Innovative Reagents for Improving Rapid Diagnosis of Mycobacterial Infections

Introduction M. tuberculosis (TB) is a significant public health problem in the United Kingdom and abroad. A total of 7832 cases were reported in the UK in 2013. Of those that were culture confirmed (59%) the rate of drug resistance was 7.8%. In certain populations the incidence of drug resistance is higher: homeless patients, those who have been in prison and particularly those from Eastern Europe. Typically the patient will be on treatment for 18 months or more and the PHE has estimated the cost of this as being upto £50000.

Current diagnosis rests on the culture of the M. tuberculosis and drug sensitivity testing. This can take six or eight weeks, meaning that patients may be on ineffective therapy for some time, leading to further transmission and deterioration of the patient's clinical condition. If the speed of culture of the organism could be increased substantially then the delays in diagnosis and getting the correct treatment started could be reduced. In addition if the percentage of culture confirmed cases could be increased then the patient and clinician would benefit. Often patients are started on TB treatment without a confident culture confirmed diagnosis. Other mycobacteria may masquerade as TB causing delays in diagnosis and treatment uncertainty before the confirmed culture result becomes available.

Tuberculosis will be diagnosed in the usual way, by routine analysis of appropriate samples, including standard PCR and culture. Patients who are thought to have or have been confirmed to have tuberculosis will be recruited to the trial.

The patients will be managed in the usual way according to the standard protocols for treating tuberculosis as directed by the treating physician.

Currently the diagnosis of tuberculosis is a lengthy process requiring several weeks of culture of the organism. Identification of a quicker or easier test that might be performed on samples would have great benefits to future patients. The investigators of this research are looking to see if this different method of culture will significantly increase the speed of diagnosis.