Shi Chao, Wei Bing, Liu Xiaohui, Meng Lin, Zhao Chengzhi, Chang Yuxi, Sun Rui, Zhang Zhongxian, Yu Yang, Ma Jie
Department of Molecular Pathology, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Henan Key Laboratory of Molecular Pathology, Zhengzhou, China.
Ann Transl Med. 2022 Jan;10(2):45. doi: 10.21037/atm-21-6230.
The 2018 Guideline from the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) established a benchmark turnaround time (TAT), according to which the results should be available to the treating oncologist within 10 working days. This article focused on the application process of a new protocol for pathological diagnosis and gene testing pathway and a sample collector. We want to solve the problem that there are not enough puncture samples for gene testing, and the benchmark turnaround time of gene detection was long in clinic.
In this study, we established and validated a new protocol for a pathological diagnosis and treatment pathway that was tested in the Henan Cancer Hospital, China. The "Biology collector (BIOCO)" tool was designed by our team, was made of polyvinyl chloride (PVC) material (patent application number is 201820902335.6). It consisted of two round magnets on the collector that can be adsorbed on the microtome blade holder, thus making it to move arbitrarily. It collected specimens that were discarded when the wax block was trimmed. We analyzed the TAT, testing accuracy and anti-pollution of new protocol based on BIOCO, compared with the conventional process based on the Routine Collection (ROUCO).
The new pathway adopts a parallel approach to conventional pathology and molecular pathology, which significantly shortens the TAT to 4-6 days. The use of the BIOCO tool can effectively save pathological samples, avoid cross-contamination, and reduce the time delay caused by re-sampling. Most importantly, its accuracy and effectiveness are consistent with conventional collection methods.
The new diagnosis and treatment pathway based on the BIOCO collector can be used as a practical approach for the molecular diagnostic platform of the hospital pathology department.
美国病理学家学会（CAP）、国际肺癌研究协会（IASLC）和分子病理学协会（AMP）2018年发布的指南设定了一个基准周转时间（TAT），即治疗肿瘤学家应在10个工作日内获得检测结果。本文重点介绍了一种新的病理诊断和基因检测流程及样本采集器的应用过程。我们希望解决基因检测穿刺样本不足以及临床基因检测基准周转时间长的问题。
在本研究中，我们在中国河南省肿瘤医院建立并验证了一种新的病理诊断和治疗流程。我们团队设计了“生物采集器（BIOCO）”工具，其由聚氯乙烯（PVC）材料制成（专利申请号为201820902335.6）。它在采集器上有两个圆形磁铁，可吸附在切片机刀片架上，从而使其能任意移动。它收集在修整蜡块时被丢弃的标本。我们基于BIOCO分析了新流程的周转时间、检测准确性和抗污染能力，并与基于常规采集（ROUCO）的传统流程进行了比较。
新流程采用了与传统病理学和分子病理学并行的方法，显著缩短周转时间至4 - 6天。使用BIOCO工具可有效节省病理样本，避免交叉污染，并减少因重新采样导致的时间延迟。最重要的是，其准确性和有效性与传统采集方法一致。
基于BIOCO采集器的新诊断和治疗流程可作为医院病理科分子诊断平台的一种实用方法。
