Roche has received CE Mark approval for Elecsys IGRA TB, a blood-based test for identifying tuberculosis infection in routine laboratory settings.
The assay runs on Roche’s cobas immunoassay systems and is designed to provide automated, high-throughput testing for tuberculosis infection, also known as latent TB. Roche says the workflow can deliver results in under 24 hours, with the interferon gamma release assay processing stage taking around 19 minutes per patient.
Elecsys IGRA TB is intended to support laboratories that need a scalable alternative to more manual tuberculosis infection testing methods. The assay uses cobas IGRA TB tubes to stimulate T cells in whole blood with Mycobacterium tuberculosis antigens. If the patient has developed a cell-mediated immune response to the bacterium, reactive T cells release interferon gamma, which is then measured using an automated electrochemiluminescence immunoassay on cobas e analysers.
The test is an indirect aid to diagnosis and is intended for use alongside risk assessment and other medical and diagnostic evaluations. Roche has also placed the assay within a broader tuberculosis diagnostic workflow, alongside cobas MTB and cobas MTB-RIF/INH molecular assays used for active disease and resistance-related testing.
The CE Mark gives Roche a regulated route into applicable European markets and other territories recognising the certification framework. Clinical performance data reported by the company include 91.12% positive percent agreement and 94.57% negative percent agreement against standard-of-care methods in the intended-use population. Roche also reported 100% relative sensitivity in bacteriologically confirmed TB disease patients compared with an established IGRA method, and 95.32% specificity in a low-risk cohort.
Laboratory automation is central to the product’s industrial value. Tuberculosis infection testing has traditionally involved workflows that can be manual, labour-intensive, and difficult to scale. Manual handling can limit throughput, extend turnaround, increase variation, and place additional pressure on laboratory staff.
By moving more of the process onto established immunoassay platforms, Roche is addressing both clinical and operational constraints. Automation can improve consistency, reduce manual data handling, support traceable reporting, and allow laboratories to incorporate TB infection testing into existing instrument environments.
Diagnostic laboratories are being asked to process more tests with constrained staffing and tighter quality requirements. Roche says Elecsys IGRA TB will include digital tools for result calculation, interpretation, and reporting, while also integrating with third-party automated liquid handlers for front-end processes before tube incubation.
Laboratory diagnostics now operates as a systems engineering market as much as a reagent market. An assay has to perform analytically, but it also has to fit into real laboratory operations. Sample flow, instrument availability, software connectivity, quality control, maintenance, data handling, and reporting into clinical systems all determine whether a test can be adopted at scale.
TB testing highlights that operational challenge clearly. Tuberculosis remains a major global public health issue, and infection can remain latent before progressing to active disease in a proportion of cases. Identifying infection in higher-risk individuals supports preventive treatment decisions and can reduce onward transmission, but that value depends partly on whether laboratories can deliver testing at sufficient scale and with appropriate turnaround.
Blood-based IGRA tests offer practical advantages over tuberculin skin testing in many settings because they require a single patient visit and are less affected by BCG vaccination history. They can also create laboratory handling demands when testing volumes rise. Roche’s strategy places TB infection testing inside an immunoassay platform environment already used by many laboratories for other clinical assays.
The approval strengthens Roche’s infectious disease diagnostics portfolio as laboratory networks balance routine screening with preparedness for higher-volume testing. The same pressure is visible across diagnostics and medtech: faster assay development, more automated processing, stronger traceability, and better integration between instruments and data systems.
Manufacturing and supply will now shape adoption. Assay kits, tubes, reagents, instrument capacity, software tools, service support, and distribution all need to align if laboratories are to introduce the test at scale. Diagnostics companies increasingly compete not only on analytical performance, but on whether they can support the complete operating pathway around the assay.
Elecsys IGRA TB gives Roche a regulated product in a disease area where workflow efficiency and testing capacity remain important. Adoption will depend on laboratory economics, clinical guidelines, procurement decisions, and the ability of automated platforms to reduce the friction that has historically limited wider use of blood-based TB infection testing.
