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

Autor:	Anthwal D; Translational Health Science and Technology Institute, NCR Biotech Science Cluster, Faridabad, India; Department of Experimental Medicine and Biotechnology, Postgraduate Institute of Medical Education and Research, Chandigarh, India., Gupta RK; Translational Health Science and Technology Institute, NCR Biotech Science Cluster, Faridabad, India; Department of Experimental Medicine and Biotechnology, Postgraduate Institute of Medical Education and Research, Chandigarh, India., Gomathi NS; Department of Bacteriology, National Institute for Research in Tuberculosis, Chennai, India., Tripathy SP; Department of Bacteriology, National Institute for Research in Tuberculosis, Chennai, India., Das D; Regional Medical Research Center, Bhubaneshwar, India., Pati S; Regional Medical Research Center, Bhubaneshwar, India., Panwalkar N; Bhopal Memorial Hospital and Research Centre, Bhopal, India., Desikan P; Bhopal Memorial Hospital and Research Centre, Bhopal, India., Bala K; Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India., Singh UB; Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India., Bhalla M; Department of Microbiology, National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India., Singhal R; Department of Microbiology, National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India., Verma AK; Department of Microbiology, National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India., Khayyam KU; Department of Microbiology, National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India., Myneedu VP; Department of Microbiology, National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India., Sarin R; Department of Microbiology, National Institute of Tuberculosis and Respiratory Diseases, New Delhi, India., Sharma S; National JALMA Institute of Leprosy and Other Mycobacterial Diseases, Agra, India., Bansal AK; National JALMA Institute of Leprosy and Other Mycobacterial Diseases, Agra, India., Gupta UD; National JALMA Institute of Leprosy and Other Mycobacterial Diseases, Agra, India., Patil SA; National JALMA Institute of Leprosy and Other Mycobacterial Diseases, Agra, India., Goyal A; Advanced Microdevices Pvt Ltd, Industrial Area, Ambala Cantt, India., Gupta A; Advanced Microdevices Pvt Ltd, Industrial Area, Ambala Cantt, India., Singh M; India Tuberculosis Research Consortium (ITRC), Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, India., Gupta NK; Advanced Microdevices Pvt Ltd, Industrial Area, Ambala Cantt, India., Haldar S; Translational Health Science and Technology Institute, NCR Biotech Science Cluster, Faridabad, India; Department of Experimental Medicine and Biotechnology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: sagarikahaldar.pgimer@gmail.com., Tyagi JS; Translational Health Science and Technology Institute, NCR Biotech Science Cluster, Faridabad, India; Department of Biotechnology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India. Electronic address: jayatyagi.aiims@gmail.com.
Jazyk:	angličtina
Zdroj:	Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2021 Jun; Vol. 27 (6), pp. 911.e1-911.e7. Date of Electronic Publication: 2020 Aug 21.
DOI:	10.1016/j.cmi.2020.08.020
Abstrakt:	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. (Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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