Dataset Information

Evaluation of serological assays for the diagnosis of childhood tuberculosis disease: a study protocol.

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.

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.

Clinicaltrials

Gov identifier

NCT03044509.

SUBMITTER: Neudecker D

PROVIDER: S-EPMC11084122 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature

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Publications

Evaluation of serological assays for the diagnosis of childhood tuberculosis disease: a study protocol.

Neudecker Daniela D Fritschi Nora N Sutter Thomas T Lu Lenette L LL Lu Pei P Tebruegge Marc M Santiago-Garcia Begoña B Ritz Nicole N

BMC infectious diseases 20240510 1

<h4>Background</h4>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 ...[more]

PMID: 38730343

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Dataset Information

Evaluation of serological assays for the diagnosis of childhood tuberculosis disease: a study protocol.

Background

Methods

Discussion

Clinicaltrials

Gov identifier

Publications

Evaluation of serological assays for the diagnosis of childhood tuberculosis disease: a study protocol.

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