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.<\/p>\n
The blood-based test can deliver results in under 24 hours, with the assay itself requiring just 19 minutes per patient to process.<\/p>\n
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.<\/p>\n
Laboratories have an option that enables faster turnaround and increased throughput compared to traditional manual procedures.<\/p>\n
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.<\/p>\n
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.<\/p>\n
“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.”<\/p>\n
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.<\/p>\n
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.<\/p>\n
The results showed a 91.12% positive and 94.57% negative percent agreements compared with current standard methods.<\/p>\n
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.<\/p>\n