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Evaluation of serological assays for the diagnosis of childhood tuberculosis disease: a study protocol
Daniela Neudecker1, Nora Fritschi1,2, Thomas Sutter3
1Mycobacterial and Migrant Health Research Group, Department of Clinical Research, University of Basel Children's Hospital Basel, University of Basel, Spitalstrasse 33, Basel, CH-4031, Switzerland.
Insights
Developing a sensitive point-of-care test for childhood tuberculosis (TB) is crucial. This study evaluates serological assays to accurately diagnose TB disease in children, distinguishing it from other respiratory infections and TB infection.
Area of Science:
- Pediatric infectious diseases
- Immunology
- Diagnostic assay development
Background:
- Tuberculosis (TB) presents a significant global health burden, with a high number of undetected pediatric cases.
- Accurate and accessible diagnostic tools for childhood TB are urgently needed, especially for point-of-care use.
- Current diagnostic methods often fall short in sensitivity and accessibility for pediatric populations.
Purpose of the Study:
- To evaluate the performance of serological assays in diagnosing TB disease in children aged 0-18 years.
- To differentiate TB disease from healthy TB-exposed children, non-TB lower respiratory tract infections, and latent TB infection.
- To identify key antigen targets and antibody features for improved diagnostic accuracy.
Main Methods:
- Utilized biobanked plasma samples from three multicentric observational studies (CITRUS, pTBred, ProPAED).
- Included children with confirmed TB disease, TB infection, healthy TB-exposed children, and those with non-TB lower respiratory tract infections.
- Performed serological multiplex assays to analyze Mycobacterium tuberculosis antigen-specific antibodies, including isotypes, subclasses, Fc receptor binding, and IgG glycosylation.
Main Results:
- Results are pending analysis; the study aims to identify specific serological markers for TB diagnosis in children.
Conclusions:
- Findings will guide the design of novel serological assays for childhood TB diagnosis.
- Developed assays have the potential for low-cost, point-of-care application, benefiting resource-limited settings.
- This research could significantly improve the detection and management of TB in pediatric populations worldwide.
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.
Discussion:
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.
Gov Identifier:
NCT03044509.
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