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Performance analysis of high-throughput HPV testing on three automated workflows.

三种自动化工作流的高通量HPV检测性能分析。

  • 影响因子:1.98
  • DOI:10.1111/apm.13064
  • 作者列表:"Loonen AJM","Huijsmans CJJ","Geurts-Giele WRR","Leeijen C","van der Linden JC","van den Brule AJC
  • 发表时间:2020-08-01
Abstract

: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.

摘要

: 包括荷兰在内的多个国家已经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hrHPV检测的三种自动化工作流程程序,其中hrHPV检测测定法符合国际HPV检测指南。为了模拟现实的筛查情况,我们的目标是在3个月的时间内处理15 000个残留的阴道标本。在3个月期间,4名技术人员参与了在3个自动化平台上每月处理5000个标本,(1) Qiagen Digene®HC2 HPV DNA检测 (HC2,信号放大); (2) 罗氏Cobas®HPV检测 (DNA扩增),和 (3) Hologic Aptima®HPV检测 (RNA扩增)。我们测量并评分了一般方面 (结果时间,动手时间 (HOT)),维护,运行前,运行和运行后方面,库存 (订单,存储) 和错误数量,范围从1到10。根据每个完整工作流程的测定,最大处理能力和热为296个样品和2 h:55 m,对于Aptima、Cobas和HC2,分别为282个样品和3 h:20 m,和264个样品和4 h:15 m。每次运行的平均处理时间为5 h: 对于Cobas而言为51 m,其中可以处理94个样品。对于Aptima,对于60个样品,每次运行的平均吞吐量时间为6 h:30 m。HC2的平均处理时间较长,因为结果在第二天提供。在这项研究中,全自动Aptima工作流程得分最好,为7.2,其次是Cobas,得分为7.1,HC2得分为5.8。虽然在该比较中使用的所有HPV测试都符合国际测试指南,但测定的性能 (工作流程) 特征差异很大。高通量测试实验室的具体选择可以根据实验室的需求而有所不同,但也可以根据实际操作时间、结果时间/# 样品、维护、运行前、运行中和运行后的参数、消耗品、技术支持、错误的数量是选择用于hrHPV测试的全自动工作流的重要操作因素。

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影响因子:0.85
发表时间:2020-01-02
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DOI:10.1093/labmed/lmz030
作者列表:["Yang R","Zhang R","Zhang Y","Huang Y","Liang H","Gui G","Gong S","Wang H","Xu M","Fan J"]

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DOI:10.1016/j.cmi.2019.05.010
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