与接受阴道镜检查的女性进行HPV检测相比，自行收集的阴道和尿液样本的临床表现和可接受性与临床医生所采集的宫颈样本相比较。横断面研究,BMJ Open

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与接受阴道镜检查的女性进行HPV检测相比，自行收集的阴道和尿液样本的临床表现和可接受性与临床医生所采集的宫颈样本相比较。横断面研究
BMJ Open ( IF 2.4 ) Pub Date : 2021-03-01 , DOI: 10.1136/bmjopen-2020-041512
Dorthe Ørnskov , Kirsten Jochumsen , Pernille Husted Steiner , Ivan Moulun Grunnet , Annemette Wildfang Lykkebo , Marianne Waldstrøm

目的为了提高子宫颈癌筛查程序的有效性，可以选择自采样。自我收集的阴道样本（SCV）和尿液样本都可以代替临床医生采集的宫颈样本（CS）。设计横断面研究。设置阴道镜诊疗所。参与者女性（n = 305）在异常子宫颈筛查结果或性交后出血等情况下接受阴道镜检查。干预所有妇女在进行阴道镜检查之前会自行收集尿液和阴道样本，然后进行CS和活检。使用Cobas HPV分析法对所有样品进行了高危人乳头瘤病毒（HPV）测试。金标准是根据在同一检查中获得的活检组织学诊断（CIN2 + / CIN3 +）。主要结果与CS相比，HPV检测SCV和尿液对CIN2 + / CIN3 +的绝对和相对敏感性和特异性。次要结果妇女接受自我抽样调查的可接受性。结果在确定严重的上皮内瘤变（CIN2 + / CIN3 +）方面，阴道和尿液样本均与CS相当。绝对灵敏度的范围从尿液样本的93％到检测CIN2 +的SCV的96％不等，与CS的灵敏度（重叠95％CI）相当。对于SCV，检测CIN2 +的相对灵敏度为1.00（95％CI 0.91至1.03），对于尿液样品为0.96（95％CI 0.91至1.03）。在CIN3 +处，SCV和尿液样品的相对灵敏度分别为1.00（95％CI 0.96至1.08）和0.97（95％CI 0.89至1.07）。自我收集的样本与CS之间没有统计学差异（McNemar检验> 0.05）。相对特异性也相似（SCV为1.03（95％CI 0.95至1.12），尿液样品为0.98（95％CI 0.89至1.09）（McNemar检验> 0.05）。通过问卷评估自我抽样的可接受性。这些妇女发现样本采集说明易于理解，并且对自我采样持肯定态度，偏爱尿液样本。结论SCV和尿液自采样是CS的临床安全替代方法，具有高度的可接受性。这些妇女发现样本采集说明易于理解，并且对自我采样持肯定态度，偏爱尿液样本。结论SCV和尿液自采样是CS的临床安全替代方法，具有高度的可接受性。这些妇女发现样本采集说明易于理解，并且对自我采样持肯定态度，偏爱尿液样本。结论SCV和尿液自采样是CS的临床安全替代方法，具有高度的可接受性。

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Clinical performance and acceptability of self-collected vaginal and urine samples compared with clinician-taken cervical samples for HPV testing among women referred for colposcopy. A cross-sectional study

Objectives To increase effectiveness of the cervical cancer screening program, self-sampling can be an option. Both self-collected vaginal samples (SCV) and urine samples may be useful alternatives to clinician-taken cervical samples (CS). Design Cross-sectional study. Setting Colposcopy clinic. Participants Women (n=305) referred to colposcopy after abnormal cervical screening result or conditions like postcoital bleeding. Intervention All women self-collected a urine and a vaginal sample prior to colposcopy, where a CS and biopsies were taken. All samples were tested for high-risk human papillomavirus (HPV) using the Cobas HPV assay. The gold standard was histology diagnoses (CIN2+/CIN3+) from biopsies obtained at the same examination. Primary outcome Absolute and relative sensitivity and specificity of HPV testing on SCV and urine to detect CIN2+/CIN3+ compared with the CS. Secondary outcome The acceptability by women of self-sampling. Results Both the vaginal and urine sample were comparable to the CS in identifying severe intraepithelial neoplasia (CIN2+/CIN3+). Absolute sensitivity ranged from 93% for urine samples to 96% for SCV for detecting CIN2+, which is comparable to the sensitivity of CS (overlapping 95% CI). The relative sensitivity for detecting CIN2+ was 1.00 (95% CI 0.96 to 1.04) for SCV and 0.96 (95% CI 0.91 to 1.03) for urine samples. At CIN3+, the relative sensitivity was 1.00 (95% CI 0.96 to 1.08) and 0.97 (95% CI 0.89 to 1.07) for SCV and urine samples, respectively. There were no statistical differences between the self-collected samples and the CS (McNemar’s test >0.05). The relative specificity was also similar (1.03 (95% CI 0.95 to 1.12) for SCV and 0.98 (95% CI 0.89 to 1.09) for urine samples) (McNemar’s test >0.05). The acceptability of self-sampling was evaluated by questionnaire. The women found the instructions on sample collection easy to understand and were positive about self-sampling with a preference for the urine sample. Conclusion Self-sampling by SCV and urine is a clinically safe alternative to CS with a high degree of acceptability.

更新日期：2021-03-05

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