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Study Results Support Use Of T-SPOT®.TB To Monitor Latent TB Infection

Oxford, UK; 5th March 2007 – Oxford Immunotec Ltd, the T cell measurement company, today announced the publication of a recent study demonstrating the potential use of T-SPOT.TB to monitor the effect of treatment for latent tuberculosis infection.

In the study run at the Singapore TB control unit and reported in the American Journal of Critical Care Medicine, Chee et al investigated the potential use of T-SPOT.TB to monitor the efficacy of treatment for latent TB infection. In low TB burden countries, widespread screening for latent TB is a key tool in preventing the spread of TB. However, there is currently no way to assess the efficacy of latent TB treatment. Development of an effective tool to monitor the success of treatment would therefore represent a major step forwards and would be a vital addition to the existing tools for TB control.

In the study, 226 patients with prior exposure to TB and who had tested positive using T-SPOT.TB were treated for latent TB infection. The vast majority (96%) of patients received a 6 month course of Isoniazid with the remaining 4% receiving alternate treatments including a combination of isoniazid with rifampicin. At the end of the treatment period the patients were repeat tested with T-SPOT.TB.

The results demonstrated that there was a statistically significant change, as reflected by reversion from a positive to a negative result and by absolute spot count, for one of the two TB specific antigens used in the test, CFP 10 whereas the response to the other antigen, ESAT-6 was unchanged with treatment. The significant reduction in response to CFP 10 was consistent with the hypothesis that there is clearing of the CFP 10 antigen as the mycobacterial load declines with treatment and was repeated across both the isoniazid group and the other treatment regimes. The lack of change in response to ESAT-6 was also examined and a possible explanation supported by evidence published in other papers.

Commenting on the results, Dr Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec said, “This study has demonstrated for the first time the potential to use T-SPOT.TB as an effective tool to monitor the treatment of latent TB infection. These preliminary findings, if supported by future studies, could lead to the development of an efficient and effective way to monitor the progression of treatment and the clearance of disease, providing a key tool in the control of latent TB infection. In addition, the T-SPOT.TB test may have a role to play in the testing of new anti-TB therapies.”