Launched in countries accepting the CE mark, the new test has been designed to detect individuals with an adaptive T-cell response to the SARS-CoV-2 virus, indicating whether the person has immunity protection after infection or vaccination.
It combines the cobas IGRA SARS-CoV-2 Tubes for in vitro T cell stimulation and an automated electrochemiluminescence immunoassay (ECLIA) for interferon-gamma measurement to detect the T cell-mediated immune response to the virus in human whole blood.
The Elecsys IGRA SARS-CoV-2 test provides physicians with information regarding the T cell response of a patient and allows them to make better care decisions.
It uses 189 different SARS-CoV-2 antigens that cover the viral genome and host HLA subtypes. The assay has been developed for robustness against viral variants and population diversity.
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Roche Diagnostics CEO Thomas Schinecker said: “The Elecsys IGRA SARS-CoV-2 test can provide a deeper understanding into immune response.
“This, in turn, may help to understand and identify those at higher risk of progressing to severe disease during an existing or future infection.
“This is particularly important in immunocompromised and high-risk patient groups that represent up to 20% in a given population.”
The company stated that the launch of the Elecsys IGRA SARS-CoV-2 test adds another important diagnostic solution to its portfolio of Covid-19 solutions, which have been developed to assist public health authorities, health care providers and patients in the fight against the pandemic.
Last month, the company’s Elecsys Amyloid Plasma Panel received breakthrough device designation from the US Food and Drug Administration (FDA).