Roche receives CE Mark for blood test to identify tuberculosis infection

Roche has received the CE Mark for its Elecsys IGRA TB test, a new blood-based solution for identifying tuberculosis infection (TBI, also known as latent TB) in routine laboratory settings.

The Elecsys IGRA TB test is performed on Roche’s cobas^® immunoassay systems, enabling laboratories across Europe and other CE Mark regions to diagnose tuberculosis infection quickly and efficiently, support tuberculosis screening programs, and advance progress toward the World Health Organization (WHO) global TB elimination targets.

Expanding access to tuberculosis infection testing

The Elecsys IGRA TB test expands global access to tuberculosis infection testing by offering a rapid, high-throughput, and cost-effective solution. The Interferon Gamma Release Assay (IGRA) takes just 19 minutes per patient to process, approximately half the time of currently used methods, and delivers reliable results in under 24 hours.

By running on Roche’s industry-leading cobas immunoassay systems, the test reduces reliance on manual workflows through automation and digital solutions, helping laboratories meet growing tuberculosis infection testing needs.

Addressing a major global public health challenge

Tuberculosis remains one of the world’s most significant public health challenges. Diagnosis of tuberculosis infection is essential to breaking the cycle of disease progression and transmission, preventing severe health complications, and guiding decisions about preventive treatment in high-risk populations. Expanding access to reliable diagnostics remains critical to achieving the WHO global elimination targets, which aim to decrease tuberculosis deaths by 90% and new cases by 80% by 2030¹.

Benefits of blood-based IGRA testing for tuberculosis infection

Blood-based IGRA tests and tuberculin skin tests are established methods for identifying tuberculosis infections. In addition to offering higher accuracy and reliability, IGRAs provide a less invasive alternative to skin tests, requiring only a single patient visit and reducing dependency on specialized healthcare staff.

Unlike tuberculin skin tests, IGRAs show minimal interference from Bacillus Calmette-Guérin (BCG) vaccinations, which remain widely used worldwide².

Traditional IGRA testing often involves labor-intensive workflows and manual procedures that significantly burden laboratory resources. These demanding processes increase the risk of errors and create barriers for laboratories attempting to implement more reliable blood-based testing methods or scale their operations to meet the rising demand for tuberculosis infection diagnostics.

Automated, integrated solution on cobas immunoassay systems

By pairing the Elecsys IGRA TB test with existing molecular cobas MTB and cobas MTB-RIF/INH assays, laboratories gain an integrated solution for managing both tuberculosis infection and active TB disease. This combined approach supports comprehensive TB testing strategies in both low-incidence and high-incidence settings.

The Elecsys IGRA TB assay will feature a novel digital tool to fully automate result calculation, interpretation, and reporting. This digital solution ensures rapid, reliable, and fully traceable results while freeing up valuable laboratory resources. To further reduce manual workloads, the Elecsys IGRA TB assay is designed to integrate seamlessly with third-party automated liquid handlers for front-end processes prior to tube incubation.

Roche’s long-term automation roadmap includes plans to introduce fully integrated, proprietary front-end automation. This will allow laboratories to optimize their workflows now while preparing for complete, end-to-end operational efficiency in the future.

Clinical performance data for Elecsys IGRA TB

The performance of Elecsys IGRA TB was evaluated in a global, multi-centre study conducted in both low-incidence and high-incidence settings across the European, Western Pacific, African regions and regions of the Americas.

In the intended use population, i.e. individuals currently requiring tuberculosis infection testing as part of their clinical care, Elecsys IGRA TB achieved 91.12% positive percent agreement (PPA) and 94.57% negative percent agreement (NPA) when compared to standard-of-care methods.

In bacteriologically confirmed TB disease patients, Elecsys IGRA TB demonstrated a relative sensitivity of 100% compared to an established IGRA method. In accordance with established clinical trial protocols, the specificity of Elecsys IGRA TB was estimated in a low-risk cohort and demonstrated a specificity of 95.32%³. Taken together, these results demonstrate highly reliable performance for tuberculosis infection testing.

“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.”

References

1. World Health Organization, End TB Strategy.

2. BCG World Atlas.

3. Elecsys IGRA TB Method Sheet 2026-04 V1.0.

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