{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T22:19:16Z","timestamp":1791757156775,"version":"4.3.4"},"reference-count":30,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2021,6,22]],"date-time":"2021-06-22T00:00:00Z","timestamp":1624320000000},"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"}]},{"DOI":"10.13039\/501100002347","name":"Bundesministerium f\u00fcr Bildung und Forschung","doi-asserted-by":"publisher","award":["01KA1617"],"award-info":[{"award-number":["01KA1617"]}],"id":[{"id":"10.13039\/501100002347","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Field-applicable, high-quality, and low-cost diagnostic tools are urgently needed for Taenia solium. The aim of this paper is to describe the design, challenges, and rationale for the design of a diagnostic accuracy study in low-resource community settings in Zambia. The trial was designed as a prospective study with a two-stage design to evaluate a new point-of-care test (TS POC) for the detection of taeniosis and (neuro)cysticercosis. Participants within randomly selected households were tested with the TS POC test (index test). Participants who tested TS POC positive for taeniosis and\/or cysticercosis and a subset of the negatives were requested to give blood and stool samples for reference testing, and to undergo clinical examination and a cerebral CT scan. The difficulties of conducting a clinical trial in settings with limited research and neuroimaging infrastructure as well as peculiarities specifically related to the disease (low prevalence of taeniosis and the lack of a gold standard) were taken into consideration for the design of this study. The two-stage design increased the efficiency of the study by reducing the number of samples, clinical examinations, and CT scans. Simplified flows and sampling processes were preferred over complex follow-up and randomization systems, aiming to reduce bias and increase the generalizability of the study.<\/jats:p>","DOI":"10.3390\/diagnostics11071138","type":"journal-article","created":{"date-parts":[[2021,6,22]],"date-time":"2021-06-22T13:02:10Z","timestamp":1624366930000},"page":"1138","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Trial Design for a Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and (Neuro)Cysticercosis in Community Settings of Highly Endemic, Resource-Poor Areas in Zambia: Challenges and Rationale"],"prefix":"10.3390","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2488-1132","authenticated-orcid":false,"given":"Inge","family":"Van Damme","sequence":"first","affiliation":[{"name":"Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4920-6750","authenticated-orcid":false,"given":"Chiara","family":"Trevisan","sequence":"additional","affiliation":[{"name":"Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium"},{"name":"Department of Biomedical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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":[{"vocabulary":"crossref","role":"author"}]},{"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":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Magnussen","sequence":"additional","affiliation":[{"name":"Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gideon","family":"Zulu","sequence":"additional","affiliation":[{"name":"Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia"},{"name":"Ministry of Health, Lusaka 10101, Zambia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chishimba","family":"Mubanga","sequence":"additional","affiliation":[{"name":"Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium"},{"name":"Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Bottieau","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3536-865X","authenticated-orcid":false,"given":"Isaac","family":"Phiri","sequence":"additional","affiliation":[{"name":"Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Johansen","sequence":"additional","affiliation":[{"name":"Independent Researcher, 2100 Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chishala","family":"Chabala","sequence":"additional","affiliation":[{"name":"Paediatrics and Child Health, Children\u2019s Hospital, University 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Multicriteria-Based Ranking for Risk Management of Food-Borne Parasites, Food and Agriculture Organization of the United Nations\/World Health Organization."},{"key":"ref_2","first-page":"595","article-title":"Taenia solium: WHO endemicity map update","volume":"91","author":"Donadeu","year":"2016","journal-title":"Wkly. Epidemiol. Rec."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Mwape, K.E., Blocher, J., Wiefek, J., Schmidt, K., Dorny, P., Praet, N., Chiluba, C., Schmidt, H., Phiri, I.K., and Winkler, A.S. (2015). Prevalence of Neurocysticercosis in People with Epilepsy in the Eastern Province of Zambia. PLoS Negl. Trop. Dis., 9.","DOI":"10.1371\/journal.pntd.0003972"},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Mwape, K.E., Phiri, I.K., Praet, N., Speybroeck, N., Muma, J.B., Dorny, P., and Gabri\u00ebl, S. (2013). The incidence of human cysticercosis in a rural community of Eastern Zambia. PLoS Negl. Trop. Dis., 7.","DOI":"10.1371\/journal.pntd.0002142"},{"key":"ref_5","doi-asserted-by":"crossref","unstructured":"Mwape, K.E., Phiri, I.K., Praet, N., Muma, J.B., Zulu, G., Van den Bossche, P., de Deken, R., Speybroeck, N., Dorny, P., and Gabri\u00ebl, S. (2012). Taenia solium Infections in a Rural Area of Eastern Zambia-A Community Based Study. PLoS Negl. Trop. Dis., 6.","DOI":"10.1371\/journal.pntd.0001594"},{"key":"ref_6","doi-asserted-by":"crossref","unstructured":"Pai, N.P., Vadnais, C., Denkinger, C., Engel, N., and Pai, M. (2012). Point-of-care testing for infectious diseases: Diversity, complexity, and barriers in low- and middle-Income Countries. PLoS Med., 9.","DOI":"10.1371\/journal.pmed.1001306"},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Donadeu, M., Fahrion, A.S., Olliaro, P.L., and Abela-Ridder, B. (2017). Target product profiles for the diagnosis of Taenia solium taeniasis, neurocysticercosis and porcine cysticercosis. PLoS Negl. Trop. Dis., 11.","DOI":"10.1371\/journal.pntd.0005875"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1016\/j.actatropica.2019.03.030","article-title":"Progress on the development of rapid diagnostic tests for foodborne neglected zoonotic helminthiases: A systematic review","volume":"194","author":"Mubanga","year":"2019","journal-title":"Acta Trop."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1016\/j.molbiopara.2006.02.004","article-title":"Characterization and cloning of T24, a Taenia solium antigen diagnostic for cysticercosis","volume":"147","author":"Hancock","year":"2006","journal-title":"Mol. Biochem. Parasitol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1645\/GE-189R","article-title":"Characterization, cloning, and expression of two diagnostic antigens for Taenia solium tapeworm infection","volume":"90","author":"Levine","year":"2004","journal-title":"J. Parasitol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1097\/01.ede.0000198422.64801.8d","article-title":"Estimating Disease Prevalence in a Bayesian Framework Using Probabilistic Constraints","volume":"17","author":"Berkvens","year":"2006","journal-title":"Epidemiology"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"202","DOI":"10.1016\/j.jns.2016.11.045","article-title":"Revised diagnostic criteria for neurocysticercosis","volume":"372","author":"Nash","year":"2017","journal-title":"J. Neurol. Sci."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e00082","DOI":"10.1016\/j.parepi.2018.e00082","article-title":"Taenia solium control in Zambia: The potholed road to success","volume":"4","author":"Mwape","year":"2019","journal-title":"Parasite Epidemiol. Control"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"895","DOI":"10.1111\/j.1553-2712.1996.tb03538.x","article-title":"Statistical Methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity","volume":"3","author":"Buderer","year":"1996","journal-title":"Acad. Emerg. Med."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"S21","DOI":"10.1038\/nrmicro1523","article-title":"Evaluation of diagnostic tests for infectious diseases: General principles","volume":"4","author":"Banoo","year":"2006","journal-title":"Nat. Rev. Microbiol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1016\/j.jclinepi.2019.05.018","article-title":"Development of practical recommendations for diagnostic accuracy studies in low-prevalence situations","volume":"114","author":"Holtman","year":"2019","journal-title":"J. Clin. Epidemiol."},{"key":"ref_17","unstructured":"Mubanga, C., Mwape, K.E., Phiri, I.K., Trevisan, C., Kabululu, M., Zulu, G., Van Damme, I., Schmidt, V., Dorny, P., and Gabri\u00ebl, S. Operational characteristics of an antibody-detecting point of care test for Taenia solium infections in a community and hospital setting, BMC Infect. Dis., accepted."},{"key":"ref_18","doi-asserted-by":"crossref","unstructured":"Saelens, G., and Gabri\u00ebl, S. (2020). Currently available monitoring and surveillance systems for Taenia spp., Echinococcus spp., Schistosoma spp., and soil-transmitted helminths at the control\/elimination stage: A systematic review. Pathogens, 9.","DOI":"10.3390\/pathogens9010047"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1053\/j.semnuclmed.2018.11.005","article-title":"Diagnostic accuracy studies","volume":"49","author":"Fergusson","year":"2019","journal-title":"Semin. Nucl. Med."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1186\/1745-6215-13-137","article-title":"Diagnostic randomized controlled trials: The final frontier","volume":"13","author":"Rodger","year":"2012","journal-title":"Trials"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"473","DOI":"10.1017\/S0031182000060686","article-title":"Immunodiagnosis of taeniasis by coproantigen detection","volume":"101","author":"Allan","year":"1990","journal-title":"Parasitology"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"548","DOI":"10.1128\/JCM.42.2.548-553.2004","article-title":"DNA differential diagnosis of taeniasis and cysticercosis by multiplex PCR","volume":"42","author":"Yamasaki","year":"2004","journal-title":"J. Clin. Microbiol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"1429","DOI":"10.1128\/JCM.03260-13","article-title":"Recombinant protein- and synthetic peptide-based immunoblot test for diagnosis of neurocysticercosis","volume":"52","author":"Noh","year":"2014","journal-title":"J. Clin. Microbiol."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1093\/infdis\/159.1.50","article-title":"An enzyme-linked immunoelectrotransfer blot assay and glycoprotein antigens for diagnosing human cysticercosis (Taenia solium)","volume":"159","author":"Tsang","year":"1989","journal-title":"J. Infect. Dis."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"569","DOI":"10.1016\/j.ijpara.2003.11.014","article-title":"A Bayesian approach for estimating values for prevalence and diagnostic test characteristics of porcine cysticercosis","volume":"34","author":"Dorny","year":"2004","journal-title":"Int. J. Parasitol."},{"key":"ref_26","unstructured":"Sokal, R.R., and Rohlf, J.F. (1981). Biometry: The Principles and Practice of Statistics in Biological Research, W. H. Freeman. [2nd ed.]."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"236","DOI":"10.4315\/0362-028X-70.1.236","article-title":"Validation of meat inspection results for Taenia saginata cysticercosis by PCR\u2013Restriction Fragment Length Polymorphism","volume":"70","author":"Geysen","year":"2007","journal-title":"J. Food Prot."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1179\/2047773212Y.0000000047","article-title":"Neurocysticercosis in sub-Saharan Africa: A review of prevalence, clinical characteristics, diagnosis, and management","volume":"106","author":"Winkler","year":"2012","journal-title":"Pathog. Glob. Health"},{"key":"ref_29","unstructured":"Allaire, J., Xie, Y., McPherson, J., Luraschi, J., Ushey, K., Atkins, A., Wickham, H., Cheng, J., Chang, W., and Iannone, R. (2021, January 01). Rmarkdown: Dynamic Documents for R. R Package Version 2.3. Available online: https:\/\/rmarkdown.rstudio.com."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"e012799","DOI":"10.1136\/bmjopen-2016-012799","article-title":"STARD 2015 guidelines for reporting diagnostic accuracy studies: Explanation and elaboration","volume":"6","author":"Cohen","year":"2016","journal-title":"BMJ Open"}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/11\/7\/1138\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T06:21:25Z","timestamp":1760163685000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/11\/7\/1138"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6,22]]},"references-count":30,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2021,7]]}},"alternative-id":["diagnostics11071138"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics11071138","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6,22]]}}}