Ji Eun Choi, Min-Sun Jin, Ilias P Nikas, Han Suk Ryu
{"title":"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。","authors":"Ji Eun Choi, Min-Sun Jin, Ilias P Nikas, Han Suk Ryu","doi":"10.1159/000527165","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":"67 1","pages":"27-37"},"PeriodicalIF":1.6000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Diagnostic Performance of the Newly Developed WellPrep® Liquid-Based Cytology System and Its Comparison with SurePathTM in Cervical Squamous Lesions.\",\"authors\":\"Ji Eun Choi, Min-Sun Jin, Ilias P Nikas, Han Suk Ryu\",\"doi\":\"10.1159/000527165\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>This is the first study demonstrating that WP has a comparable performance to SP. 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Diagnostic Performance of the Newly Developed WellPrep® Liquid-Based Cytology System and Its Comparison with SurePathTM in Cervical Squamous Lesions.
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.
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.
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