Company has ramped manufacturing capacity to deliver 30
million tests per month
Serology test detects IgG antibodies targeting the
receptor-binding domain of the spike protein and has confirmed 100%
sensitivity and 99.8% specificity
Test helps identify donors of convalescent plasma in
combatting second wave of infections
BREA, California, June 15, 2020 /PRNewswire/ -- Beckman
Coulter today announced that its Access SARS-CoV-2 IgG assay is now
available in markets accepting the CE Mark. The company has already
shipped tests to more than 400 hospitals, clinics and diagnostics
laboratories in the U.S. and has begun shipping to customers
globally. Beckman Coulter has more than 16,000 immunoassay
analyzers worldwide and has ramped its manufacturing to deliver
more than 30 million tests a month.
Henry Ford Health System was one of the first health systems to
receive Beckman Coulter's test and independently validate its
performance.
"We selected the Beckman Coulter Access SARS-CoV-2 IgG antibody
assay to be the backbone of Henry
Ford's COVID-19 serology testing program because of its
outstanding performance in our rigorous independent evaluation,"
said Dr. Bernard C Cook, Division Head of Chemistry-Pathology,
Henry Ford Health System. "Henry
Ford found when running the Beckman Coulter SARS-CoV-2
assay on 204 PCR-confirmed COVID-19 patient samples, a test
sensitivity of 100% at 14 days post-PCR and testing of 80
patient samples from the pre-COVID era yielded a specificity
of 100%."
The Beckman Coulter Access SARS-CoV-2 IgG assay detects
immunoglobulin G (IgG), and 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. This is significant as
antibodies that 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.1
"Our assay has the potential to identify individuals who have
already mounted an immune response to the novel coronavirus and
could donate convalescent plasma for use in combatting the disease
in seriously ill patients," said Julie
Sawyer Montgomery, president of Beckman Coulter.
"Convalescent plasma therapy will be a critical tool in our
treatment arsenal in the absence of an effective vaccine as we look
toward the fall and winter when many epidemiologists anticipate a
second large wave of infections."
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. This test seamlessly
integrates into laboratory workflows making it easy to add serology
testing to routine blood tests performed during inpatient and
wellness testing, so health systems can begin to comprehensively
determine the immune status of their communities.
"An IgG antibody assay such as the test Beckman Coulter has
developed can provide valuable information regarding community
levels of immunity that will inform public health decision making
and rollout of a vaccine when one does become available," said
Shamiram R. Feinglass, M.D., MPH,
chief medical officer Beckman Coulter. "The very high sensitivity
and specificity of this assay provides a high positive predictive
value, even when overall incidence of disease is low. Additionally,
since our assay can be run on multiple different types of
analyzers, it can be adapted to a variety of healthcare settings to
best meet the needs of each community."
Beckman Coulter will continue to focus on bringing innovative
tests to market, and will be seeking CE Mark for its Access
SARS-CoV-2 IgM assay in the near future. For the latest information
on the Access SARS-CoV-2 IgG assay, or for more information about
Beckman Coulter's commitment to fight against COVID-19, visit:
www.BeckmanCoulter.com/Coronavirus.
About the Access SARS-CoV-2 IgG Assay
The Access
SARS-CoV-2 IgG Assay is a qualitative immunoassay that detects IgG
antibodies directed to the receptor-binding domain of the spike
protein of the novel coronavirus that is driving the ongoing global
pandemic. It is believed that these antibodies have the potential
to be neutralizing antibodies and may play a role in lasting
immunity. The test has a confirmed 99.8% specificity and 100%
sensitivity at 18 days post PCR confirmed positive test. The assay
uses immobilized virus antigens on magnetic particles to capture
IgG antibodies from patient serum or plasma samples and reveals
them using labelled anti-IgG antibodies. The Access SARS-CoV-2 IgG
assay can 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 DxCi and Access 2 analyzers
for smaller labs and healthcare clinics. The assay can be
seamlessly integrated into existing workflows without batch
processing.
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, California,
and has more than 11,000 global associates working diligently to
make the world a healthier place.
1 Grifoni, A., et al., Targets of T cell responses to
SARS-CoV-2 coronavirus in humans with COVID-19 disease and
unexposed individuals, Cell (2020), prepublication, doi:
https://doi.org/10.1016/j.cell.2020.05.015
© 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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