Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol

Introduction Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when...

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Main Authors: Claudia Denkinger, Sonjelle Shilton, Elena Ivanova Reipold, Seda Yerlikaya, Maria del Mar Castro, Horeya M Ismail, Carlos Alberto Montenegro-Quiñonez
Format: Article
Language:English
Published: BMJ Publishing Group 2025-08-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/8/e092774.full
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author Claudia Denkinger
Sonjelle Shilton
Elena Ivanova Reipold
Seda Yerlikaya
Maria del Mar Castro
Horeya M Ismail
Carlos Alberto Montenegro-Quiñonez
author_facet Claudia Denkinger
Sonjelle Shilton
Elena Ivanova Reipold
Seda Yerlikaya
Maria del Mar Castro
Horeya M Ismail
Carlos Alberto Montenegro-Quiñonez
author_sort Claudia Denkinger
collection DOAJ
description Introduction Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings.Methods and analysis This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review.Ethics and dissemination No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.
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spelling doaj-art-bae57d509f12411c94558dbc3bf7b59d2025-08-20T03:41:21ZengBMJ Publishing GroupBMJ Open2044-60552025-08-0115810.1136/bmjopen-2024-092774Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocolClaudia Denkinger0Sonjelle Shilton1Elena Ivanova Reipold2Seda Yerlikaya3Maria del Mar Castro4Horeya M Ismail5Carlos Alberto Montenegro-Quiñonez6Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, GermanyFIND, Geneva, SwitzerlandFIND, Geneva, SwitzerlandDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, GermanyDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, GermanyDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, GermanyDepartment of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, GermanyIntroduction Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings.Methods and analysis This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review.Ethics and dissemination No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.https://bmjopen.bmj.com/content/15/8/e092774.full
spellingShingle Claudia Denkinger
Sonjelle Shilton
Elena Ivanova Reipold
Seda Yerlikaya
Maria del Mar Castro
Horeya M Ismail
Carlos Alberto Montenegro-Quiñonez
Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol
BMJ Open
title Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol
title_full Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol
title_fullStr Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol
title_full_unstemmed Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol
title_short Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol
title_sort current practices for assessing usability of novel point of care diagnostics for infectious diseases a scoping review protocol
url https://bmjopen.bmj.com/content/15/8/e092774.full
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