Published in PLOS One on 2025-12-08, this study is presented as an attributed evidence briefing. The excerpts below are the original researchers’ words, reproduced under their Creative Commons Attribution licence. Health Signal has selected the abstract and, where needed, opening background paragraphs; the complete methods, results, limitations and references remain in the linked paper.
Original authors: Muluwork Getahun, Yenew Kebede, Hilina Molalegn, Ayinalem Alemu, Getu Diriba, Waganeh Sinshaw, Mengistu Tadesse, Ephrem Tesfaye, Kassahun Belachew, Ameha Mekasha, Beniam Feleke
Source: PLOS One • DOI 10.1371/journal.pone.0338557
Read the complete primary study ↗ · Creative Commons Attribution licence
From the researchers
Abstract
Childhood tuberculosis (TB) remains under-reported and undiagnosed. A full complement of diagnostic tests is oftentimes unavailable in resource limited country like Ethiopia. This study assesses the contribution of Xpert MTB/RIF assay and urine LF-LAM for childhood TB diagnosis using sputum and urine samples.
A facility based cross-sectional study was conducted in children between 5 and 14 years of age. Sputum and urine samples were collected from children with presumptive TB. The samples were tested for TB using LF-LAM, Xpert MTB/RIF assay, concentrated smear microscopy, and culture. Diagnostic performance of Xpert MTB/RIF assay was analyzed and compared against culture, which was used as the gold standard. Urine LF-LAM test result was compared to a composite reference standard.
Of 576 participants with presumptive TB enrolled in the study, 519 (90.1%) had complete clinical data and bacteriological laboratory test results. Active TB was diagnosed in 14.1% (73/519), and bacteriological confirmation was made in 10.1% (52/515) of children with presumptive TB. The odds of being diagnosed with a bacteriologically confirmed TB are significantly higher in children who have household contact history with TB patient (aOR 2.27, P = 0.03) and age above 10 years (aOR 3.67, P < 0.001). Xpert MTB/RIF test had sensitivity of 79% using culture as the gold standard. Compared to smear microscopy, the sensitivity of the Xpert MTB/RIF assay increased by 50% for children aged 5–9 years and by 40% for children and adolescents living with HIV (C/ALHIV). All bacteriologically confirmed (n = 2) and clinically diagnosed TB children (n = 2) who live with HIV were tested positive for urine LF-LAM. The overall sensitivity of urine LF-LAM was 27.6% when using the composite reference standard, compared to 17.9% when the bacteriological reference standard was applied.
Pulmonary TB diagnosis was greatly improved with the use of Xpert MTB/RIF assay, particularly in children aged 5–9 years and C/ALHIV who typically have difficulty producing good quality sputum. Urine LF-LAM performed well in children/adolescents who tested positive for HIV, but it performed poorly in the other variables, which suggests that urine LF-LAM testing did not play a critical role in TB diagnosis in children with negative HIV status.
Introduction
Pulmonary tuberculosis (PTB) in children less than 15 years accounts for 11% of all tuberculosis (TB) globally [1]. Of the estimated global TB deaths, 14% were among children with human immunodeficiency virus (HIV) negative and 11% among children living with HIV (CLHIV). National TB programs in most countries notify less than half of the estimated TB in children. More than two third (69%) of childhood TB under the age of 5 years, and 40% of childhood TB remain unreported and undiagnosed [2]. In Ethiopia, childhood TB accounts for 10% of all forms of TB [1]. However, only less than half of the estimated TB in children is notified by the National TB Program, of which 28% are between the ages of 0 and 4 years; the remaining 72% are between the ages of 5 and 14 years. In 2022, 33% of TB in children notified by the national TB Program were bacteriologically confirmed PTB, 28% were clinically diagnosed PTB, and 38% were extra-pulmonary tuberculosis (EPTB) [3]. Generally, microbiological confirmation was only possible for 30% of children with pulmonary TB [4]. Therefore, the true burden of TB is underestimated [2].
Reading this evidence
Use the full paper to check the study design, participant selection, comparator and outcome definitions before drawing a practical conclusion. An association does not by itself show cause and effect. A reported performance measure needs its denominator and uncertainty. A finding from a particular facility, sample or time period should retain that scope when it is discussed elsewhere.
This briefing makes the source accessible within the wider technology & industry desk. It does not assess an individual patient or certify a product. When considering relevance to another health system, examine the original authors’ account of context and limitations, then seek local implementation evidence. The related reporting below provides other studies to read alongside this one; it is a topic connection, rather than a claim that their results are directly comparable.
© 2025 Muluwork Getahun, Yenew Kebede, Hilina Molalegn, Ayinalem Alemu, Getu Diriba, Waganeh Sinshaw, Mengistu Tadesse, Ephrem Tesfaye, Kassahun Belachew, Ameha Mekasha, Beniam Feleke. Excerpts reproduced under CC BY. Selection, formatting and contextual notes by Health Signal. The researchers are the authors of the source study, not members of Health Signal’s staff.
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- Evidence brief: Diagnostic accuracy of the TrueNat™ MTB plus assay for detecting pulmonary tuberculosis in adults
- Evidence brief: Uncovering overlooked bacterial infections in gene X-pert MTB/RIF negative sputum samples of adult patients with presumptive tuberculosis in Harar, Eastern Ethiopia
- Evidence brief: Annual trends in Mycobacterium tuberculosis detection and rifampicin resistance at a regional referral hospital in Northern Ghana, 2019–2024
