PDF(Pubmed)
Abstract：
BACKGROUND: Tuberculosis (TB) poses a major public health challenge, particularly in children. A substantial proportion of children with TB disease remain undetected and unconfirmed. Therefore, there is an urgent need for a highly sensitive point-of-care test. This study aims to assess the performance of serological assays based on various antigen targets and antibody properties in distinguishing children (0-18 years) with TB disease (1) from healthy TB-exposed children, (2) children with non-TB lower respiratory tract infections, and (3) from children with TB infection.
METHODS: The study will use biobanked plasma samples collected from three prospective multicentric diagnostic observational studies: the Childhood TB in Switzerland (CITRUS) study, the Pediatric TB Research Network in Spain (pTBred), and the Procalcitonin guidance to reduce antibiotic treatment of lower respiratory tract infections in children and adolescents (ProPAED) study. Included are children diagnosed with TB disease or infection, healthy TB-exposed children, and sick children with non-TB lower respiratory tract infection. Serological multiplex assays will be performed to identify M. tuberculosis antigen-specific antibody features, including isotypes, subclasses, Fc receptor (FcR) binding, and IgG glycosylation.
CONCLUSIONS: The findings from this study will help to design serological assays for diagnosing TB disease in children. Importantly, those assays could easily be developed as low-cost point-of-care tests, thereby offering a potential solution for resource-constrained settings.
RESULTS:
UNASSIGNED: NCT03044509.
METHODS: The study will use biobanked plasma samples collected from three prospective multicentric diagnostic observational studies: the Childhood TB in Switzerland (CITRUS) study, the Pediatric TB Research Network in Spain (pTBred), and the Procalcitonin guidance to reduce antibiotic treatment of lower respiratory tract infections in children and adolescents (ProPAED) study. Included are children diagnosed with TB disease or infection, healthy TB-exposed children, and sick children with non-TB lower respiratory tract infection. Serological multiplex assays will be performed to identify M. tuberculosis antigen-specific antibody features, including isotypes, subclasses, Fc receptor (FcR) binding, and IgG glycosylation.
CONCLUSIONS: The findings from this study will help to design serological assays for diagnosing TB disease in children. Importantly, those assays could easily be developed as low-cost point-of-care tests, thereby offering a potential solution for resource-constrained settings.
RESULTS:
UNASSIGNED: NCT03044509.
摘要：
背景：结核病（TB）构成了重大的公共卫生挑战，特别是在儿童中。很大一部分患有结核病的儿童仍未被发现和证实。因此,迫切需要高度敏感的即时测试。这项研究旨在评估基于各种抗原靶标和抗体特性的血清学测定的性能，以区分患有结核病的儿童（0-18岁）与健康的结核病暴露儿童（1），（2）非结核患儿下呼吸道感染，和（3）来自患有结核病感染的儿童。
方法：该研究将使用从三项前瞻性多中心诊断观察性研究中收集的生物样本：瑞士儿童结核病（CITRUS）研究，西班牙儿科结核病研究网络（pTBred），和降钙素原指导减少抗生素治疗儿童和青少年下呼吸道感染（ProPAED）研究。包括被诊断患有结核病或感染的儿童，健康的结核病暴露儿童，和非结核下呼吸道感染的患病儿童。将进行血清学多重分析以鉴定结核分枝杆菌抗原特异性抗体特征，包括同种型,子类，Fc受体（FcR）结合，和IgG糖基化。
结论：这项研究的结果将有助于设计诊断儿童结核病的血清学检测方法。重要的是,这些检测可以很容易地发展成为低成本的即时检测，从而为资源受限的设置提供了一个潜在的解决方案。
结果：
■NCT03044509。
方法：该研究将使用从三项前瞻性多中心诊断观察性研究中收集的生物样本：瑞士儿童结核病（CITRUS）研究，西班牙儿科结核病研究网络（pTBred），和降钙素原指导减少抗生素治疗儿童和青少年下呼吸道感染（ProPAED）研究。包括被诊断患有结核病或感染的儿童，健康的结核病暴露儿童，和非结核下呼吸道感染的患病儿童。将进行血清学多重分析以鉴定结核分枝杆菌抗原特异性抗体特征，包括同种型,子类，Fc受体（FcR）结合，和IgG糖基化。
结论：这项研究的结果将有助于设计诊断儿童结核病的血清学检测方法。重要的是,这些检测可以很容易地发展成为低成本的即时检测，从而为资源受限的设置提供了一个潜在的解决方案。
结果：
■NCT03044509。
