Following an intensive 6-year development program, the innovative Tuberculosis (TB) Breathalyser from Rapid Biosensor Systems, (RBS) Cambridge, England, will be in active use for the first time on World TB Day, March 24.
The RBS TB Breathalyser is based on patented bio-optical sensor technologies and is the fastest and most reliable method available for detecting infected subjects capable of transmitting TB to others, providing a result in minutes to a verified accuracy level of +95%. The TB Breathalyser is a complete, lightweight, portable system.
"The most prevalent method of screening currently is the Mantoux TB test, which involves a health worker injecting test fluid under the patient’s skin, then waiting for as many as 72-hours to see if there is a localized reaction that indicates the presence of TB. There are however, many factors that can influence the reaction, meaning that expert assessment—and with it a degree of subjectivity—is involved in interpreting the results. Further, the test is prone to delivering false positives or false negatives, implying that further testing and interpretation may be required,” says Dennis Camilleri, Chief executive officer of RBS.
"By contrast, the RBS Breathalyser delivers an unequivocal positive or negative result within minutes, with no interpretation required. Significantly, it is highly specific to detecting active TB and is not compromised by the presence of HIV or other co-infections,” said Camilleri. “The unit is extremely portable and easy to use and requires no running water or electricity for operation, it can therefore be deployed in remote locations, without the need for subjects to attend a screening clinic."
The performance of the Breathalyser has been validated in a series of clinical trials within a hospital environment in India and in independent trials in Ethiopia supervised by the London School of Hygiene and Tropical Medicine. A further trial at a World Health Organization-approved hospital in South Africa is also nearing completion. The Breathalyser is to be launched first in India and South Africa. Concurrent with the launch, RBS will begin the approvals processes required to allow use of the Breathalyser in Europe and the United States.