Background: Implementing self-sampling (SS) in cervical cancer screening requires comparable results to clinician-collected samples (CCS). Agreement measures are essential for evaluating HPV test performance. Previous studies on non-paired samples have reported higher viral cycle threshold (Ct) values in SS compared to CCS, affecting sensitivity for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+).Objectives:We aimed to evaluate the agreement of high-risk (hr)HPV testing results between SS and CCS using paired samples and to explore differences in Ct values.Methods: Women aged 30 to 65 years attending cervical cancer screening in two regions of Spain were invited to participated in this study. For each woman there was: CCS collected during the screening visit using liquid-based cytology and cytobrush, and a SS using a brush at home one month later. A PCR-based assay was used for hrHPV detection. Agreement in hrHPV results among both samples, Ct value differences, and their association with screening outcomes were analyzed.Results: This study included 981 women with paired samples. SS had a higher hrHPV prevalence than CCS (overall ratio of 1.3). Positive agreement for all hrHPV genotypes, HPV16, HPV18, and other hrHPV types were 85%, 91.3%, 66.7%, and 83.3%, respectively. Negative agreement was >95% for all results. Median Ct values was slightly higher in SS than in CSS (32.9 vs. 30.6,p= 0.02). Seven CIN2+ cases HPV positive were detected by both methods. One CIN3 case was missed by SS.Conclusions: This study showed a good agreement between SS and CCS for hrHPV testing in a routine screening in Spain. Despite the slightly higher Ct values for SS, no significant impact on sensitivity could be determined due to the low incidence of CIN2+ cases. Further research on larger paired samples is needed to assess the implications of Ct values on test sensitivity.
背景：在宫颈癌筛查中实施自采样方法时，其检测结果需与临床医生采样具有可比性。一致性评估对评价HPV检测效能至关重要。既往基于非配对样本的研究显示，自采样标本的病毒循环阈值较临床采样更高，这可能影响对宫颈上皮内瘤变2级及以上病变的检测灵敏度。 目的：本研究旨在通过配对样本评估自采样与临床采样在高危型HPV检测结果的一致性，并探讨循环阈值的差异。 方法：邀请西班牙两个地区参与宫颈癌筛查的30-65岁女性参与研究。每位受试者均采集两种样本：筛查访视时采用液基细胞学及细胞刷进行临床采样，一个月后居家使用采样刷完成自采样。采用基于PCR的检测方法进行高危型HPV检测。分析两种样本在高危型HPV结果的一致性、循环阈值差异及其与筛查结局的关联。 结果：本研究共纳入981名配对样本女性。自采样组高危型HPV阳性率高于临床采样组（总体比值为1.3）。所有高危型HPV基因型、HPV16、HPV18及其他高危型别的阳性符合率分别为85%、91.3%、66.7%和83.3%，所有结果的阴性符合率均>95%。自采样组中位循环阈值略高于临床采样组（32.9 vs. 30.6，p=0.02）。两种方法共同检出7例高危型HPV阳性的CIN2+病例，自采样漏检1例CIN3病例。 结论：本研究表明在西班牙常规筛查中，自采样与临床采样在高危型HPV检测方面具有良好一致性。尽管自采样循环阈值略高，但由于CIN2+病例发生率较低，未发现对检测灵敏度产生显著影响。未来需要通过更大规模的配对样本研究，进一步评估循环阈值对检测灵敏度的影响。
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