Product News: Roche launches new diagnostic test for the better understanding of immune response to SARS-CoV-2

The test detects T-cell response, which may play an important role in determining if immune protection has been achieved

18 Aug 2022


Roche has announced the launch of the Elecsys® IGRA SARS-CoV-2 test in countries that accept the CE Mark1. The Elecsys IGRA SARS-CoV-2 test supports the better understanding of immune response to SARS-CoV-2 infection and vaccination. The test will be an additional tool to make better-informed decisions around care, sanitary measures and treatment options. This will be particularly important for at-risk patient groups. 

With the transition from a pandemic to an endemic state of COVID-19, there is an increasing need to better understand the adaptive response of the human immune system to SARS-CoV-2. An effective antiviral immune response requires coordinated T- and B-cell activities. While B-cells produce antibodies that can potentially neutralise viruses, T-cells can target infected cells to prevent further viral replication and spread. SARS-CoV-2 infection, as well as COVID-19 vaccination, induce both T- and B-cell responses, in people with a normally functioning immune system, and a timely and well-coordinated T- and B-cell response is likely the key in infection control.

While antibody testing has been adopted to measure antibody-mediated immunity, there is increasing evidence that measuring the complementary T-cell response may play an important role in determining the overall protection level achieved2,3. The Elecsys IGRA SARS-CoV-2 test is intended as an aid in identifying individuals with an adaptive T-cell response to SARS-CoV-2, which is indicative of past exposure to the virus or COVID-19 vaccination. 

“The Elecsys IGRA SARS-CoV-2 test can provide a deeper understanding into immune response,” said Thomas Schinecker, CEO of Roche Diagnostics. “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 population4. The test results can help healthcare professionals to provide them with long-term guidance like appropriate treatment.”

With the launch of Elecsys IGRA SARS-CoV-2 test, Roche adds another important diagnostic solution to its COVID-19 portfolio to help health care providers, public health authorities, and patients in the fight against the COVID-19 pandemic. This further highlights Roche’s commitment to support clinicians and their patients in reducing the impact of infectious diseases.

About the Elecsys IGRA SARS-CoV-2 test

The Elecsys® IGRA SARS-CoV-2 test is intended as an aid in identifying individuals with an adaptive T-cell response to SARS-CoV-2, indicative of past exposure to the virus or COVID-19 vaccination. The Elecsys IGRA SARS‐CoV‐2 test combines in vitro T-cell stimulation, using SARS‐CoV‐2 antigens in the cobas IGRA SARS‐CoV‐2 Tubes developed in cooperation with LG Chem Life Sciences and an automated electrochemiluminescence immunoassay (“ECLIA”) for interferon gamma to qualitatively detect T cell-mediated immune response to SARS‐CoV‐2 in human whole blood.

Using SARS-CoV-2 antigens with a broad viral genome and HLA coverage the assay is designed for robustness against viral variants and population variability. The product runs on the cobas e 411, e 601/602, e 402 and e 801 analysers providing a fully automated random access workflow. 

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References 

1.Elecsys IGRA SARS-CoV-2, Method sheet 2022-06, V 1.0
2. Abbasi, J. JAMA. 2021;326(18):1781–1782;
3. Bonifacius A, et al. Immunity. 2021;54(2):340–354.e6
4. Clark A, et al. Lancet Glob Health. 2020;8(8):e1003-e1017