T-SPOT®.TB

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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 world’s 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.

The T‑SPOT.TB test offers:

Unrivalled clinical performance
Simple and robust laboratory performance
Cost-effective in TB control

Unrivalled Clinical Performance

  • Very few false negative results (sensitivity of 98.8%)
    • Reliable detection of truly infected individuals
  • No patient exclusions
    • Can be used in HIV, very young children, screening before anti-TNF α treatment, transplant, renal dialysis, malnourished and other immunocompromised patient groups, as well as in pregnancy

Simple and Robust Laboratory Performance

  • Reduced repeat testing (due to low frequency of indeterminates)
  • Results next day
  • No need for patient return visit
  • All procedures carried out in a controlled laboratory environment

Saves Costs in TB Control

  • Minimises costs associated with onward transmission
  • Reduces unnecessary treatment & monitoring costs from false positive results
  • The T-SPOT.TB-test based screening strategies are significantly cost-saving when compared to TST-based TB control programmes1
  • The use of the T-SPOT.TB test greatly reduces the number of contacts treated to prevent one TB case1

To see a summary of key clinical studies, please view our T-SPOT.TB Publications Summary.

1Diel R, et al. ERJ 2007 30: 321-332