Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study

<i>Taenia solium</i> 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, <i>T. soliu...

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Autores principales: 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
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Publicado: MDPI AG 2021
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spelling oai:doaj.org-article:9b6a69a47204407e9420f7f27de4aa742021-11-25T17:21:03ZChallenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study10.3390/diagnostics111120392075-4418https://doaj.org/article/9b6a69a47204407e9420f7f27de4aa742021-11-01T00:00:00Zhttps://www.mdpi.com/2075-4418/11/11/2039https://doaj.org/toc/2075-4418<i>Taenia solium</i> 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, <i>T. solium</i> 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.Chishimba MubangaChiara TrevisanInge Van DammeVeronika SchmidtIsaac K. PhiriGideon ZuluJohn NohSukwan HandaliRichard MamboMwelwa ChembensofuMaxwell MasukuDries ReyndersFamke JansenEmmanuel BottieauPascal MagnussenAndrea S. WinklerPierre DornyKabemba E. MwapeSarah GabrielMDPI AGarticle<i>Taenia solium</i>point of care testdiagnosistaeniosiscopro Ag ELISAcopro PCRMedicine (General)R5-920ENDiagnostics, Vol 11, Iss 2039, p 2039 (2021)
institution DOAJ
collection DOAJ
language EN
topic <i>Taenia solium</i>
point of care test
diagnosis
taeniosis
copro Ag ELISA
copro PCR
Medicine (General)
R5-920
spellingShingle <i>Taenia solium</i>
point of care test
diagnosis
taeniosis
copro Ag ELISA
copro PCR
Medicine (General)
R5-920
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
Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study
description <i>Taenia solium</i> 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, <i>T. solium</i> 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.
format article
author 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
author_facet 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
author_sort Chishimba Mubanga
title Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study
title_short Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study
title_full Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study
title_fullStr Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study
title_full_unstemmed Challenges Encountered When Evaluating an Antibody-Detecting Point-of-Care Test for Taeniosis in an Endemic Community in Zambia: A Prospective Diagnostic Accuracy Study
title_sort challenges encountered when evaluating an antibody-detecting point-of-care test for taeniosis in an endemic community in zambia: a prospective diagnostic accuracy study
publisher MDPI AG
publishDate 2021
url https://doaj.org/article/9b6a69a47204407e9420f7f27de4aa74
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