Loonen Anne J M, Huijsmans Cornelis J J, Geurts-Giele Willemina R R, Leeijen Cindy, van der Linden Johannes C, van den Brule Adriaan J C
Pathologie-DNA, Lab for Molecular Diagnostics, Location Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
Department of Applied Natural Sciences, Section Diagnostics and Test Development, Fontys University of Applied Sciences, Eindhoven, The Netherlands.
APMIS. 2020 Aug;128(8):497-505. doi: 10.1111/apm.13064.
Primary high-risk human papillomavirus (hrHPV) DNA testing has been introduced in several countries worldwide, including The Netherlands. The objective of this study was to compare three automated workflow procedures for hrHPV testing of which the hrHPV detection assays meet the international guidelines for HPV testing. To mimic a realistic screening situation, we aimed to process 15 000 residual PreservCyt cervical samples in a period of 3 months. During a 3 months period, four technicians were involved in processing 5000 specimens per month on three automated platforms, (1) Qiagen Digene® HC2 HPV DNA test (HC2, signal amplification); (2) Roche Cobas® HPV test (DNA amplification), and (3) Hologic Aptima® HPV test (RNA amplification). We measured and scored general aspects (time-to-results, hands-on-time (HOT)), maintenance, pre-run, run and post-run aspects, inventory (orders, storage), and number of errors on a scale from 1 to 10. As determined for one complete workflow each, maximum processing capacity and HOT were 296 samples and 2 h:55 m, 282 samples and 3 h:20 m, and 264 samples and 4 h:15 m for Aptima, Cobas, and HC2, respectively. The mean throughput time per run was 5 h:51 m for Cobas in which 94 samples could be processed. For Aptima, the mean throughput time per run was 6 h:30 m for 60 samples. Mean throughput time for HC2 is longer since results were provided on day 2. In this study, the fully automated Aptima workflow scores best with a 7.2, followed by Cobas with a score of 7.1 and HC2 with a score of 5.8. Although all HPV tests used in this comparison meet the international test guidelines, the performance (workflow) characteristics of the assays vary widely. A specific choice of a laboratory for high-throughput testing can be different based on the laboratory's demands, but also hands-on-time, time-to-results/ # samples, maintenance, pre-run, run and post-run parameters, consumables, technical support, and number of errors are important operational factors for the selection of a fully automated workflow for hrHPV testing.
包括荷兰在内，全球已有多个国家引入了原发性高危型人乳头瘤病毒（hrHPV）DNA检测。本研究的目的是比较三种hrHPV检测的自动化工作流程程序，其中hrHPV检测分析符合HPV检测的国际指南。为模拟实际筛查情况，我们旨在3个月内处理15000份剩余的PreservCyt宫颈样本。在3个月的时间里，四名技术人员参与在三个自动化平台上每月处理5000份样本，（1）Qiagen Digene® HC2 HPV DNA检测（HC2，信号放大）；（2）罗氏Cobas® HPV检测（DNA扩增），以及（3）Hologic Aptima® HPV检测（RNA扩增）。我们对一般方面（出结果时间、实际操作时间（HOT））、维护、运行前、运行中和运行后方面、库存（订单、存储）以及错误数量进行了1至10分的测量和评分。就每个完整工作流程而言，Aptima、Cobas和HC2的最大处理能力和HOT分别为296个样本和2小时55分钟、282个样本和3小时20分钟以及264个样本和4小时15分钟。Cobas每次运行的平均通量时间为5小时51分钟，可处理94个样本。对于Aptima，每次运行60个样本的平均通量时间为6小时30分钟。HC2的平均通量时间更长，因为结果在第2天提供。在本研究中，全自动Aptima工作流程得分最高，为7.2分，其次是Cobas，得分为7.1分，HC2得分为5.8分。尽管本比较中使用的所有HPV检测均符合国际检测指南，但各检测分析的性能（工作流程）特征差异很大。根据实验室的需求，高通量检测实验室的具体选择可能会有所不同，但实际操作时间、出结果时间/样本数量、维护、运行前、运行中和运行后参数、耗材、技术支持以及错误数量也是选择hrHPV检测全自动工作流程的重要操作因素。
