Analytic and clinical performance of major commercial SARS-CoV-2 molecular assays in the United States
The rapid development of commercially-available molecular assays in response to the COVID-19 pandemic has been essential in identifying positive cases and guiding state and national response plans. With over 200 SARS-CoV-2 molecular tests having received emergency use authorization by the U.S. Food and Drug Administration, numerous studies have been conducted to evaluate these methods and compare their analytic and clinical performance. By applying the lessons learned from the rapid development of molecular assays in response to the COVID-19 pandemic, the diagnostic industry will be better prepared to respond to future out...
Source: Clinics in Laboratory Medicine - February 20, 2022 Category: Laboratory Medicine Authors: Michelle R. Campbell, Matthew J. Binnicker Source Type: research

Cycle threshold values from SARS-CoV-2 PCR assays: Interpretation and potential use cases
Reverse-transcription polymerase chain reaction (RT-PCR) tests for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), are approved for qualitative use. The cycle threshold (Ct) value reflects the concentration of viral RNA in the sample, with lower Ct values indicating higher levels of RNA. Caregivers may wish to use the Ct value to determine progression of infection, how severe the infection will be and whether the patient can transmit the virus. Variability of Ct values and the data supporting these uses should be considered when deciding whether and how to use...
Source: Clinics in Laboratory Medicine - February 20, 2022 Category: Laboratory Medicine Authors: Alexander J. McAdam Source Type: research

Detection of SARS-CoV-2 Antibodies in Diagnosis and Treatment of COVID-19
CLINICS IN LABORATORY MEDICINE (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 11, 2022 Category: Laboratory Medicine Authors: Daimon P. Simmons, Peter H. Schur Source Type: research

Copyright
Elsevier (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 11, 2022 Category: Laboratory Medicine Source Type: research

Contributors
MILENKO JOVAN TANASIJEVIC, MD, MBA (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 11, 2022 Category: Laboratory Medicine Source Type: research

Contents
Daimon P. Simmons and Peter H. Schur (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 11, 2022 Category: Laboratory Medicine Source Type: research

Forthcoming Issues
Covid-19 Molecular Testing and Clinical Correlates (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - February 11, 2022 Category: Laboratory Medicine Source Type: research

Perspectives on Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 and Its Implications for Diagnostics, Biology, and Clinical Management
When the pandemic coronavirus disease 2019 (COVID-19) swept around the world in early 2020, diagnostic testing moved into the spotlight. Although molecular diagnostic tests have been a mainstay in identification of patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, detection of viral nucleic acids may be limited to the initial phase of infection. Detection of anti-SARS-CoV-2 antibodies complements molecular testing as a method of detecting previously infected individuals. (Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - December 20, 2021 Category: Laboratory Medicine Authors: Daimon P. Simmons, Peter H. Schur Tags: Preface Source Type: research

Preface: Perspectives on Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 and Its Implications for Diagnostics, Biology, and Clinical Management
(Source: Clinics in Laboratory Medicine)
Source: Clinics in Laboratory Medicine - December 20, 2021 Category: Laboratory Medicine Authors: Daimon P. Simmons, Peter H. Schur Source Type: research

Severe Acute Respiratory Syndrome Coronavirus 2 Antigens as Targets of Antibody Responses
Humoral immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during acute infection and convalescence has been widely studied since March 2020. In this review, the authors summarize literature on humoral responses to SARS-CoV-2 antigens with a focus on spike, nucleocapsid, and the receptor-binding domain as targets of antibody responses. They highlight serologic 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, the authors discuss antibody responses during ...
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

Severe Acute Respiratory Syndrome Coronavirus 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 health care. In addition, SARS-CoV-2 has placed a spotlight on laboratory medicine and its 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 informat...
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Patricia R. Slev Source Type: research

Antibody Dynamics and Durability in Coronavirus Disease-19
Severe acute respiratory syndrome coronavirus 2 (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 ...
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 Coronavirus Disease-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. Serologic assays detect humoral responses to the virus, to determine seroprevalence in target populations, or induction of antibodies at t...
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 Severe Acute Respiratory Syndrome Coronavirus 2 with Food and Drug Administration Emergency Use Authorization
This review provides a broad summary of the performance characteristics of high-throughput severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic assays with Food and Drug Administration Emergency Use Authorization, which are commonly found in central clinical laboratories. In addition, 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 Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies
The COVID-19 pandemic has resulted in the development, validation, and rapid adoption of multiple novel diagnostic approaches. Hundreds of SARS-CoV-2 serologic assays have been developed and deployed to contain the spread of the virus, and to supply timely and important health information. Most of these serologic assays were based on a conventional enzyme-linked immunosorbent assay or the lateral flow assay format. The immunoassays that were developed were based on alternative technologies and are highlighted in this article with a brief discussion of the assay principle and the pros and cons for each assay. Measurement of...
Source: Clinics in Laboratory Medicine - November 2, 2021 Category: Laboratory Medicine Authors: Rashmi Patel, Siddharth Khare, Vinay S. Mahajan Source Type: research