Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study
Chishimba Mubanga,
Chiara Trevisan,
Inge Van Damme,
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 Gabriel
Affiliations
Chishimba Mubanga
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia
Chiara Trevisan
Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium
Inge Van Damme
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 Gabriel
Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium
Taenia solium taeniosis diagnosis is challenging because current tests perform sub-optimally and/or are expensive, require sophisticated equipment, infrastructure and trained manpower, and therefore are not community deployable. A recently-developed, multi-strip, T. solium point-of-care test (TS POC) for simultaneous detection of tapeworm (TS POC T) and cysticercus (TS POC CC) human antibodies was evaluated for diagnostic accuracy on consecutively recruited community participants in Sinda district, Zambia. All participants were tested using the TS POC test. All test-positives and 20% of the test-negative participants were invited to give a blood and stool sample for reference testing. Three different reference tests were used for taeniosis diagnosis: recombinant rES33 enzyme-linked immunoelectrotransfer blot (rES33 EITB), copro PCR and copro Ag ELISA. Bayesian analysis with probabilistic constraints was used to estimate sensitivity and specificity. In total, 1254 participants were tested with the TS POC test, of whom 13 tested positive using the TS POC T. Based on 161 participants with complete data, the estimated sensitivity and specificity for the TS POC T test were 38% (95% CI: 5–93%) and 99% (95% CI: 98–100%), respectively. The challenge of highly variable inter-assay performance is highlighted. We recommend either increasing the sensitivity or redesigning the test.