The new Xpert Mycobacterium tuberculosis/rifampicin (MTB/Rif) Ultra assay in comparison to Xpert MTB/Rif assay for diagnosis of tuberculosis in children and adolescents.

IF 1.8 4区 医学 Q2 PEDIATRICS Journal of Tropical Pediatrics Pub Date : 2023-12-06 DOI:10.1093/tropej/fmad046
Harveen Kaur, Vishal Guglani, Lipika Singhal, Shivani Randev, Pankaj Kumar, Varsha Gupta
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Abstract

Background: Microbiological diagnosis of pediatric tuberculosis (TB) using conventional microbiological techniques has been challenging due to paucibacillary nature of the disease. Molecular methods using cartridge-based tests like Xpert, have immensely improved diagnosis. A novel next-generation cartridge test, Xpert Ultra, incorporates two additional molecular targets and claims to have much lower detection limit. We attempted to compare the two techniques in presumptive pediatric TB patients.

Objectives: The aim of this study was to compare the diagnostic performance of Xpert MTB/Rif Ultra with Xpert MTB/Rif for the detection of pediatric TB.

Study design: This is an observational comparative analytical study.

Methods: Children under 15 years of age with presumptive TB were enrolled. Appropriate specimens were obtained (sputum, induced sputum or gastric aspirate for suspected pulmonary TB, cerebrospinal fluid for suspected tubercular meningitis and pleural fluid for suspected tubercular pleural effusion), subjected to smear microscopy, mycobacterial culture, Xpert and Xpert ultra tests and other appropriate diagnostic investigations.

Results: Out of 130 enrolled patients, 70 were diagnosed with TB using a composite reference standard (CRS). The overall sensitivity of Xpert was 64.29% [95% confidence interval (CI) 51.93-75.93%] and that of Xpert Ultra was 80% (95% CI 68.73-88.61%) with 100% overall specificity for both. The sensitivity of Xpert and Xpert Ultra in pulmonary specimens (n = 112) was 66.67% and 79.37% and in extrapulmonary specimens (n = 18) was 42.86% and 85.71%, respectively.

Conclusion: Our study found Ultra to be more sensitive than Xpert for the detection of Mycobacterium tuberculosis in children. Our findings support the use of Xpert Ultra as initial rapid molecular diagnostic test in children under evaluation for TB.

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新型 Xpert 结核分枝杆菌/利福平(MTB/Rif)Ultra 检测法与 Xpert MTB/Rif 检测法在诊断儿童和青少年结核病方面的比较。
背景:由于小儿肺结核(TB)的贫血症性质,使用传统微生物学技术对该病进行微生物诊断一直是一项挑战。使用 Xpert 等盒式检验的分子方法大大提高了诊断率。新型下一代盒式检测试剂盒 Xpert Ultra 又增加了两个分子靶标,并声称其检测限更低。我们试图在推定的儿童肺结核患者中比较这两种技术:本研究旨在比较 Xpert MTB/Rif Ultra 与 Xpert MTB/Rif 在检测儿科结核病方面的诊断性能:研究设计:这是一项观察性比较分析研究:研究设计:这是一项观察性比较分析研究。获取适当的标本(肺结核疑似患者的痰液、诱导痰液或胃液、结核性脑膜炎疑似患者的脑脊液、结核性胸腔积液疑似患者的胸腔积液),进行涂片镜检、分枝杆菌培养、Xpert 和 Xpert ultra 检测以及其他适当的诊断检查:在 130 名登记患者中,有 70 人通过综合参考标准(CRS)确诊为肺结核。Xpert 的总体灵敏度为 64.29% [95% 置信区间 (CI) 51.93-75.93%],Xpert Ultra 的总体灵敏度为 80% (95% CI 68.73-88.61%),两者的总体特异性均为 100%。Xpert 和 Xpert Ultra 对肺部标本(n = 112)的敏感性分别为 66.67% 和 79.37%,对肺外标本(n = 18)的敏感性分别为 42.86% 和 85.71%:我们的研究发现,在检测儿童结核分枝杆菌方面,Ultra 比 Xpert 更为敏感。我们的研究结果支持使用 Xpert Ultra 作为儿童结核病评估的初始快速分子诊断检测。
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来源期刊
Journal of Tropical Pediatrics
Journal of Tropical Pediatrics 医学-热带医学
CiteScore
4.00
自引率
0.00%
发文量
97
审稿时长
6-12 weeks
期刊介绍: The Journal of Tropical Pediatrics provides a link between theory and practice in the field. Papers report key results of clinical and community research, and considerations of programme development. More general descriptive pieces are included when they have application to work preceeding elsewhere. The journal also presents review articles, book reviews and, occasionally, short monographs and selections of important papers delivered at relevant conferences.
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