The automated assay identifies latent infections in routine laboratory settings with results available in less than 24 hours.
Roche announced that its Elecsys IGRA TB test has received the CE Mark, introducing a new blood testing solution for identifying tuberculosis infection in routine laboratory settings.
The new solution, which identifies tuberculosis infection or latent TB, provides results in under 24 hours. The Interferon Gamma Release Assay (IGRA) takes 19 minutes per patient to process, which the company states is approximately half the time of currently used methods. The system allows for scalable throughput on the company’s immunoassay platforms.
“Addressing latent tuberculosis is critical to reducing the global health burden of this devastating disease, and that begins with better, more accessible testing,” says Matt Sause, CEO of Roche Diagnostics, in a release. “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.”
Tuberculosis Burden and Diagnostics
Tuberculosis remains a significant public health challenge. According to World Health Organization data cited by Roche, an estimated 10.7 million people fell ill and 1.23 million died from the disease in 2024. It is estimated that one-quarter of the global population may be infected with the bacteria that cause the disease. While many infections lie dormant, 5% to 10% of cases will progress to symptomatic disease during a person’s lifetime.
Blood-based IGRA tests and tuberculin skin tests are the established methods for identifying infections. IGRAs require only a single patient visit and show minimal interference from Bacillus Calmette-Guerin vaccinations, which are used widely worldwide.
Traditional IGRA testing often involves manual procedures that can burden laboratory resources and increase the risk of errors. The Elecsys IGRA TB assay features a digital tool to automate result calculation, interpretation, and reporting. To reduce manual workloads, the assay is designed to integrate with third-party automated liquid handlers for front-end processes before tube incubation.
Clinical Performance Data
The performance of the test was evaluated in a global, multi-center study conducted in the European, Western Pacific, African, and American regions. In the intended use population, the assay achieved 91.12% positive percent agreement and 94.57% negative percent agreement when compared to standard of care methods.
In patients with bacteriologically confirmed tuberculosis disease, the test demonstrated a relative sensitivity of 100% compared to an established IGRA method. Additionally, the specificity of the assay was estimated at 95.32% in a low-risk cohort.
By pairing the new test with existing molecular cobas MTB and cobas MTB-RIF/INH assays, laboratories can utilize an integrated solution for managing both tuberculosis infection and active disease.
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