Agilent Technologies has launched a new immunoassay kit for the qualitative detection of SARS-CoV-2 immunoglobulin G (IgG) antibodies in human serum or plasma.

A qualitative two-step indirect ELISA, the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit is intended to be used for detecting people with an adaptive immune response to SARS-CoV-2, signifying recent or prior infection.

The kit marks Agilent’s entrance into SARS-CoV-2 testing in the US. The company plans to register the kit in other markets, including Canada, Europe, and some of the Asia Pacific and Latin American countries this year.

Clinical study results showed that the SARS-CoV-2 IgG ELISA kit is a highly accurate immunoassay with a sensitivity of 98.9% and specificity of 98.8%.

Agilent Diagnostics and Genomics Group president Sam Raha said: “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.

“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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The kit has consumables required for meeting the needs of small to medium-sized clinical labs in providing easy and sustainable access to serology tests with an increase in demand.

It has all the necessary reagents, including negative, positive, and cut-off controls, making it a ready-to-use solution for facilitating labs in consistently carrying out dependable SARS-COV-2 serological testing.

With the acquisition of BioTek recently, the company has further expanded its position as a comprehensive provider of the hardware, software, assays, and support that labs require to perform serological assays.

Last November, Agilent Technologies introduced the new NanoDis System to address the pharma industry’s need for compliant, semi-automated testing of nanoparticle drug formulations.