在南非一家三级医院就诊的女性中，基于涂抹器棉塞的液基细胞学自我采集表现不佳。
Poor Performance of Applicator Tampon-Based Self-Collection for Liquid-Based Cytology Among Women Attending a Tertiary Hospital in South Africa.
作者信息
Tiiti Teboho Amelia, Nkwinika Varsetile Varster, Mashishi Tebogo Loraine, Molefi Kgotlaethata Aaron, Msibi Thembeni Lucia, Khaba Moshawa, Bogers Johannes, Lebelo Ramokone Lisbeth
机构信息
Department of Virological Pathology, Sefako Makgatho Health Sciences University, Pretoria, South Africa.
Laboratory of Cell Biology and Histology, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerpen, Belgium.
出版信息
Diagn Cytopathol. 2025 Apr;53(4):150-160. doi: 10.1002/dc.25429. Epub 2024 Dec 12.
BACKGROUND
The South African Cervical Cancer Prevention and Control Policy was updated in June 2017, recommending liquid-based cytology (LBC) as the preferred screening method and the investigation of self-sampling for cervical cancer screening.
AIM
To compare the performance of the Self Collection Cervical Health Screening Kit [SelfCerv (applicator tampon)] to the Cervex-Brush Combi for cytology screening. The study further aimed to compare high-risk (hr-) human papillomavirus (HPV) and LBC test results from both methods.
METHODS
The study included 446 paired samples, comprising self-collected (SelfCerv) and healthcare provider-collected (Cervex-Brush Combi) samples from women aged ≥ 18 years attending gynaecology outpatient clinics at a tertiary hospital in Pretoria, South Africa. LBC slides were prepared using the ThinPrep 5000 processor and manually stained with Hematoxylin and Eosin (H&E). Detection of 14 hr-HPV types was performed using the Abbott RealTime HR-HPV assay. Statistical analyses were performed using STATA version 17.0 (Stata Corp., College Station, Texas, USA).
RESULTS
A statistically significant difference in cervical cytology detection between the two methods was observed (p = 0.0025). The Cervex-Brush Combi was more effective in collecting endocervical cells (73.4%; 95% CI: 69.0-77.9) compared to the SelfCerv applicator tampon (7.3%; 95% CI: 4.7-9.9); (p < 0.001). Cytological abnormalities were detected in 65.4% (136/208) of participants who tested positive for hr-HPV by healthcare provider sampling compared to 40.8% (84/206) by self-sampling. A fair agreement (κ: 0.35) with a concordance rate of 96.2% (95% CI: 94.4-98.0) was observed for specimen adequacy and diagnosis parameters [κ: 0.34, with a concordance rate of 67.7% (95% CI: 63.2-72.1)] between the two methods.
CONCLUSION
The findings of this study do not support the implementation of applicator tampon-based self-collection as a method for cytology-based cervical cancer screening.
背景
2017年6月更新了《南非宫颈癌预防与控制政策》，推荐液基细胞学检查（LBC）作为首选筛查方法，并对宫颈癌筛查的自我采样进行研究。
目的
比较自我采集宫颈健康筛查试剂盒[SelfCerv（涂抹式棉塞）]与Cervex-Brush Combi用于细胞学筛查的性能。该研究还旨在比较两种方法检测高危（hr-）人乳头瘤病毒（HPV）和LBC的检测结果。
方法
该研究纳入了446对样本，包括来自南非比勒陀利亚一家三级医院妇科门诊≥18岁女性的自我采集样本（SelfCerv）和医护人员采集样本（Cervex-Brush Combi）。使用ThinPrep 5000处理器制备LBC玻片，并用苏木精和伊红（H&E）进行手工染色。使用雅培实时HR-HPV检测法检测14种hr-HPV类型。使用STATA 17.0版（美国德克萨斯州大学站市Stata公司）进行统计分析。
结果
观察到两种方法在宫颈细胞学检测方面存在统计学显著差异（p = 0.0025）。与SelfCerv涂抹式棉塞（7.3%；95%CI：4.7-9.9）相比，Cervex-Brush Combi在采集宫颈管细胞方面更有效（73.4%；95%CI：69.0-77.9）；（p < 0.001）。医护人员采样检测hr-HPV呈阳性的参与者中，65.4%（136/208）检测到细胞学异常，而自我采样的这一比例为40.8%（84/206）。两种方法在样本充足性和诊断参数方面观察到中等一致性（κ：0.35），一致性率为96.2%（95%CI：94.4-98.0）[κ：0.34，一致性率为67.7%（95%CI：63.2-72.1）]。
结论
本研究结果不支持采用涂抹式棉塞进行自我采样作为基于细胞学的宫颈癌筛查方法。
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