Mafirakureva Nyashadzaishe, Daniel Olugbenga Kayode, Olayinka Olabamiji Jamiu, Ochei Kingsley Chinedum, Klinkenberg Eveline, Ihesie Austin, Nongo Debby, Eneogu Rupert Amanze, Mwansasu Andwele, Elom Emeka Uga, Aderonke Agbaje Vivian, Dakum Patrick Sunday, Mensah Charles Olalekan, Odola Oluwafemi Christopher, Olayemi Abiola Oladotun, Faleye Emily Yemisi, Makinde Adekunle Omotoso, Dodd Peter J
Sheffield Centre for Health and Related Research, School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.
Institute of Human Virology, Abuja, Nigeria.
PLOS Glob Public Health. 2025 Jun 26;5(6):e0004016. doi: 10.1371/journal.pgph.0004016. eCollection 2025.
The World Health Organisation (WHO) recommends rapid molecular diagnostics to improve bacteriological confirmation of tuberculosis in children. TrueNat MTB, MTB Plus and MTB-RIF Dx assays (Molbio Diagnostics, India), recommended by WHO, hold potential as point-of-care tests in resource-limited settings. Using stool samples with these assays could enhance testing access, improve linkage to care, reduce costs, and increase cost-effectiveness over traditional methods. However, evidence on their costs and cost-effectiveness is limited and needed for informed policy decisions on adoption and scale up. We used a decision-tree analytic modelling approach, time-and-motion study, and routine data to estimate the potential impact of implementing stool-based TrueNat testing for the diagnosis of pulmonary tuberculosis in children within Nigerian primary healthcare settings on healthcare outcomes, resource use, health system costs, and cost-effectiveness relative to the standard of care (SoC). The cost per test was $13.06 (standard deviation; $0.77) for TrueNat and $16.25 (standard deviation; $1.34) for Xpert. For every 100 children with presumptive tuberculosis, the stool-based TrueNat testing intervention was projected to increase case detection rate by 2 (95% uncertainty interval [UI 0-6]) cases and bacteriological confirmation by 21% (95% UI 11-32). Diagnoses at primary health centres (PHC) would increase by 22% (95% UI 11-32), averting 1 (95% UI 0-2) deaths and 15 (95% UI -4-41) discounted DALYs. Although resource use and health system costs increased by $2,682 (95% UI 1,039-4,731) per 100 children, the incremental cost-effectiveness ratio of $183 per DALY averted suggests cost-effectiveness at thresholds of 0.5 × GDP per capita. Implementing stool-based TrueNat testing has potential to increase access and reduce direct health system costs associated with the diagnosis of pulmonary tuberculosis in children in routine health care settings. Such an approach is likely to represent a good value for money compared to SoC.
世界卫生组织（WHO）建议采用快速分子诊断方法，以提高儿童结核病的细菌学确诊率。WHO推荐的TrueNat MTB、MTB Plus和MTB-RIF Dx检测（印度Molbio诊断公司），在资源有限的环境中作为即时检测具有潜力。使用粪便样本进行这些检测可以增加检测机会，改善与治疗的联系，降低成本，并比传统方法提高成本效益。然而，关于其成本和成本效益的证据有限，而这对于就是否采用和扩大规模做出明智的政策决策是必要的。我们采用决策树分析建模方法、时间和动作研究以及常规数据，来估计在尼日利亚初级卫生保健机构中对儿童实施基于粪便的TrueNat检测以诊断肺结核对医疗结果、资源使用、卫生系统成本以及相对于护理标准（SoC）的成本效益的潜在影响。TrueNat每次检测的成本为13.06美元（标准差；0.77美元），Xpert为16.25美元（标准差；1.34美元）。对于每100名疑似结核病儿童，基于粪便的TrueNat检测干预预计将使病例检出率提高2例（95%不确定区间[UI 0-6]），细菌学确诊率提高21%（95% UI 11-32）。初级卫生中心（PHC）的诊断将增加22%（95% UI 11-32），避免1例（95% UI 0-2）死亡和15例（95% UI -4-41）贴现伤残调整生命年（DALY）。虽然每100名儿童的资源使用和卫生系统成本增加了2682美元（95% UI 1039-4731），但每避免一个DALY的增量成本效益比为183美元，这表明在人均GDP的0.5倍阈值下具有成本效益。在常规医疗环境中，实施基于粪便的TrueNat检测有可能增加儿童肺结核诊断的机会，并降低与之相关的直接卫生系统成本。与护理标准相比，这种方法可能具有良好的性价比。
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