Diagnostic Performance of the Newly Developed WellPrep® Liquid-Based Cytology System and Its Comparison with SurePathTM in Cervical Squamous Lesions.

IF 1.6 4区医学 Q3 PATHOLOGY

Acta Cytologica Pub Date : 2023-01-01 Epub Date: 2022-11-22 DOI:10.1159/000527165

Ji Eun Choi, Min-Sun Jin, Ilias P Nikas, Han Suk Ryu

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引用次数: 0

Abstract

Introduction: WellPrep® (WP), a fully automated, one-step liquid-based cytology (LBC) platform using an all-in-one closed chamber, has recently been developed as a next-generation LBC technology. This study aimed to evaluate the diagnostic performance and cytomorphologic features of WP regarding cervical cytology and also to compare WP with the SurePathTM (SP), one of the most widely used LBC systems used worldwide.

Methods: Cervicovaginal samples were taken from 212 females who enrolled in the study, and each sample was split and subsequently used for WP and SP LBC. Following the exclusion of seven cases with insufficient quality, a total of 205 cases were used for subsequent analysis. Among them, 75 (36.6%) received histologic follow-up. All cases were interpreted according to the Bethesda System, while three experienced pathologists evaluated their cytomorphologic features.

Results: The diagnostic concordance rate between the two LBC technologies was 84.4% (kappa = 0.776). Furthermore, the diagnostic concordance rates between SP and histology and between WP and histology were 73.3% (kappa = 0.516) and 70.7% (kappa = 0.497), respectively. The two LBC methods showed comparable sensitivity, specificity, and area under the curve (AUC) for histologic HSIL+ (SP: sensitivity 82.8%, specificity 84.8%, and AUC 0.838; WP: sensitivity 79.3%, specificity 87.0%, and AUC 0.831). No significant difference was found regarding the sensitivity, specificity, and AUC between SP and WP (p = 0.586, p = 0.670, and p = 0.924, respectively). In terms of cytomorphologic features, WP revealed more often than SP the presence of coarse chromatin (p = 0.031) and mitoses (p = 0.008) but less commonly perinuclear clearing (p = 0.001).

Conclusion: This is the first study demonstrating that WP has a comparable performance to SP. In conclusion, WP may be an alternative LBC technology for cervical cancer screening.

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新开发的 WellPrep® 液基细胞学系统在宫颈鳞状病变中的诊断性能及其与 SurePathTM 的比较。

简介WellPrep®（WP）是一种全自动、一步式液基细胞学（LBC）平台，采用一体化封闭腔室，是最近开发的新一代LBC技术。本研究旨在评估 WP 在宫颈细胞学方面的诊断性能和细胞形态学特征，并将 WP 与全球使用最广泛的 LBC 系统之一 SurePathTM (SP) 进行比较：方法：从 212 名参与研究的女性中采集宫颈阴道样本，将每个样本分开，然后分别用于 WP 和 SP LBC。在排除了 7 个质量不合格的病例后，共有 205 个病例被用于后续分析。其中，75 例（36.6%）接受了组织学随访。所有病例均按照贝塞斯达系统（Bethesda System）进行解读，由三位经验丰富的病理学家对其细胞形态学特征进行评估：结果：两种 LBC 技术的诊断吻合率为 84.4%（kappa = 0.776）。此外，SP 和组织学之间以及 WP 和组织学之间的诊断吻合率分别为 73.3%（kappa = 0.516）和 70.7%（kappa = 0.497）。两种 LBC 方法对组织学 HSIL+ 的敏感性、特异性和曲线下面积（AUC）相当（SP：敏感性 82.8%，特异性 84.8%，AUC 0.838；WP：敏感性 79.3%，特异性 87.0%，AUC 0.831）。SP和WP的敏感性、特异性和AUC均无明显差异（分别为p = 0.586、p = 0.670和p = 0.924）。就细胞形态学特征而言，WP比SP更常显示粗染色质（p = 0.031）和有丝分裂（p = 0.008），但核周清亮较少（p = 0.001）：这是第一项证明 WP 与 SP 性能相当的研究。总之，WP 可能是宫颈癌筛查的一种替代性 LBC 技术。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Acta Cytologica 生物-病理学

CiteScore

3.70

自引率

11.10%

发文量

审稿时长

4-8 weeks

期刊介绍： With articles offering an excellent balance between clinical cytology and cytopathology, ''Acta Cytologica'' fosters the understanding of the pathogenetic mechanisms behind cytomorphology and thus facilitates the translation of frontline research into clinical practice. As the official journal of the International Academy of Cytology and affiliated to over 50 national cytology societies around the world, ''Acta Cytologica'' evaluates new and existing diagnostic applications of scientific advances as well as their clinical correlations. Original papers, review articles, meta-analyses, novel insights from clinical practice, and letters to the editor cover topics from diagnostic cytopathology, gynecologic and non-gynecologic cytopathology to fine needle aspiration, molecular techniques and their diagnostic applications. As the perfect reference for practical use, ''Acta Cytologica'' addresses a multidisciplinary audience practicing clinical cytopathology, cell biology, oncology, interventional radiology, otorhinolaryngology, gastroenterology, urology, pulmonology and preventive medicine.