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Study results confirm maintained performance of T-SPOT.TB in repeat testing environment

30 Mar 2010
Kerry Parker
CEO

Oxford Immunotec Ltd, the T cell measurement company, has today announced the outcome of a recent study, which confirmed that the Company’s T-SPOTTM.TB test is more suitable for repeated testing for tuberculosis than the traditionally used Tuberculin Skin Test (‘TST’). The study, which was completed by Luca Richeldi at Modena University Hospital, Italy, addressed one of the main shortcomings with the TST, that the boosting effect of repeat testing induces false positive results in uninfected people. This shortcoming has significant implications for the use of the TST in routine screening programs, including those for healthcare workers.

In the study a group of 44 BCG unvaccinated people who had prior contact with a patient with confirmed multi-drug resistant TB were followed for a period of 2 years and tested with both the TST and T-SPOT.TB after 9, 15 and 24 months. At each time point all 44 individuals remained negative when tested with T-SPOT.TB whilst 3 of them had become TST positive. The results therefore showed that repeated testing did not result in the development of false positive results when using T-SPOT.TB.

Commenting on the reported findings, Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec said “This study clearly demonstrates that T-SPOT.TB is unaffected by prior TST testing, even in those individuals who show signs of TST boosting. It is clear that T-SPOT.TB offers a much more reliable tool in screening programs for healthcare workers and in other routine settings than the TST”.

T-SPOT®.TB

Oxford Immunotec

The T-SPOT®.TB test is a revolutionary product that diagnoses both latent TB infection and active disease by measuring T cells that have been specifically activated by Mycobacterium tuberculosis (MTB) antigens. The T-SPOT.TB test sets new clinical standards of sensitivity and reliability. The product was licensed across Europe in July 2004 and received FDA premarket approval in July 2008. It has been designed to replace the current tuberculin skin test (Mantoux test), bringing effective TB testing to many new patient groups where the skin test gives poor or unreliable results. This revolutionary technology has been tested in many thousands of patients in all parts of the world. Studies have shown the excellent sensitivity and specificity of the T-SPOT.TB test and demonstrate its utility for the diagnosis and control of TB. The T-SPOT.TB kit is supplied with a plate containing 12 X 8 well strips. 4 wells are required for each patient sample

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Study results confirm maintained performance of T-SPOT.TB in repeat testing environment