Roche Elecsys IGRA TB gains CE mark for automated latent‑TB blood test
- Elecsys IGRA TB has received CE Mark for identifying tuberculosis infection in routine laboratories.
- The IGRA process takes 19 minutes per patient and yields results in under 24 hours, cutting standard processing time by roughly half.
- The assay runs on Roche cobas immunoassay systems, integrates with cobas MTB and cobas MTB‑RIF/INH assays, supports third‑party liquid handlers and will be linked to future proprietary front‑end automation.
- Clinical performance versus standard methods: 91.12% positive percent agreement, 94.57% negative percent agreement, 100% relative sensitivity in bacteriologically confirmed TB, and 95.32% specificity in a low‑risk cohort.
Regulatory clearance and intended use
Roche’s Elecsys IGRA TB assay received the CE Mark as a blood-based Interferon Gamma Release Assay for identifying tuberculosis infection (latent TB) in routine laboratory settings, enabling faster, automated IGRA testing on widely deployed immunoassay platforms.
Speed and throughput
The IGRA analytic step processes in 19 minutes per patient and the solution can deliver results in under 24 hours, which Roche says halves standard processing times and supports higher-throughput screening needs.
Automation and workflow integration
The assay is designed to run on cobas immunoassay systems, offers a digital tool for automated calculation, interpretation and reporting, integrates with third‑party automated liquid handlers for pre‑incubation steps, and is planned to pair with future proprietary front‑end automation; it can be used alongside cobas MTB and cobas MTB‑RIF/INH molecular assays.
Clinical validation and public‑health role
In a global multicentre study across low‑ and high‑incidence regions, Elecsys IGRA TB showed 91.12% PPA and 94.57% NPA versus standard methods, 100% relative sensitivity in bacteriologically confirmed TB, and 95.32% specificity in a low‑risk cohort; Roche positions the test as a tool to expand access and support WHO End TB elimination targets.
Source: Roche
