Product category: Other infectious immunology testing
The T‑SPOT.TB test is a revolutionary in vitro diagnostic assay that measures T cells primed to Mycobacterium tuberculosis (MTB) antigens. Based on the pioneering T-SPOT technology, it was developed for diagnosing both latent TB infection and TB disease in humans. The T-SPOT.TB test sets new clinical standards of sensitivity and reliability, even in the immunocompromised. The product was licensed in the European Union in July 2004, received FDA premarket approval in July 2008. It is replacing the tuberculin skin test, bringing effective TB testing to many new patient groups where the skin test gives poor results.
This revolutionary technology has been described in a hundreds of peer-reviewed publications which highlight the tests excellent performance in a wide range of clinical and epidemiological settings (see clinical information). These studies confirm the excellent sensitivity and specificity of T‑SPOT.TB and demonstrate its utility for the diagnosis and control of TB around the world.
The test offers hope at a time when TB has re-emerged as a major global health threat. Nearly one third of the worlds population is infected with Mycobacterium Tuberculosis. Nine million people develop active disease and TB kills an estimated 2-3 million people each year (one person every 15 seconds). The huge toll of TB on human life prompted the World Health Organisation to declare TB a “global emergency” in 1993.
Oxford Immunotec Global PLC is a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of underserved immune-regulated conditions. The Companys T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.oxfordimmunotec.com.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd. Immunetics is a trademark of Immunetics, Inc.