Evidence map›Paper›PMID 25185458›Full record

ArticleThe Lancet. Infectious diseases2014

Assessment of the novel T-cell activation marker-tuberculosis assay for diagnosis of active tuberculosis in children: a prospective proof-of-concept study.

Damien Portevin, Felicien Moukambi, Petra Clowes, Asli Bauer, Mkunde Chachage, Nyanda E Ntinginya, Elirehema Mfinanga, Khadija Said, Frederick Haraka, Andrea Rachow and 9 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in The Lancet. Infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04923958 (Rapid Research in Diagnostics Development for TB Network), which is not on this map. Cited by 78 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 2 pooled it
7.7field-weighted citation impact, top 2% 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.

NCT04923958 narecruitingnot on this mapstarted 2021, after this paper: background citation

Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study

TypeinterventionalSponsorUniversity of California, San FranciscoRan2021 to 2031Enrolled26,436ConditionsTuberculosisArmsNovel mycobacterial culture techniques, Novel sputum smear microscopy techniques, Sputum-based molecular assays, Tongue swab-based molecular assays, Urine LAM assays
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 2 syntheses or guidelines pooled it, 138 citations in OpenAlex.

  1. Screening tests for active pulmonary tuberculosis in children.The Cochrane database of systematic reviews · 2021
    Pooled it
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  5. Two-HitFrontiers in immunology · 2019
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  15. Diagnostic accuracy of a sequence-specificMicrobiology spectrum · 2024
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  17. Differences in PPD- and mitogen-induced T-cell activation marker expression characterize immunopathology in acute tuberculosis patients.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2024
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  18. Specific immune response toFrontiers in immunology · 2024
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  20. Article

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 2 institutions in 2 countries.

Damien PortevinSwiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.
Felicien MoukambiNIMR-Mbeya Medical Research Center, Mbeya, Tanzania; Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich, Germany.
Petra ClowesNIMR-Mbeya Medical Research Center, Mbeya, Tanzania; Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich, Germany.
Asli BauerNIMR-Mbeya Medical Research Center, Mbeya, Tanzania; Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich, Germany.
Mkunde ChachageNIMR-Mbeya Medical Research Center, Mbeya, Tanzania.
Nyanda E NtinginyaNIMR-Mbeya Medical Research Center, Mbeya, Tanzania.
Elirehema MfinangaIfakara Health Institute, Bagamoyo, Tanzania.
Khadija SaidIfakara Health Institute, Bagamoyo, Tanzania.
Frederick HarakaIfakara Health Institute, Bagamoyo, Tanzania.
Andrea RachowDivision of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich, Germany; German Centre for Infection Research, Partner Site Munich, Germany.
Elmar SaathoffDivision of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich, Germany; German Centre for Infection Research, Partner Site Munich, Germany.
Maximilian MpinaIfakara Health Institute, Bagamoyo, Tanzania.
Levan JugheliSwiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Ifakara Health Institute, Bagamoyo, Tanzania.
Fred LwillaIfakara Health Institute, Bagamoyo, Tanzania.
Ben J MaraisChildren's Hospital at Westmead, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
Michael HoelscherDivision of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich, Germany; German Centre for Infection Research, Partner Site Munich, Germany.
Claudia DaubenbergerSwiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.
Klaus ReitherSwiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; Ifakara Health Institute, Bagamoyo, Tanzania. Electronic address: klaus.reither@unibas.ch.
Christof GeldmacherDivision of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich, Germany; German Centre for Infection Research, Partner Site Munich, Germany. Electronic address: geldmacher@lrz.uni-muenchen.de.
Ifakara Health Institute · TZUniversity of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe diagnosis of paediatric tuberculosis is complicated by non-specific symptoms, difficult specimen collection, and the paucibacillary nature of the disease. We assessed the accuracy of a novel immunodiagnostic T-cell activation marker-tuberculosis (TAM-TB) assay in a proof-of-concept study to identify children with active tuberculosis.

methodsChildren with symptoms that suggested tuberculosis were prospectively recruited at the NIMR-Mbeya Medical Research Center in Mbeya, and the Ifakara Health Institute in Bagamoyo, Tanzania, between May 10, 2011, and Sept 4, 2012. Sputum and peripheral blood mononuclear cells were obtained for Mycobacterium tuberculosis culture and performance assessment of the TAM-TB assay. The children were assigned to standardised clinical case classifications based on microbiological and clinical findings.

findingsAmong 290 children screened, we selected a subgroup of 130 to ensure testing of at least 20 with culture-confirmed tuberculosis. 17 of 130 children were excluded because of inconclusive TAM-TB assay results. The TAM-TB assay enabled detection of 15 of 18 culture-confirmed cases (sensitivity 83·3%, 95% CI 58·6-96·4). Specificity was 96·8% (95% CI 89·0-99·6) in the cases that were classified as not tuberculosis (n=63), with little effect from latent tuberculosis infection. The TAM-TB assay identified five additional patients with highly probable or probable tuberculosis, in whom M tuberculosis was not isolated. The median time to diagnosis was 19·5 days (IQR 14-45) for culture.

interpretationThe sputum-independent TAM-TB assay is a rapid and accurate blood test that has the potential to improve the diagnosis of active tuberculosis in children.

fundingEuropean and Developing Countries Clinical Trials Partnership, German Federal Ministry of Education and Research, and Swiss National Science Foundation.

Indexed as

AdolescentBiomarkersChildChild, PreschoolFemaleHumansImmunologic TestsInfantLeukocytes, MononuclearLymphocyte ActivationMaleMycobacterium tuberculosisProspective StudiesReproducibility of ResultsSensitivity and SpecificitySputumBiomarkers

Identifiers

PMID25185458
OpenAlexW2160202077

What OpenQuestion holds

Textmetadata
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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.