Barbieri Daniela, Venturoli Simona, Costa Silvano, Landini Maria Paola
Unit of Microbiology, Department of Diagnostic Medicine and Prevention, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy; Current address for DB: Department of Industrial Engeneering (DIN), University of Bologna, Bologna, Italy.
Unit of Microbiology, Department of Diagnostic Medicine and Prevention, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy; Current address for DB: Department of Industrial Engeneering (DIN), University of Bologna, Bologna, Italy
J Lab Autom. 2016 Jun;21(3):432-8. doi: 10.1177/2211068215569347. Epub 2015 Feb 11.
Cervical specimens collected in liquid-based cytology (LBC) media are the most common sample type used for high-risk human papillomavirus (HPV) testing. Since preanalytic steps such as vortexing and decapping vials, liquid transfer to a sample input tube with matching unique identifier, and recapping the original vials are required for processing LBC samples prior to running the Abbott RealTime High Risk HPV assay (Abbott, Wiesbaden, Germany), a full manual execution can be complicated, especially in high-throughput diagnostic contexts. Here, a custom-configured worktable setup for the Tecan Freedom EVO (Tecan, Männedorf, Switzerland) designed to automate and control preanalytic steps for ThinPrep (Hologic, Marlborough, MA) samples was used to evaluate the impact of automated versus manual preanalytics. Archival results for manual processing of 226 samples were compared with those obtained with the Tecan protocol, observing a very good overall concordance for final assay interpretation (95.6%). High overall agreement (100%) resulted also from retesting 99 samples by both the preanalytical protocols. High reproducibility was observed analyzing 23 randomly selected samples by automated preprocessing in triplicate. Hence, the new configuration of the Tecan platform translates the manual steps required to process ThinPrep specimens into automated operations, controls sample identification, and allows for saving hands-on time, while maintaining assay reproducibility and ensuring reliability of results, making it suitable for screening settings.
在液基细胞学(LBC)培养基中收集的宫颈标本是用于高危型人乳头瘤病毒(HPV)检测的最常见样本类型。由于在运行雅培实时高危型HPV检测(雅培,德国威斯巴登)之前处理LBC样本需要进行诸如涡旋和打开小瓶瓶盖、将液体转移至带有匹配唯一标识符的样本输入管以及重新盖上原始小瓶瓶盖等分析前步骤,完全手动操作可能会很复杂,尤其是在高通量诊断环境中。在此,使用了为Tecan Freedom EVO(Tecan,瑞士曼纳多夫)定制配置的工作台设置,旨在自动化和控制ThinPrep(Hologic,美国马萨诸塞州马尔伯勒)样本的分析前步骤,以评估自动化与手动分析前操作的影响。将226个样本手动处理的存档结果与通过Tecan方案获得的结果进行比较,观察到最终检测结果解释的总体一致性非常好(95.6%)。两种分析前方案对99个样本进行重新检测也得到了很高的总体一致性(100%)。通过对23个随机选择的样本进行三次重复自动预处理分析,观察到了高重现性。因此,Tecan平台的新配置将处理ThinPrep标本所需的手动步骤转化为自动化操作,控制样本识别,并节省了人工操作时间,同时保持了检测的重现性并确保了结果的可靠性,使其适用于筛查环境。