disease. Suboptimal humoral and cellular immunity may provide the optimal conditions for the generation and selection of viral variants. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Shiv Pillai Source Type: research
Sub-optimal Humoral immunity in SARS CoV-2 infection and viral variant generation
This review describes the underlying basis for the sup-optimal humoral immune response in COVID-19 including the absence of evidence for affinity maturation in the vast majority of patients and the absence of germinal centers even in severe disease. Sub-optimal humoral and cellular immunity provide the optimal conditions for the generation and selection of viral variants. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Shiv Pillai Source Type: research
Coronavirus antigens as targets of antibody responses
Humoral immunity to SARS-CoV-2 during acute infection and convalescence has been widely studied since March 2020. In this review, we summarize literature on humoral responses to SARS-CoV-2 with focus on spike, nucleocapsid, and the receptor-binding domain antigens as targets of antibody responses. We highlight serological studies during acute SARS-CoV-2 infection and discuss the clinical relevance of antibody levels in COVID-19 progression. Antibody responses in pediatric COVID-19 patients are also reviewed. Finally, we discuss antibody responses during convalescence and their role in protection from SARS-CoV-2 reinfection...
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Alana F. Ogata, Roey Lazarovits, Augusta Uwamanzu-Nna, Tal Gilboa, Chi-An Cheng, David R. Walt Source Type: research
SARS-CoV-2 Serology Testing – A Laboratory Primer
In 2019 an emerging coronavirus, SARS-COV-2 was first identified. In the months since, SARS-CoV-2 has become a global pandemic of unimaginable scale. In 2021, SARS-CoV-2 continues to be a huge public health burden and a dominating issue in healthcare. In addition, SARS-CoV-2 has placed a spotlight on laboratory medicine and its ’s key role in infectious disease management. The SARS-CoV-2 antibody testing landscape is vast and consists of dozens of antibody tests that have received EUA. The laboratory is faced with choosing the right test, staying current with the rapidly evolving recommendations and updating test informa...
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Patricia R. Slev Source Type: research
Antibody dynamics and durability in COVID-19
COVID-19 has emerged as the greatest global health threat in generations. An unprecedented mobilization of researchers has generated a wealth of data on humoral responses to SARS-CoV-2 within a year of the pandemic ’s beginning. The rapidly developed understanding of acute phase antibody induction and medium-term antibody durability in COVID-19 is important at an individual level to inform patient care and a population level to help predict transmission dynamics. In this brief review, we will describe the de velopment and maintenance of antibody responses to immunization and infections generally and the specific antibody...
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Adam Zuiani, Duane R. Wesemann Source Type: research
Performance evaluation of lateral flow assays for COVID-19 serology
The Coronavirus disease of 2019 (COVID-19) pandemic, caused by infection with the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has undoubtedly resulted in significant morbidities, mortalities, and economic disruptions across the globe. Affordable and scalable tools to monitor the transmission dynamics of the SARS-CoV-2 virus and the longevity of induced antibodies will be paramount to monitor and control the pandemic as multiple waves continue to rage in many countries. Serological assays detect humoral responses to the virus, to determine seroprevalence in target populations, or induction of antibodies at ...
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Lucy Ochola, Paul Ogongo, Samuel Mungai, Jesse Gitaka, Sara Suliman Source Type: research
Performance Characteristics of High-Throughput Serologic Assays for SARS-CoV-2 with FDA Emergency Use Authorization: A Review
This review provides a broad summary of the performance characteristics of high-throughput SARS-CoV-2 serologic assays with Food and Drug Administration Emergency Use Authorization, which are commonly found in central clinical laboratories. Additionally, this review discusses the current roles of serologic testing for SARS-CoV-2 and provides a perspective for the future. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Elitza S. Theel Source Type: research
Alternative methods to detect SARS-CoV-2 antibodies
The coronavirus disease 2019 (COVID-19) pandemic has resulted in the development, validation, and rapid adoption of multiple novel diagnostic approaches across the world. As a result, hundreds of SARS-CoV2 serological assays have been developed and deployed across the world in the effort to contain the spread of the virus, as well as to supply timely and important health information. Drawing upon decades of experience, most of these serological assays were based on a conventional ELISA or the lateral flow assay format. The immunoassays that were developed were based on alternative technologies and are highlighted in this c...
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Rashmi Patel, Siddharth Khare, Vinay S. Mahajan Source Type: research
Vaccine-induced SARS-CoV-2 Antibody Response and the Path to Accelerating Development (Determining a Correlate of Protection)
(Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Amy C. Sherman, Michael Desjardins, Lindsey R. Baden Source Type: research
Donor Screening and Deferral
The maintenance of an adequate and safe blood supply begins with choosing the right donor at the right time. The evolution of donor screening has been shaped by experience, donor satisfaction, and the ever-challenging emergence of relevant infectious diseases. Screening donors has been standardized over the past 6 decades to protect donor and recipient safety. In this review, we outline, define, and simplify the requirements to assess and defer donors with a focus on recent and ongoing changes to provide up to date information on donor qualification and current challenges in maintaining the blood supply. (Source: Clinics i...
Source: Clinics in Laboratory Medicine - October 22, 2021 Category: Laboratory Medicine Authors: Lisa Rosochacki, Jaleah Hawkins Source Type: research
Blood Product (Donor) Noninfectious and Infectious Testing and Modification
This article offers an overview of blood donor infectious and noninfectious testing in the United States. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - October 22, 2021 Category: Laboratory Medicine Authors: Tania Sarker, Louis M. Katz, Evan M. Bloch, Ruchika Goel Source Type: research
Updates in Blood Banking and Transfusion Medicine
The seeming duality of transfusion medicine as both a remarkably consistent and a notably dynamic clinical field is fascinating. Over a century ago, Karl Landsteiner discovered the ABO blood group by mixing red blood cells and sera from different individuals and observing agglutination, and this method, albeit with refinements, to characterize both red blood cells and antibodies against them remains a mainstay in blood bank testing today. Other aspects of blood banking and transfusion medicine, such as the use of pathogen reduction technology to mitigate risk of transfusion-transmitted infections in platelet products, unde...
Source: Clinics in Laboratory Medicine - October 22, 2021 Category: Laboratory Medicine Authors: Suzanne R. Thibodeaux Tags: Preface Source Type: research
Updates in Blood Banking and Transfusion Medicine
CLINICS IN LABORATORY MEDICINE (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - October 22, 2021 Category: Laboratory Medicine Authors: Suzanne R. Thibodeaux Source Type: research
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Elsevier (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - October 22, 2021 Category: Laboratory Medicine Source Type: research
