Diagnostic utility of microRNA profiles in cavitatory and non-cavitatory pulmonary tuberculosis: Research protocol.

Swathy Moorthy, Emmanuel Bhaskar, Shivakumar Singh, Santhi Silambanan
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Abstract

Background: Tuberculosis (TB) is a common infection causing huge morbidity and mortality to mankind. The analytical methods used in diagnosing TB are not sensitive in paucibacillary infections and also require trained technical personnel. MicroRNAs are stable in serum and other body fluids, and hold great potential in the diagnosis of TB.

Aim: To analyze the dysregulated microRNA profiles among patients with cavitatory and non-cavitatory pulmonary TB.

Methods: The prospective study will be conducted in a tertiary care center in India. Adult patients with newly diagnosed pulmonary TB will be included. There will be two groups: Patients with sputum positive pulmonary TB with cavity and without cavity (group1), and apparently healthy individuals (group 2). The participants will undergo sputum examination, Xpert Mycobacterium TB complex/resistance to rifampin (Mtb/RIF) assay, chest X-ray, and blood investigations and serum microRNA detection. Ethics approval has been obtained. Written informed consent will be obtained. Appropriate statistical analyses will be used.

Results: MicroRNAs will be correlated with sputum positivity, Xpert Mtb/RIF assay, radiological involvement, inflammatory markers, and course of the disease among cases and controls.

Conclusion: MicroRNAs could serve as potential diagnostic biomarkers in diagnostically challenging TB patients.

microRNA谱在空化和非空化肺结核中的诊断应用:研究方案。
背景:结核病(TB)是人类常见的传染病,发病率和死亡率都很高。用于诊断结核病的分析方法对少杆菌感染不敏感,而且还需要训练有素的技术人员。microrna在血清和其他体液中是稳定的,在结核病的诊断中具有很大的潜力。目的:分析空泡性和非空泡性肺结核患者的microRNA表达异常。方法:前瞻性研究将在印度三级保健中心进行。新诊断的肺结核成年患者将被纳入研究范围。将分为两组:痰阳性的有空腔和无空腔的肺结核患者(第一组)和表面健康的个体(第二组)。参与者将进行痰检查、Xpert结核分枝杆菌复合体/利福平耐药性(Mtb/RIF)测定、胸部x线检查、血液检查和血清microRNA检测。已获得伦理批准。将获得书面知情同意。将使用适当的统计分析。结果:在病例和对照组中,MicroRNAs将与痰阳性、Xpert Mtb/RIF检测、放射学累及、炎症标志物和病程相关。结论:microrna可作为诊断挑战性结核病患者的潜在诊断生物标志物。
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