Evaluation of an Antibody Detecting Point of Care Test for Diagnosis of <i>Taenia solium</i> Cysticercosis in a Zambian Rural Community: A Prospective Diagnostic Accuracy Study
Chishimba Mubanga,
Inge Van Damme,
Chiara Trevisan,
Veronika Schmidt,
Isaac K. Phiri,
Gideon Zulu,
John Noh,
Sukwan Handali,
Richard Mambo,
Mwelwa Chembensofu,
Maxwell Masuku,
Dries Reynders,
Famke Jansen,
Emmanuel Bottieau,
Pascal Magnussen,
Andrea S. Winkler,
Pierre Dorny,
Kabemba E. Mwape,
Sarah Gabriël
Affiliations
Chishimba Mubanga
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia
Inge Van Damme
Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium
Chiara Trevisan
Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium
Veronika Schmidt
Department of Neurology, Center for Global Health, Faculty of Medicine, Technical University of Munich, 81675 Munich, Germany
Isaac K. Phiri
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia
Gideon Zulu
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia
John Noh
Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
Sukwan Handali
Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
Richard Mambo
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia
Mwelwa Chembensofu
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia
Maxwell Masuku
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia
Dries Reynders
Department of Applied Mathematics, Computer Science and Statistics, Faculty of Sciences, Ghent University, 9000 Ghent, Belgium
Famke Jansen
Department of Biomedical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium
Emmanuel Bottieau
Department of Clinical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium
Pascal Magnussen
Faculty of Health and Medical Sciences, University of Copenhagen, 2200 Copenhagen, Denmark
Andrea S. Winkler
Department of Neurology, Center for Global Health, Faculty of Medicine, Technical University of Munich, 81675 Munich, Germany
Pierre Dorny
Department of Biomedical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium
Kabemba E. Mwape
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia
Sarah Gabriël
Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium
The lack of cheap, easy-to-use, rapid diagnostic tests has led to the development of several rapid diagnostic tests for cysticercosis. The new prototype two-strip, Taenia solium point of care test (TS POC) detects antibodies against taeniosis (TS POC T) and cysticercosis (TS POC CC). This study evaluated the diagnostic performance of the TS POC CC in the Sinda district in eastern Zambia. A sample of 1254 participants was recruited and tested with the TS POC. Out of the 1249 participants with a valid TS POC result, 177 (14%) tested positive while 1072 (86%) tested negative. All individuals with a positive TS POC and a subset of negative TS POC participants were selected for serum sampling, and were subjected to the recombinant glycoprotein T24H enzyme-linked immunoelectrotransfer blot (rT24H EITB) and the serum B60/158 (serum Ag) enzyme-linked immunosorbent assay (Ag ELISA). Performance characteristics were estimated using a Bayesian approach with probabilistic constraints. Based on 255 complete cases, the estimated sensitivity and specificity of the TS POC CC test were 35% (95% CI: 14–63%) and 87% (95% CI: 83–90%), respectively. The diagnostic performance needs to be improved, possibly by titrating antigen and other reagents’ concentration in the strip to produce a performance similar to existing cysticercosis tests such as the rT24H EITB.
