Problem being addressed
TB kills an estimated 2-3 million people per year worldwide, with an estimated 50% of cases going undiagnosed. Unfortunately, the TB skin test, which has been used for the past century, is prone to false negatives and false positives, particularly in developing country settings. In developing countries, a more specific and sensitive test is needed.
Detailed description of the solution
The T-SPOT TB test measures the specific antigens that stimulate the effector T cells. Effector T cells are short-lived, and their presence indicates that the cellular immune response is currently countering pathogens, and is diagnostic of an active infection. The proteins that the T-SPOT TB test measures are not found in the BCG vaccine, which eliminates one potential source for false positive rates. Additionally, these antigens are produced even by immunocompromised individuals, reducing false negative rates. The manufacturer reports that the sensitivity of the T-SPOT.TB test is 95.6% and the specificity of the T-SPOT.TB test is 97.1%.
Designed by
- Designed: Oxford Immunotec. Main website here.
- Manufacturing: Oxford, England.
When and where it was tested/implemented
This device has been used in different parts of the world.
Funding Source
Initial research funded and conducted through the University of Oxford. This project has also received private funding from international investors such as Clarus Ventures, Wellington Partners and DFJ Esprit. The complete list can be found here.
References
Peer-reviewed publication
Dozens of peer-reviewed publications are provided by Oxford Immunotec in the following list.
Oxford Immunotec. Cost-Effectiveness Studies. Retrieved in 2010. Link available here.
- NOTE: There are over 1500 papers that reference this technology online in Google Scholar with the search term "T-spot TB."
Other internally generated reports
Guidelines for use for multiple countries. Link available here.
Press releases. Link available here.
IP and copyright
IP and copyrights are privately held by Oxford Immunotech.
Approval by regulatory bodies or standards boards
FDA approval in US (30 July 2008) Carries CE mark in EU as of 2004. Approved in Canada in 2005. Approval currently being sought in other countries.