Operational feasibility and multi-centric evaluation of 'TBDetect sputum microscopy kit' for the direct detection of Mycobacterium tuberculosis in field settings

• Published in: Infectious diseases (London, England) England), 2024-12, Vol.56 (12), p.1040
• Main Authors: Chauhan, Keerti, Gupta, Rakesh Kumar, Anthwal, Divya, Panwalkar, Nikita, Desikan, Prabha, Bhalla, Manpreet, Singhal, Ritu, Myneedu, Vithal Prasad, Umar Khayyam, Khalid, Kumar Shanmugam, Siva, Silambu Chelvi, K, Radhakrishnan, A, Chandrasekaran, Padmapriyadarsini, Giri, Sidhartha, Turuk, Jyotirmayee, Das, Dasarathi, Pati, Sanghamitra, Goyal, Abhinav, Gupta, Ashawant, Kant Gupta, Nalini, Singh, Manjula, Sivaswami Tyagi, Jaya, Haldar, Sagarika
• Format: Article
• Language: English
• ISSN: 2374-4243; 2374-4243
• DOI: 10.1080/23744235.2024.2375599

India relies primarily on direct smear microscopy for tuberculosis (TB) diagnosis. However, the low sensitivity of smear microscopy emphasizes the need to improve its performance. We recently described the development of 'TBDetect' kit which showed improved performance over direct smear microscopy at National Reference Laboratories (NRLs) in India.BACKGROUNDIndia relies primarily on direct smear microscopy for tuberculosis (TB) diagnosis. However, the low sensitivity of smear microscopy emphasizes the need to improve its performance. We recently described the development of 'TBDetect' kit which showed improved performance over direct smear microscopy at National Reference Laboratories (NRLs) in India.The present study was aimed to assess the operational feasibility of 'TBDetect' microscopy in field settings. This was evaluated by (i) assessing the performance of 'TBDetect' microscopy vs. LED-fluorescence microscopy (LED-FM) on consecutive presumptive pulmonary TB patients (n = 5300) who attended Designated Microscopy Centres (DMCs, n = 13) under 4 NRLs at Bhubaneswar, Bhopal, Chennai, and New Delhi, and (ii) obtaining feedback from Scientists (n = 10) and laboratory technicians (n = 42) using semi-structured questionnaires under the following parameters: feasibility of initiation of 'TBDetect' microscopy in DMCs, sample preparation and testing, training, time-to-result, logistics, and troubleshooting. A scoring questionnaire was also used to assess 'TBDetect' microscopy vs. LED-FM and statistical significance of the scores was calculated using paired t-test.METHODSThe present study was aimed to assess the operational feasibility of 'TBDetect' microscopy in field settings. This was evaluated by (i) assessing the performance of 'TBDetect' microscopy vs. LED-fluorescence microscopy (LED-FM) on consecutive presumptive pulmonary TB patients (n = 5300) who attended Designated Microscopy Centres (DMCs, n = 13) under 4 NRLs at Bhubaneswar, Bhopal, Chennai, and New Delhi, and (ii) obtaining feedback from Scientists (n = 10) and laboratory technicians (n = 42) using semi-structured questionnaires under the following parameters: feasibility of initiation of 'TBDetect' microscopy in DMCs, sample preparation and testing, training, time-to-result, logistics, and troubleshooting. A scoring questionnaire was also used to assess 'TBDetect' microscopy vs. LED-FM and statistical significance of the scores was calculated using paired t-test.The overall positivity of 'TBDetect