Independent Peer-Reviewed Study Demonstrates That T-SPOT®.TB Assay Outperforms Tuberculin Skin Test In Predicting Tuberculosis Disease
Independent Peer-Reviewed Study Demonstrates That T-SPOT®.TB Assay Outperforms Tuberculin Skin Test In Predicting Tuberculosis Disease
Oxford, UK; 19 July 2010 – The authors of a recent study[i] published in the American Journal of Respiratory and Critical Care Medicine concluded that the T-SPOT.TB test is better than the tuberculin skin test (TST) at predicting which patients will develop active TB.
There are significant practical difficulties in designing studies to show the predictive value of assays for the later development of active TB disease. Such studies require population cohorts with high rates of TB infection, high conversion rates to active disease and the absence of preventive therapy for TB infection.
This landmark study overcame these difficulties by examining a unique cohort of silicosis patients, who have an elevated risk of developing active TB[ii], [iii], and by excluding those who received preventive therapy.
The study compared the predictive value of test results of the
T-SPOT.TB test and TST for the development of active disease in over 300 subjects over a 4 year period.
The T-SPOT.TB test was shown to be more sensitive than the TST at identifying subjects who would later convert to active disease. A significant proportion (7.9%) of T-SPOT.TB test positive persons developed TB even within the follow-up period. The T-SPOT.TB test only missed one subject who was later diagnosed with active TB disease, although the diagnosis was not confirmed by culture or histology. In contrast the TST was negative (even using the most sensitive 5mm cut-off) in four subjects who converted to active TB disease during the follow-up period. Two of these were confirmed to have TB by culture or histology. Statistical analysis of these results showed that a positive T-SPOT.TB test predicted the subsequent development of active TB while TST did not.
Since only a few of the subjects had received a BCG vaccination, the superior performance of the T-SPOT.TB test was not related solely to the higher specificity of the test. Importantly, the greater discrimination of the T-SPOT.TB test was largely due to the higher sensitivity of this test compared to the TST.
Commenting on these results, Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec said “This landmark paper is the first significant study to be published on the predictive value of the
T-SPOT.TB test. It is well known that the T-SPOT.TB test is both more sensitive and more specific than the TST. This study has confirmed that this greater accuracy translates into a higher predictive value for the T-SPOT.TB test over the TST.” He continued “The use of the T-SPOT.TB test, in place of the TST, to identify those TB infected persons most at risk of developing active TB disease, should greatly increase the efficacy and cost-effectiveness of TB control programs worldwide.”
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Notes to Editors:
About Oxford Immunotec
Oxford Immunotec Ltd., the T cell measurement company, is headquartered near Oxford, UK; its US operations are based inMarlborough, MA. The company develops and sells clinical diagnostic products based on its patented T-SPOT® technology, the first FDA-approved method for directly quantifying antigen-specific T cells.
T-SPOT technology is a simple and extremely accurate method of studying a person’s cellular immune response to infection and could be applied to diagnose and monitor any major disease driven by a T cell response.
About T-SPOT®.TB test
The T-SPOT.TB test is an in vitro T cell measurement assay used for diagnosing TB disease and latent TB infection and is the first product from Oxford Immunotec using T-SPOT technology. The product offers unrivalled sensitivity with results unaffected by a patient’s immune status. The T-SPOT.TB test is approved for sale in Europe, USA, Canada and over 40 other countries worldwide and is designed to replace the 115 year old tuberculin skin test. It offers a substantially more accurate and effective tool for controlling the spread of TB, addressing a market exceeding $1bn.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
[i] Leung CC, Yam WC, Yew WW, Ho PL, Tam CM, Law WS, Au KF, Tsui PW. T-SPOT.TB outperforms tuberculin skin test in predicting tuberculosis disease. Epub May 27, 2010 as doi:10.1164/rccm.200912-1875OC AJRCCM 2010
[ii] Hong Kong Chest Service/ Tuberculosis Research Centre, Madras/ British Medical Research Council. A double-blind placebo-controlled clinical trial of three anti-tuberculosis chemoprophylaxis regimens in patients with silicosis in Hong Kong. Am Rev Respir Dis 1992; 145: 36 – 41
[iii] Chang KC, Leung CC, Tam CM. Tuberculosis risk factors in a silicotic cohort in Hong Kong. Int J Tuberc Lung Dis. 2001; 5:177-84
