Dataset Information

Blood-based Diagnostics of Pediatric Tuberculosis: A Prospective Case-controlled Study

ABSTRACT: Background Pediatric tuberculosis (TB) diagnosis is often challenging due to difficultly obtaining diagnostic respiratory specimens, which may contain low concentrations of Mycobacterium tuberculosis (Mtb) bacilli. However, we have reported that an immuno-affinity liquid chromatography-tandem mass spectrometry TB assay (ILM-TB) that detects a peptide derived from Mtb 10-kDa culture filtrate protein (CFP10pep) can diagnose TB regardless of patient age or infection site when analyzing trypsin-digested blood samples. Methods Discovery and validation cohorts were respectively generated from children who consecutively presented at two hospitals in South Africa (SA) from April 2012 to August 2017 (157 children <13 years-of-age) or at two communities in the Dominican Republic (DR) from July 2019 to May 2023 (101 children <17 years-of-age). All children were evaluated for TB at enrollment and 6-months post-enrollment, and assigned confirmed, unconfirmed, or unlikely TB diagnoses based on the 2015 NIH criteria for pediatric TB. Serum samples were collected at and two and six months after SA/DR enrollment, and at two weeks DR post-enrollment (270 SA and 304 DR samples) to evaluate ILM-TB assay performance. Findings SA and DR serum ILM-TB results had comparable sensitivity (82·9% and 84·4%) to respiratory culture and Xpert for confirmed TB, and robust sensitivity (80·5% and 76·5%) for unconfirmed TB, with differential specificity for unlikely TB cases with and without TB consistent symptoms (78·4–98·1%). CFP10pep levels decreased by six months post-treatment initiation only in children with positive treatment responses. Interpretation Serum CFP10pep detection can effectively diagnose pediatric TB, including unconfirmed and extrapulmonary TB cases missed by sputum-based methods, while decreases after treatment anti-TB treatment initiation can monitoring effective treatment responses.

ORGANISM(S): Homo Sapiens

SUBMITTER: Lin Li

PROVIDER: PXD053274 | panorama | Wed Oct 01 00:00:00 BST 2025

REPOSITORIES: PanoramaPublic

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Publications

Blood-based diagnosis of pediatric tuberculosis: A prospective cohort study in South Africa and Dominican Republic.

Li Lin L Mao Liyan L van der Zalm Marieke M MM Olivo Juan J Liu Shan S Vergara Carlos C Palmer Megan M Shu Qingbo Q Demers Anne-Marie AM Lyon Christopher J CJ Goussard Pierre P Schaaf H Simon HS Hesseling Anneke C AC Nachman Sharon S Pérez-Then Eddy E Mitchell Charles D CD Ghimenton Elisabetta E Hu Tony Y TY

The Journal of infection 20250102 2

<h4>Objectives</h4>Pediatric tuberculosis (TB) diagnosis is complicated by challenges in obtaining invasive respiratory specimens that frequently contain few Mycobacterium tuberculosis (Mtb) bacilli. We report the diagnostic performance of an Mtb antigen-derived peptide (MAP-TB) assay and its ability to monitor TB treatment response.<h4>Methods</h4>Study cohorts enrolled children who presented with presumptive TB at two hospitals in South Africa from 2012 to 2017 (157 children aged <13 years) an ...[more]

PMID: 39755278

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Project description:The aim of the longitudinal analysis was to examine the transcriptional blood profile of active TB patients at the time of recruitment (before drug treatment) and then subsequently at specific time points after drug treatment to determine whether the signature is extinguished with treatment and when. Whole blood collected in tempus tubes from patients with different spectra of TB disease and healthy controls. All patients were sampled prior to the initiation of any antimycobacterial therapy. Active Pulmonary TB: PTB - All patients confirmed by isolation of Mycobacterium Tuberculosis on culture of sputum or bronchoalvelolar lavage fluid. Healthy controls - these were volunteers without exposure to TB who were negative by both tuberculin skin test (<15mm if BCG vaccinated, <6mm if unvaccinated); who were also negative by Interferon-Gamma Release assay(IGRA); specifically Quantiferon Gold In-Tube Assay (Cellestis, Australia). Here the aim of the experiment is to assess the longitudinal effect of antimycobacterial treatment on the active TB signature, during and after treatment. Blood was taken from the active TB patients at baseline, pre-treatment, 2 months after treatment inititation, and 12 months after treatment initiation, which would be after treatment was completed. These samples were then amplified at the same time with samples from healthy controls and hybridised to the same chips to permit an assessment of whether the post treatment samples had similar transcriptional profiles to healthy controls or were distinct. In this dataset: PTB baseline, n = 7; PTB 2 months, n = 7; PTB 12 months, n = 7. BCG+ control baseline, n =12. Experimental variables: Patient group: Active PTB; Healthy controls (all BCG vaccinated). ethnicity - a wide range of ethnic groups is represented. The active PTB group incorporates a range of smear positive and smear negative disease and a spectrum of disease extent/severity. Timepoint: 0 months = baseline pre-treatment;2 months = 2 months after initiation of treatment; 12 months = 12 months after initiation of treatment.

Dataset Information

Blood-based Diagnostics of Pediatric Tuberculosis: A Prospective Case-controlled Study

Publications

Blood-based diagnosis of pediatric tuberculosis: A prospective cohort study in South Africa and Dominican Republic.

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