Pivotal Clinical Study Data:
A pivotal clinical study was conducted which established the clinical performance of the T-SPOT®.TB test in both culture-confirmed active TB disease and in potentially latent TB infection in populations stratified by risk of exposure to M. tuberculosis. A total of 2,355 subjects were enrolled at eleven study sites. The study population included subjects from all major risk groups indicated for screening for TB infection according to guidelines from the CDC.¹ The results of this study were²:
- Sensitivity of 95.6%
- Specificity of 97.1%
- T-SPOT.TB results were not associated with being immunocompromised
- T-SPOT.TB results were not associated with BCG vaccination
- T-SPOT.TB results were not impacted by age
To see the summary of the Pivotal Clinical Study click here.
Published Studies:
The body of scientific evidence continues to grow demonstrating the performance of the T-SPOT.TB test. A significant number of peer-reviewed studies have been published worldwide in a variety of clinical and epidemiological settings, including:
- Latent TB infection and TB disease (including pulmonary and extrapulmonary TB)
- HIV positive and negative patients
- Anti-TNF-α treated patients
- Children, adults and the elderly
- Malnourished individuals
- Renal patients undergoing dialysis
- Patients with hematological disorders
- Low prevalence countries in the developed world and high prevalence countries in the developing world
- TB contact tracing
To see a summary of key published studies click here.
¹CDC. Targeted Tuberculin Testing and Treatment of Latent Tuberculosis. MMWR weekly, June 03, 2000; 49(RR06): 1-54.
²T-SPOT.TB Package Insert.
