BREA, Calif., June 29,
2020 /PRNewswire/ -- Beckman Coulter
today announced that its Access SARS-CoV-2 IgG assay has
received Emergency Use Authorization (EUA) from the U.S. Food &
Drug Administration (FDA). Beckman
Coulter has already shipped tests to more than 400
hospitals, clinics and diagnostics laboratories in the U.S., 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.
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%."
"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%.1,2"
Additionally, of the tests developed by the top four in
vitro diagnostic manufacturers capable of delivering
high-volume testing to the U.S., 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. 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.3
Beckman Coulter has more than
16,000 immunoassay analyzers worldwide, 3,500 of which are in
the United States. 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. 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.
"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."
Sawyer Montgomery added, "Our
assay can be utilized in a variety of healthcare settings,
including central laboratories, as well as smaller clinics and
hospitals in underserved communities with a range of Beckman Coulter immunoassay analyzers. This
accessibility is vital to ensuring all communities, including
minority, rural and urban have access to this testing and answers
they can trust."
While immunoglobulin M (IgM) antibodies play a prominent role in
the body's primary antibody response to infection, they decline
within a short timeframe. IgG antibodies begin developing within
the first 14 days, and may last for months or years depending upon
the pathogen and the individual.
Dr. Feinglass added, "We developed the Access SARS-CoV-2 IgG
test to help clinicians determine if a patient was infected with
COVID-19 in the past and developed an immune response. In contrast,
a total antibody test can't help a clinician determine whether an
individual is currently infected or whether they developed an
immune response from an earlier infection. The clinician must
therefore perform additional testing, requiring added time and
cost."
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 100% Positive Percent Agreement
(sensitivity) and 99.6% Negative Percent Agreement (specificity)
and at 18 days post PCR confirmed positive test. The assay uses
immobilized virus antigens on magnetic particles to capture IgG
antibodies from patient blood or serum samples and reveals them
using labeled 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.
Beckman Coulter will continue to
focus on bringing innovative tests to market, and will be seeking
EUA for IL-6 and Access SARS-CoV-2 IgM 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 the fight against COVID-19, visit:
www.BeckmanCoulter.com/Coronavirus.
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.
Media
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Beckman
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Whiteboard video and
other video assets
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B-Roll footage of
Access SARS-CoV-2 IgG Assay being shipped from Hebron, KY Beckman
Coulter and lab footage
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Infographics, medical
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References:
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1 At 3.5% prevalence rate,
PPV is 90.1%; at 16% prevalence rate PPV is 97.9%. When equivocal
results are excluded, a 2% prevalence rate yields a 91.1% PPV and a
16% prevalence rate yields 99% PPV.
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2 Koenig, D. Evidence
Mounts for Greater COVID Prevalence, WebMD,
https://www.webmd.com/lung/news/20200424/more-data-bolsters-higher-covid-prevalence
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3 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
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© 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