Evidence map›Paper›PMID 26554383›Full record

Trial reportPloS one2015

Evaluation of Xpert® MTB/RIF Assay in Induced Sputum and Gastric Lavage Samples from Young Children with Suspected Tuberculosis from the MVA85A TB Vaccine Trial.

Erick Wekesa Bunyasi, Michele Tameris, Hennie Geldenhuys, Bey-Marrie Schmidt, Angelique Kany Kany Luabeya, Humphrey Mulenga, Thomas J Scriba, Willem A Hanekom, Hassan Mahomed, Helen McShane and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00953927 (Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 17% 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.

NCT00953927 phase2completednot on this map

Phase II Double-blinded Randomized Controlled Evaluation of MVA85A/AERAS-485 for Safety, Immunogenicity and Prevention of Tuberculosis in BCG-vaccinated, HIV-negative Infants

TypeinterventionalSponsorAerasRan2009Enrolled2,797ConditionsTuberculosisArmsMVA85A/AERAS-485, Candida Skin Test Antigen
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. MVA85A vaccine to enhance BCG for preventing tuberculosis.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Article
  4. Article
  5. HIV-associated tuberculosis.International journal of STD & AIDS · 2021
    Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Trends in Tuberculosis Case Notification and Treatment Success, Haiti, 2010-2015.The American journal of tropical medicine and hygiene · 2017
    Article
  11. Article
  12. Article
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

11 authors at 4 institutions in 2 countries.

Erick Wekesa BunyasiSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Michele TamerisSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Hennie GeldenhuysSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Bey-Marrie SchmidtSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Angelique Kany Kany LuabeyaSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Humphrey MulengaSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Thomas J ScribaSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Willem A HanekomSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Hassan MahomedDepartment of Health, Western Cape Province and Division of Community Health, Stellenbosch University, Stellenbosch, South Africa.
Helen McShaneJenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Mark HatherillSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases and Molecular Medicine, and Department of Pediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
South African Tuberculosis Vaccine Initiative · ZAUniversity of Cape Town · ZAJenner Institute · GBStellenbosch University · ZA

Funding

Wellcome Trust 095780
6 · The paper itself

Abstract

objectiveDiagnosis of childhood tuberculosis is limited by the paucibacillary respiratory samples obtained from young children with pulmonary disease. We aimed to compare accuracy of the Xpert® MTB/RIF assay, an automated nucleic acid amplification test, between induced sputum and gastric lavage samples from young children in a tuberculosis endemic setting.

methodsWe analyzed standardized diagnostic data from HIV negative children younger than four years of age who were investigated for tuberculosis disease near Cape Town, South Africa [2009-2012]. Two paired, consecutive induced sputa and early morning gastric lavage samples were obtained from children with suspected tuberculosis. Samples underwent Mycobacterial Growth Indicator Tube [MGIT] culture and Xpert MTB/RIF assay. We compared diagnostic yield across samples using the two-sample test of proportions and McNemar's χ2 test; and Wilson's score method to calculate sensitivity and specificity.

results1,020 children were evaluated for tuberculosis during 1,214 admission episodes. Not all children had 4 samples collected. 57 of 4,463[1.3%] and 26 of 4,606[0.6%] samples tested positive for Mycobacterium tuberculosis on MGIT culture and Xpert MTB/RIF assay respectively. 27 of 2,198[1.2%] and 40 of 2,183[1.8%] samples tested positive [on either Xpert MTB/RIF assay or MGIT culture] on induced sputum and gastric lavage samples, respectively. 19/1,028[1.8%] and 33/1,017[3.2%] admission episodes yielded a positive MGIT culture or Xpert MTB/RIF assay from induced sputum and gastric lavage, respectively. Sensitivity of Xpert MTB/RIF assay was 8/30[26.7%; 95% CI: 14.2-44.4] for two induced sputum samples and 7/31[22.6%; 11.4-39.8] [p = 0.711] for two gastric lavage samples. Corresponding specificity was 893/893[100%;99.6-100] and 885/890[99.4%;98.7-99.8] respectively [p = 0.025].

conclusionSensitivity of Xpert MTB/RIF assay was low, compared to MGIT culture, but diagnostic performance of Xpert MTB/RIF did not differ sufficiently between induced sputum and gastric lavage to justify selection of one sampling method over the other, in young children with suspected pulmonary TB.

trial registrationClinicalTrials.gov NCT00953927.

Indexed as

Nucleic Acid Amplification TechniquesBacteriological TechniquesChild, PreschoolDouble-Blind MethodEndemic DiseasesFemaleGastrointestinal ContentsHIV SeronegativityHumansInfantMaleMycobacterium tuberculosisOrgan SpecificitySensitivity and SpecificitySouth AfricaSputumTuberculosis Vaccines

Identifiers

PMID26554383
PMCPMC4640848
OpenAlexW2266366375

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.