随着对宫颈癌筛查的需求不断增长，自我采样方法为传统医生主导的采样提供了一种有前景的替代方案。本研究旨在评估 HygeiaTouch 女性自我采样试剂盒在检测人乳头瘤病毒 (HPV) 类型和预测宫颈病变方面的功效。我们研究了医生采集的样本和女性使用自我采样试剂盒进行验证时自行采集的样本在识别高危 HPV (hrHPV) 类型方面的一致性。年龄在 21-65 岁之间、根据宫颈健康史归入特定类别的女性符合资格。还计算了用于衡量两种样本类型之间一致性的科恩卡帕系数以及识别宫颈上皮内瘤变 (CIN) 的相对准确性指标，并以医生采样的样本作为参考。共有来自三个机构的 1210 名参与者参与其中。自采样试剂盒在收集有效样本（100% vs. 100%）、识别 hrHPV 类型（kappa：0.75，95% 置信区间 [95% CI]：0.72-0.79；一致性）方面与医生主导的方法密切匹配：87.7%，95% CI：85.8-89.6）并预测 CIN 2 级或更严重（CIN2）（相对灵敏度：0.949，相对准确度：0.959）。不同 hrHPV 类型和组合的 Kappa 值在 0.71 和 0.83 之间变化，总体值为 0.75 (95% CI: 0.72-0.79)，表明两种方法之间具有很强的兼容性。我们的研究强调了 HygeiaTouch 自采样套件作为传统采样方法的可靠、高效且用户友好的替代方案的潜力。这表明自我采样对于扩大宫颈癌筛查可及性和提高检出率至关重要。© 2024 Wiley periodicals LLC。

With the rising need for accessible cervical cancer screening, self-sampling methods offer a promising alternative to traditional physician-led sampling. This study aims to evaluate the efficacy of the HygeiaTouch Self Sampling Kit for Women in detecting human papillomavirus (HPV) types and predicting cervical lesions. We studied the concordance in identifying high-risk HPV (hrHPV) types between samples collected by physicians and those self-collected by women using a self-sampling kit for validation. Women aged 21-65, fitting into specific categories based on their cervical health history were eligible. Cohen's kappa coefficient to gauge concordance between the two specimen types and relative accuracy metrics in identifying cervical intraepithelial neoplasia (CIN) were also calculated, with physician-sampled specimens serving as a reference. A total of 1210 participants from three institutes were involved. The self-sampling kit closely matched the physician-led method in terms of collecting valid specimens (100% vs. 100%), identifying hrHPV types (kappa: 0.75, 95% confidence interval [95% CI]: 0.72-0.79; agreement: 87.7%, 95% CI: 85.8-89.6) and predicting CIN grade 2 or worse (CIN2+) (relative sensitivity: 0.949, relative accuracy: 0.959). Kappa values varied between 0.71 and 0.83 for different hrHPV types and combinations, with an overall value 0.75 (95% CI: 0.72-0.79) signifying robust compatibility between the two methods. Our study underscores the potential of the HygeiaTouch Self Sampling Kit as a reliable, efficient, and user-friendly alternative to traditional sampling methods. This suggests that self-sampling could be pivotal in expanding cervical cancer screening accessibility and enhancing detection rates.© 2024 Wiley Periodicals LLC.