Roche has received CE Mark approval for its Elecsys IGRA TB test, a new blood testing solution for identifying tuberculosis infection (TBI), also known as latent tuberculosis, in routine laboratory settings.
According to the company, the test can provide results in less than 24 hours, while the Interferon Gamma Release Assay (IGRA) itself takes only 19 minutes per patient to process—approximately half the time of currently used methods.
“Addressing latent tuberculosis is critical to reducing the global health burden of this devastating disease, and that begins with better, more accessible testing,” said Matt Sause, CEO of Roche Diagnostics.
“The Elecsys IGRA TB test brings an automated solution for latent TB to Roche’s industry-leading immunoassay platforms, which will enable screening programs and drive significant progress toward achieving global TB elimination targets,” he added.
Tuberculosis remains one of the world’s most significant public health challenges. In 2024, an estimated 10.7 million people developed the disease, and 1.23 million lost their lives to it. Expanding access to reliable diagnostic tools is considered essential to achieving the World Health Organization’s goal of reducing TB deaths by 90 per cent and new cases by 80 per cent by 2030.
Blood-based IGRA tests and tuberculin skin tests are widely used to detect tuberculosis infections. However, IGRAs provide a less invasive alternative to skin tests, requiring only a single patient visit and reducing dependency on specialised healthcare staff, while offering higher accuracy and reliability. In addition, IGRAs show minimal interference from Bacillus Calmette-Guérin (BCG) vaccinations, which can affect skin test results.
Traditional IGRA testing often relies on labour-intensive manual workflows, increasing the burden on laboratories and the potential for human error. Roche’s new assay addresses these challenges through automation, helping laboratories improve efficiency while expanding testing capacity.
Traditional IGRA testing often involves labour-intensive workflows and manual procedures that significantly burden laboratory resources and increase the risk of errors. Roche’s new Elecsys IGRA TB test addresses these challenges through automation and digital solutions.
When combined with Roche’s cobas MTB and cobas MTB-RIF/INH molecular assays, laboratories get an integrated solution for detecting both latent tuberculosis infection and active TB disease.
The new assay also features a digital tool that automates result calculation, interpretation and reporting, ensuring rapid, reliable and fully traceable results while reducing manual laboratory work. It is compatible with third-party automated liquid handling systems for pre-incubation processing, and Roche plans to introduce fully integrated proprietary front-end automation as part of its long-term laboratory automation strategy.
The Elecsys IGRA TB test was evaluated in a global, multicentre clinical study conducted across low- and high-incidence regions in Europe, the Western Pacific, Africa and the Americas. Among individuals undergoing routine tuberculosis infection testing, the assay achieved a positive per cent agreement of 91.12% and a negative per cent agreement of 94.57% compared with standard-of-care methods.
In patients with bacteriologically confirmed tuberculosis, the test demonstrated 100% relative sensitivity compared with an established IGRA method. It also achieved a specificity of 95.32% in a low-risk population, highlighting its strong diagnostic performance across diverse clinical settings.
