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Xpert MTB/RIF ultra for the diagnosis of tuberculous meningitis: A diagnostic accuracy study from India
Tuberculosis ( IF 2.8 ) Pub Date : 2020-12-01 , DOI: 10.1016/j.tube.2020.101990
Kusum Sharma 1 , Megha Sharma 1 , Ritu Shree 2 , Manish Modi 2 , Manoj Goyal 2 , Dhawal Narang 2 , Aman Sharma 3 , Vivek Lal 2 , Navneet Sharma 3 , Pallab Ray 1
Affiliation  

SETTING Studies evaluating Xpert MTB/RIF Ultra assay (Xpert Ultra) for diagnosing tuberculous meningitis (TBM) are scarce and have reported contrasting results in comparison to Xpert MTB/RIF assay (Xpert). OBJECTIVE To evaluate the performance of Xpert Ultra in diagnosing TBM and compare it with Xpert and multiplex polymerase chain reaction (MPCR). DESIGN Xpert Ultra was performed on 244 cerebrospinal fluid (CSF) samples: 56 definite TBM, 148 probable TBM and 40 non-TBM controls. 105/244 CSF samples were also subjected to Xpert and MPCR (IS6110, MPB64, protein B). RESULTS The overall sensitivity of Xpert Ultra in diagnosing TBM from 244 CSF samples was 72.05% (96.42% - definite TBM, 62.83% - probable TBM) with a specificity of 100%. 18 (12.24%) cases [8 definite TBM, 10 probable TBM] were reported rifampicin resistant (RifR) by Xpert Ultra and confirmed by rpoB sequencing. 60 (40.81%) cases [9 definite TBM, 51 probable TBM] were reported rifampicin indeterminate (RifI) by Xpert Ultra (all trace category), out of which 45 [8 definite, 37 probable) were rifampicin susceptible (RifS) and 5 probable cases were RifR on rpoB sequencing. Out of 105 CSF samples subjected to all three techniques, TBM was diagnosed in 70.66%, 28% and 88% by Xpert Ultra, Xpert and MPCR, respectively. CONCLUSION Xpert Ultra detected TBM with higher sensitivity than Xpert. Among trace category, constituting 40% of TBM cases, rpoB gene sequencing confirmed 5 RifR cases.

中文翻译:

Xpert MTB/RIF ultra 用于结核性脑膜炎的诊断:来自印度的诊断准确性研究

设置 评估 Xpert MTB/RIF Ultra 测定 (Xpert Ultra) 用于诊断结核性脑膜炎 (TBM) 的研究很少,并且报告的结果与 Xpert MTB/RIF 测定 (Xpert) 形成对比。目的评价Xpert Ultra诊断TBM的性能,并与Xpert和多重聚合酶链反应(MPCR)进行比较。DESIGN Xpert Ultra 对 244 个脑脊液 (CSF) 样本进行了分析:56 个确定的 TBM、148 个可能的 TBM 和 40 个非 TBM 对照。还对 105/244 CSF 样品进行了 Xpert 和 MPCR(IS6110、MPB64、蛋白 B)。结果 Xpert Ultra 从 244 份脑脊液样本中诊断 TBM 的总体敏感性为 72.05%(96.42% - 确定性 TBM,62.83% - 可能 TBM),特异性为 100%。18 (12.24%) 例 [8 个确定的 TBM,Xpert Ultra 报告了 10 个可能的 TBM] 利福平耐药 (RifR),并通过 rpoB 测序确认。Xpert Ultra(所有微量类别)报告了 60 例(40.81%)病例 [9 确定的 TBM,51 例可能的 TBM] 利福平不确定 (RifI),其中 45 例 [确定的 8 例,37 可能的) 对利福平敏感 (RifS) 和 5可能的病例是 rpoB 测序上的 RifR。在接受所有三种技术的 105 份 CSF 样本中,Xpert Ultra、Xpert 和 MPCR 分别诊断出 70.66%、28% 和 88% 的 TBM。结论 Xpert Ultra 探测到的 TBM 比 Xpert 具有更高的灵敏度。在微量类别中,占 TBM 病例的 40%,rpoB 基因测序确认了 5 个 RifR 病例。其中 45 个 [8 个确定的,37 个可能的] 是利福平敏感的 (RifS),5 个可能的病例是 rpoB 测序上的 RifR。在接受所有三种技术的 105 份 CSF 样本中,Xpert Ultra、Xpert 和 MPCR 分别诊断出 70.66%、28% 和 88% 的 TBM。结论 Xpert Ultra 探测到的 TBM 比 Xpert 具有更高的灵敏度。在微量类别中,占 TBM 病例的 40%,rpoB 基因测序确认了 5 个 RifR 病例。其中 45 个 [8 个确定的,37 个可能的] 是利福平敏感的 (RifS),5 个可能的病例是 rpoB 测序上的 RifR。在接受所有三种技术的 105 份 CSF 样本中,Xpert Ultra、Xpert 和 MPCR 分别诊断出 70.66%、28% 和 88% 的 TBM。结论 Xpert Ultra 探测到的 TBM 比 Xpert 具有更高的灵敏度。在微量类别中,占 TBM 病例的 40%,rpoB 基因测序确认了 5 个 RifR 病例。
更新日期:2020-12-01
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