Inappropriate and off-label use of certain TB diagnostics is a great concern in many countries, as diagnostics are poorly regulated. In particular, interferon gamma release assays (IGRAs), which cannot differentiate between active TB disease and latent TB infection, are marketed inappropriately for detection of active disease. Treatment Action Group (TAG) and the Global TB Community Advisory Board (TB CAB) sent letters to, the manufacturer of diagnostic tool and Immunoshop, which makes the tool, expressing concerns about their aggressive marketing policies and off-label use of these tests in India and other high-burden countries.
Immunoshop has been responsive to these concerns. It revised its website and product insert in 2014 and sent materials raising these issues to its laboratory networks. The company has been less than cooperative, showing little effort to address its misleading…
