{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T11:01:05Z","timestamp":1779102065658,"version":"3.51.4"},"reference-count":29,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2021,8,24]],"date-time":"2021-08-24T00:00:00Z","timestamp":1629763200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership","doi-asserted-by":"publisher","award":["DRIA2014-308"],"award-info":[{"award-number":["DRIA2014-308"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]},{"name":"German Federal Ministry of Education and Research","award":["01KA1617"],"award-info":[{"award-number":["01KA1617"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.3390\/diagnostics11091528","type":"journal-article","created":{"date-parts":[[2021,8,24]],"date-time":"2021-08-24T22:12:22Z","timestamp":1629843142000},"page":"1528","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["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"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4920-6750","authenticated-orcid":false,"given":"Chiara","family":"Trevisan","sequence":"first","affiliation":[{"name":"Department of Biomedical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium"},{"name":"Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2488-1132","authenticated-orcid":false,"given":"Inge","family":"Damme","sequence":"additional","affiliation":[{"name":"Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard","family":"Ngowi","sequence":"additional","affiliation":[{"name":"National Institute for Medical Research, Muhimbili Medical Research Centre Dar es Salaam, Dar es Salaam 11101, Tanzania"},{"name":"Department of Public Health, University of Dar es Salaam Tanzania, Dar es Salaam 65015, Tanzania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6108-2586","authenticated-orcid":false,"given":"Veronika","family":"Schmidt","sequence":"additional","affiliation":[{"name":"Department of Neurology, Center for Global Health, Klinikum rechts der Isar, Technical University of Munich, 81675 Munich, Germany"},{"name":"Centre for Global Health, Institute of Health and Society, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6743-2818","authenticated-orcid":false,"given":"Dominik","family":"Stelzle","sequence":"additional","affiliation":[{"name":"Department of Neurology, Center for Global Health, Klinikum rechts der Isar, Technical University of Munich, 81675 Munich, Germany"},{"name":"Chair of Epidemiology, Department of Sport and Health Sciences, Technical University of Munich, 80809 Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"M\u00f8ller","sequence":"additional","affiliation":[{"name":"Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, 1870 Frederiksberg, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8621-9411","authenticated-orcid":false,"given":"Mwemezi","family":"Kabululu","sequence":"additional","affiliation":[{"name":"Tanzania Livestock Research Institute (TALIRI)-Uyole, Mbeya P.O. Box 6191, Tanzania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Makasi","sequence":"additional","affiliation":[{"name":"National Institute for Medical Research, Muhimbili Medical Research Centre Dar es Salaam, Dar es Salaam 11101, Tanzania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pascal","family":"Magnussen","sequence":"additional","affiliation":[{"name":"Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Bottieau","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Abatih","sequence":"additional","affiliation":[{"name":"Department of Applied Mathematics, Computer Sciences and Statistics, Faculty of Sciences, Ghent University, 9000 Ghent, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Johansen","sequence":"additional","affiliation":[{"name":"Independent Researcher, 2100 Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helena","family":"Ngowi","sequence":"additional","affiliation":[{"name":"Department of Veterinary Medicine and Public Health, College of Veterinary Medicine and Biomedical Sciences, Sokoine University of Agriculture, Morogoro P.O. Box 3021, Tanzania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benedict","family":"Ndawi","sequence":"additional","affiliation":[{"name":"Primary Health Care Institute, Iringa 235, Tanzania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6788-2592","authenticated-orcid":false,"given":"Kabemba","family":"Mwape","sequence":"additional","affiliation":[{"name":"Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gideon","family":"Zulu","sequence":"additional","affiliation":[{"name":"Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia"},{"name":"Eastern Provincial Health Office, Ministry of Health, Lusaka 30205, Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Dorny","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3131-6983","authenticated-orcid":false,"given":"Andrea","family":"Winkler","sequence":"additional","affiliation":[{"name":"Department of Neurology, Center for Global Health, Klinikum rechts der Isar, Technical University of Munich, 81675 Munich, Germany"},{"name":"Centre for Global Health, Institute of Health and Society, Faculty of Medicine, University of Oslo, 0450 Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2523-233X","authenticated-orcid":false,"given":"Sarah","family":"Gabri\u00ebl","sequence":"additional","affiliation":[{"name":"Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of the SOLID Consortium","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,8,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1016\/j.actatropica.2015.12.021","article-title":"The societal cost of Taenia solium cysticercosis in Tanzania","volume":"165","author":"Trevisan","year":"2017","journal-title":"Acta Trop."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Ngowi, H.A., Winkler, A.S., Braae, U.C., Mdegela, R.H., Mkupasi, E.M., Kabululu, M.L., Lekule, F.P., and Johansen, M.V. 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