Giubbi Chiara, Martinelli Marianna, Vallini Ivan, Paganoni Silvia, Dafa'alla Tarig, Perdoni Federica, Musumeci Rosario, Wu Winnie, Castriciano Santina, Romano Paolo, Cocuzza Clementina E
Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
Hiantis S.r.l., Milano, Italy.
Open Res Eur. 2022 Jul 22;2:35. doi: 10.12688/openreseurope.14344.2. eCollection 2022.
Human Papillomavirus (HPV) testing on self-collected samples allows for improved coverage rates of cervical cancer (CC) screening programs. ThinPrep®PreservCyt® (HOLOGIC®, USA) medium is widely used for the suspension of cervical and vaginal self-samples. However, this medium is costly, toxic, and flammable, involving special handling procedures which make its use difficult in screening programs, particularly in low- and middle-income countries. This pilot study aimed to evaluate the analytical performance of eNat (Copan SpA), an alternative non-alcohol-based suspension medium, compared to ThinPrep®PreservCyt® (HOLOGIC®) for high-risk HPV (hrHPV) detection in vaginal self-collected swabs using three different real-time polymerase chain reaction (RT-PCR) HPV assays: Anyplex™II HPV28 (Seegene, Korea), Papilloplex® High Risk HPV (GeneFirst, UK), and HPV OncoPredict (Hiantis, Italy). 30 women, referred to colposcopy, were enrolled in this observational, prospective pilot study and asked to collect two vaginal self-taken samples, which were suspended in 5 mL of ThinPrep®PreservCyt® or eNat®. Nucleic acids were extracted from 200 μL using Microlab Nimbus platform (Seegene, Korea) and tested with the three different RT-PCR full-genotyping high-risk HPV assays. The HPV results of vaginal samples resuspended in the two different media were compared to those obtained from the reference clinician-collected cervical sample from the same woman. hrHPV detection in vaginal self-samples suspended in both media demonstrated a substantial agreement with cervical samples with the three assays under-investigation (0.667 <k <0.796). Moreover, the discordances between vaginal self-samples collected from the same woman were found only in cases of normal cytology or low-grade cytological lesions and were generally related to low hrHPV viral loads as indicated by the quantitative HPV OncoPredict assay (6.24E+02 copies/10,000 cells). The study's preliminary findings demonstrated a very good agreement between cervical and vaginal self-collected samples suspended in ThinPrep®PreservCyt® and eNat®, suggesting that the latter could represent a good alternative medium in HPV screening programs based on self-collection.
对自行采集的样本进行人乳头瘤病毒（HPV）检测可提高宫颈癌（CC）筛查项目的覆盖率。ThinPrep®PreservCyt®（美国HOLOGIC公司）培养基广泛用于宫颈和阴道自行采集样本的悬浮保存。然而，这种培养基成本高、有毒且易燃，需要特殊处理程序，这使得其在筛查项目中使用困难，尤其是在低收入和中等收入国家。这项前瞻性试点研究旨在评估eNat（意大利Copan SpA公司）这种替代性非酒精基悬浮培养基与ThinPrep®PreservCyt®（HOLOGIC公司）相比，在使用三种不同的实时聚合酶链反应（RT-PCR）HPV检测方法检测自行采集的阴道拭子中高危型HPV（hrHPV）时的分析性能：Anyplex™II HPV28（韩国Seegene公司）、Papilloplex®高危型HPV（英国GeneFirst公司）和HPV OncoPredict（意大利Hiantis公司）。30名转诊至阴道镜检查的女性参与了这项观察性前瞻性试点研究，并被要求自行采集两份阴道样本，分别悬浮于5 mL ThinPrep®PreservCyt®或eNat®中。使用Microlab Nimbus平台（韩国Seegene公司）从200 μL样本中提取核酸，并使用三种不同的RT-PCR全基因分型高危型HPV检测方法进行检测。将悬浮于两种不同培养基中的阴道样本的HPV检测结果与同一女性由临床医生采集的宫颈参考样本的检测结果进行比较。在三种研究的检测方法中，悬浮于两种培养基中的阴道自行采集样本中的hrHPV检测结果与宫颈样本结果具有高度一致性（0.667 <κ<0.796）。此外，同一女性自行采集的阴道样本之间的不一致情况仅出现在细胞学正常或低度细胞学病变的病例中，并且如定量HPV OncoPredict检测所示（6.24E+02拷贝/10,000个细胞），通常与hrHPV病毒载量低有关。该研究的初步结果表明，悬浮于ThinPrep®PreservCyt®和eNat®中的宫颈样本与自行采集的阴道样本之间具有很好的一致性，这表明后者可能是基于自行采集的HPV筛查项目中的一种良好替代培养基。
