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.

中文翻译：

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在三个自动化工作流程上进行高通量HPV测试的性能分析。

在包括荷兰在内的全球多个国家/地区已经引入了主要的高危人类乳头瘤病毒（hrHPV）DNA检测方法。这项研究的目的是比较hrHPV检测的三种自动化工作流程程序，其中hrHPV检测测定符合HPV检测的国际准则。为了模拟现实的筛查情况，我们的目标是在3个月内处理15 000个残留的PreservCyt宫颈样品。在三个月的时间里，四名技术人员每月在三个自动化平台上处理5000个样本，（1）QiagenDigene®HC2 HPV DNA测试（HC2，信号放大）；（2）罗氏Cobas®HPV测试（DNA扩增）和（3）HologicAptima®HPV测试（RNA扩增）。我们对一般方面（结果产生时间，动手操作（HOT）），维护，运行前，运行中和运行后方面，库存（订单，存储）和错误数量进行了衡量和评分从1到10。对于每个完整的工作流程，确定的最大处理能力和HOT为296个样品和2 h：55 m，282个样品和3 h：20 m，以及Aptima，Cobas的264个样品和4 h：15 m和HC2。Cobas每次运行的平均吞吐时间为5 h：51 m，其中可以处理94个样品。对于Aptima，60个样品的每次运行平均吞吐时间为6 h：30 m。由于第2天提供了结果，因此HC2的平均吞吐时间更长。在这项研究中，全自动Aptima工作流程得分最高，为7.2，其次是Cobas得分为7.1，HC2得分为5.8。尽管此比较中使用的所有HPV检测均符合国际检测指南，但检测的性能（工作流程）特征差异很大。根据实验室的需求，针对高通量测试的实验室的具体选择可能会有所不同，但动手时间，结果生成时间/样品数量，维护，运行前，运行和运行后参数，消耗品，技术支持和错误数量是选择用于hrHPV测试的全自动工作流程的重要操作因素。分析的性能（工作流程）特征差异很大。根据实验室的需求，针对高通量测试的实验室的具体选择可能会有所不同，但动手时间，结果生成时间/样品数量，维护，运行前，运行和运行后参数，消耗品，技术支持和错误数量是选择用于hrHPV测试的全自动工作流程的重要操作因素。分析的性能（工作流程）特征差异很大。对于高通量测试，实验室的具体选择可能会根据实验室的要求而有所不同，但动手时间，结果生成时间/样品数量，维护，运行前，运行和运行后参数，消耗品，技术支持和错误数量是选择用于hrHPV测试的全自动工作流程的重要操作因素。