Evidence map›Paper›PMID 38730343›Full record

ArticleBMC infectious diseases2024

Evaluation of serological assays for the diagnosis of childhood tuberculosis disease: a study protocol.

Daniela Neudecker, Nora Fritschi, Thomas Sutter, Lenette L Lu, Pei Lu, Marc Tebruegge, Begoña Santiago-Garcia, Nicole Ritz

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03044509 (Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT03044509 recruitingnot on this map

Evaluation and Validation of Novel Immunodiagnostic Tests for Childhood Tuberculosis Infection and Disease in Switzerland. The CITRUS (ChIldhood TubeRcUlosis in Switzerland) Study.

Typeobservational_patient_registrySponsorUniversity Children's Hospital BaselRan2017 to 2028Enrolled190ConditionsTuberculosis, Mycobacterium TuberculosisArmsSecreted cytokine assay, Intracellular cytokine assay
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Recent Characterization of Key Proteins to Combat Tuberculosis.Advances in experimental medicine and biology · 2026
    Review
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Daniela NeudeckerMycobacterial and Migrant Health Research Group, Department of Clinical Research, University of Basel Children's Hospital Basel, University of Basel, Spitalstrasse 33, Basel, CH-4031, Switzerland.
Nora FritschiMycobacterial and Migrant Health Research Group, Department of Clinical Research, University of Basel Children's Hospital Basel, University of Basel, Spitalstrasse 33, Basel, CH-4031, Switzerland.
Thomas SutterDepartment of Computer Science, Medical Data Science, Eidgenössische Technische Hochschule (ETH) Zurich, Zurich, Switzerland.
Lenette L LuDepartment of Immunology, UT Southwestern Medical Center, Dallas, TX, USA.
Pei LuDivision of Geographic Medicine and Infectious Diseases, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA.
Marc TebrueggeDepartment of Paediatrics, The Royal Children's Hospital Melbourne, The University of Melbourne, Parkville, Australia.
Begoña Santiago-GarciaPediatric Infectious Diseases Department, Gregorio Marañón University Hospital, Madrid, Spain.
Nicole RitzMycobacterial and Migrant Health Research Group, Department of Clinical Research, University of Basel Children's Hospital Basel, University of Basel, Spitalstrasse 33, Basel, CH-4031, Switzerland. nicole.ritz@unibas.ch.

Funding

Defining the antibody interface between Mycobacterium tuberculosis and host immunityR01AI158858 · NIAID · UT SOUTHWESTERN MEDICAL CENTER · PI LU, LENETTE · 2021 to 2025
$2.1M
NIAID NIH HHS R01 AI158858
6 · The paper itself

Abstract

backgroundTuberculosis (TB) poses a major public health challenge, particularly in children. A substantial proportion of children with TB disease remain undetected and unconfirmed. Therefore, there is an urgent need for a highly sensitive point-of-care test. This study aims to assess the performance of serological assays based on various antigen targets and antibody properties in distinguishing children (0-18 years) with TB disease (1) from healthy TB-exposed children, (2) children with non-TB lower respiratory tract infections, and (3) from children with TB infection.

methodsThe study will use biobanked plasma samples collected from three prospective multicentric diagnostic observational studies: the Childhood TB in Switzerland (CITRUS) study, the Pediatric TB Research Network in Spain (pTBred), and the Procalcitonin guidance to reduce antibiotic treatment of lower respiratory tract infections in children and adolescents (ProPAED) study. Included are children diagnosed with TB disease or infection, healthy TB-exposed children, and sick children with non-TB lower respiratory tract infection. Serological multiplex assays will be performed to identify M. tuberculosis antigen-specific antibody features, including isotypes, subclasses, Fc receptor (FcR) binding, and IgG glycosylation. DISCUSSION: The findings from this study will help to design serological assays for diagnosing TB disease in children. Importantly, those assays could easily be developed as low-cost point-of-care tests, thereby offering a potential solution for resource-constrained settings. CLINICALTRIALS: GOV IDENTIFIER: NCT03044509.

Indexed as

Serologic TestsTuberculosisAdolescentAntibodies, BacterialAntigens, BacterialChildChild, PreschoolFemaleHumansInfantInfant, NewbornMaleMycobacterium tuberculosisPoint-of-Care TestingProspective StudiesSpainAntibodies, BacterialAntigens, BacterialAntibodyAntigenChildhood TBPaediatricSerodiagnosisSerology

Identifiers

PMID38730343
PMCPMC11084122

What Socratic holds

Textmetadata
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 Socratic graph.