We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Technopath Clinical Diagnostics - An LGC Company

Download Mobile App





AACC Publishes New COVID-19 Guidelines for Clinical Laboratories

By LabMedica International staff writers
Posted on 21 Jul 2021
Print article
Illustration
Illustration
The American Association for Clinical Chemistry (AACC; Washington, DC, USA) has released new guidance that offers answers on SARS-CoV-2 antibodies for clinical laboratorians amidst constant questions and emerging data about serologic testing.

As the COVID-19 pandemic evolved over the past year, so too did available antibody tests for SARS-CoV-2 and clinicians’ understanding of how to use them. In 2020, AACC had published initial recommendations about the use and limitations of serology testing but felt there was a need for a more in-depth guideline. This spring, the expert panel, including professionals from clinical chemistry, microbiology, and immunology laboratories, as well as specialists from in vitro diagnostics, industry, and regulatory agencies, released a document of practical recommendations for implementing and interpreting evolving SARS-CoV-2 emergency use authorization (EUA) and laboratory-developed test (LDT) serologic testing.

The document provides information about serologic assay design, antibody classes, and the kinetics of the humoral immune response, as well as verification and validation of both EUA and LDTs. It also discusses four indications for serologic testing: supporting the diagnosis of COVID-19 and related sequelae (e.g., multisystem inflammatory syndrome in children); identifying potential convalescent plasma donors and manufacturing of convalescent plasma; epidemiologic and seroprevalence studies; and vaccine efficacy studies.

Clinical laboratories can find multiple uses for the document. It could be a reference guide for understanding the host immune response to SARS-CoV-2, antibody kinetics, and available EUA assays; or it could help laboratorians understand the clinical utilities and limitations of serology testing and gain insights into the nuances in implementing EUA or LDT serology testing. Importantly, serology tests are not recommended for diagnostic purposes for SARS-CoV-2 infection. But they could identify different types of antibodies, such as IgG and IgM, and antibodies for S and N proteins or neutralizing antibodies. There are a lot of vaccine-preventable diseases for which laboratories perform serologic testing, although the key is first identifying a minimum antibody threshold or correlate of protective immunity for those pathogens.

“Though various organizations have published guidelines on clinical utilities of serology testing, ours is the first and most comprehensive document we know so far for the implementation of the tests, particularly EUA tests, in clinical laboratories,” said Y. Victoria Zhang, PhD, MBA, vice chair for clinical enterprise strategy and director of clinical chemistry for the University of Rochester Medical Center. “We wanted this guideline to be a reference for our own labs and trainees for implementing EUA and LDT serology tests in-house. It is our intention to provide a full reference for laboratory professionals and healthcare workers to appropriately implement these assays in the clinical laboratory and interpret the results to serve their patient needs during this pandemic.”

Related Links:
AACC

Platinum Supplier
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
New
Lactose Intolerance Test
Lactose Intolerance LCT Kit
New
Silver Supplier
Urea Breath Test
13C-Urea Breath Test
New
Gold Supplier
Automated, Random Access Chemistry Analyzer
LIDA 300

Print article

Channels

Molecular Diagnostics

view channel
Image: The new multiplex QIAstat-Dx Viral Vesicular Panel is designed to support research and surveillance efforts (Photo courtesy of QIAGEN)

First Syndromic Test Differentiates Between Monkeypox and Five Pathogens with Similar Symptoms

A new syndromic test differentiates between monkeypox and five other pathogens which cause similar symptoms. This first-ever test detects the two known forms of monkeypox virus (the so-called West African... Read more

Industry

view channel
Image: The Accelerate Arc Module & BC kit is registered as an IVD (Photo courtesy of Accelerate Diagnostics)

BD and Accelerate Diagnostics Collaborate to Offer Rapid Antimicrobial Identification and Susceptibility Diagnostics

Becton, Dickinson and Company (BD, Franklin Lakes, NJ, USA) and Accelerate Diagnostics, Inc. (Tucson, AZ, USA) have entered into a worldwide commercial collaboration agreement where BD will offer Accelerate's... Read more
Copyright © 2000-2022 Globetech Media. All rights reserved.