BREA, Calif., Oct. 9, 2020 /PRNewswire/ -- Beckman Coulter, a
clinical diagnostics leader, today announced its Access
SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration
(FDA). The assay detects antibodies that recognize the
receptor binding domain (RBD) of the spike protein which the
SARS-CoV-2 virus uses to enter the human host cells. The assay,
which demonstrates 99.9% specificity and 98.3% sensitivity, is part
of a suite of diagnostic solutions being developed by Beckman
Coulter in response to the ongoing COVID-19 pandemic to guide
physicians and patients in their healthcare decision making.
Beckman Coulter's Access SARS-CoV-2 IgM antibody assay receives
Emergency Use Authorization from the U.S. FDA
"Since March, the Beckman Coulter team has worked around the
clock to develop a suite of assays that play a critical role in the
ongoing global fight against COVID-19," said Julie Sawyer Montgomery, president of Beckman
Coulter. "As a science-driven company, we continue in our
commitment to deliver rigorously validated diagnostics of the
highest quality that provide meaningful information, so doctors and
patients alike can trust the results for urgent, care
decisions."
Beckman Coulter's suite of COVID-19 testing solutions includes
the Access SARS-CoV-2 IgM assay and the Access SARS CoV-2 IgG
assay, which received EUA in June. The company also recently
received FDA Emergency Use Authorization for its interleukin 6
(IL-6) assay, which can be used to assist in identifying severe
inflammatory response in patients with confirmed COVID 19 illness
to aid in determining the risk of intubation with mechanical
ventilation, in conjunction with clinical findings and the results
of other laboratory testing. Beckman Coulter is also currently
developing a SARS CoV-2 antigen assay as well as a quantitative IgG
assay anticipated to be launched later this year.
All of the Beckman Coulter assays to address COVID-19 can be
performed in automated or high-throughput immunoassay formats, as
well as 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. Additionally, all of the assays
seamlessly integrate into laboratory workflows making it easy to
add these tests to routine blood tests performed during inpatient
and wellness testing.
For more information on Beckman Coulter's suite of testing
solutions or its commitment to the fight against COVID-19, visit:
www.BeckmanCoulter.com/Coronavirus.
About the Access SARS-CoV-2 IgM Assay
The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay
that detects IgM antibodies. The test has confirmed 98.3% positive
percent agreement (sensitivity) at 15-30 days post symptom onset
and 99.9% negative percent agreement (specificity). The assay
utilizes an immunocapture format to bind patient IgM antibodies on
the magnetic particle solid phase and a recombinant SARS-CoV-2
protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The
Access SARS-CoV-2 IgM assay can be used in Random Access Mode
(RAM), which means that the antibody tests can be run along with
other immunoassay tests. The assay can also be used with a variety
of Beckman Coulter analyzers, including the high-throughput DxI 800
designed for large labs, to the DxI 600 for mid-sized labs and the
DxC 600i and Access 2 analyzers for smaller labs and healthcare
clinics.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every
person by applying the power of science, technology and the passion
and creativity of our teams to enhance the diagnostic laboratory's
role in improving healthcare outcomes. Our diagnostic systems are
used in complex biomedical testing, and are found in hospitals,
reference laboratories and physician office settings around the
globe. Beckman Coulter offers a unique combination of people,
processes and solutions designed to elevate the performance of
clinical laboratories and healthcare networks. We do this by
accelerating care with a menu that matters, bringing the benefit of
automation to all, delivering greater insights through clinical
informatics and unlocking hidden value through performance
partnership. An operating company of Danaher Corporation (NYSE:
DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global
associates working diligently to make the world a healthier
place.
© 2020 Beckman Coulter. All rights reserved. Beckman Coulter,
the stylized logo, and the Beckman Coulter product and service
marks mentioned herein are trademarks or registered trademarks of
Beckman Coulter, Inc. in the United
States and other countries.
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SOURCE Beckman Coulter Diagnostics