Agilent Technologies Inc. has 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 of 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.

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.

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