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

Abstract Objectives The present study aimed to evaluate the performance of ‘TBDetect’ kit-based Bio-safe fluorescent microscopy filter (BioFM-Filter) microscopy in comparison to 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 BioFM-Filter for improved and bio-safe smear microscopy. We evaluated the performance of ‘TBDetect’ kit in a 6-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 smear was significant (p 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 (DMCs) and Primary Healthcare Centres (PHCs).