Roche has announced that its Elecsys IGRA TB test has received CE Mark approval, introducing a new automated blood-based diagnostic solution for Identifying Tuberculosis Infection (TBI), also known as latent tuberculosis, in routine laboratory settings.

The new Interferon Gamma Release Assay (IGRA) is designed to simplify laboratory workflows while delivering faster results. According to the company, the test can provide results within 24 hours, with the assay itself requiring approximately 19 minutes per patient, nearly half the processing time of conventional IGRA methods.

The approval expands diagnostic options for laboratories by enabling scalable, automated tuberculosis infection testing on Roche's immunoassay platforms. The system also incorporates a digital tool that automates result calculation, interpretation and reporting, helping reduce manual intervention and improve laboratory efficiency.

Tuberculosis continues to pose a significant global public health challenge. In 2024, an estimated 10.7 million people developed the disease and 1.23 million deaths were attributed to tuberculosis. Approximately one-quarter of the global population is estimated to carry the bacteria that cause TB, although the infection often remains dormant. Around 5–10 percent of infected individuals are expected to develop active disease during their lifetime, highlighting the importance of early detection and preventive treatment.

Compared with the traditional tuberculin skin test, blood-based IGRA testing offers improved diagnostic accuracy, requires only a single patient visit and is minimally affected by prior Bacillus Calmette-Guérin (BCG) vaccination, which remains widely used in many countries.

The Elecsys IGRA TB test is designed to integrate with Roche's existing cobas MTB and cobas MTB-RIF/INH molecular assays, providing laboratories with a comprehensive diagnostic workflow for both latent tuberculosis infection and active TB disease. The company also stated that the assay is compatible with third-party automated liquid handling systems and forms part of its long-term strategy to deliver fully integrated laboratory automation.

The test's clinical performance was evaluated in a global multicentre study conducted across low- and high-incidence tuberculosis settings in Europe, Africa, the Western Pacific and the Americas. In the intended-use population, the assay demonstrated a 91.12 percent Positive Percent Agreement (PPA) and 94.57 percent Negative Percent Agreement (NPA) compared with standard diagnostic methods. It also achieved 100 percent relative sensitivity in bacteriologically confirmed tuberculosis cases and an estimated 95.32 percent specificity in low-risk populations.

The introduction of the Elecsys IGRA TB test comes as global health agencies continue to strengthen tuberculosis screening and prevention programmes in support of the World Health Organization's goal of reducing TB deaths by 90 percent and new cases by 80 percent by 2030.