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

Chishimba Mubanga,Pierre Dorny,Veronika Schmidt,Inge Van Damme,Mwemezi Kabululu,Kabemba E Mwape,Chiara Trevisan,Gideon Zulu,Isaac K Phiri,Sarah Gabriël

doi:10.1186/s12879-021-06320-3

Abstract

BackgroundDiagnostic 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.MethodsThe 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.ResultsEnd-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.ConclusionEnd-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.

Highlights

Diagnostic test evaluation includes measures of performance and assessments of operational characteristics
Frequency of TS Taenia solium point of care test (POC) test use The majority of end-users (27/33) from the main evaluation database performed more than 50 TS POC tests (Fig. 2) (Detailed summary data are shown in Additional file 3: Table S2)
Our study found that the end-users perceived they were sufficiently trained for TS POC evaluation

Summary

Introduction

Diagnostic test evaluation includes measures of performance and assessments of operational characteristics. Performance characteristics incorporate measures of diagnostic accuracy while operational characteristics include end-user practices in terms of understanding of test operational instructions, test robustness under different storage conditions, simplicity or ease of use, test user acceptability, result ease of interpretation, and turnaround time [1]. Several studies evaluating operational characteristics have included assessments of the clarity of instructions for use [3, 5] and ease of use or test performance simplicity [6,7,8] These parameters provide insight in explaining the performance outcomes of diagnostic evaluations and identify points of improvement. 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

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Discussion

Conclusion