Xpert MTB/RIF Ultra for the rapid diagnosis of extrapulmonary tuberculosis in a clinical setting of high tuberculosis prevalence country and interpretation of ‘trace’ results

IF 2.8 3区医学 Q3 IMMUNOLOGY Tuberculosis Pub Date : 2024-01-08 DOI:10.1016/j.tube.2024.102478

Rumana Nasrin , Mohammad Khaja Mafij Uddin , Sk Nazmul Kabir , Tanjina Rahman , Samanta Biswas , Aazia Hossain , S.M. Mazidur Rahman , Shahriar Ahmed , Stephane Pouzol , Jonathan Hoffmann , Sayera Banu

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Abstract

To evaluate the diagnostic performance of Xpert MTB/RIF Ultra (Ultra) for the diagnosis of extrapulmonary tuberculosis (EPTB) from different types of extrapulmonary specimens in comparison with culture and composite microbiological reference standard (CRS). A total of 240 specimens were prospectively collected from presumptive EPTB patients between July 2021–January 2022 and tested by Ultra, Xpert, culture and acid-fast bacilli (AFB) smear microscopy. Out of 240 specimens, 35.8 %, 20.8 %, 11.3 %, and 7.1 % were detected as Mycobacterium tuberculosis complex by Ultra, Xpert, culture and AFB microscopy, respectively. An additional 15.0 % cases were detected by Ultra compared to Xpert MTB/RIF (Xpert) assay. A total of 28 (11.7 %) cases were identified as ‘trace’ category by Ultra with indeterminate rifampicin resistance result; of which 36.4 % were clinically confirmed as EPTB. Compared to culture, the sensitivity and specificity of Ultra and Xpert were 100 % and 72.3 %; 92.6 % and 88.3 %, respectively. In comparison with CRS, these were respectively: 98.9 % and 100 %; 57.5 % and 100 %. For individual category of specimens, sensitivity of Ultra was 100 % with varying specificity. We found that Ultra was highly sensitive for the rapid diagnosis of EPTB and has extensive potential over current diagnostics in high TB burden countries, but ‘trace’ results should be interpreted with caution.

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Xpert MTB/RIF Ultra 用于在结核病高发国家的临床环境中快速诊断肺外结核病并解释 "微量 "结果

目的：评估 Xpert MTB/RIF Ultra（Ultra）与培养和复合微生物参考标准（CRS）相比在诊断不同类型肺外标本的肺外结核病（EPTB）方面的诊断性能。2021 年 7 月至 2022 年 1 月期间，研究人员前瞻性地从推定肺结核患者身上采集了 240 份标本，并通过 Ultra、Xpert、培养和酸性无菌杆菌（AFB）涂片显微镜进行了检测。在 240 份标本中，经 Ultra、Xpert、培养和 AFB 涂片显微镜检测，分别有 35.8%、20.8%、11.3% 和 7.1%的标本被检测为复合结核分枝杆菌。与 Xpert MTB/RIF（Xpert）检测相比，Ultra 检测出的病例增加了 15.0%。经 Ultra 检测，共有 28 例（11.7%）病例被确定为 "微量 "类别，且利福平耐药性结果不确定；其中 36.4% 经临床确诊为 EPTB。与培养相比，Ultra 和 Xpert 的敏感性和特异性分别为 100 % 和 72.3 %；92.6 % 和 88.3 %。与 CRS 相比，敏感性和特异性分别为分别为 98.9 % 和 100 %；57.5 % 和 100 %。对于不同类别的标本，Ultra 的灵敏度为 100%，特异性各不相同。我们发现，Ultra 对 EPTB 的快速诊断具有很高的灵敏度，与结核病高负担国家的现有诊断方法相比具有广泛的潜力，但对 "微量 "结果的解释应谨慎。

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来源期刊

Tuberculosis 医学-呼吸系统

CiteScore

4.60

自引率

3.10%

发文量

审稿时长

49 days

期刊介绍： Tuberculosis is a speciality journal focusing on basic experimental research on tuberculosis, notably on bacteriological, immunological and pathogenesis aspects of the disease. The journal publishes original research and reviews on the host response and immunology of tuberculosis and the molecular biology, genetics and physiology of the organism, however discourages submissions with a meta-analytical focus (for example, articles based on searches of published articles in public electronic databases, especially where there is lack of evidence of the personal involvement of authors in the generation of such material). We do not publish Clinical Case-Studies. Areas on which submissions are welcomed include: -Clinical TrialsDiagnostics- Antimicrobial resistance- Immunology- Leprosy- Microbiology, including microbial physiology- Molecular epidemiology- Non-tuberculous Mycobacteria- Pathogenesis- Pathology- Vaccine development. This Journal does not accept case-reports. The resurgence of interest in tuberculosis has accelerated the pace of relevant research and Tuberculosis has grown with it, as the only journal dedicated to experimental biomedical research in tuberculosis.