Device data
Health topic Tuberculosis
Classification Diagnosis
Scope Commercialized
Manufacturer
location
England, United Kingdom

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

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.

Other internally generated reports

Guidelines for use for multiple countries. Link available here.

Press releases. Link available here.

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.

Page data
SDG SDG03 Good health and well-being, SDG09 Industry innovation and infrastructure
Authors Lonny Grafman, Chris Waterguy, Emilio, Kathleen Sienko, Amir Sabet Sarvestani
License CC-BY-SA-3.0
Organizations Appropedia Foundation, University of Michigan
Language English (en)
Related 0 subpages, 1 pages link here
Redirects T-Spot TB Test
Views 167 page views (analytics)
Created February 14, 2012 by Evashiu
Last edit September 10, 2026 by Felipe Schenone