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
PURITAN MEDICAL

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 Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
Anti-Cyclic Citrullinated Peptide Test
GPP-100 Anti-CCP Kit
Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The study showed the blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% (Photo courtesy of Guardant Health)

Blood Test Shows 83% Accuracy for Detecting Colorectal Cancer

Colorectal cancer is the second biggest cause of cancer deaths among adults in the U.S., with forecasts suggesting 53,010 people might die from it in 2024. While fewer older adults are dying from this... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read more

Microbiology

view channel
Image: The new platform is designed to perform blood-based diagnoses of nontuberculosis mycobacteria (Photo courtesy of 123RF)

New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don't cause any problems.... Read more

Industry

view channel
Image: These new assays are being developed for use on the recently introduced DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics (Brea, CA, USA) and Fujirebio Diagnostics (Tokyo, Japan) have expanded their partnership focused on the development, manufacturing and clinical adoption of neurodegenerative... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.