Lala Sanjay G, Ealand Christopher, Dangor Ziyaad, Hlongwane Khuthadzo, Milovanovic Minja, Car Kathleen, van der Nest Alison, Cleak Tannah, Jacobs Olivia, Sewcharran Astika, Keenan Serene, Reubenson Gary, Abraham Pattamukkil, Mudau Mulisa, Golub Jonathan E, Martinson Neil, Kana Bavesh
Department of Paediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
DSI/NRF Centre of Excellence for Biomedical TB Research, Faculty of Health Sciences, University of the Witwatersrand, National Health Laboratory Service, Johannesburg, South Africa.
Open Forum Infect Dis. 2025 Aug 20;12(9):ofaf474. doi: 10.1093/ofid/ofaf474. eCollection 2025 Sep.
Tuberculosis (TB) diagnosis remains difficult in children under 5 years of age (under-5s), who have high TB morbidity and mortality rates. In a high-burden TB setting, we investigated the diagnostic characteristics of Xpert MTB/RIF Ultra testing of tongue swabs (TS-XU) collected from under-5s.
In a masked, prospective, observational study, tongue swabs were collected from enrolled hospitalized under-5s deemed high risk for TB disease who were categorized into 1 of the following: confirmed, unconfirmed, or unlikely TB.
Of 201 enrolled under-5s, 11 (5.5%) had confirmed TB, 53 (26.4%) unconfirmed TB, and 137 (68.2%) unlikely TB. TS-XU testing reported " detected" in 116 (57.7%) of 201 under-5s: positive results were "trace" (90/116, 77.6%), "very low" (21/116, 18.1%), and "low" or "medium" (4/116 [3.4%] and 1/116 [0.8%], respectively). There were no "high" TS-XU results. When trace results were presumed negative, TS-XU sensitivity was 17.2% (95% CI, 7.9%-26.4%) and specificity 89.1% (95% CI, 83.8%-94.3%), and TS-XU detected in 15 (10.9%) of 137 children with unlikely TB. Our data showed that TS-XU, in addition to routine TB testing, increased TB detection rates by 19.2%.
Despite the difficulty of interpreting trace-positive results, TS-XU testing increased TB detection rates in hospitalized under-5s with presumptive TB.
5岁以下儿童结核病（TB）的诊断仍然困难，该年龄段儿童结核病的发病率和死亡率很高。在结核病高负担地区，我们调查了对5岁以下儿童采集的舌拭子进行Xpert MTB/RIF Ultra检测（TS-XU）的诊断特征。
在一项双盲、前瞻性观察性研究中，从登记入住的被认为结核病患病风险高的5岁以下住院儿童中采集舌拭子，这些儿童被分为以下类别之一：确诊、未确诊或疑似非结核病。
在201名登记的5岁以下儿童中，11名（5.5%）确诊为结核病，53名（26.4%）未确诊为结核病，137名（68.2%）疑似非结核病。TS-XU检测在201名5岁以下儿童中的116名（57.7%）报告为“检测到”：阳性结果为“微量”（90/116，77.6%）、“极低”（21/116，18.1%）以及“低”或“中等”（分别为4/116[3.4%]和1/116[0.8%]）。没有“高”的TS-XU结果。当将微量结果视为阴性时，TS-XU的敏感性为17.2%（95%CI，7.9%-26.4%），特异性为89.1%（95%CI，83.8%-94.3%），并且TS-XU在137名疑似非结核病儿童中的15名（10.9%）检测到结核菌。我们的数据表明，除常规结核病检测外，TS-XU使结核病检测率提高了19.2%。
尽管难以解释微量阳性结果，但TS-XU检测提高了疑似结核病的5岁以下住院儿童的结核病检测率。
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