Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka, Zambia.
Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.
BMC Infect Dis. 2021 Jun 25;21(1):607. doi: 10.1186/s12879-021-06320-3.
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.
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.
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.
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.
诊断测试评估包括性能指标和操作特性评估。后者侧重于终端用户对执行测试的指令的理解、易用性、测试周转时间和结果解释的容易程度。本研究旨在评估在赞比亚和坦桑尼亚的社区和医院环境中分别评估的猪带绦虫即时检测（TS POC）的培训和易用性的用户理解。
TS POC 是一种三步式内部生产的快速诊断检测（RDT），用于同时检测带绦虫病（TST）和囊尾蚴病（TSCC）抗体。通过向 29 名终端用户发放问卷和从主要评估数据库收集的数据进行定量分析。
终端用户（29/29，97%）认为他们接受的测试执行培训足够。他们进行了 4080 次测试，其中 80 次无效。基于社区的研究和 TST 测试的无效率更高。总体结果解释在 RDT 的可接受范围内，读者之间的总体不一致率为 3.3%。读者之间的一致性 Kappa 系数分别为 85%和 82%，用于 TSCC 和 TST。基于社区的研究中读者之间的分歧更大。
终端用户对 TS POC 试剂盒的易用性评价适中，指出测试周转时间长且使用血液转移设备困难。总体而言，TS POC 试剂盒和终端用户的操作性能在既定的可接受性能范围内。
