Frayle Helena, Gori Silvia, Rizzi Martina, Graziani Bianca Nives, Vian Elisa, Giorgi Rossi Paolo, Del Mistro Annarosa
Immunology and Molecular Diagnostic Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Via Gattamelata, 64, 35128, Padova, Italy.
Pathology Unit, Ospedale di Santorso, Via Garziere, 42-36014, Santorso (VI), Italy.
BMC Womens Health. 2019 Mar 25;19(1):47. doi: 10.1186/s12905-019-0743-0.
European guidelines for cervical cancer screening now recommend the use of clinically validated assays for high-risk HPV-DNA sequences as primary test in women older than 30 years, performed in centralized laboratories, and run on systems providing automated solutions for all steps.
We conducted a comparison study, according to the international guidelines, nested within the organized population-based cervical screening program, between the cobas 4800 and 6800 systems (Roche Diagnostics), to evaluate accuracy and reproducibility of HPV test results and laboratory workflow. In Italy implementation of HPV cervical screening is under way on a regional basis; in Veneto it started in June 2015, following a piloting phase; the assay in use in the three centralized laboratories is the cobas 4800 HPV test, run on the cobas 4800 system. Comparison of HPV results with a new version of the assay (cobas 6800/8800 HPV) run on the cobas 6800 system, and intra- and inter-reproducibility analyses have been conducted in samples collected in PreservCyt medium (Hologic) from women without and with a subsequent diagnosis of high-grade lesion.
Samples from women older than 30 years attending organized cervical cancer screening were used. Clinical sensitivity and specificity were evaluated on 60 cases and 925 controls, respectively; intra-laboratory reproducibility and inter-laboratory agreement by the 6800 system were evaluated on 593 and 460 specimens, respectively. Our results showed a very high agreement (> 98%) for overall qualitative results between the two systems; clinical sensitivity and specificity of the HPV assay run on 6800 were non-inferior to those of the HPV assay run on 4800 (p = 0,0157 and p = 0,0056, respectively, at the recommended thresholds of 90 and 98%); kappa values of 0.967 and 0.969 were obtained for intra- and inter-laboratory reproducibility analyses in the 6800 system. The 6800 platform displayed several technological improvements over the 4800 system, with higher throughput and laboratory productivity, and lower operator's hands-on time.
The new cobas 6800/8800 HPV assay run on the 6800 instrument is suitable for use in large centralized laboratories included within population-based cervical cancer screening programs.
欧洲宫颈癌筛查指南现推荐，对于30岁以上女性，应使用经临床验证的高危型人乳头瘤病毒（HPV）-DNA序列检测方法作为初筛检测，检测在集中化实验室进行，并采用能为所有步骤提供自动化解决方案的系统。
我们依据国际指南，在基于人群的有组织宫颈癌筛查项目中，对cobas 4800和6800系统（罗氏诊断公司）进行了一项比较研究，以评估HPV检测结果的准确性和可重复性以及实验室工作流程。在意大利，HPV宫颈癌筛查正在按地区逐步实施；在威尼托地区，经过试点阶段后，于2015年6月开始实施；三个集中化实验室使用的检测方法是在cobas 4800系统上运行的cobas 4800 HPV检测。我们对在PreservCyt培养基（豪洛捷公司）中采集的、随后被诊断为无高级别病变和有高级别病变的女性样本，进行了在cobas 6800系统上运行的新版检测方法（cobas 6800/8800 HPV）的HPV结果比较，以及批内和批间可重复性分析。
使用了参加有组织宫颈癌筛查的30岁以上女性的样本。分别在60例病例和925例对照中评估了临床敏感性和特异性；在6800系统上，分别对593份和460份标本评估了批内可重复性和实验室间一致性。我们的结果显示，两个系统之间的总体定性结果一致性非常高（>98%）；在6800系统上运行的HPV检测的临床敏感性和特异性不低于在4800系统上运行的HPV检测（在推荐阈值90%和98%时，p分别为0.0157和0.0056）；在6800系统的批内和批间可重复性分析中，kappa值分别为0.967和0.969。6800平台相对于4800系统有多项技术改进，通量和实验室生产力更高，操作人员的实际操作时间更短。
在6800仪器上运行的新型cobas 6800/8800 HPV检测适用于基于人群的宫颈癌筛查项目中的大型集中化实验室。
