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
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Dokumenter
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.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 1528 |
| Tidsskrift | Diagnostics |
| Vol/bind | 11 |
| Udgave nummer | 9 |
| ISSN | 2075-4418 |
| DOI | |
| Status | Udgivet - 2021 |
Bibliografisk note
Funding Information:
This research was funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) (grant number DRIA2014-308) and the German Federal Ministry of Education and Research (BMBF) (grant number: 01KA1617) within the research grant ?Evaluation of an antibody detecting point-of-care test for the diagnosis of Taenia solium taeniosis, and (neuro)cysticercosis in communities and primary care settings of highly endemic, resource-poor areas in Tanzania and Zambia, including training of?and technology transfer to the Regional Reference Laboratory and health centers (SOLID)?. John Noh, Holly Chastain, and Sukwan Handali from the Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA, are acknowledged for helping with the compilation of the TS POC kits, development of the test manual, and handling of the logistics at the study sites. We acknowledge all members of the SOLID consortium who are not included in the author list of this paper: Ana Lucia Fajardo Castaneda, Anke Van Hul, Charlotte R?ther, Chishala Chabala, Chishimba Mubanga, Dries Reynders, Famke Jansen, Isaac K. Phiri, Maxwell Masuku, Richard Mambo, Rune Stensvold, and Sandra Vangeenberghe. We thank all the staff for their hard work and the participants for their willingness to participate. We also wish to acknowledge members of the SOLID External Advisory Board for their advice. Finally, all members of the SOLID consortium dedicate this work to the memory of our late colleague and friend, Benedict Ndawi.
Funding Information:
Funding: This research was funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) (grant number DRIA2014-308) and the German Federal Ministry of Education and Research (BMBF) (grant number: 01KA1617) within the research grant “Evaluation of an antibody detecting point-of-care test for the diagnosis of Taenia solium taeniosis, and (neuro)cysticercosis in communities and primary care settings of highly endemic, resource-poor areas in Tanzania and Zambia, including training of—and technology transfer to the Regional Reference Laboratory and health centers (SOLID)”.
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
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