Agilent Announces Immunoassay Kit to Detect SARS-CoV-2 Antibodies
February 18 2021 - 8:00AM
Business Wire
Kit marks first of multiple planned for 2021 aimed at
COVID-19
Agilent Technologies Inc. (NYSE: A) today announced the launch
of the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent
Assay (ELISA) kit intended for the qualitative detection of
immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or
plasma. The kit, which marks Agilent’s entrance into SARS-CoV-2
testing in the US, has completed the notification process to FDA in
accordance with Section IV.D of FDA’s “Policy for Coronavirus
Disease-2019 Tests During the Public Health Emergency (Revised)”.
The assay is planned to be registered in other markets in 2021
including Canada, Europe, and selected Asia Pacific and Latin
American countries.
The kit is a qualitative two-step indirect ELISA for the
detection of human IgG antibodies to the SARS-CoV-2 S1 RBD protein.
It is intended for use as an aid in identifying individuals with an
adaptive immune response to SARS-CoV-2, indicating recent or prior
infection. In Agilent’s clinical study, the SARS-CoV-2 IgG ELISA
kit is a highly accurate immunoassay with 98.9% sensitivity and
98.8% specificity.
The ELISA kit includes consumables that meet the needs for small
to medium-sized clinical labs to ensure easy and sustainable access
to serology tests when the demands arise. By providing a kit that
contains all the necessary reagents – including negative, positive,
and cut-off controls – Agilent has developed a ready-to-use
solution that enables labs to consistently execute dependable
SARS-COV-2 serological testing.
"Implementing new technologies into clinical workflows can be
daunting, and the pressures of the SARS-CoV-2 pandemic have further
exacerbated the need for technology solutions that are quick and
easy to implement,” said Sam Raha, president of Agilent’s
Diagnostics and Genomics Group. “Providing turnkey solutions eases
the implementation and validation resources for clinical labs,
which helps lower the barrier to the adoption of additional
SARS-CoV-2 tests.”
With its recent acquisition of BioTek, Agilent has further
strengthened its position as a comprehensive provider of the
hardware, software, assays, and support that labs need to
seamlessly perform serological assays. Agilent has developed the
SARS-CoV-2 IgG ELISA assay using BioTek microplate liquid handlers
and plate readers.
Agilent is a premier provider of high-quality antibodies and
assay solutions for many top IVD manufacturers globally. Leveraging
this expertise, Agilent is introducing a high-performance kit as
its initial entry into SARS-CoV-2 serological testing.
Agilent is committed to supporting its customers throughout the
world by providing solutions for detecting SARS-CoV-2. This is the
first of multiple tests that are planned to support the management
of this disease in patients who have been exposed to COVID-19. In
addition to this immunoassay test, Agilent is developing a
quantitative RT-PCR SARS-CoV-2 test, which will be CE marked in
Europe, as well as registered in additional countries throughout
the world.
Forward-Looking Statements
This news release contains forward-looking statements as defined
in the Securities Exchange Act of 1934 and is subject to the safe
harbors created therein. The forward-looking statements contained
herein include, but are not limited to, information regarding
expansion into other markets, regulatory authorizations, and future
growth plans. These forward-looking statements involve risks and
uncertainties that could cause Agilent’s results to differ
materially from management’s current expectations. Such risks and
uncertainties include, but are not limited to, unforeseen changes
in the strength of Agilent’s customers’ businesses; unforeseen
changes in the demand for current and new products, technologies,
and services; unforeseen changes in the currency markets; customer
purchasing decisions and timing, and the risk that Agilent is not
able to realize the savings expected from integration and
restructuring activities. In addition, other risks that Agilent
faces in running its operations include the ability to execute
successfully through business cycles; the ability to meet and
achieve the benefits of its cost-reduction goals and otherwise
successfully adapt its cost structures to continuing changes in
business conditions; ongoing competitive, pricing and gross-margin
pressures; the risk that its cost-cutting initiatives will impair
its ability to develop products and remain competitive and to
operate effectively; the impact of geopolitical uncertainties and
global economic conditions on its operations, its markets and its
ability to conduct business; the ability to improve asset
performance to adapt to changes in demand; the ability of its
supply chain to adapt to changes in demand; the ability to
successfully introduce new products at the right time, price and
mix; the ability of Agilent to successfully integrate recent
acquisitions; the ability of Agilent to successfully comply with
certain complex regulations; the adverse impacts of and risks posed
by the COVID-19 pandemic and other risks detailed in Agilent’s
filings with the Securities and Exchange Commission, including its
annual report on Form 10-K for the fiscal year ended October 31,
2020. Forward-looking statements are based on the beliefs and
assumptions of Agilent’s management and on currently available
information. Agilent undertakes no responsibility to publicly
update or revise any forward-looking statement.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in life
sciences, diagnostics, and applied chemical markets, delivering
insight and innovation toward improving the quality of life.
Agilent instruments, software, services, solutions, and people
provide trusted answers to customers' most challenging questions.
The company generated revenue of $5.34 billion in fiscal 2020 and
employs 16,400 people worldwide. Information about Agilent is
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Naomi Goumillout +1.781.266.2819
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
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