Evidence map›Paper›PMID 31924551›Full record

ArticleThe Lancet. Infectious diseases2020

Xpert MTB/RIF Ultra versus Xpert MTB/RIF for the diagnosis of tuberculous meningitis: a prospective, randomised, diagnostic accuracy study.

Joseph Donovan, Do Dang Anh Thu, Nguyen Hoan Phu, Vu Thi Mong Dung, Tran Phu Quang, Ho Dang Trung Nghia, Pham Kieu Nguyet Oanh, Tran Bao Nhu, Nguyen Van Vinh Chau, Vu Thi Ngoc Ha and 6 more

Open access · hybridAbstract read
In one paragraph

Article in The Lancet. Infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 72 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 9 pooled it
19.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 9 syntheses or guidelines pooled it, 156 citations in OpenAlex.

  1. A clinical practice guideline for tuberculous meningitis.The Lancet. Infectious diseases · 2026
    Guideline
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  6. Evaluating the efficacy of stool sample on Xpert MTB/RIF Ultra and its comparison with other sample types by meta-analysis for TB diagnostics.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2022
    Pooled it
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12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 3 institutions in 2 countries.

Joseph DonovanOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: jdonovan@oucru.org.
Do Dang Anh ThuOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.
Nguyen Hoan PhuOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.
Vu Thi Mong DungOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.
Tran Phu QuangOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.
Ho Dang Trung NghiaOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.
Pham Kieu Nguyet OanhOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.
Tran Bao NhuViet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.
Nguyen Van Vinh ChauOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.
Vu Thi Ngoc HaOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.
Vu Thi Ty HangOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.
Dong Huu Khanh TrinhOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.
Ronald B GeskusOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Le Van TanOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Nguyen Thuy Thuong ThuongOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Guy E ThwaitesOxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Oxford University Clinical Research Unit · VNHospital for Tropical Diseases · VNUniversity of Oxford · GB

Funding

Wellcome Trust 106680/B/14/ZWellcome Trust 204904/Z/16/ZWellcome Trust 206724/Z/17/Z
6 · The paper itself

Abstract

backgroundXpert 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.

methodsIn 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.

findingsBetween 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.

interpretationXpert 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.

fundingWellcome Trust and the Foundation for Innovative New Diagnostics.

Indexed as

HIV InfectionsHumansMolecular Diagnostic TechniquesPredictive Value of TestsProspective StudiesRandom AllocationSensitivity and SpecificityTuberculosis, MeningealTuberculosis, Multidrug-ResistantVietnam

Identifiers

PMID31924551
PMCPMC7045088
OpenAlexW3000453407

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.