Evidence map›Paper›PMID 40391711›Full record

ArticleJournal of the Pediatric Infectious Diseases Society2025

Performance of a Novel Stool Quantitative Polymerase Chain Reaction Assay for Pediatric Tuberculosis Detection in Sub-Saharan Africa.

Anca Vasiliu, Lucia Carratala-Castro, Abigail Seeger, Joanna Ehrlich, Babongile Nkala, Tara Ness, Miguel Mario Cumbe, Durbbin Mulengwa, Shilzia Munguambe, Bariki Mtafya and 11 more

Abstract read
In one paragraph

Article in Journal of the Pediatric Infectious Diseases Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Article
  2. Review
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

21 authors.

Anca VasiliuBaylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX 77030, United States.ORCID 0000-0001-5336-7859
Lucia Carratala-CastroBarcelona Institute for Global Health, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0003-2355-6477
Abigail SeegerBaylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX 77030, United States.
Joanna EhrlichBarcelona Institute for Global Health, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.
Babongile NkalaBaylor College of Medicine Children's Foundation Eswatini, Mbabane, Eswatini.
Tara NessBaylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX 77030, United States.ORCID 0000-0002-4425-418X
Miguel Mario CumbeCentro de Investigação em Saude de Manhiça (CISM), Maputo, Mozambique.
Durbbin MulengwaBaylor College of Medicine Children's Foundation Eswatini, Mbabane, Eswatini.
Shilzia MunguambeCentro de Investigação em Saude de Manhiça (CISM), Maputo, Mozambique.
Bariki MtafyaNational Institute for Medical Research (NIMR)-Mbeya Medical Research Center, Mbeya, Tanzania.
Edson MambuqueCentro de Investigação em Saude de Manhiça (CISM), Maputo, Mozambique.ORCID 0000-0002-9106-1444
Nosisa ShibaBaylor College of Medicine Children's Foundation Eswatini, Mbabane, Eswatini.
Sozinho AcacioCentro de Investigação em Saude de Manhiça (CISM), Maputo, Mozambique.
Lilian KombaBaylor College of Medicine Children's Foundation Mbeya, Mbeya, Tanzania.
Clement Gascua Adu-GyamfiBaylor College of Medicine Children's Foundation Eswatini, Mbabane, Eswatini.
H Lester KirchnerBaylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX 77030, United States.
Christoph LangeBaylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX 77030, United States.ORCID 0000-0002-9691-4741
Andrew R DiNardoBaylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX 77030, United States.ORCID 0000-0001-5990-6470
Alberto L Garcia-BasteiroBarcelona Institute for Global Health, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-2038-5505
Anna Maria MandalakasBaylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX 77030, United States.ORCID 0000-0002-8091-3509
Alexander KayBaylor College of Medicine, Department of Pediatrics, Global TB Program, Houston, TX 77030, United States.ORCID 0000-0001-5283-4697

Funding

Quantifiable stool-based TB PCR to Improve Diagnostics and Treatment MonitoringR01AI137527 · NIAID · BAYLOR COLLEGE OF MEDICINE · PI MANDALAKAS, ANNA M · 2019 to 2022
$2.7M
Wastewater surveillance to enhance the public health response to HIV and TB in EswatiniDP1HD115427 · NICHD · BAYLOR COLLEGE OF MEDICINE · PI Alexander William Kay · 2024 to 2026
$1.7M
Developing Clinical Prediction Tools to Define Strategies for Differentiated Service Delivery in Children and Adolescents Living with HIV in sub-Saharan Africa.K01TW011482 · FIC · BAYLOR COLLEGE OF MEDICINE · PI KAY, ALEXANDER WILLIAM · 2020 to 2024
$749k
FIC NIH HHS K01 TW011482German Center of Infection ResearchNIAID NIH HHS R01 AI137527NICHD NIH HHS DP1 HD115427NIH Allergy and Infectious Diseases R01AI137527-01A1NIH Fogarty International Center 1K01TW011482-01A1
6 · The paper itself

Abstract

backgroundChildren have paucibacillary tuberculosis and cannot provide expectorated sputum. Invasive specimen collection, by gastric aspiration or sputum induction, has a low diagnostic yield. In this study, we aimed to evaluate the diagnostic performance and additive yield of a novel stool-based assay in children diagnosed with tuberculosis in sub-Saharan Africa.

methodsWe conducted a prospective case-control study from October 2020 to June 2023 in Eswatini, Mozambique, and Tanzania. Children under 15 years newly diagnosed with tuberculosis completed clinical examination, chest radiography, culture, sputum Xpert Ultra, stool Xpert Ultra, and stool-based quantitative polymerase chain reaction (stool qPCR) assessment. Stool qPCR sensitivity was calculated against culture, a composite microbiological reference standard, and a clinical reference standard. Specificity was calculated in a control population of healthy, TB disease-free, child household contacts.

resultsAmong 456 children, 232 were diagnosed with TB and 224 controls. Stool sample collection was achieved in 95.6% of children. The qPCR was positive in 17.2% (40/232) of clinically diagnosed participants. In the same population, test positivity was 8% (13/162) for culture, 13.4% (27/202) sputum Xpert Ultra, and 14.8% (33/223) stool Xpert Ultra. When compared to a microbiological reference standard (any positive test), the sensitivity of stool qPCR was 35.6% (21/59). Specificity in the control population was 96.1% (196/204), and the additive yield of qPCR with all tests performed was of 8.7%.

conclusionThis stool qPCR assay can increase the microbiologic confirmation of tuberculosis in pediatric populations from TB high-burden settings. It may be particularly useful where resource limitations or clinical capacity impedes diagnostic specimen collection via sputum induction or gastric aspiration.

Indexed as

FecesMycobacterium tuberculosisReal-Time Polymerase Chain ReactionTuberculosisAdolescentAfrica South of the SaharaCase-Control StudiesChildChild, PreschoolFemaleHumansInfantMaleProspective StudiesSensitivity and SpecificitySputumchildrendiagnostic accuracystool diagnosistuberculosis

Identifiers

PMID40391711
PMCPMC12167930

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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.