Roche has secured the CE Mark for its new Elecsys IGRA TB test, launching an automated blood-testing solution designed to identify tuberculosis infection (TBI), also known as latent TB, in routine laboratory settings.

 

The new test delivers results in less than 24 hours and reduces processing time to just 19 minutes per patient — around half the time required by currently used methods. 

 

The technology expands access to faster, scalable Interferon Gamma Release Assay (IGRA) testing on Roche’s established immunoassay platforms, giving laboratories a more efficient way to manage rising demand for TB diagnostics.

 

"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.”

 

Identifying tuberculosis infection early is critical to preventing disease progression, reducing transmission, and guiding preventive treatment decisions for people at higher risk. Expanding access to accurate diagnostics is also central to achieving World Health Organization (WHO) targets of reducing TB deaths by 90% and new cases by 80% by 2030.

 

IGRA blood tests and tuberculin skin tests are widely used methods for detecting TB infection. Compared with skin testing, IGRAs offer advantages including a single patient visit, reduced reliance on specialised healthcare staff, and minimal interference from Bacillus Calmette-Guérin (BCG) vaccination, which is still widely administered around the world.

 

However, conventional IGRA workflows often depend on manual procedures and labour-intensive laboratory processes. These challenges can increase the risk of errors, limit efficiency, and make it harder for laboratories to expand testing capacity.

 

Roche’s Elecsys IGRA TB test aims to address these challenges by bringing greater automation to latent TB testing. When combined with Roche’s molecular cobas MTB and cobas MTB-RIF/INH assays, laboratories can access an integrated approach for managing both TB infection and active disease.

 

The assay will also include a digital tool designed to automate result calculation, interpretation, and reporting, providing rapid, reliable, and traceable results while reducing laboratory workload. The system is designed to work with third-party automated liquid handlers for pre-incubation processes, with Roche planning further automation developments to support fully integrated workflows in the future.

 

With faster turnaround times and increased scalability, Roche’s new test is positioned to help laboratories improve TB screening capacity and support global efforts to eliminate tuberculosis.