NIHR London In Vitro Diagnostics Co-operative, Department of Surgery and Cancer, Imperial College London, London, UK
CRUK Convergence Science Centre, Institute of Cancer Research & Imperial College London, London, UK.
BMJ Open. 2021 Mar 19;11(3):e047163. doi: 10.1136/bmjopen-2020-047163.
There is a lack of evidence addressing several important human factors questions pertaining to the quality of supportive information provided by commercial manufacturers that can affect the adoption and use of lateral flow serology assays in practice. We aimed to: (1) identify and assess the quality of information that commercial manufacturers provided for their point-of-care tests (POCTs) and (2) examine the implications of these findings on real-world settings.
We used a content analysis methodology in two stages to systematically, code and analyse textual data from documents of commercial manufacturers. A deductive approach was applied using a coding guide based on the validated Point-of-Care Key Evidence Tool (POCKET) multidimensional checklist. An inductive approach was used to identify new patterns or themes generated from our textual analysis.
Publicly available supportive information documents by commercial manufacturers for lateral flow serology, were identified and gathered from online searches.
Supportive information documents retrieved from online searches over 3 months (March 2020 to June 2020).
A total of 79 POCTs were identified that met the study inclusion criteria. Using the POCKET coding guide, we found that the quality of information varied significantly between the manufacturers and was often lacking in detail. Our inductive approach further examined these topics and found that several statements were vague and that significant variations in the level of details existed between manufacturers.
This study revealed significant concerns surrounding the supportive information reported by manufacturers for lateral flow serology assays. Information transparency was poor and human factor issues were not properly addressed to mitigate the risk of improper device use, although it should be noted that the results of our study are limited by the data that manufactures were prepared to disclose. Overall, commercial manufacturers should improve the quality and value of information presented in their supporting documentation.
关于商业制造商提供的支持信息的质量，存在一些重要的人为因素问题，这些问题可能会影响侧向流动血清学检测在实践中的采用和使用，但目前缺乏相关证据。我们的目的是：（1）识别和评估商业制造商为其即时检测（POCT）提供的信息的质量；（2）研究这些发现对实际情况的影响。
我们使用内容分析法，分两个阶段对商业制造商文件中的文本数据进行系统地、编码和分析。采用演绎方法，使用基于经验证的即时护理关键证据工具（POCKET）多维清单的编码指南。采用归纳法，从文本分析中识别新的模式或主题。
从在线搜索中确定并收集了商业制造商提供的侧向流动血清学的公开支持信息文件。
在 3 个月（2020 年 3 月至 2020 年 6 月）期间，从在线搜索中检索到支持信息文件。
确定了 79 个符合研究纳入标准的 POCT。使用 POCKET 编码指南，我们发现制造商之间的信息质量差异很大，而且往往缺乏细节。我们的归纳方法进一步研究了这些主题，发现一些声明比较模糊，而且制造商之间在细节水平上存在显著差异。
本研究揭示了制造商报告的侧向流动血清学检测的支持信息存在严重问题。信息透明度较差，人为因素问题没有得到妥善解决，以降低设备使用不当的风险，尽管应该注意到，我们的研究结果受到制造商准备披露的数据的限制。总的来说，商业制造商应该提高支持文档中提供的信息的质量和价值。
