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Operational characteristics of an antibody detecting point of care test for Taenia solium infections in a community and hospital setting

BACKGROUND: Diagnostic test evaluation includes measures of performance and assessment of operational characteristics. The latter focuses on end-user understanding of instructions to perform the test, ease of use, test turnaround time and ease of result interpretation. This study aimed to assess use...

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Autores principales: Mubanga, Chishimba, Mwape, Kabemba E., Phiri, Isaac K., Trevisan, Chiara, Kabululu, Mwemezi, Zulu, Gideon, Van Damme, Inge, Schmidt, Veronika, Dorny, Pierre, Gabriël, Sarah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8235832/
https://www.ncbi.nlm.nih.gov/pubmed/34172004
http://dx.doi.org/10.1186/s12879-021-06320-3
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author Mubanga, Chishimba
Mwape, Kabemba E.
Phiri, Isaac K.
Trevisan, Chiara
Kabululu, Mwemezi
Zulu, Gideon
Van Damme, Inge
Schmidt, Veronika
Dorny, Pierre
Gabriël, Sarah
author_facet Mubanga, Chishimba
Mwape, Kabemba E.
Phiri, Isaac K.
Trevisan, Chiara
Kabululu, Mwemezi
Zulu, Gideon
Van Damme, Inge
Schmidt, Veronika
Dorny, Pierre
Gabriël, Sarah
author_sort Mubanga, Chishimba
collection PubMed
description BACKGROUND: Diagnostic test evaluation includes measures of performance and assessment of operational characteristics. The latter focuses on end-user understanding of instructions to perform the test, ease of use, test turnaround time and ease of result interpretation. This study aimed to assess user comprehension of training for and ease of use of a Taenia solium point of care test (TS POC) evaluated in a community and hospital setting in Zambia and Tanzania, respectively. METHODS: The TS POC is a three-step in-house-produced rapid diagnostic test (RDT) for the simultaneous detection of taeniosis (TST) and cysticercosis (TSCC) antibodies. Data collected by administering questionnaires to 29 end-users and from the main evaluation database was analyzed quantitatively. RESULTS: End-users (28/29, 97%) perceived that the training they received for performing the test was sufficient. They performed 4080 tests, of which 80 were invalid. The community-based study and TST tests had higher invalid rates. The overall result interpretation was within the acceptable range of RDTs with an overall disagreement between readers of 3.3%. The Kappa coefficient of agreement was 85 and 82% for TSCC and TST, respectively. There was more disagreement among readers in the community-based study. CONCLUSION: End-users rated the TS POC kit moderate in terms of ease of use citing long test turnaround time and difficulties in using the blood transfer device. Overall, the operational performance of the TS POC kit and end-users was within the established acceptable performance range. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-021-06320-3.
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spelling pubmed-82358322021-06-28 Operational characteristics of an antibody detecting point of care test for Taenia solium infections in a community and hospital setting Mubanga, Chishimba Mwape, Kabemba E. Phiri, Isaac K. Trevisan, Chiara Kabululu, Mwemezi Zulu, Gideon Van Damme, Inge Schmidt, Veronika Dorny, Pierre Gabriël, Sarah BMC Infect Dis Research BACKGROUND: Diagnostic test evaluation includes measures of performance and assessment of operational characteristics. The latter focuses on end-user understanding of instructions to perform the test, ease of use, test turnaround time and ease of result interpretation. This study aimed to assess user comprehension of training for and ease of use of a Taenia solium point of care test (TS POC) evaluated in a community and hospital setting in Zambia and Tanzania, respectively. METHODS: The TS POC is a three-step in-house-produced rapid diagnostic test (RDT) for the simultaneous detection of taeniosis (TST) and cysticercosis (TSCC) antibodies. Data collected by administering questionnaires to 29 end-users and from the main evaluation database was analyzed quantitatively. RESULTS: End-users (28/29, 97%) perceived that the training they received for performing the test was sufficient. They performed 4080 tests, of which 80 were invalid. The community-based study and TST tests had higher invalid rates. The overall result interpretation was within the acceptable range of RDTs with an overall disagreement between readers of 3.3%. The Kappa coefficient of agreement was 85 and 82% for TSCC and TST, respectively. There was more disagreement among readers in the community-based study. CONCLUSION: End-users rated the TS POC kit moderate in terms of ease of use citing long test turnaround time and difficulties in using the blood transfer device. Overall, the operational performance of the TS POC kit and end-users was within the established acceptable performance range. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-021-06320-3. BioMed Central 2021-06-25 /pmc/articles/PMC8235832/ /pubmed/34172004 http://dx.doi.org/10.1186/s12879-021-06320-3 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Mubanga, Chishimba
Mwape, Kabemba E.
Phiri, Isaac K.
Trevisan, Chiara
Kabululu, Mwemezi
Zulu, Gideon
Van Damme, Inge
Schmidt, Veronika
Dorny, Pierre
Gabriël, Sarah
Operational characteristics of an antibody detecting point of care test for Taenia solium infections in a community and hospital setting
title Operational characteristics of an antibody detecting point of care test for Taenia solium infections in a community and hospital setting
title_full Operational characteristics of an antibody detecting point of care test for Taenia solium infections in a community and hospital setting
title_fullStr Operational characteristics of an antibody detecting point of care test for Taenia solium infections in a community and hospital setting
title_full_unstemmed Operational characteristics of an antibody detecting point of care test for Taenia solium infections in a community and hospital setting
title_short Operational characteristics of an antibody detecting point of care test for Taenia solium infections in a community and hospital setting
title_sort operational characteristics of an antibody detecting point of care test for taenia solium infections in a community and hospital setting
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8235832/
https://www.ncbi.nlm.nih.gov/pubmed/34172004
http://dx.doi.org/10.1186/s12879-021-06320-3
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