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Comparing deep learning models for tuberculosis detection: A retrospective study of digital vs. analog chest radiographs 比较用于肺结核检测的深度学习模型:数字与模拟胸片的回顾性研究
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2024.05.008
Subhankar Chattoraj, Bhargava Reddy, Manoj Tadepalli, Preetham Putha

Purpose

Chest X-ray (CXR) is an essential tool and one of the most prescribed imaging to detect pulmonary abnormalities, with a yearly estimate of over 2 billion imaging performed worldwide. However, the accurate and timely diagnosis of TB remains an unmet goal. The prevalence of TB is highest in low-middle-income countries, and the requirement of a portable, automated, and reliable solution is required. In this study, we compared the performance of DL-based devices on digital and analog CXR. The evaluated DL-based device can be used in resource-constraint settings.

Methods

A total of 10,000 CXR DICOMs (.dcm) and printed photos of the films acquired with three different cellular phones - Samsung S8, iPhone 8, and iPhone XS along with their radiological report were retrospectively collected from various sites across India from April 2020 to March 2021.

Results

10,000 chest X-rays were utilized to evaluate the DL-based device in identifying radiological signs of TB. The AUC of qXR for detecting signs of tuberculosis on the original DICOMs dataset was 0.928 with a sensitivity of 0.841 at a specificity of 0.806. At an optimal threshold, the difference in the AUC of three cellular smartphones with the original DICOMs is 0.024 (2.55%), 0.048 (5.10%), and 0.038 (1.91%). The minimum difference demonstrates the robustness of the DL-based device in identifying radiological signs of TB in both digital and analog CXR.

Conclusion

The DL-based device underwent evaluation using 10,000 chest X-rays to identify radiological signs of tuberculosis. When tested on the original DICOMs dataset, the device achieved an Area Under the Curve (AUC) of 0.928, with a sensitivity of 0.841 and a specificity of 0.806. Comparing the device's performance with three cellular smartphones on the same original DICOMs dataset, the AUC differences were found to be 0.024 (2.55%), 0.048 (5.10%), and 0.038 (1.91%) at optimal thresholds. These results highlight the device's robustness in detecting radiological signs of TB, showcasing consistent performance across both digital and analog chest X-rays. The smallest difference in AUC further underscores the device's reliability in accurately identifying TB indicators, reaffirming its potential clinical utility.
目的:x线检查(CXR)是检测肺部异常的重要工具,也是最常用的影像学检查之一,全球每年估计进行超过20亿次影像学检查。然而,准确和及时诊断结核病仍然是一个未实现的目标。结核病患病率在中低收入国家最高,因此需要一种便携式、自动化和可靠的解决方案。在本研究中,我们比较了基于dl的器件在数字和模拟CXR上的性能。评估后的基于dll的设备可用于资源受限的设置。方法从2020年4月至2021年3月,从印度各地回顾性收集了从三种不同的手机(三星S8、iPhone 8和iPhone XS)获取的总计10,000张CXR dicom (.dcm)和胶片的打印照片,以及它们的放射学报告。结果利用1万张胸片评估基于dl的设备识别TB放射学征象的效果。在原始DICOMs数据集上检测结核病征象的qXR AUC为0.928,灵敏度为0.841,特异性为0.806。在最优阈值下,三种蜂窝智能手机与原始dicom的AUC差异分别为0.024(2.55%)、0.048(5.10%)和0.038(1.91%)。最小的差异表明基于dl的设备在数字和模拟CXR中识别TB放射学征象的稳健性。结论使用1万张胸片对基于dl的设备进行评估,以识别结核病的放射学征象。在原始DICOMs数据集上进行测试时,该设备的曲线下面积(AUC)为0.928,灵敏度为0.841,特异性为0.806。在同一原始DICOMs数据集上,将该设备与三种蜂窝智能手机的性能进行比较,发现在最佳阈值下,AUC差异分别为0.024(2.55%)、0.048(5.10%)和0.038(1.91%)。这些结果突出了该设备在检测结核病放射学征象方面的稳健性,在数字和模拟胸部x光检查中显示出一致的性能。AUC的最小差异进一步强调了该设备在准确识别结核病指标方面的可靠性,重申了其潜在的临床用途。
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引用次数: 0
Trends in TB scores and efficiency of molecular diagnostic methods across key districts of Madhya Pradesh 中央邦主要地区结核病评分和分子诊断方法效率的趋势
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2025.03.004
Manohar Bhatia , Vikas Sabharwal , Vikas Dwivedi , Bikramjeet Mitra , Yogesh Sharma , Varsha Rai

Background

Tuberculosis (TB) poses a significant public health challenge in India, contributing substantially to the global burden.

Objectives

This study examines trends in TB scores and diagnostic efficiency, measured by the number needed to test (NNT), in three key districts of Madhya Pradesh—Tikamgarh, Datia, and Niwari—over five years (2018–2022).

Methods

A retrospective analysis was conducted using TB notification data from the National Tuberculosis Elimination Program (NTEP) across the selected districts. TB scores, encompassing case notifications and treatment outcomes, were compared alongside the NNT for diagnostic methods, including Sputum Microscopy, TrueNAT, and CBNAAT. Statistical analyses evaluated trends and differences in diagnostic efficiency.

Results

The analysis revealed significant variations in TB scores and NNT across the districts. Tikamgarh's TB scores increased from 50.67 in 2018 to 81.98 in 2022, indicating improved case notifications and treatment outcomes. Datia's scores fluctuated, peaking at 79.32 in 2022, while Niwari consistently grew, reaching 77.64. The NNT for Sputum Microscopy in Tikamgarh decreased from 12.04 to 8.52, and TrueNAT/CBNAAT showed a reduction from 49.69 to 24.52. In Datia, Sputum Microscopy NNT declined from 14.42 to 6.33, while TrueNAT/CBNAAT NNT varied, stabilizing at 10.3 in 2022. In Niwari, Sputum Microscopy NNT decreased from 7.76 to 10.65, and TrueNAT/CBNAAT improved from 3.08 to 7.14.

Conclusion

This study highlights the importance of understanding regional differences in TB epidemiology and diagnostic efficiency. Insights gained can inform local TB control strategies and optimize resource allocation, contributing to more effective TB management in Madhya Pradesh.
结核病在印度构成了一项重大的公共卫生挑战,在很大程度上造成了全球负担。本研究考察了中央邦三个关键地区(tikamgarh、Datia和niwari) 5年(2018-2022年)结核病评分和诊断效率的趋势,以需要检测的数量(NNT)衡量。方法对选定地区国家消除结核病规划(NTEP)的结核病通报数据进行回顾性分析。结核病评分,包括病例报告和治疗结果,与NNT的诊断方法进行比较,包括痰液显微镜、TrueNAT和CBNAAT。统计分析评估了诊断效率的趋势和差异。结果分析显示各地区结核病评分和NNT存在显著差异。Tikamgarh的结核病得分从2018年的50.67分上升到2022年的81.98分,表明病例通报和治疗结果有所改善。达蒂亚的分数波动较大,在2022年达到79.32分的峰值,而尼瓦里的分数持续上升,达到77.64分。Tikamgarh地区痰液镜检NNT从12.04降至8.52,TrueNAT/CBNAAT从49.69降至24.52。在意大利,痰液显微镜NNT从14.42下降到6.33,而TrueNAT/CBNAAT NNT变化,在2022年稳定在10.3。在Niwari,痰液显微镜NNT从7.76下降到10.65,TrueNAT/CBNAAT从3.08提高到7.14。结论本研究强调了了解结核病流行病学和诊断效率的地区差异的重要性。获得的见解可以为地方结核病控制战略提供信息并优化资源配置,从而有助于在中央邦更有效地管理结核病。
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引用次数: 0
Tumor necrosis factor inhibitors and nasal tuberculosis: A rare but complex intersection 肿瘤坏死因子抑制剂与鼻结核:罕见但复杂的交集
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2025.03.008
Hamrish Kumar Rajakumar
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引用次数: 0
BacilliFinder: Revolutionizing Tuberculosis Detection with Computer Vision BacilliFinder:利用计算机视觉实现结核病检测的革命
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2023.12.005
Nagaraju Y , Venkatesh , Rajani G , Satish Basapur

Background

Pulmonary tuberculosis, caused by Mycobacterium, remains a global health concern despite being treatable, preventable, and curable. Diagnosis traditionally relies on X-rays and sputum smear samples. However, sputum smear tests are dependent on the quality of sputum, and X-rays often lack the necessary contrast. Both methods demand skilled technicians and require a closer examination.

Methods

This paper introduces an innovative solution, presenting an efficient and computationally lighter deep convolutional model for the detection of Mycobacterium Bacilli in sputum smear samples. The model is deliberately downscaled in width and depth to reduce computational demands, enabling its integration into edge devices. Furthermore, to make the model more robust, a collection of sputum smear test sample images dataset is formed for this study.

Results

The performance of the proposed model is assessed using our own dataset. The results demonstrate exceptional stability and a significantly improved detection rate. Specifically, the model achieves an impressive mean Average Precision (mAP) of 87.2 % at an Intersection over Union (IoU) threshold of 0.5 and a mAP of 50.5 % at an IoU threshold ranging from 0.5 to 0.95. Additionally, the model exhibits robust recall and precision metrics, standing at 86 % and 84 %, respectively.

Conclusions

The detection results indicate that the proposed YOLOv7_Lite model addresses challenges associated with close examination and mitigates potential biases. Its efficiency and adaptability to memory-constrained devices make it a valuable tool that can significantly contribute to early and accurate tuberculosis diagnosis, by increasing the sensitivity of smear microscopy.
背景:由分枝杆菌引起的肺结核,尽管是可治疗、可预防和可治愈的,但仍然是一个全球性的健康问题。传统的诊断依赖于x射线和痰涂片样本。然而,痰涂片检查依赖于痰的质量,而x射线往往缺乏必要的对比。这两种方法都需要熟练的技术人员,需要更仔细的检查。方法提出了一种高效且计算量较轻的痰涂片样本中杆菌检测的深度卷积模型。该模型的宽度和深度被故意缩小,以减少计算需求,使其能够集成到边缘设备中。此外,为了使模型更具鲁棒性,本研究形成了痰涂片测试样本图像集。结果使用我们自己的数据集评估了所提出模型的性能。结果显示出优异的稳定性和显著提高的检出率。具体来说,该模型在交汇路口(IoU)阈值为0.5的情况下实现了令人印象深刻的平均精度(mAP),达到了78.2%,在IoU阈值为0.5至0.95的情况下,mAP达到了50.5%。此外,该模型显示出强大的召回率和精度指标,分别为86%和84%。结论提出的YOLOv7_Lite模型解决了与近距离检查相关的挑战,并减轻了潜在的偏差。它的效率和对内存受限设备的适应性使其成为一种有价值的工具,可以通过提高涂片显微镜的灵敏度,为早期和准确的结核病诊断做出重大贡献。
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引用次数: 0
Comparative study of CBNAAT and TB LAMP in a tertiary care hospital, RIMS Ranchi, Jharkhand 贾坎德邦兰契一家三级医院CBNAAT和TB LAMP的比较研究
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2025.06.008
Ankita Kumari , Manoj Kumar , Ashok Kumar Sharma , Kumari Seema , Abhay Kumar , Manju Boipai , Brajesh Mishra

Background

Tuberculosis is among the leading contagious illnesses in India and continues to pose a significant public health challenge. It is caused by Mycobacterium tuberculosis and can be potentially fatal. The burden of tuberculosis is relatively high in India. Hence, it is necessary to diagnose and treat tuberculosis as soon as possible, for which a foundation of promising diagnostic modalities is necessary.

Methods

Over one year, a cross-sectional investigation was conducted at the Department of Microbiology, RIMS, Ranchi. Two hundred samples from clinically suspected cases of Tuberculosis were evaluated. Ziehl-Neelsen staining, CBNAAT, and TB LAMP were done on all patients. The diagnostic yield and efficacy of both testing methods were compared and evaluated.

Results

ZN staining was positive in 22 out of the 200 samples in our study. The sensitivity and specificity were 58.8 % and 98.7 %, respectively. On conducting TB LAMP testing, it was found that 30 cases were positive for tuberculosis, and two samples were false positives. TB-LAMP demonstrated a sensitivity of 82.35 % and a positivity rate of 98.79 %, with positive and negative predictive values of 93.33 % and 96.4 %, respectively. On the other hand, 34 samples out of 200 were positive for Mycobacterium tuberculosis by CB NAAT.

Conclusion

CBNAAT and TB LAMP are both effective techniques for detecting tuberculosis with comparable results. Our study demonstrated that both methods have nearly equal sensitivity and specificity, and should be recommended for detecting Mycobacterium tuberculosis. TB LAMP can be considered in developing countries like ours in laboratory setups with poor resources.
结核病是印度的主要传染病之一,并继续对公共卫生构成重大挑战。它是由结核分枝杆菌引起的,可能是致命的。印度的结核病负担相对较高。因此,有必要尽早诊断和治疗结核病,为此有必要建立有前途的诊断方式的基础。方法在一年多的时间里,在兰契医学院微生物科进行了横断面调查。对来自临床疑似结核病病例的200份样本进行了评估。所有患者均行Ziehl-Neelsen染色、CBNAAT和TB LAMP。比较和评价两种检测方法的诊断率和疗效。结果200例标本中有22例锌染色阳性。敏感性为58.8%,特异性为98.7%。在进行结核病LAMP检测时,发现30例结核病呈阳性,2个样本呈假阳性。TB-LAMP的敏感性为82.35%,阳性率为98.79%,阳性预测值为93.33%,阴性预测值为96.4%。另一方面,200个样本中有34个样本经CB NAAT检测呈结核分枝杆菌阳性。结论cbnaat和TB LAMP是检测结核病的有效方法,检测结果具有可比性。我们的研究表明,这两种方法具有几乎相同的敏感性和特异性,应该推荐用于检测结核分枝杆菌。在像我国这样的发展中国家,在实验室设施缺乏资源的情况下,可以考虑结核病LAMP。
{"title":"Comparative study of CBNAAT and TB LAMP in a tertiary care hospital, RIMS Ranchi, Jharkhand","authors":"Ankita Kumari ,&nbsp;Manoj Kumar ,&nbsp;Ashok Kumar Sharma ,&nbsp;Kumari Seema ,&nbsp;Abhay Kumar ,&nbsp;Manju Boipai ,&nbsp;Brajesh Mishra","doi":"10.1016/j.ijtb.2025.06.008","DOIUrl":"10.1016/j.ijtb.2025.06.008","url":null,"abstract":"<div><h3>Background</h3><div><span>Tuberculosis is among the leading contagious illnesses in India and continues to pose a significant public health challenge. It is caused by </span><span><span>Mycobacterium tuberculosis</span></span> and can be potentially fatal. The burden of tuberculosis is relatively high in India. Hence, it is necessary to diagnose and treat tuberculosis as soon as possible, for which a foundation of promising diagnostic modalities is necessary.</div></div><div><h3>Methods</h3><div>Over one year, a cross-sectional investigation was conducted at the Department of Microbiology, RIMS, Ranchi. Two hundred samples from clinically suspected cases of Tuberculosis were evaluated. Ziehl-Neelsen staining, CBNAAT, and TB LAMP were done on all patients. The diagnostic yield and efficacy of both testing methods were compared and evaluated.</div></div><div><h3>Results</h3><div>ZN staining was positive in 22 out of the 200 samples in our study. The sensitivity and specificity were 58.8 % and 98.7 %, respectively. On conducting TB LAMP testing, it was found that 30 cases were positive for tuberculosis, and two samples were false positives. TB-LAMP demonstrated a sensitivity of 82.35 % and a positivity rate of 98.79 %, with positive and negative predictive values of 93.33 % and 96.4 %, respectively. On the other hand, 34 samples out of 200 were positive for <em>Mycobacterium tuberculosis</em> by CB NAAT.</div></div><div><h3>Conclusion</h3><div>CBNAAT and TB LAMP are both effective techniques for detecting tuberculosis with comparable results. Our study demonstrated that both methods have nearly equal sensitivity and specificity, and should be recommended for detecting <em>Mycobacterium tuberculosis</em>. TB LAMP can be considered in developing countries like ours in laboratory setups with poor resources.</div></div>","PeriodicalId":39346,"journal":{"name":"Indian Journal of Tuberculosis","volume":"72 ","pages":"Pages S130-S133"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145692929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The performance of A rpob gene mutation linked to A resistant to rifampicin mycobacterium tuberculosis isolate from an Indonesian referral hospital 印度尼西亚一家转诊医院结核分枝杆菌分离株对利福平耐药的rpob基因突变的表现
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2024.06.013
Deby Kusumaningrum , Ni Made Mertaniasih , Soedarsono Soedarsono

Introduction

Indonesia has the world's second-highest tuberculosis and is one of the 30 countries with an increased MDR/RR TB burden. Even though the number of people with tuberculosis is rising every year, several cases of latent or active tuberculosis remain unreported. Microscopy has its limitations, and factors such as quality sample, quality smear, bacterial load, and experience of reading AFB influence the sensitivity of the test. Utilizing a quick, point-of-care testing system based on molecular techniques can increase the sensitivity of tuberculosis early diagnosis. Cepheid Xpert ®MTB/RIF is Indonesia's most widely utilized molecular technology. It is a nested real-time PCR diagnostic device that is cartridge-based and semiquantitative. In the TB complex of Mycobacterium tuberculosis, it identifies alterations in the RNA polymerase (rpoB) gene beta-subunit that result in rifampicin resistance (RR). By utilizing the Xpert ® MTB/RIF assay at Soetomo General Hospital, one of Indonesia's primary tertiary referral hospitals, the current study seeks to improve our knowledge of the prevalence of rpoB gene mutations in individuals with tuberculosis.

Methods

Between January 2021 and December 2021, Soetomo General Hospital used the Xpert®MTB/RIF system to screen sputum and extrapulmonary specimens from 3584 for tuberculosis.

Results

Of the 665 samples, 18,5% tested positive for M. tuberculosis, with 7.6% (51 out of 665) showing resistance to Rifampicin Rifampicin compounds at codons 529–533 (probe E) of the rpoB gene were detected in 56.8% (29/51) of rifampicin-resistant tuberculosis (RR-TB) samples. And then Probe D (19.6%). 7.8% for probes A and B, respectively (5.8%). Probe C did not exhibit any mutations. On the other hand, two samples revealed two mutations in probes D and E, while among 13.7% (7/51) of RR TB samples, no mutations in the probe type were observed.

Conclusion

The Xpert®MTB/RIF system is a compassionate, fast, accurate, and efficient diagnostic tool for RR-TB, tuberculosis, and the molecular epidemiology of mutations associated with rifampin resistance.
印度尼西亚是世界上结核病发病率第二高的国家,也是耐多药/耐药结核病负担增加的30个国家之一。尽管结核病患者人数每年都在上升,但仍有几例潜伏性或活动性结核病病例未得到报告。镜检有其局限性,样品质量、涂片质量、细菌负荷和阅读AFB的经验等因素都会影响检测的灵敏度。利用基于分子技术的快速即时检测系统可以提高结核病早期诊断的敏感性。Cepheid Xpert®MTB/RIF是印度尼西亚应用最广泛的分子技术。这是一个嵌套的实时PCR诊断设备,是基于墨盒和半定量。在结核分枝杆菌的结核复合体中,它确定了导致利福平耐药性的RNA聚合酶(rpoB)基因β亚基的改变。目前的研究利用印度尼西亚一级三级转诊医院之一Soetomo总医院的Xpert®MTB/RIF检测,旨在提高我们对结核病患者rpoB基因突变患病率的认识。方法:在2021年1月至2021年12月期间,Soetomo总医院使用Xpert®MTB/RIF系统对3584例结核病患者的痰液和肺外标本进行筛查。结果665份样本中结核分枝杆菌阳性18.5%,对利福平耐药51份(7.6%),对利福平耐药56.8%(29/51)的样本检测到rpoB基因密码子529-533(探针E)部位的利福平化合物。然后是探针D(19.6%)。探针A和B分别为7.8%(5.8%)。探针C未表现出任何突变。另一方面,两份样本中探针D和E出现了两种突变,而在13.7%(7/51)的RR TB样本中,探针类型未发生突变。结论Xpert®MTB/RIF系统是一种富有同情、快速、准确和高效的诊断工具,可用于RR-TB、结核病以及与利福平耐药相关的突变分子流行病学。
{"title":"The performance of A rpob gene mutation linked to A resistant to rifampicin mycobacterium tuberculosis isolate from an Indonesian referral hospital","authors":"Deby Kusumaningrum ,&nbsp;Ni Made Mertaniasih ,&nbsp;Soedarsono Soedarsono","doi":"10.1016/j.ijtb.2024.06.013","DOIUrl":"10.1016/j.ijtb.2024.06.013","url":null,"abstract":"<div><h3>Introduction</h3><div><span>Indonesia has the world's second-highest tuberculosis and is one of the 30 countries with an increased MDR/RR TB burden. Even though the number of people with tuberculosis is rising every year, several cases of latent or active tuberculosis remain unreported. Microscopy has its limitations, and factors such as quality sample, quality smear, bacterial load, and experience of reading AFB influence the sensitivity of the test. Utilizing a quick, point-of-care testing system based on molecular techniques can increase the sensitivity of tuberculosis early diagnosis. Cepheid Xpert ®MTB/RIF is Indonesia's most widely utilized molecular technology. It is a nested real-time PCR diagnostic device that is cartridge-based and semiquantitative. In the TB complex of </span><em>Mycobacterium tuberculosis</em><span><span>, it identifies alterations in the RNA polymerase (rpoB) gene beta-subunit that result in rifampicin resistance (RR). By utilizing the Xpert ® MTB/RIF assay at Soetomo General Hospital, one of Indonesia's primary tertiary referral hospitals, the current study seeks to improve our knowledge of the prevalence of rpoB </span>gene mutations in individuals with tuberculosis.</span></div></div><div><h3>Methods</h3><div>Between January 2021 and December 2021, Soetomo General Hospital used the Xpert®MTB/RIF system to screen sputum and extrapulmonary specimens from 3584 for tuberculosis.</div></div><div><h3>Results</h3><div>Of the 665 samples, 18,5% tested positive for <em>M. tuberculosis</em><span>, with 7.6% (51 out of 665) showing resistance to Rifampicin Rifampicin compounds at codons 529–533 (probe E) of the rpoB gene were detected in 56.8% (29/51) of rifampicin-resistant tuberculosis (RR-TB) samples. And then Probe D (19.6%). 7.8% for probes A and B, respectively (5.8%). Probe C did not exhibit any mutations. On the other hand, two samples revealed two mutations in probes D and E, while among 13.7% (7/51) of RR TB samples, no mutations in the probe type were observed.</span></div></div><div><h3>Conclusion</h3><div>The Xpert®MTB/RIF system is a compassionate, fast, accurate, and efficient diagnostic tool for RR-TB, tuberculosis, and the molecular epidemiology of mutations associated with rifampin resistance.</div></div>","PeriodicalId":39346,"journal":{"name":"Indian Journal of Tuberculosis","volume":"72 ","pages":"Pages S47-S50"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145692968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Blueprint for scalable laboratory driven quality management systems: Insights from tuberculosis diagnostic pilots in India 可扩展实验室驱动的质量管理体系蓝图:来自印度结核病诊断试点的见解
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2025.05.004
Manjula Singh , Kamal Kishore Chopra , Zeeshan Sidiq , Gaurav Mehta , Farida Khatun , Seevan Asad , Himshweta Tyagi , Arbaz Khan , Pankaj Bansal , Farah Mohammed Aamir , Sonali Kar , Pooja Priyadarshini , Pritina Samal , Shalini Puri , Ngilang Taley , Sooman Sundaray , Md Abdus Samad Khan , Ranjan Kumar Singh , Himadri Bal , Prasanta Kumar Hota , Shikha Dhawan

Background

Laboratory driven Quality Management Systems (QMS) are “sine qua non” for patient management. Weak QMS may lead to under/over diagnosing TB, unnecessary anti-TB treatment and delayed reporting of results that negatively impact patient care. QMS provides an effective mechanism for health system strengthening as it yields long-term benefits in the quality, cost-effectiveness, and sustainability of public health programs.

Methods

Indian Council of Medical Research (ICMR), Central TB Division (CTD), National TB Elimination Program (NTEP) and SHARE INDIA introduced QMS as a pilot at four TB diagnostic laboratories. Baseline assessments ensured data collection to identify lacunae through standard checklists and provided recommendations for improvement. Capacity building of the healthcare cadre dovetailed to supportive supervision and mentoring ensured that gaps in QMS were plugged so that all laboratories achieved an excellent performance rating in endline assessment.

Results

QMS improved quality of services for patient management and care. It strengthened TB case finding and improved documentation and laboratory performance.

Conclusions

Accuracy and reliability of laboratory service and overarching patient management can be improved by continuous quality improvement based on quality system essentials and QMS.
实验室驱动的质量管理系统(QMS)是患者管理的“必要条件”。质量管理体系薄弱可能导致结核病诊断不足/过度,不必要的抗结核治疗和延迟报告结果,从而对患者护理产生负面影响。质量管理体系为加强卫生系统提供了一种有效的机制,因为它在公共卫生项目的质量、成本效益和可持续性方面产生了长期效益。方法印度医学研究委员会(ICMR)、中央结核病司(CTD)、国家结核病消除计划(NTEP)和SHARE INDIA在4个结核病诊断实验室引入了质量管理体系作为试点。基线评估确保通过标准检查表收集数据以识别漏洞,并提供改进建议。医疗保健干部的能力建设与支持性监督和指导相结合,确保了质量管理体系的空白被填补,从而使所有实验室在终端评估中获得了优异的绩效评级。结果质量管理体系提高了患者管理和护理服务质量。它加强了结核病病例发现并改进了文件记录和实验室绩效。结论以质量体系要点和质量管理体系为基础,通过持续的质量改进,可提高实验室服务的准确性和可靠性,提高患者总体管理水平。
{"title":"Blueprint for scalable laboratory driven quality management systems: Insights from tuberculosis diagnostic pilots in India","authors":"Manjula Singh ,&nbsp;Kamal Kishore Chopra ,&nbsp;Zeeshan Sidiq ,&nbsp;Gaurav Mehta ,&nbsp;Farida Khatun ,&nbsp;Seevan Asad ,&nbsp;Himshweta Tyagi ,&nbsp;Arbaz Khan ,&nbsp;Pankaj Bansal ,&nbsp;Farah Mohammed Aamir ,&nbsp;Sonali Kar ,&nbsp;Pooja Priyadarshini ,&nbsp;Pritina Samal ,&nbsp;Shalini Puri ,&nbsp;Ngilang Taley ,&nbsp;Sooman Sundaray ,&nbsp;Md Abdus Samad Khan ,&nbsp;Ranjan Kumar Singh ,&nbsp;Himadri Bal ,&nbsp;Prasanta Kumar Hota ,&nbsp;Shikha Dhawan","doi":"10.1016/j.ijtb.2025.05.004","DOIUrl":"10.1016/j.ijtb.2025.05.004","url":null,"abstract":"<div><h3>Background</h3><div><span>Laboratory driven Quality Management Systems (QMS) are “sine qua non” for patient management. Weak QMS may lead to under/over diagnosing TB, unnecessary anti-TB treatment and delayed reporting of results that negatively impact patient care. QMS provides an effective mechanism for health system strengthening as it yields long-term benefits in the quality, cost-effectiveness, and sustainability of </span>public health programs.</div></div><div><h3>Methods</h3><div>Indian Council of Medical Research (ICMR), Central TB Division (CTD), National TB Elimination Program (NTEP) and SHARE INDIA introduced QMS as a pilot at four TB diagnostic laboratories. Baseline assessments ensured data collection to identify lacunae through standard checklists and provided recommendations for improvement. Capacity building of the healthcare cadre dovetailed to supportive supervision and mentoring ensured that gaps in QMS were plugged so that all laboratories achieved an excellent performance rating in endline assessment.</div></div><div><h3>Results</h3><div>QMS improved quality of services for patient management and care. It strengthened TB case finding and improved documentation and laboratory performance.</div></div><div><h3>Conclusions</h3><div>Accuracy and reliability of laboratory service and overarching patient management can be improved by continuous quality improvement based on quality system essentials and QMS.</div></div>","PeriodicalId":39346,"journal":{"name":"Indian Journal of Tuberculosis","volume":"72 ","pages":"Pages S80-S85"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145692972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Multidrug-resistant tuberculosis of the knee: A case report describing challenges in diagnosis and treatment 膝关节耐多药结核病:一个病例报告,描述了诊断和治疗的挑战
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2025.04.003
Vikar Singh , Afsana Kajee , Keeren Lutchminarain , Khine Swe Swe-Han
Multidrug-resistant tuberculosis (MDR-TB) of osteoarticular sites poses significant diagnostic and therapeutic challenges. Rapid diagnosis and targeted treatment are critical to managing drug-resistant cases effectively, especially in limited-resourced settings with high TB burden. We describe a rare case of MDR-TB of the knee in an adult female patient who was successfully treated with an individualized exclusive oral multidrug regimen for 18 months.
骨关节部位的耐多药结核病(MDR-TB)带来了重大的诊断和治疗挑战。快速诊断和靶向治疗对于有效管理耐药病例至关重要,特别是在资源有限、结核病负担高的环境中。我们描述了一例罕见的膝关节耐多药结核病病例,该病例为一名成年女性患者,通过个体化独家口服多药方案成功治疗了18个月。
{"title":"Multidrug-resistant tuberculosis of the knee: A case report describing challenges in diagnosis and treatment","authors":"Vikar Singh ,&nbsp;Afsana Kajee ,&nbsp;Keeren Lutchminarain ,&nbsp;Khine Swe Swe-Han","doi":"10.1016/j.ijtb.2025.04.003","DOIUrl":"10.1016/j.ijtb.2025.04.003","url":null,"abstract":"<div><div>Multidrug-resistant tuberculosis (MDR-TB) of osteoarticular sites poses significant diagnostic and therapeutic challenges. Rapid diagnosis and targeted treatment are critical to managing drug-resistant cases effectively, especially in limited-resourced settings with high TB burden. We describe a rare case of MDR-TB of the knee in an adult female patient who was successfully treated with an individualized exclusive oral multidrug regimen for 18 months.</div></div>","PeriodicalId":39346,"journal":{"name":"Indian Journal of Tuberculosis","volume":"72 ","pages":"Pages S177-S180"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145693043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
TB LAMP- a potential way forward to diagnose smear negative suspected TB cases TB LAMP-一种诊断涂片阴性疑似结核病例的潜在方法
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2025.06.018
Bharat Kumawat , Man Mohan Puri , Manpreet Bhalla , Ananya Prabhu , Neha Sharma , Paras Singh , Rajesh Kumar

Objective

Mycobacterium tuberculosis has co-existed with humans for millennia. Even after century from its discovery, TB is currently one of the major health problems globally, especially in developing nations. Tuberculosis diagnostics poses the biggest challenge particularly in peripheral settings in TB endemic countries. Smear microscopy still remains the method of choice for identifying TB; however the need of the hour calls for replacement of this technique, by a rapid diagnostic tool with higher sensitivity and specificity. TB LAMP was approved by WHO in 2016, as substitute for smear microscopy. However more data is required, especially for smear negative suspected TB patients, before its deployment into field setting.

Study design

A total of 51 smear negative suspected TB patients were enrolled in this study. The patients were clinically/radiological diagnosed with TB. Microbiological confirmation in terms of culture and NAAT based diagnosis by Xpert MTB/RIF and TB LAMP was performed for all the patients.

Results

TB LAMP was found to be positive in 74.50 % samples. The sensitivity of TB LAMP and Xpert MTB/RIF, using culture as reference standard, was found to be 84.85 % (95 %CI: 68.10–94.89 %) and 82.35 % (95CI: 65.47–93.24 %) respectively. The specificity of TB LAMP and Xpert MTB/RIF, using culture as reference standard, was found to be 47.06 % (95 %CI: 22.98–72.19 %) and 41.1 (95CI: 18.44–67.08 %) respectively. The PPV and NPV of TB LAMP was 40.72 % (95 %CI: 30.02–52.38 %) and 87.87 % (95 %CI: 73.67–94.94 %) respectively.

Conclusion

We observed similar sensitivity and specificity of TB LAMP and Xpert MIB/RIF for smear negative suspected TB patients. TB LAMP was also able to detect M.tb in 5 % of smear negative, culture negative samples as well. These results indicate that TB LAMP could be a promising candidate of rapid detection of TB in otherwise ‘hidden TB’ cases. However, further validation is required, before TB LAMP can be introduced to mainstream TB elimination program.
目的结核分枝杆菌已与人类共存数千年。即使在它被发现的一个世纪之后,结核病仍然是目前全球主要的健康问题之一,特别是在发展中国家。结核病诊断是最大的挑战,特别是在结核病流行国家的外围环境中。涂片镜检仍然是鉴定结核病的首选方法;然而,时间的需要需要替代这种技术,由一个快速的诊断工具具有更高的灵敏度和特异性。TB LAMP于2016年获得世卫组织批准,作为涂片镜检的替代品。然而,在将其部署到现场之前,需要更多的数据,特别是对于涂片阴性的疑似结核病患者。研究设计本研究共纳入51例涂片阴性的疑似结核病患者。患者经临床/放射学诊断为结核。采用Xpert MTB/RIF和TB LAMP对所有患者进行微生物学培养和NAAT诊断确认。结果stb LAMP阳性检出率为74.50%。TB LAMP和Xpert MTB/RIF以培养物为参比标准,灵敏度分别为84.85% (95% CI: 68.10 ~ 94.89%)和82.35% (95% CI: 65.47 ~ 93.24%)。TB LAMP和Xpert MTB/RIF以培养为参比标准,特异性分别为47.06% (95% CI: 22.98 ~ 72.19%)和41.1 (95% CI: 18.44 ~ 67.08%)。TB LAMP的PPV和NPV分别为40.72% (95% CI: 30.02 ~ 52.38%)和87.87% (95% CI: 73.67 ~ 94.94%)。结论TB LAMP和Xpert MIB/RIF对涂片阴性的疑似结核病患者的敏感性和特异性相似。TB LAMP也能在5%的涂片阴性、培养阴性样本中检测出结核分枝杆菌。这些结果表明,TB LAMP可能是一种很有前途的候选方法,可以在其他“隐性结核病”病例中快速检测结核病。然而,在将TB LAMP引入主流结核病消除规划之前,需要进一步验证。
{"title":"TB LAMP- a potential way forward to diagnose smear negative suspected TB cases","authors":"Bharat Kumawat ,&nbsp;Man Mohan Puri ,&nbsp;Manpreet Bhalla ,&nbsp;Ananya Prabhu ,&nbsp;Neha Sharma ,&nbsp;Paras Singh ,&nbsp;Rajesh Kumar","doi":"10.1016/j.ijtb.2025.06.018","DOIUrl":"10.1016/j.ijtb.2025.06.018","url":null,"abstract":"<div><h3>Objective</h3><div><span><span>Mycobacterium tuberculosis</span></span><span> has co-existed with humans for millennia. Even after century from its discovery, TB is currently one of the major health problems globally, especially in developing nations. Tuberculosis diagnostics poses the biggest challenge particularly in peripheral settings in TB endemic countries. Smear microscopy still remains the method of choice for identifying TB; however the need of the hour calls for replacement of this technique, by a rapid diagnostic tool with higher sensitivity and specificity. TB LAMP was approved by WHO in 2016, as substitute for smear microscopy. However more data is required, especially for smear negative suspected TB patients, before its deployment into field setting.</span></div></div><div><h3>Study design</h3><div>A total of 51 smear negative suspected TB patients were enrolled in this study. The patients were clinically/radiological diagnosed with TB. Microbiological confirmation in terms of culture and NAAT based diagnosis by Xpert MTB/RIF and TB LAMP was performed for all the patients.</div></div><div><h3>Results</h3><div>TB LAMP was found to be positive in 74.50 % samples. The sensitivity of TB LAMP and Xpert MTB/RIF, using culture as reference standard, was found to be 84.85 % (95 %CI: 68.10–94.89 %) and 82.35 % (95CI: 65.47–93.24 %) respectively. The specificity of TB LAMP and Xpert MTB/RIF, using culture as reference standard, was found to be 47.06 % (95 %CI: 22.98–72.19 %) and 41.1 (95CI: 18.44–67.08 %) respectively. The PPV and NPV of TB LAMP was 40.72 % (95 %CI: 30.02–52.38 %) and 87.87 % (95 %CI: 73.67–94.94 %) respectively.</div></div><div><h3>Conclusion</h3><div>We observed similar sensitivity and specificity of TB LAMP and Xpert MIB/RIF for smear negative suspected TB patients. TB LAMP was also able to detect <em>M.tb</em> in 5 % of smear negative, culture negative samples as well. These results indicate that TB LAMP could be a promising candidate of rapid detection of TB in otherwise ‘hidden TB’ cases. However, further validation is required, before TB LAMP can be introduced to mainstream TB elimination program.</div></div>","PeriodicalId":39346,"journal":{"name":"Indian Journal of Tuberculosis","volume":"72 ","pages":"Pages S145-S151"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145693484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nanoparticle-based biosensor- from existing to advanced tools in diagnosis of tuberculosis 基于纳米粒子的生物传感器——从现有的到先进的结核病诊断工具
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1016/j.ijtb.2025.06.014
Karthikeyan Sundaram , Sathyapriya Subramani , Venkataraman Prabhu
Mycobacterium tuberculosis (MTB) causes Tuberculosis (TB), which is a fatal infectious disease. Timely diagnosis of tuberculosis is crucial, and the conventional culture method is time-consuming and smear microscopic staining is less sensitive. Significantly, rapid molecular diagnostic assays are frequently used to detect this infection with high sensitivity and specificity. However, tuberculosis and associated ailments have been identified by several tuberculosis marker proteins. A range of biosensing methodologies, such as nucleic acid amplification tests, enzyme-linked immunosorbent assay (ELISA), flow cytometry, radiometric detection, and latex agglutination have been utilized to enhance tuberculosis diagnosis. Majorly, the detection of two biomarkers in Mycobacterium tuberculosis bacilli prominently produce a 10 kDa culture filtrate antigen (CFP-10) and a 6-kDa early secretory antigenic target (ESAT-6). In this context, Nanoparticle-based biosensors make it easier to find different stages of disease development. In recent years, it has been strongly linked to tubercular disease diagnoses. Nanoparticles are likely to be inorganic and organic, and predominantly inorganic (Silver, Gold, zinc oxide, iron oxide, and silica) nanoparticles have been well studied. Notably, antibacterials are made from gold and silver nanoparticles that are made from vegetable oil. Therefore, this review aims to comprehensively analyze the recent developments of nanoparticle-based diagnostics advances to detect tuberculosis.
结核分枝杆菌(MTB)引起结核病(TB),这是一种致命的传染病。结核病的及时诊断是至关重要的,传统的培养方法耗时长,涂片显微镜染色灵敏度低。值得注意的是,快速分子诊断分析经常用于检测这种感染,具有高灵敏度和特异性。然而,结核病和相关疾病已被几种结核病标记蛋白鉴定出来。一系列生物传感方法,如核酸扩增试验、酶联免疫吸附试验(ELISA)、流式细胞术、放射检测和胶乳凝集已被用于提高结核病的诊断。在结核分枝杆菌中检测到的两个生物标志物主要产生一个10 kDa的培养滤液抗原(CFP-10)和一个6 kDa的早期分泌抗原靶标(ESAT-6)。在这种情况下,基于纳米粒子的生物传感器可以更容易地发现疾病发展的不同阶段。近年来,它与结核病的诊断密切相关。纳米粒子可能是无机和有机的,并且主要是无机纳米粒子(银、金、氧化锌、氧化铁和二氧化硅)已经得到了很好的研究。值得注意的是,抗菌剂是由植物油制成的金和银纳米颗粒制成的。因此,本文旨在全面分析基于纳米颗粒的结核病诊断进展的最新进展。
{"title":"Nanoparticle-based biosensor- from existing to advanced tools in diagnosis of tuberculosis","authors":"Karthikeyan Sundaram ,&nbsp;Sathyapriya Subramani ,&nbsp;Venkataraman Prabhu","doi":"10.1016/j.ijtb.2025.06.014","DOIUrl":"10.1016/j.ijtb.2025.06.014","url":null,"abstract":"<div><div><em>Mycobacterium tuberculosis</em> (MTB) causes Tuberculosis (TB), which is a fatal infectious disease. Timely diagnosis of tuberculosis is crucial, and the conventional culture method is time-consuming and smear microscopic staining is less sensitive. Significantly, rapid molecular diagnostic assays are frequently used to detect this infection with high sensitivity and specificity. However, tuberculosis and associated ailments have been identified by several tuberculosis marker proteins. A range of biosensing methodologies, such as nucleic acid amplification tests, enzyme-linked immunosorbent assay (ELISA), flow cytometry, radiometric detection, and latex agglutination have been utilized to enhance tuberculosis diagnosis. Majorly, the detection of two biomarkers in <em>Mycobacterium tuberculosis</em> bacilli prominently produce a 10 kDa culture filtrate antigen (CFP-10) and a 6-kDa early secretory antigenic target (ESAT-6). In this context, Nanoparticle-based biosensors make it easier to find different stages of disease development. In recent years, it has been strongly linked to tubercular disease diagnoses. Nanoparticles are likely to be inorganic and organic, and predominantly inorganic (Silver, Gold, zinc oxide, iron oxide, and silica) nanoparticles have been well studied. Notably, antibacterials are made from gold and silver nanoparticles that are made from vegetable oil. Therefore, this review aims to comprehensively analyze the recent developments of nanoparticle-based diagnostics advances to detect tuberculosis.</div></div>","PeriodicalId":39346,"journal":{"name":"Indian Journal of Tuberculosis","volume":"72 ","pages":"Pages S161-S167"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145693485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Indian Journal of Tuberculosis
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