Olbrich, Laura;
Nliwasa, Marriott;
Sabi, Issa;
Ntinginya, Nyanda E;
Khosa, Celso;
Banze, Denise;
Corbett, Elizabeth L;
... RaPaed-AIDA-TB Consortium; + view all
(2023)
Rapid and Accurate Diagnosis of Pediatric Tuberculosis Disease (RaPaed-TB): A Diagnostic Accuracy Study for Pediatric Tuberculosis.
The Pediatric Infectious Disease Journal
, Article e003853. 10.1097/INF.0000000000003853.
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Abstract
INTRODUCTION: An estimated 1.2 million children develop tuberculosis (TB) every year with 240,000 dying because of missed diagnosis. Existing tools suffer from lack of accuracy and are often unavailable. Here, we describe the scientific and clinical methodology applied in RaPaed-TB, a diagnostic accuracy study. METHODS: This prospective diagnostic accuracy study evaluating several candidate tests for TB was set out to recruit 1000 children <15 years with presumptive TB in 5 countries (Malawi, Mozambique, South Africa, Tanzania, India). Assessments at baseline included documentation of TB signs and symptoms, TB history, radiography, tuberculin skin test, HIV testing and spirometry. Respiratory samples for reference standard testing (culture, Xpert Ultra) included sputum (induced/spontaneous) or gastric aspirate, and nasopharyngeal aspirate (if <5 years). For novel tests, blood, urine and stool were collected. All participants were followed up at months 1 and 3, and month 6 if on TB treatment or unwell. The primary endpoint followed NIH-consensus statements on categorization of TB disease status for each participant. The study was approved by the sponsor's and all relevant local ethics committees. DISCUSSION: As a diagnostic accuracy study for a disease with an imperfect reference standard, RaPaed-TB was designed following a rigorous and complex methodology. This allows for the determination of diagnostic accuracy of novel assays and combination of testing strategies for optimal care for children, including high-risk groups (ie, very young, malnourished, children living with HIV). Being one of the largest of its kind, RaPaed-TB will inform the development of improved diagnostic approaches to increase case detection in pediatric TB.
| Type: | Article |
|---|---|
| Title: | Rapid and Accurate Diagnosis of Pediatric Tuberculosis Disease (RaPaed-TB): A Diagnostic Accuracy Study for Pediatric Tuberculosis |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1097/INF.0000000000003853 |
| Publisher version: | https://doi.org/10.1097/INF.0000000000003853 |
| Language: | English |
| Additional information: | This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NCND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. See: https://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Keywords: | RaPaed-AIDA-TB Consortium |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10167129 |
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