CE-Marked Blood Assay Automates Tuberculosis Infection Testing

Tuberculosis continues to pose a major global health challenge, with an estimated 10.7 million people falling ill and 1.23 million deaths in 2024. Roughly one quarter of the world’s population is believed to harbor latent infection, and 5–10% may progress to active disease during their lifetime. Faster, scalable laboratory testing is essential to interrupt transmission and support preventive treatment in high‑risk groups. Roche now announces a CE‑marked blood assay designed to identify tuberculosis infection in routine clinical laboratories.

Roche’s Elecsys IGRA TB test is a blood‑based Interferon Gamma Release Assay (IGRA) for identifying tuberculosis infection (TBI, also known as latent TB) in routine settings. Performed on the company’s cobas immunoassay systems, the solution is designed to reduce reliance on manual workflows through automation and digital tools. It can deliver results in under 24 hours, and the IGRA processing time is 19 minutes per patient, approximately half that of currently used methods.

Image: Performed on Roche’s cobas immunoassay systems, the test helps laboratories meet growing tuberculosis testing needs by automating workflows (Photo courtesy of Roche)

The assay can be paired with Roche’s molecular cobas MTB and cobas MTB‑RIF/INH tests to support workflows that address both tuberculosis infection and active disease. A dedicated digital tool automates result calculation, interpretation, and reporting to provide rapid, traceable outputs while conserving laboratory resources. The test is also designed to integrate with third‑party automated liquid handlers for pre‑incubation steps, with a long‑term automation roadmap that includes fully integrated proprietary front‑end solutions.

Clinical performance was evaluated in a global, multi‑center study across low‑ and high‑incidence settings in the European, Western Pacific, African, and Americas regions. In the intended‑use population—individuals undergoing tuberculosis infection testing as part of clinical care—Elecsys IGRA TB achieved 91.12% positive percent agreement and 94.57% negative percent agreement versus standard‑of‑care methods. In patients with bacteriologically confirmed tuberculosis disease, the assay showed 100% relative sensitivity compared with an established IGRA, and specificity was 95.32% in a low‑risk cohort.

IGRA and tuberculin skin testing are established approaches for identifying infection. IGRAs are described as offering higher accuracy and reliability while requiring only a single patient visit and showing minimal interference from Bacillus Calmette‑Guérin vaccination. Expanding access to reliable diagnostics is aligned with World Health Organization targets to reduce tuberculosis deaths by 90% and new cases by 80% by 2030.

“Addressing latent tuberculosis is critical to reducing the global health burden of this devastating disease, and that begins with better, more accessible testing. 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.” said Matt Sause, CEO of Roche Diagnostics.