Agilent Completes CE-IVD Registration of qRT-PCR In Vitro Diagnostic Kit for SARS-CoV-2 RNA Detection
March 09 2021 - 8:00AM
Business Wire
Kit expands Agilent’s product portfolio aimed at COVID-19
detection
Agilent Technologies Inc. (NYSE: A) today announced the launch
of a real-time reverse transcription (qRT) PCR-based diagnostic kit
for the detection of SARS-CoV-2 RNA. The CE-IVD mark is in
accordance with the European Union In Vitro Diagnostic Directive
98/79/EC and is available for immediate distribution.
The Agilent SARS-CoV-2 qRT-PCR Dx kit is a real-time reverse
transcriptase PCR (qRT-PCR) IVD reagent kit for the detection of
SARS-CoV-2 RNA. Agilent’s kit is intended for the qualitative
detection of CDC-recommended1 N1 and N2 targets from SARS-CoV-2 RNA
isolated and purified from nasopharyngeal swab specimens. The
single-tube assay provides greater efficiency, higher throughput,
less consumable usage, and delivers unambiguous results for
confidence in testing outcomes.
The Agilent SARS-CoV-2 qRT-PCR Dx kit has been designed for
flexibility across the entire workflow. The open system has been
validated with a variety of commercially available RNA extraction
products and multiple real-time PCR systems, which may reduce the
need to purchase new analytical equipment and allows labs to bring
testing online faster. The convenient easy-to-use format requires
minimal manual work, may reduce the potential for human error, and
be amenable to automation to fit any laboratory’s throughput needs.
The kit is also configured so that primers/probes and positive
controls can be purchased together or separately.
“As the global community enters the second year of the pandemic,
the need for accessible and reliable direct diagnostic tests
continues to grow, even as vaccine availability to the public
improves,” said Sam Raha, president of Agilent’s Diagnostics and
Genomics Group. “Fast and reliable detection kits remain a critical
tool in the ongoing effort to control the pandemic.”
The release of this qPCR-based test kit further demonstrates
Agilent’s commitment to the diagnostics community and expands the
portfolio that was initiated with the recent release of the Agilent
SARS-CoV-2 IgG ELISA kit. Together, these two products support a
multi-disciplinary approach to addressing the pandemic, providing
one test for direct virus detection, and one test to assess
post-infection immune response.
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
available at www.agilent.com.
1 Centers for Disease Control and Prevention, Division of Viral
Diseases. CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR
Diagnostic Panel. CDC/DDID/NCIRD/ Division of Viral Diseases
(2020),CDC-006-00019, Revision: 06.
https://www.fda.gov/media/134922/download
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Naomi Goumillout +1.781.266.2819
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
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