Agilent Completes CE-IVD Registration of qRT-PCR In Vitro Diagnostic Kit for SARS-CoV-2 RNA Detection

Rhea-AI Summary

Agilent Technologies (NYSE: A) has launched a real-time reverse transcription PCR-based diagnostic kit for SARS-CoV-2 RNA detection, receiving the CE-IVD mark as per EU regulations. This kit allows for high-throughput testing with reduced manual handling and human error risk. It is compatible with various RNA extraction products and PCR systems, expediting laboratory operations. The kit supports pandemic control efforts alongside Agilent's recent SARS-CoV-2 IgG ELISA kit, enhancing its diagnostics offerings.

Positive

• Launch of SARS-CoV-2 qRT-PCR diagnostic kit enhances product portfolio.
• Kit offers high efficiency and greater throughput, reducing manual handling.
• Compatibility with multiple extraction products and PCR systems facilitates faster lab testing.

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• None.

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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FAQ

What is the new product launched by Agilent Technologies?

Agilent Technologies launched a real-time reverse transcription PCR-based diagnostic kit for the detection of SARS-CoV-2 RNA.

What is the significance of the CE-IVD mark for Agilent's new kit?

The CE-IVD mark indicates the kit complies with EU In Vitro Diagnostic Directive, allowing immediate distribution in Europe.

How do Agilent's SARS-CoV-2 testing kits support pandemic efforts?

These kits provide reliable virus detection and assess post-infection immune response, critical in controlling the pandemic.

What financial performance did Agilent Technologies report in 2020?

Agilent Technologies generated revenue of $5.34 billion in fiscal 2020.

What are the benefits of the Agilent SARS-CoV-2 qRT-PCR Dx kit?

The kit provides unambiguous results, high throughput, and is designed for flexibility across laboratory workflows.