BASEL, Switzerland, July 9, 2026
Roche has announced that its Elecsys IGRA TB blood test has received CE Mark certification, expanding access to a new automated diagnostic solution for identifying tuberculosis infection (TBI), also known as latent tuberculosis (TB). The innovative assay is designed for use on Roche’s widely deployed cobas immunoassay systems, enabling clinical laboratories to deliver rapid, high-throughput, and cost-effective tuberculosis screening while significantly reducing manual laboratory workflows. The Elecsys IGRA TB test provides reliable diagnostic results in less than 24 hours, with the Interferon Gamma Release Assay (IGRA) requiring only 19 minutes of processing time per patient, approximately 50% faster than conventional laboratory methods. The CE Mark represents a significant advancement in infectious disease diagnostics, supporting global public health initiatives aimed at improving early tuberculosis detection and contributing to the World Health Organization’s (WHO) End TB Strategy.
Automated IGRA Testing Improves Laboratory Efficiency
Tuberculosis remains one of the world’s leading infectious diseases, with millions of new infections and more than one million deaths reported annually, while an estimated one-quarter of the global population carries latent tuberculosis infection. Early identification of individuals with latent infection is critical because 5% to 10% may eventually develop active tuberculosis disease during their lifetime. Unlike traditional tuberculin skin tests, blood-based IGRA testing requires only a single patient visit, delivers higher diagnostic accuracy, minimizes interference from prior BCG vaccination, and reduces dependence on specialized clinical personnel.
Roche’s Elecsys IGRA TB further enhances this approach by introducing a fully automated testing workflow that minimizes manual laboratory procedures, reduces the potential for human error, and enables laboratories to scale testing capacity efficiently. The system also incorporates a digital reporting solution that automates result calculation, interpretation, and reporting while integrating with third-party laboratory automation systems to streamline front-end specimen processing.
Clinical Performance Supports Global Tuberculosis Elimination
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Clinical validation of the Elecsys IGRA TB assay was conducted through a global multicenter study involving both high-incidence and low-incidence tuberculosis regions across Europe, Africa, the Western Pacific, and the Americas. The assay demonstrated 91.12% positive percent agreement (PPA) and 94.57% negative percent agreement (NPA) compared with current standard-of-care testing methods. Among patients with bacteriologically confirmed tuberculosis disease, the assay achieved 100% relative sensitivity compared with an established IGRA method, while specificity reached 95.32% in low-risk populations, confirming its high diagnostic reliability. Roche also highlighted that combining Elecsys IGRA TB with its existing cobas MTB and cobas MTB-RIF/INH molecular assays provides laboratories with a comprehensive diagnostic solution capable of supporting both latent tuberculosis infection screening and active tuberculosis disease detection.
The CE Mark approval reinforces Roche’s leadership in diagnostic innovation by delivering a scalable, automated, and clinically validated solution that can improve access to tuberculosis screening worldwide while supporting healthcare systems in achieving earlier diagnosis, timely preventive treatment, and more efficient laboratory operations. As countries continue working toward the WHO’s ambitious tuberculosis elimination targets, advanced diagnostic technologies such as Elecsys IGRA TB are expected to play an increasingly important role in strengthening public health surveillance and reducing the global burden of tuberculosis infection.
Source: Roche press release
