Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

BECKMAN COULTER, INC.

Beckman Coulter develops, manufactures and markets laboratory systems, reagents, centrifugation, lab automation, elec... read more Featured Products: More products

Download Mobile App





Beckman Coulter's SARS-CoV-2 IgG Antibody Test Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 30 Jun 2020
Beckman Coulter (Brea, CA, USA) has received Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) for its Access SARS-CoV-2 IgG assay.

Among the tests developed by the top four in vitro diagnostic manufacturers capable of delivering high-volume testing to the US, Beckman Coulter's test is the only SARS-CoV-2 IgG assay which targets antibodies that recognize the receptor binding domain (RBD) of the spike protein which SARS-CoV-2 uses to bind to a human cell receptor. More...
This is significant as antibodies which target the RBD have the potential to be neutralizing and thus prevent future infection by blocking the virus from entering the cell. It is for this reason many vaccine developers are also targeting the RBD of the spike protein in their vaccine development.

Beckman Coulter has more than 16,000 immunoassay analyzers worldwide, 3,500 of which are in the US. Many of Beckman Coulter's analyzers can deliver up to 400 routine tests an hour. A large number of analyzers are connected to hospital information systems, enabling laboratories to automate the reporting of serology test results. The Access SARS-CoV-2 IgG test can also be run on Beckman Coulter's Access 2 analyzer, a compact table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. The test seamlessly integrates into laboratory workflows making it easy to add serology testing to routine blood tests performed during inpatient and wellness testing. This type of testing can enable health systems to comprehensively determine the immune status of their communities and potentially identify individuals that are eligible for future plasma donation.

Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the US, and has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark. The company is able to deliver more than 30 million tests a month.

"At a time when significant confusion was created by the initial influx of poor-quality antibody tests, our team worked meticulously to develop a highly sensitive and specific assay," said Julie Sawyer Montgomery, president of Beckman Coulter. "With 100% Positive Percent Agreement and 99.6% Negative Percent Agreement, our test significantly reduces the risk for false positives, delivering the results that health care providers and their patients can trust. A lot has been written about accuracy issues with the initially launched antibody tests, but a test at this level offers positive predictive values greater than 90% even in very low prevalence communities. And, in areas hardest hit by the virus, the positive predictive values of our assay are greater than 98%."

"We anticipate that understanding the immune status of communities and convalescent plasma donation will play important roles in the fight against COVID-19 before a vaccine is widely available," said Shamiram R. Feinglass, M.D., MPH, chief medical officer Beckman Coulter. "While there is more to learn regarding how long an individual's immune response to the SARS-CoV-2 virus lasts, this test may be crucial to determining the portion of the population that may already be immune."



Gold Member
Multiplex Genetic Analyzer
MassARRAY Dx Analyzer (Europe only)
Portable Electronic Pipette
Mini 96
New
Sperm Quality Analyis Kit
QwikCheck Beads Precision and Linearity Kit
New
Autoimmune Liver Diseases Assay
Microblot-Array Liver Profile Kit
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Immunology

view channel
Image: The VENTANA HER2 (4B5) test is now CE-IVDR approved (Photo courtesy of Roche)

Companion Diagnostic Test Identifies HER2-Ultralow Breast Cancer and Biliary Tract Cancer Patients

Breast cancer is the most common cancer in Europe, with more than 564,000 new cases and 145,000 deaths annually. Metastatic breast cancer is rising in younger populations and remains the leading cause... Read more

Technology

view channel
Image: Conceptual design of the CORAL capsule for microbial sampling in the small intestine (H. Mohammed et al., Device (2025). DOI: 10.1016/j.device.2025.100904)

Coral-Inspired Capsule Samples Hidden Bacteria from Small Intestine

The gut microbiome has been linked to conditions ranging from immune disorders to mental health, yet conventional stool tests often fail to capture bacterial populations in the small intestine.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.