Evidence map›Paper›PMID 38608680›Full record

ArticleThe Lancet. Microbe2024

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

Yingda L Xie, Christie Eichberg, Nchimunya Hapeela, Elizabeth Nakabugo, Irene Anyango, Kiranjot Arora, Jeffrey E Korte, Ronald Odero, Judi van Heerden, Widaad Zemanay and 15 more

Open access · goldAbstract readMulticenter StudyComparative Study
In one paragraph

Article in The Lancet. Microbe, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
6.2field-weighted citation impact, top 3% 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

13 citing papers in PubMed, 16 citations in OpenAlex.

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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

25 authors at 14 institutions in 9 countries.

Yingda L XieDepartment of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
Christie EichbergMedical University of South Carolina, Charleston, SC, USA.
Nchimunya HapeelaDivision of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Elizabeth NakabugoInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Irene AnyangoKenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya.
Kiranjot AroraDepartment of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
Jeffrey E KorteMedical University of South Carolina, Charleston, SC, USA.
Ronald OderoKenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya.
Judi van HeerdenDivision of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Widaad ZemanayDivision of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Samuel KennedyMedical University of South Carolina, Charleston, SC, USA.
Pamela NabetaFIND, Geneva, Switzerland.
Mahmud HanifState TB Training and Demonstration Centre, New Delhi, India.
Camilla RodriguesPD Hinduja Hospital and Medical Research Centre, Mumbai, India.
Alena SkrahinaNational Reference Laboratory, Republican Scientific and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus.
Wendy StevensDepartment of Molecular Medicine and Hematology, Faculty of Health Science, School of Pathology, and the National Priority Program of the National Health Laboratory Service, Johannesburg, South Africa.
Reynaldo DietzeUniversidade Federal do Espirito Santo, Vitoria, Brazil.
Xin LiuHenan Provincial Chest Hospital, Zhengzhou, China.
Jerrold J EllnerDepartment of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
David AllandDepartment of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.
Moses L JolobaMycobacteriology Laboratory, Department of Microbiology, School of Biomedical Sciences, Makerere University, Kampala, Uganda.
Samuel G SchumacherFIND, Geneva, Switzerland.
Kimberly D McCarthyUS Centers for Disease Control and Prevention, Kisumu, Kenya.
Lydia NakiyingiInfectious Diseases Institute, Makerere University, Kampala, Uganda.
Susan E DormanMedical University of South Carolina, Charleston, SC, USA. Electronic address: dorman@musc.edu.
Medical University of South Carolina · USRutgers, The State University of New Jersey · USUniversity of Cape Town · ZAFIND · CHInfectious Diseases Institute · UGKenya Medical Research Institute · KECenters for Disease Control and Prevention · KEHenan Provincial Chest Hospital · CNMakerere University · UGNational Health Laboratory Service · ZANew Delhi Tuberculosis Center · INP. D. Hinduja Hospital and Medical Research Centre · INRepublican Scientific and Practical Centre of Pulmonology and Tuberculosis · BYUniversidade Federal do Espírito Santo · BR

Funding

FEND for TB supplement to accelerate BLINK X developmentU01AI152084 · NIAID · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · PI ALLAND, DAVID, DORMAN, SUSAN E · 2020 to 2024
$20.0M
Accuracy of the Xpert Ultra for Diagnosis of Pulmonary TuberculosisR01AI129411 · NIAID · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI ALLAND, DAVID, DORMAN, SUSAN E · 2017 to 2020
$4.5M
Multidisciplinary Clinical Research and Mentoring in Tuberculosis DiagnosticsK24AI104830 · NIAID · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DORMAN, SUSAN E · 2015 to 2019
$790k
NIAID NIH HHS HHSN272200900050CNIAID NIH HHS K24 AI104830NIAID NIH HHS R01 AI129411NIAID NIH HHS U01 AI152084
6 · The paper itself

Abstract

backgroundXpert 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.

methodsIn 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%.

findingsBetween 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).

interpretationFor 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.

fundingUS National Institute of Allergy and Infectious Diseases.

Indexed as

Mycobacterium tuberculosisSputumTuberculosis, PulmonaryAdultAgedCross-Sectional StudiesFemaleHumansMaleMiddle AgedMolecular Diagnostic TechniquesProspective StudiesSensitivity and SpecificityYoung Adult

Identifiers

PMID38608680
PMCPMC12802551
OpenAlexW4394629774

What OpenQuestion holds

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LicenceCC BY
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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.