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Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania

Authors :
Chiara Trevisan
Inge Van Damme
Bernard Ngowi
Veronika Schmidt
Dominik Stelzle
Karen Schou Møller
Mwemezi Kabululu
Charles E. Makasi
Pascal Magnussen
Emmanuel Bottieau
Emmanuel Abatih
Maria V. Johansen
Helena Ngowi
Benedict Ndawi
Kabemba E. Mwape
Gideon Zulu
Pierre Dorny
Andrea S. Winkler
Sarah Gabriël
on behalf of the SOLID Consortium
Source :
Diagnostics, Vol 11, Iss 9, p 1528 (2021)
Publication Year :
2021
Publisher :
MDPI AG, 2021.

Abstract

Taenia solium diagnosis is challenging as trained personnel, good diagnostic tools, and infrastructure is lacking in resource-poor areas. This paper aims to describe the study trial design adopted to evaluate a newly developed rapid point-of-care test that simultaneously detects taeniosis and neurocysticercosis (TS POC) in three district hospitals in Tanzania. The two-stage design included three types of patients: patients with specific neurological signs and symptoms (group 1); patients with complaints compatible with intestinal worm infections (group 2); patients with other symptom(s) (group 3). For group 1, all patients were tested using the TS POC test (stage 1), after which all positive, and a subset of negative, patients were selected for laboratory reference tests, clinical examination, and a brain computed tomography (CT) scan (stage 2). For groups 2 and 3, a similar design was adopted, but clinical examination and a brain CT scan (stage 2) were only performed in patients who were TS POC test-positive for cysticercosis. Due to the lack of a gold standard, a Bayesian approach was used to determine test accuracy for taeniosis and cysticercosis. For neurocysticercosis, a composite case definition was used as the reference standard. If successful, this study will help the future developments (commercialization and implementation) of the rapid test and improve patient management and disease prevention.

Details

Language :
English
ISSN :
20754418
Volume :
11
Issue :
9
Database :
Directory of Open Access Journals
Journal :
Diagnostics
Publication Type :
Academic Journal
Accession number :
edsdoj.63c8b9e9b7c242899c10760000b5e6ed
Document Type :
article
Full Text :
https://doi.org/10.3390/diagnostics11091528