Swiss healthcare company Roche has introduced the Elecsys IGRA SARS-CoV-2 test in countries that accept the CE Mark approval.
The new Elecsys test is designed to help identify people with an adaptive T-cell response to SARS-CoV-2, which indicates their past exposure to the virus or Covid-19 vaccination.
It combines the in-vitro T-cell stimulation with an automated electrochemiluminescence immunoassay (ECLIA) for interferon gamma to detect T cell-mediated immune response.
The T-cell stimulation is achieved using SARS‐CoV‐2 antigens in the cobas IGRA SARS‐CoV‐2 Tubes, that Roche had developed in partnership with LG Chem Life Sciences.
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 test results can help healthcare professionals to provide them with long-term guidance like appropriate treatment.”
Roche said that the new Elecsys IGRA SARS-CoV-2 test will support the better understanding of immune response to SARS-CoV-2 infection and vaccination.
It runs on the cobas e 411, e 601/602, e 402 and e 801 analysers, and provides a fully automated random-access workflow.
In addition, the new test will enable better-informed decisions around care, sanitary measures and treatment options, and is crucial for at-risk patient groups, said Roche.
According to the company, antibody testing has been adopted to measure antibody-mediated immunity.
Similarly, measuring the complementary T-cell response may play an important role in determining the overall protection level achieved, said Roche.
The new Elecsys IGRA SARS-CoV-2 test is the company’s new diagnostic solution, said to help health care providers, public health authorities, and patients in fight against Covid-19.
Last month, Roche has received Breakthrough Device Designation from the US FDA, for its Elecsys Amyloid Plasma Panel, which helps in early detection of Alzheimer’s disease (AD).
Its new Elecsys Amyloid Plasma Panel is said to detect and measure AD biomarkers in blood plasma to indicate the need for further confirmatory testing.
