The kit is a qualitative two-step indirect ELISA designed to help identify individuals with an adaptive immune response to SARS-CoV-2
Agilent Technologies has introduced a new Dako SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) kit for the detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma.
The launch marks the entry of the company into SARS-CoV-2 testing in the US.
The firm has completed the notification process with the US Food and Drug Administration (FDA) for the Agilent Dako SARS-CoV-2 IgG kit.
Agilent is also planning to register the assay in other markets this year, including Canada, Europe, and selected Asia Pacific and Latin American countries.
Agilent’s kit is a qualitative two-step indirect ELISA, which will help identify human IgG antibodies to the SARS-CoV-2 S1 RBD protein.
The assay is designed to detect individuals with an adaptive immune response to SARS-CoV-2, thereby helping to indicate recent or prior infection.
Agilent stated that the SARS-CoV-2 IgG ELISA kit demonstrated 98.9% sensitivity and 98.8% specificity in the company’s clinical trial.
The ELISA kit consists of consumables, which will allow small to medium-sized clinical labs to easily access serology tests.
Agilent kit comprises all the required reagents, including negative, positive, and cut-off controls.
The new ready-to-use solution allows labs to consistently execute dependable SARS-COV-2 serological testing, said Agilent.
Agilent’s 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.”
The SARS-CoV-2 IgG ELISA assay has been developed using BioTek microplate liquid handlers and plate readers.