Department of Experimental Medicine and Biotechnology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Microbiology, Bhopal Memorial Hospital and Research Centre (BMHRC), Bhopal, India.
Infect Dis (Lond). 2024 Dec;56(12):1040-1048. doi: 10.1080/23744235.2024.2375599. Epub 2024 Aug 16.
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 'TB' 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 'TB' microscopy in field settings. This was evaluated by (i) assessing the performance of 'TB' microscopy LED-fluorescence microscopy (LED-FM) on consecutive presumptive pulmonary TB patients ( = 5300) who attended Designated Microscopy Centres (DMCs, = 13) under 4 NRLs at Bhubaneswar, Bhopal, Chennai, and New Delhi, and (ii) obtaining feedback from Scientists ( = 10) and laboratory technicians ( = 42) using semi-structured questionnaires under the following parameters: feasibility of initiation of 'TB microscopy in DMCs, sample preparation and testing, training, time-to-result, logistics, and troubleshooting. A scoring questionnaire was also used to assess 'TB' microscopy . LED-FM and statistical significance of the scores was calculated using paired -test.
The overall positivity of 'TB' microscopy was 10.32% (547/5300) 8.96% (475/5300) of LED-FM at all sites and the increment in positivity was significant ( = 0.019). In addition, 'TB' microscopy yielded an increment in smear grade status over LED-FM ( = 0.043). The feedback from the study-in-charge and kit users indicated that 'TB' microscopy was easily adapted in point-of-care settings. An analysis of scoring feedback suggested that it was easy to perform and observe in comparison to LED-FM ( < 0.005).
This study established the feasibility of 'TB' microscopy in field settings.
印度主要依靠直接涂片显微镜检查来诊断结核病（TB）。然而，涂片显微镜检查的敏感性较低，这强调了需要提高其性能。我们最近描述了“TB”试剂盒的开发，该试剂盒在印度国家参考实验室（NRL）的表现优于直接涂片显微镜检查。
本研究旨在评估“TB”显微镜在现场环境中的操作可行性。这是通过（i）评估在 4 个 NRL （位于布巴内斯瓦尔、博帕尔、钦奈和新德里）的 13 个指定显微镜中心（DMC）就诊的连续疑似肺结核患者（ = 5300）上进行的“TB”显微镜 LED 荧光显微镜检查（LED-FM）的性能，以及（ii）通过半结构问卷调查从科学家（ = 10）和实验室技术人员（ = 42）获得反馈，以下列参数：在 DMC 中启动“TB 显微镜”的可行性、样品制备和检测、培训、结果时间、物流和故障排除。还使用评分问卷评估“TB”显微镜。使用配对检验计算 LED-FM 和评分的统计显著性。
所有地点的“TB”显微镜的总体阳性率为 10.32%（547/5300），LED-FM 的阳性率为 8.96%（475/5300），两者的阳性率均有显著增加（ = 0.019）。此外，“TB”显微镜的涂片等级状态较 LED-FM 有显著提高（ = 0.043）。研究负责人和试剂盒使用者的反馈表明，“TB”显微镜在即时护理环境中很容易适应。评分反馈的分析表明，与 LED-FM 相比，它更容易执行和观察（ < 0.005）。
本研究证实了“TB”显微镜在现场环境中的可行性。
