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
LGC Clinical Diagnostics

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

Flocked Swab
HydraFlock and PurFlock Ultra
Gold Supplier
SARS-COV-2 PLUS UK Real Time PCR kit
SARS-COV-2 PLUS UK REALTIME PCR KIT
New
Lung Cancer Molecular Diagnostic Test
LENA S1
New
Helminth Multiplex PCR Assay
Allplex GI-Helminth(I) Assay

Print article

Channels

Clinical Chem.

view channel
Image: Electrochemical cells etched by laser on wooden tongue depressor measure glucose and nitrite in saliva (Photo courtesy of Analytical Chemistry)

Biosensor-Fabricated Wooden Tongue Depressor Measures Glucose and Nitrite in Saliva

Physicians often use tongue depressors to examine a patient's mouth and throat. However, it is hard to imagine that this simple wooden tool could actively assess a patient's health. This idea has led to... Read more

Hematology

view channel
Image: The Atellica HEMA 570 and 580 hematology analyzers remove workflow barriers (Photo courtesy of Siemens)

Next-Gen Hematology Analyzers Eliminate Workflow Roadblocks and Achieve Fast Throughput

Hematology testing is a critical aspect of patient care, utilized to establish a patient's health baseline, track treatment progress, or guide timely modifications to care. However, increasing constraints... Read more

Immunology

view channel
Image: Newly observed anti-FSP antibodies have also been found to predict immune-related adverse events (Photo courtesy of Calviri)

First Blood-Based Biomarkers Test to Predict Treatment Response in Cancer Patients

Every year worldwide, lung cancer afflicts over two million individuals and almost the same number of people succumb to the disease. This malignancy leads the charts in cancer-related mortalities, with... Read more

Microbiology

view channel
Image: The rapid MTB strip test for tuberculosis can identify TB patients within two hours (Photo courtesy of Chulalongkorn University)

Rapid MTB Strip Test Detects Tuberculosis in Less Than an Hour without Special Tools

Tuberculosis (TB), a highly infectious disease, continues to pose significant challenges to public health worldwide. TB is caused by a bacterium known as "Mycobacterium tuberculosis," spreading through... Read more

Pathology

view channel
Image: The UNIQO 160 (CE-IVDR) advances diagnostic analysis for autoimmune diseases (Photo courtesy of EUROIMMUN)

Novel Automated IIFT System Enables Cutting-Edge Diagnostic Analysis

A newly-launched automated indirect immunofluorescence test (IIFT) system for autoimmune disease diagnostics offers an all-in-one solution to enhance the efficiency of the complete IIFT process, comprising... Read more

Technology

view channel
Electronic biosensor uses DNA aptamers for detecting biomarkers in whole blood samples (Photo courtesy of Freepik)

Electronic Biosensor Detects Biomarkers in Whole Blood Samples without Addition of Reagents

The absence of robust, reliable, and user-friendly bioanalytical tools for early and timely diagnosis of cardiovascular diseases, particularly sudden cardiac arrest, leads to preventable deaths and imposes... Read more

Industry

view channel
Image: The global HbA1c testing devices market is expected to reach USD 2.56 billion in 2027 (Photo courtesy of Freepik)

Global Hemoglobin A1c Testing Devices Market Driven by Rising Prevalence of Diabetes

Hemoglobin A1c (HbA1c), or glycated hemoglobin, refers to hemoglobin with glucose attached. HbA1c testing devices are used for blood tests that determine average blood glucose, or blood sugar levels.... Read more
Copyright © 2000-2023 Globetech Media. All rights reserved.