TB- Why is a new technology necessary?

There is a worldwide effort to identify, control and eliminate TB, which has led to coordinated and thorough treatment of TB globally. However, the ability of the TB germ to remain latent over decades, emerging at any time as infectious active TB disease, requires repeated use of today’s crude diagnostic tools for detection of disease and infection, even when the initial diagnosis is negative. An extremely sensitive, rapid, definitive diagnostic test for TB infection in both people and animals is urgently needed.

One third of the population of the world has a latent infection of tuberculosis; while preventive therapy reduces progression to active disease, it renders useless if there is no way to predict who is at greatest risk of progression to active disease. For nearly 100 years, the tuberculin skin test (TST) has been the only immunologic test for TB infection, despite its various limitations. In addition to the 2-3 day lapse between the skin test and the reading, there is also wide variability in applying and reading the TST, leading to false negatives and false positives. Finally, BCG vaccination and exposure to non-tuberculosis mycobacteria can produce false-positives as they have similar antigens as TB.

A fundamental problem is the absence of operationally convenient and cost-effective diagnostic tests for latent infection, such as that offered by TBfree that can more accurately predict risk of progression to active TB, especially in HIV-infected patients.

Upon validation and approval, TBfree will enable a dramatic shift in TB diagnostic testing. Millions of doctors and their health institutions will no longer be limited mainly to trying to confirm disease among people with indistinct signs of illness with the current slow, indefinite and costly alternative diagnostic approaches. Instead they can find quickly find asymptomatic cases of TB and prevent latent infections from ever emerging as infectious disease.

TBfree will enable a paradigm shift from diagnosing only individuals with active disease forms of TB, to screening large populations for unsuspected infection with the germ. This will open an untapped market for TB screening. PriTest’s new diagnostic test TBfree greatly improves the speed and accuracy of TB detection while reducing costs.