Performance evaluation of the LIOFeron®TB/LTBI IGRA for screening of paediatric LTBI and tuberculosis.

IF 3 3区医学 Q1 PEDIATRICS European Journal of Pediatrics Pub Date : 2025-01-20 DOI:10.1007/s00431-025-05972-6

Chiara Della Bella, Marco Antonio Motisi, Elisabetta Venturini, Sofia D'Elios, Evangelia Asvestopoulou, Agnese Maria Tamborino, Luisa Galli, Mario Milco D'Elios, Elena Chiappini

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Abstract

Purpose: High-accuracy diagnostic screening tests for Mycobacterium tuberculosis (MTB) infection are required, primarily to detect patients with latent infections (LTBIs) in order to avoid their progression to active tuberculosis disease. The performance of the novel IGRA LIOFeron®TB/LTBI was evaluated in children. The originality of this test is the new MTB antigen contained (L-alanine dehydrogenase), identified as a tool to differentiate active TB from LTBI infection.

Methods: From March 2022 to November 2023, a population of 90 children was enrolled and grouped into healthy, active TB or LTBI individuals, based on diagnostic guidelines. The blood of all these participants was tested with LIOFeron®TB/LTBI assay in comparison to diagnosis, as gold standard, and to the current used IGRA QuantiFERON®-TB Gold Plus.

Results: The two assays demonstrated an excellent concordance of their results with patients' diagnosis of MTB infection. The performance of LIOFeron®TB/LTBI assay in terms of accuracy of MTB infection diagnosis was high at ROC analysis (AUC = 0.997), and the test showed 100% sensitivity in LTBI detection. The QuantiFERON®-TB Gold Plus sensitivity for LTBI detection was 85.7%.

Conclusions: Based on the obtained results, the LIOFeron®TB/LTBI assay appears to be a promising test for TB and LTBI screening among paediatric patients.

What is known: • The detection of LTBI in children, exposed to MTB infections, followed by appropriate treatment, has a pivotal role in reducing tuberculosis burden. • IGRA tests are easy-to-use methods for helping large TB screening in paediatrics.

What is new: • The LIOFeron®TB/LTBI performance evaluation showed 100% of sensitivity in the detection of LTBI patients. • The LIOFeron®TB/LTBI assay might be useful for the detection of LTBI and active tuberculosis paediatric patients.

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LIOFeron®TB/LTBI IGRA筛查儿童LTBI和结核病的性能评估

目的：需要对结核分枝杆菌（MTB）感染进行高精度诊断筛选试验，主要用于检测潜伏感染（LTBIs）患者，以避免其发展为活动性结核病。在儿童中评估新型IGRA LIOFeron®TB/LTBI的性能。该试验的独创性在于含有新的MTB抗原（l -丙氨酸脱氢酶），被确定为区分活动性结核和LTBI感染的工具。方法：从2022年3月至2023年11月，纳入90名儿童，并根据诊断指南将其分为健康、活动性结核病或LTBI个体。所有参与者的血液都用LIOFeron®TB/LTBI检测，与诊断结果（金标准）和目前使用的IGRA QuantiFERON®-TB gold Plus进行比较。结果：两种检测结果与结核分枝杆菌感染的诊断结果具有良好的一致性。在ROC分析中，LIOFeron®TB/LTBI检测方法诊断MTB感染的准确性较高（AUC = 0.997），检测LTBI的灵敏度为100%。QuantiFERON®-TB Gold Plus对LTBI检测的灵敏度为85.7%。结论：基于获得的结果，LIOFeron®TB/LTBI检测似乎是一种很有前景的儿科患者结核病和LTBI筛查测试。已知情况：•在暴露于结核分枝杆菌感染的儿童中发现LTBI，然后进行适当治疗，在减少结核病负担方面具有关键作用。•IGRA测试是易于使用的方法，有助于在儿科进行大规模结核病筛查。新发现：•LIOFeron®TB/LTBI性能评估显示，对LTBI患者的检测灵敏度为100%。•LIOFeron®TB/LTBI检测可能对LTBI和活动性肺结核患儿的检测有用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Pediatrics 医学-小儿科

CiteScore

5.90

自引率

2.80%

发文量

367

审稿时长

3-6 weeks

期刊介绍： The European Journal of Pediatrics (EJPE) is a leading peer-reviewed medical journal which covers the entire field of pediatrics. The editors encourage authors to submit original articles, reviews, short communications, and correspondence on all relevant themes and topics. EJPE is particularly committed to the publication of articles on important new clinical research that will have an immediate impact on clinical pediatric practice. The editorial office very much welcomes ideas for publications, whether individual articles or article series, that fit this goal and is always willing to address inquiries from authors regarding potential submissions. Invited review articles on clinical pediatrics that provide comprehensive coverage of a subject of importance are also regularly commissioned. The short publication time reflects both the commitment of the editors and publishers and their passion for new developments in the field of pediatrics. EJPE is active on social media (@EurJPediatrics) and we invite you to participate. EJPE is the official journal of the European Academy of Paediatrics (EAP) and publishes guidelines and statements in cooperation with the EAP.