Evaluation of 'TBDetect' sputum microscopy kit for improved detection of Mycobacterium tuberculosis: a multi-centric validation study.

OBJECTIVES: The present study aimed to evaluate the performance of the 'TBDetect' kit-based bio-safe fluorescent microscopy filter (BioFM-Filter) microscopy in comparison with direct smear microscopy and culture for the detection of pulmonary tuberculosis (TB) in a multi-centric setting in India. METHODS: The TBDetect kit enables sputum concentration through filtration using the BioFM-Filter for improved and bio-safe smear microscopy. We evaluated the performance of the TBDetect kit in a six-site multi-centric validation study on sputum collected from 2086 presumptive TB patients. RESULTS: The combined positivity of TBDetect microscopy performed on these sputum samples was 20% (n = 417/2086) vs 16.1% of light-emitting diode fluorescence microscopy (LED-FM, n = 337/2086) and 16% of Ziehl Neelsen (ZN) smear microscopy (n = 333/2086). The increment in positivity of TBDetect over both LED-FM and ZN smears was significant (p < 0.001). The overall sensitivity of TBDetect for six sites was ~55% (202/367, 95% confidence interval (CI): 50, 60%) vs 52% (191/367, 95% CI: 47, 57%) for LED-FM (p 0.14) and 50.9% (187/367, 95% CI: 46, 56%) for ZN smear (p < 0.05), using Mycobacterium Growth Indicator Tube culture (MGIT, n = 1949, culture positive, n = 367) as the reference standard. A bio-safety evaluation at six sites confirmed efficient sputum disinfection by TBDetect; 99.95% samples (1873/1874) were sterile after 42 days of incubation. Scientists and technicians at the study sites indicated the ease of use and convenience of TBDetect microscopy during feedback. CONCLUSIONS: TBDetect added value to the smear microscopy test due to its improved performance, convenience and user safety. These findings indicate that equipment-free TBDetect technology has the potential to improve TB diagnosis in basic laboratory settings by leveraging on the existing nationwide network of designated microscopy centres and primary healthcare centres.

Effects of Ecuador's national monetary incentive program on adherence to treatment for drug-resistant tuberculosis.

BACKGROUND: Non-adherence to tuberculosis (TB) treatment jeopardizes patient health and promotes disease transmission. In July 2011, Ecuador's National Tuberculosis Program (NTP) enacted a monetary incentive program giving adherent drug-resistant TB (DR-TB) patients a US240 bonus each month. OBJECTIVE: To describe patients' experiences with the program qualitatively, and to assess its effects on treatment adherence. METHODS: We interviewed 92 current and five default patients about their treatment experience. NTP data on DR-TB patients receiving treatment were used to compare 12-month default rates among the incentive program group and non-program controls. RESULTS: Our interviews found that patients are financially challenged and use the bonus for a variety of expenses, most commonly food. The most common complaint was that bonus payments were frequently delayed. The 1-year default rate among program patients (9.5%) was significantly lower than the rate among pre-program patients (26.7%). CONCLUSION: Ecuador's monetary incentive program alleviates the economic burden placed by treatment on patients. The bonus does not, however, directly address other treatment barriers, including psychological distress and side effects. The program could benefit from timely delivery of payments. Further research is necessary to assess the program's effect on default rates.