Hayden Dorothy, Herndon Joseph M, Campion James C, Feng Janine D, Lian Fangru, Baumann Jessica L, Roland Bryan K, ElGabry Ehab A
Companion Diagnostics Pathology, Roche Tissue Diagnostics, Tucson, AZ, USA.
Assay and Reagent Development, Roche Tissue Diagnostics, Tucson, AZ, USA.
J Pathol Inform. 2021 Nov 22;12:47. doi: 10.4103/jpi.jpi_16_21. eCollection 2021.
The COVID-19 pandemic presented numerous challenges to the continuity of programmed cell death ligand 1 (PD-L1) assay training events conducted by our organization. Under typical conditions, these training events are face-to-face affairs, where participants are trained to assay algorithms on glass slides during multi-headed scope sessions. Social distancing measures undertaken to slow pandemic spread necessitated the adaptation of our training methods to facilitate assay training and subsequent continuation of clinical trials. The present report details the creation and use of the Roche pathology training portal (PTP) that allowed for remote training to diagnostic assay algorithms. The PTP is a web-based system comprised of a learning management system (LMS) coupled to an image management system (IMS). Whole slide images (WSIs) were produced using a DP200 instrument (Roche, Pleasanton, CA) and these scan files were then uploaded to an IMS. Courses were created on the LMS using annotated WSIs that were shared with enrolled pathologists worldwide during assay training events. These courses culminated in assay certification examinations, where pathologists evaluated test-case WSIs and evaluated these cases within the LMS. Trainee submissions were analyzed for pass/fail status by comparing user data entries with consensus scores on these test-case WSIs. To date, 47 pathologist trainings have occurred and of these, 44 have successfully passed the associated assay certification exam on the first attempt (93% 1-try pass rate). The PTP allowed roche to continue training sites during the COVID-19 pandemic, and these early results demonstrate the capability of this digital solution regarding PD-L1 diagnostic assay training events.
新型冠状病毒肺炎疫情给本组织开展的程序性细胞死亡配体1(PD-L1)检测培训活动的连续性带来了诸多挑战。在正常情况下,这些培训活动是面对面进行的,参与者在多头显微镜观察过程中接受在载玻片上检测算法的培训。为减缓疫情传播而采取的社交距离措施使得我们必须调整培训方法,以促进检测培训及后续临床试验的继续开展。本报告详细介绍了罗氏病理培训平台(PTP)的创建和使用情况,该平台实现了对诊断检测算法的远程培训。PTP是一个基于网络的系统,由一个学习管理系统(LMS)和一个图像管理系统(IMS)组成。使用DP200仪器(罗氏公司,加利福尼亚州普莱森顿)生成全切片图像(WSIs),然后将这些扫描文件上传到IMS。在LMS上使用带注释的WSIs创建课程,这些课程在检测培训活动期间与全球注册的病理学家共享。这些课程最终以检测认证考试结束,病理学家在考试中评估测试病例的WSIs,并在LMS内对这些病例进行评估。通过将用户数据输入与这些测试病例WSIs的一致评分进行比较,分析学员提交的材料的通过/失败状态。到目前为止,已经进行了47次病理学家培训,其中44人首次成功通过了相关的检测认证考试(一次通过率为93%)。PTP使罗氏公司能够在新型冠状病毒肺炎疫情期间继续开展培训,这些早期结果证明了这种数字解决方案在PD-L1诊断检测培训活动方面的能力。