Xpert MTB/RIF Ultra versus mycobacterial growth indicator tube liquid culture for detection of Mycobacterium tuberculosis in symptomatic adults: a diagnostic accuracy study

IF 20.9 1区生物学 Q1 INFECTIOUS DISEASES Lancet Microbe Pub Date : 2024-06-01 DOI:10.1016/S2666-5247(24)00001-6

Yingda L Xie MD , Christie Eichberg BS , Nchimunya Hapeela MPhil , Elizabeth Nakabugo BSc , Irene Anyango BSN , Kiranjot Arora MPH , Jeffrey E Korte PhD , Ronald Odero BSc , Judi van Heerden MSc , Widaad Zemanay PhD , Samuel Kennedy MPH , Pamela Nabeta MD , Mahmud Hanif PhD , Camilla Rodrigues MD , Alena Skrahina MD , Wendy Stevens MBBCh , Reynaldo Dietze MD , Xin Liu MD , Jerrold J Ellner MD , David Alland MD , Susan E Dorman MD

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Abstract

Background

Xpert MTB/RIF Ultra (Ultra) is an automated molecular test for the detection of Mycobacterium tuberculosis in sputum. We compared the sensitivity of Ultra to that of mycobacterial growth indicator tube (MGIT) liquid culture, considered the most sensitive assay in routine clinical use.

Methods

In this prospective, multicentre, cross-sectional diagnostic accuracy study, we used a non-inferiority design to assess whether the sensitivity of a single Ultra test was non-inferior to that of a single liquid culture for detection of M tuberculosis in sputum. We enrolled adults (age ≥18 years) with pulmonary tuberculosis symptoms in 11 countries and each adult provided three sputum specimens with a minimum volume of 2 mL over 2 days. Ultra was done directly on sputum 1, and Ultra and MGIT liquid culture were done on resuspended pellet from sputum 2. Results of MGIT and solid media cultures done on sputum 3 were considered the reference standard. The pre-defined non-inferiority margin was 5·0%.

Findings

Between Feb 18, 2016, and Dec 4, 2019, we enrolled 2906 participants. 2600 (89%) participants were analysed, including 639 (25%) of 2600 who were positive for tuberculosis by the reference standard. Of the 2357 included in the non-inferiority analysis, 877 (37%) were HIV-positive and 984 (42%) were female. Sensitivity of Ultra performed directly on sputum 1 was non-inferior to that of sputum 2 MGIT culture (MGIT 91·1% vs Ultra 91·9%; difference –0·8 percentage points; 95% CI –2·8 to 1·1). Sensitivity of Ultra performed on sputum 2 pellet was also non-inferior to that of sputum 2 MGIT (MGIT 91·1% vs Ultra 91·9%; difference –0·8 percentage points; –2·7 to 1·0).

Interpretation

For the detection of M tuberculosis in sputum from adults with respiratory symptoms, there was no difference in sensitivity of a single Ultra test to that of a single MGIT culture. Highly sensitive, rapid molecular approaches for M tuberculosis detection, combined with advances in genotypic methods for drug resistance detection, have potential to replace culture.

Funding

US National Institute of Allergy and Infectious Diseases.

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Xpert MTB/RIF Ultra 与分枝杆菌生长指示管液体培养法检测有症状成人的结核分枝杆菌：诊断准确性研究。

背景Xpert MTB/RIF Ultra（Ultra）是一种自动分子检验，用于检测痰中的结核分枝杆菌。在这项前瞻性、多中心、横断面诊断准确性研究中，我们采用了非劣效性设计，以评估在检测痰中结核分枝杆菌时，单次 Ultra 检测的灵敏度是否不低于单次液体培养的灵敏度。我们在 11 个国家招募了有肺结核症状的成年人（年龄≥18 岁），每个成年人在 2 天内提供 3 份痰标本，最小量为 2 毫升。对痰 1 直接进行超培养，对痰 2 中重新悬浮的颗粒进行超培养和 MGIT 液体培养。在痰 3 上进行的 MGIT 和固体培养基培养结果被视为参考标准。预设的非劣效性差值为 5-0%。研究结果从 2016 年 2 月 18 日到 2019 年 12 月 4 日，我们共招募了 2906 名参与者。我们对 2600 名参与者（89%）进行了分析，其中 2600 名参与者中有 639 人（25%）的肺结核检测结果呈阳性（参考标准）。在纳入非劣效性分析的 2357 人中，877 人（37%）为 HIV 阳性，984 人（42%）为女性。直接在痰 1 上进行 Ultra 检测的灵敏度不低于痰 2 MGIT 培养（MGIT 91-1% vs Ultra 91-9%；差异-0-8 个百分点；95% CI -2-8 to 1-1）。对痰 2 颗粒进行 Ultra 检测的灵敏度也不低于痰 2 MGIT（MGIT 91-1% vs Ultra 91-9%；差异 -0-8 个百分点；-2-7 到 1-0）。高灵敏度、快速的分子方法检测结核杆菌，加上基因型方法在耐药性检测方面的进步，有可能取代培养方法。

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来源期刊

Lancet Microbe Multiple-

CiteScore

27.20

自引率

0.80%

发文量

278

审稿时长

6 weeks

期刊介绍： The Lancet Microbe is a gold open access journal committed to publishing content relevant to clinical microbiologists worldwide, with a focus on studies that advance clinical understanding, challenge the status quo, and advocate change in health policy.