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基于试剂盒的核酸扩增试验(CBNAAT)与传统方法在三级保健中心诊断小儿结核病中的比较分析。

Comparative analysis of cartridge-based nucleic acid amplification test (CBNAAT) with conventional methods in the diagnosis of pediatric tuberculosis at a tertiary care center.

机构信息

Department of Pediatrics, SMS Medical College, Jaipur, Rajasthan, India.

Microbiology, SMS Medical College, Jaipur, Rajasthan, India.

出版信息

Indian J Tuberc. 2023;70 Suppl 1:S65-S71. doi: 10.1016/j.ijtb.2023.04.007. Epub 2023 Apr 14.

DOI:10.1016/j.ijtb.2023.04.007
PMID:38110263
Abstract

BACKGROUND

Tuberculosis is an important cause of morbidity and mortality among children. Early diagnosis and treatment in children are challenging, more so in resource-limited, tuberculosis-endemic countries. In 2017, the WHO endorsed the use of CBNAAT for tuberculosis diagnosis. We have undertaken this study to evaluate the diagnostic value of CBNAAT in pediatric tuberculosis in comparison to other methods like microscopic detection of acid-fast bacilli and detection of mycobacteria-by-mycobacteria growth indicator tube (MGIT).

MATERIAL AND METHODS

This hospital-based, cross-sectional, observational prospective study was conducted in the department of pediatrics, at a tertiary care center. A detailed history, general physical examination, and relevant physical examination were performed systematically and the findings were noted in the proforma. All necessary basic investigations like CBC, ESR, X-Ray, etc., and advanced investigations like MRI, CT, and FNAC were done as per the requirement of the subjects and the results were mentioned in the study proforma. Sensitivity, specificity, positive and negative predictive value, and diagnostic accuracy were calculated for various methods. A comparison between the two methods was done using the Mc Nemar test. p-value ≤0.05 was taken as statistically significant. All statistical analyses were done using Epi info version 7.2.1.0 statistical software.

RESULTS

Among 102 children suspected to be suffering from tuberculosis, the maximum number of TB cases were found in the age group of 11-16 years (43.2%), there were 58.2% of females, 58.8% belonged to the rural population, fever (78.4%) was the most common presenting symptom and 35.3% had a history of contact. In the present study, CBNAAT and ZN staining had equal sensitivity (60.8%) and specificity (100%) while the yield for MGIT culture was quite low (sensitivity 37.3%, specificity 100%).

CONCLUSIONS

CBNAAT as a test was found to be useful, especially for early diagnosis and detection of rifampicin resistance in pediatric tuberculosis against MGIT culture. Since MGIT results become available only after 42 days and have a relatively lower yield so they can be utilized only in a selected clinical situation or in patients with high suspicion of tuberculosis where another test is not able to detect the organisms.

摘要

背景

结核病是儿童发病和死亡的重要原因。在资源有限、结核病流行的国家,儿童的早期诊断和治疗具有挑战性。2017 年,世界卫生组织(WHO)批准使用 CBNAAT 进行结核病诊断。我们进行了这项研究,以评估 CBNAAT 在儿科结核病诊断中的价值,并与其他方法(如抗酸杆菌的显微镜检测和分枝杆菌生长指示管(MGIT)检测分枝杆菌)进行比较。

材料和方法

这是一项在三级保健中心儿科进行的基于医院的横断面观察性前瞻性研究。对所有患者进行详细的病史采集、全面的体格检查和相关的体格检查,并将发现记录在病例记录表上。所有必要的基本检查(如全血细胞计数、血沉、X 射线等)和高级检查(如 MRI、CT 和 FNAC 等)均根据患者的需求进行,并在研究病例记录表上记录结果。计算了各种方法的敏感性、特异性、阳性和阴性预测值以及诊断准确性。使用 McNemar 检验比较两种方法。p 值≤0.05 被认为具有统计学意义。所有统计分析均使用 Epi info 版本 7.2.1.0 统计软件进行。

结果

在 102 名疑似患有结核病的儿童中,年龄在 11-16 岁的结核病病例最多(43.2%),女性占 58.2%,农村人口占 58.8%,发热(78.4%)是最常见的首发症状,35.3%有接触史。在本研究中,CBNAAT 和 ZN 染色具有相同的敏感性(60.8%)和特异性(100%),而 MGIT 培养的产率相当低(敏感性 37.3%,特异性 100%)。

结论

CBNAAT 作为一种检测方法,特别是在儿科结核病的早期诊断和检测利福平耐药方面,具有一定的应用价值。由于 MGIT 结果需要 42 天才能获得,且产率相对较低,因此只能在特定的临床情况下或在另一种检测方法无法检测到病原体的情况下,用于高度怀疑结核病的患者。

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