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Truenat™ MTB Plus 与 Xpert Ultra 诊断结核性脑膜炎的对比分析。

Comparative analysis of Truenat™ MTB Plus and Xpert Ultra in diagnosing tuberculous meningitis.

机构信息

Department of Microbiology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.

Department of Microbiology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, Department of Microbiology, All India Institute of Medical Sciences, Bilaspur, India.

出版信息

Int J Tuberc Lung Dis. 2021 Aug 1;25(8):626-631. doi: 10.5588/ijtld.21.0156.

DOI:10.5588/ijtld.21.0156
PMID:34330347
Abstract

Diagnostic delay and drug resistance not only worsen the outcomes of tuberculous meningitis (TBM), but are also important impediments to TB elimination efforts. Given the need for a near point-of-care test suitable for primary healthcare centres and simultaneous detection of resistance, Truenat™ MTB Plus assay was evaluated on a large cohort of TBM patients. Truenat assay was performed on 148 cerebrospinal fluid specimens (76 definite TBM, 32 probable TBM and 40 non-TBM controls) and its performance was compared with Xpert Ultra. The overall sensitivity of Truenat and Ultra was respectively 78.7% and 67.6% in diagnosing TBM, and respectively 85.5% and 96% in diagnosing definite TBM. Twenty-three additional cases were detected using Truenat and 11 using Ultra. Truenat missed seven cases of rifampicin (RIF) resistance and indicated false RIF resistance in four cases. Performance of Truenat was comparable to that of Ultra in diagnosing TBM and inferior to Xpert Ultra in determining RIF resistance.

摘要

诊断延迟和耐药不仅使结核性脑膜炎(TBM)的预后恶化,也是结核病消除工作的重要障碍。鉴于需要一种适合基层医疗中心的即时检测方法,并同时检测耐药性,因此对 Truenat™ MTB Plus 检测方法进行了一项针对大量 TBM 患者的评估。Truenat 检测方法在 148 份脑脊液标本(76 份明确的 TBM、32 份可能的 TBM 和 40 份非 TBM 对照)上进行了检测,并与 Xpert Ultra 进行了比较。Truenat 和 Ultra 在诊断 TBM 方面的总灵敏度分别为 78.7%和 67.6%,在诊断明确的 TBM 方面分别为 85.5%和 96%。使用 Truenat 额外检测到 23 例,使用 Ultra 额外检测到 11 例。Truenat 漏检了 7 例利福平(RIF)耐药,4 例报告假 RIF 耐药。Truenat 在诊断 TBM 方面的性能与 Ultra 相当,但在确定 RIF 耐药方面劣于 Xpert Ultra。

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