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Multicenter Study
. 2021 Jun;27(6):911.e1-911.e7.
doi: 10.1016/j.cmi.2020.08.020. Epub 2020 Aug 21.

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

Divya Anthwal  1 , Rakesh Kumar Gupta  1 , Narayan Sivaramakrishnan Gomathi  2 , Srikanth Prasad Tripathy  2 , Dasarathi Das  3 , Sanghamitra Pati  3 , Nikita Panwalkar  4 , Prabha Desikan  4 , Kiran Bala  5 , Urvashi B Singh  5 , Manpreet Bhalla  6 , Ritu Singhal  6 , Ajoy Kumar Verma  6 , Khalid Umar Khayyam  6 , Vithal Prasad Myneedu  6 , Rohit Sarin  6 , Sandeep Sharma  7 , Avi Kumar Bansal  7 , Umesh D Gupta  7 , Sripad A Patil  7 , Abhinav Goyal  8 , Ashawant Gupta  8 , Manjula Singh  9 , Nalini Kant Gupta  8 , Sagarika Haldar  10 , Jaya Sivaswami Tyagi  11
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Free article
Multicenter Study

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

Divya Anthwal et al. Clin Microbiol Infect. 2021 Jun.
Free article

Abstract

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.

Keywords: Bio-safety; Diagnosis; Filter; Ki; Smear microscopy; TBDetectt; Tuberculosis.

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