The performance of the Rapid Biosensor Systems TB Breathalyser has been validated in a series of field trials with over just under 1000 patients within five different a hospital environments, as part of five different trials.
The system successfully passed completely independent trials in Ethiopia under the supervision of the London School of Hygiene and Tropical Medicine see:
"Field test of a novel detection device for Mycobacterium tuberculosis antigen in cough" http://www.biomedcentral.com/1471-2334/10/161 and at the WHO-approved Shri K. J. Mehta TB hospital in India.
Our most recent trials were conducted successfully on pre-production beta prototypes at the Ayder Hospital, Mekelle University, Ethiopia, where tests were carried out in 3-centres, the Ayder Referral Hospital, Mekelle & Wukro Hospitals in 2012-13. The results showed sensitivities and specificities of >95% for early stage actively infectious patients.