Roche Secures CE Mark for Automated Elecsys IGRA TB Diagnostic Test
核心洞察
Roche received CE Mark approval for its Elecsys IGRA TB (搜索) test, a fully automated blood-based diagnostic for identifying tuberculosis (搜索) infection in routine laboratory settings.
The assay delivers results in just 19 minutes per patient, cutting standard processing times in half and enabling results within 24 hours.
In a global multi-centre study, the test achieved 91.12% positive percent agreement and 94.57% negative percent agreement compared to standard of care methods.
Roche has received the CE Mark for its Elecsys Interferon Gamma Release Assay (IGRA) TB test, a blood-based diagnostic designed to identify tuberculosis (搜索) infection (TBI) in routine laboratory settings. The regulatory milestone marks a significant advancement in TB diagnostics, offering laboratories an automated, high-throughput solution that addresses longstanding workflow challenges associated with traditional IGRA testing.
Tuberculosis (搜索) remains one of the world's most urgent public health challenges, continuing to affect millions annually. Diagnosis of tuberculosis infection is essential to breaking the cycle of disease progression and transmission, preventing severe health complications. Blood-based IGRA tests and tuberculin skin tests are established methods for identifying tuberculosis infections, with IGRAs providing a less invasive alternative to skin tests that requires only a single patient visit.
Performance and Clinical Validation
The performance of Elecsys IGRA TB (搜索) was evaluated in a global, multi-centre study conducted across the European, Western Pacific, African regions and the Americas. The assay achieved 91.12% positive percent agreement (PPA) and 94.57% negative percent agreement (NPA) when compared to standard of care methods. Notably, among bacteriologically confirmed TB patients, Elecsys IGRA TB demonstrated a relative sensitivity of 100% compared with an established IGRA method.
Workflow Integration and Automation
The new solution provides rapid, high-throughput, and cost-effective tuberculosis (搜索) testing that delivers reliable results in under 24 hours. The Elecsys IGRA TB (搜索) assay takes just 19 minutes per patient to process, which is approximately half the time of the currently used method. The assay will include a digital tool to fully automate result calculation, interpretation, and reporting. In addition, it is designed to integrate with third-party automated liquid handlers for front-end processes prior to tube incubation.
Traditional IGRA testing often involves labour-intensive workflows and manual procedures. Roche notes that pairing the new Elecsys IGRA TB (搜索) test with its existing molecular cobas MTB (搜索) and cobas MTB-RIF/INH (搜索) assays provides laboratories with an integrated solution for managing both tuberculosis (搜索) infection and active disease.
Strategic Importance
"The Elecsys IGRA TB (搜索) test brings an automated solution for latent TB," said Matt Sause, CEO of Roche Diagnostics. The company also highlighted that expanding access to reliable diagnostics remains critical to achieving the World Health Organization's global elimination targets, which aim to decrease tuberculosis (搜索) deaths by 90% and new cases by 80% by 2030.