Agilent Launches New Immunoassay Kit to Detect SARS-CoV-2 Antibodies

Agilent Technologies (Santa Clara, CA, USA) has launched 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 entry into SARS-CoV-2 testing in the US, 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 proved to be 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. Agilent has developed the SARS-CoV-2 IgG ELISA assay using microplate liquid handlers and plate readers from its recent acquisition of BioTek.

Leveraging its expertise as a provider of high-quality antibodies and assay solutions for many top IVD manufacturers globally, Agilent is introducing the high-performance kit as its initial entry into SARS-CoV-2 serological testing. This is the first of multiple tests that are planned by the company 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.

"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.”


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