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Xpert MTB/RIF Ultra versus Xpert MTB/RIF for the diagnosis of tuberculous meningitis: a prospective, randomised, diagnostic accuracy study.
The Lancet Infectious Diseases ( IF 36.4 ) Pub Date : 2020-01-07 , DOI: 10.1016/s1473-3099(19)30649-8
Joseph Donovan 1 , Do Dang Anh Thu 2 , Nguyen Hoan Phu 3 , Vu Thi Mong Dung 2 , Tran Phu Quang 2 , Ho Dang Trung Nghia 3 , Pham Kieu Nguyet Oanh 3 , Tran Bao Nhu 4 , Nguyen Van Vinh Chau 3 , Vu Thi Ngoc Ha 2 , Vu Thi Ty Hang 2 , Dong Huu Khanh Trinh 2 , Ronald B Geskus 1 , Le Van Tan 1 , Nguyen Thuy Thuong Thuong 1 , Guy E Thwaites 1
Affiliation  

BACKGROUND Xpert MTB/RIF Ultra (Xpert Ultra) might have higher sensitivity than its predecessor, Xpert MTB/RIF (Xpert), but its role in tuberculous meningitis diagnosis is uncertain. We aimed to compare Xpert Ultra with Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. METHODS In this prospective, randomised, diagnostic accuracy study, adults (≥16 years) with suspected tuberculous meningitis from a single centre in Vietnam were randomly assigned to cerebrospinal fluid testing by either Xpert Ultra or Xpert at baseline and, if treated for tuberculous meningitis, after 3-4 weeks of treatment. Test performance (sensitivity, specificity, and positive and negative predictive values) was calculated for Xpert Ultra and Xpert and compared against clinical and mycobacterial culture reference standards. Analyses were done for all patients and by HIV status. FINDINGS Between Oct 16, 2017, and Feb 10, 2019, 205 patients were randomly assigned to Xpert Ultra (n=103) or Xpert (n=102). The sensitivities of Xpert Ultra and Xpert for tuberculous meningitis diagnosis against a reference standard of definite, probable, and possible tuberculous meningitis were 47·2% (95% CI 34·4-60·3; 25 of 53 patients) for Xpert Ultra and 39·6% (27·6-53·1; 21 of 53) for Xpert (p=0·56); specificities were 100·0% (95% CI 92·0-100·0; 44 of 44) and 100·0% (92·6-100·0; 48 of 48), respectively. In HIV-negative patients, the sensitivity of Xpert Ultra was 38·9% (24·8-55·1; 14 of 36) versus 22·9% (12·1-39·0; eight of 35) by Xpert (p=0·23). In HIV co-infected patients, the sensitivities were 64·3% (38·8-83·7; nine of 14) for Xpert Ultra and 76·9% (49·7-91·8; ten of 13) for Xpert (p=0·77). Negative predictive values were 61·1% (49·6-71·5) for Xpert Ultra and 60·0% (49·0-70·0) for Xpert. Against a reference standard of mycobacterial culture, sensitivities were 90·9% (72·2-97·5; 20 of 22 patients) for Xpert Ultra and 81·8% (61·5-92·7; 18 of 22) for Xpert (p=0·66); specificities were 93·9% (85·4-97·6; 62 of 66) and 96·9% (89·5-91·2; 63 of 65), respectively. Six (22%) of 27 patients had a positive test by Xpert Ultra after 4 weeks of treatment versus two (9%) of 22 patients by Xpert. INTERPRETATION Xpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. A negative Xpert Ultra or Xpert test does not rule out tuberculous meningitis. New diagnostic strategies are urgently required. FUNDING Wellcome Trust and the Foundation for Innovative New Diagnostics.

中文翻译:


Xpert MTB/RIF Ultra 与 Xpert MTB/RIF 诊断结核性脑膜炎的比较:一项前瞻性、随机、诊断准确性研究。



背景 Xpert MTB/RIF Ultra (Xpert Ultra) 可能比其前身 Xpert MTB/RIF (Xpert) 具有更高的灵敏度,但其在结核性脑膜炎诊断中的作用尚不确定。我们的目的是比较 Xpert Ultra 与 Xpert 在未感染 HIV 和感染 HIV 的成人中诊断结核性脑膜炎的情况。方法 在这项前瞻性、随机、诊断准确性研究中,来自越南单个中心的疑似结核性脑膜炎成人(≥16 岁)被随机分配接受 Xpert Ultra 或 Xpert 基线脑脊液检测,如果接受结核性脑膜炎治疗,治疗3-4周后。计算 Xpert Ultra 和 Xpert 的测试性能(灵敏度、特异性以及阳性和阴性预测值),并与临床和分枝杆菌培养参考标准进行比较。对所有患者和艾滋病毒状况进行了分析。结果 2017 年 10 月 16 日至 2019 年 2 月 10 日期间,205 名患者被随机分配至 Xpert Ultra (n=103) 或 Xpert (n=102)。 Xpert Ultra 和 Xpert 诊断结核性脑膜炎的敏感性相对于确诊、疑似和可能结核性脑膜炎的参考标准为 47·2%(95% CI 34·4-60·3;53 名患者中的 25 名)。 Xpert 为 39·6%(27·6-53·1;53 中的 21)(p=0·56);特异性分别为 100·0%(95% CI 92·0-100·0;44 中的 44)和 100·0%(92·6-100·0;48 中的 48)。在 HIV 阴性患者中,Xpert Ultra 的敏感性为 38·9%(24·8-55·1;36 名中的 14 名),而 Xpert 的敏感性为 22·9%(12·1-39·0;35 名中的 8 名)。 p=0·23)。在 HIV 合并感染患者中,Xpert Ultra 的敏感性为 64·3%(38·8-83·7;14 人中的 9 人),Xpert 的敏感性为 76·9%(49·7-91·8;13 人中的 10 人) (p=0·77)。 Xpert Ultra 的阴性预测值为 61·1% (49·6-71·5),Xpert 的阴性预测值为 60·0% (49·0-70·0)。根据分枝杆菌培养的参考标准,Xpert Ultra 的敏感性为 90·9%(72·2-97·5;22 名患者中的 20 名),而 Xpert Ultra 的敏感性为 81·8%(61·5-92·7;22 名患者中的 18 名) Xpert (p=0·66);特异性分别为 93·9%(85·4-97·6;66 中的 62)和 96·9%(89·5-91·2;65 中的 63)。治疗 4 周后,27 名患者中有 6 名 (22%) 的 Xpert Ultra 检测呈阳性,而 Xpert 的 22 名患者中有 2 名 (9%) 呈阳性。解释 对于 HIV 未感染者和 HIV 感染者的结核性脑膜炎诊断,Xpert Ultra 在统计学上并不优于 Xpert。 Xpert Ultra 或 Xpert 测试呈阴性并不能排除结核性脑膜炎。迫切需要新的诊断策略。资助威康信托基金和创新诊断基金会。
更新日期:2020-02-27
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