Roche has secured the CE Mark for its Elecsys Interferon Gamma Release Assay (IGRA) TB blood-based test designed to detect latent tuberculosis infection (TBI) in routine laboratory settings.
The blood-based test can deliver results in under 24 hours, with the assay itself requiring just 19 minutes per patient to process.
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The Elecsys IGRA TB test runs on Roche’s cobas immunoassay systems. It aims to support rising TBI testing needs by reducing manual workflows through automation and digital integration.
Laboratories have an option that enables faster turnaround and increased throughput compared to traditional manual procedures.
Roche stated that the assay is intended to help address the global health impact of latent tuberculosis, which can remain dormant in individuals and later progress to active disease.
Roche Diagnostics CEO Matt Sause said: “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 programmes and drive significant progress toward achieving global TB elimination targets.”
The test is positioned as a method to improve access to reliable diagnostics, aligning with efforts from the World Health Organization (WHO) to reduce TB deaths by 90% and new cases by 80% by 2030.
Its clinical evaluation included a global, multi-centre study spanning low-incidence and high-incidence areas in Europe, the Western Pacific, Africa, and the Americas.
The results showed a 91.12% positive and 94.57% negative percent agreements compared with current standard methods.
In patients with bacteriologically confirmed TB, the test showed a relative sensitivity of 100% and a specificity of 95.32% in a low-risk cohort.
Last month, Roche introduced its Axelios 1 platform, a next-generation sequencing system that is available for research use and powered by its sequencing by expansion technology.
