用于筛查儿童潜伏性结核感染和结核病的LIOFeron®TB/LTBI干扰素释放试验的性能评估

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

作者信息

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

机构信息

Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.

Paediatrics resident, Department of Health Sciences, Anna Meyer Children's University Hospital, University of Florence, Florence, Italy.

出版信息

Eur J Pediatr. 2025 Jan 20;184(2):147. doi: 10.1007/s00431-025-05972-6.

DOI:10.1007/s00431-025-05972-6

PMID:39831989

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11753305/

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.

摘要

目的

需要用于结核分枝杆菌（MTB）感染的高精度诊断筛查试验，主要用于检测潜伏感染（LTBI）患者，以避免其进展为活动性结核病。对新型IGRA LIOFeron®TB/LTBI在儿童中的性能进行了评估。该试验的独特之处在于所含的新型MTB抗原（L-丙氨酸脱氢酶），被确定为区分活动性结核病与LTBI感染的工具。

方法

从2022年3月至2023年11月，根据诊断指南招募了90名儿童，并将其分为健康、活动性结核病或LTBI个体。将所有这些参与者的血液用LIOFeron®TB/LTBI检测法进行检测，并与作为金标准的诊断结果以及当前使用的IGRA QuantiFERON®-TB Gold Plus进行比较。

结果

两种检测方法的结果与患者MTB感染的诊断显示出极好的一致性。在ROC分析中，LIOFeron®TB/LTBI检测法在MTB感染诊断准确性方面表现很高（AUC = 0.997），并且该检测法在LTBI检测中显示出100%的敏感性。QuantiFERON®-TB Gold Plus对LTBI检测的敏感性为85.7%。