加纳女性使用careHPV进行自我采集阴道样本以检测生殖道人乳头瘤病毒（HPV）
Self-collected vaginal sampling for the detection of genital human papillomavirus (HPV) using careHPV among Ghanaian women.
作者信息
Obiri-Yeboah Dorcas, Adu-Sarkodie Yaw, Djigma Florencia, Hayfron-Benjamin Anna, Abdul Latif, Simpore Jacques, Mayaud Philippe
机构信息
Department of Microbiology and Immunology, School of Medical Sciences, University of Cape Coast, Cape Coast, Ghana.
Department of Clinical Microbiology, School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
出版信息
BMC Womens Health. 2017 Sep 26;17(1):86. doi: 10.1186/s12905-017-0448-1.
BACKGROUND
Detection of genital HPV DNA is recommended as an important strategy for modern cervical cancer screening. Challenges include access to services, the reliance on cervical samples taken by clinicians, and patient's preference regarding provider gender. The objective of this research was to determine the acceptability, feasibility and performance of alternative self-collected vaginal samples for HPV detection among Ghanaian women.
METHODS
A comparative frequency-matched study was conducted in a systematic (1:5) sample of women attending HIV and outpatient clinics in the Cape Coast Teaching Hospital, Ghana. Participants were instructed on self-collection (SC) of vaginal samples using the careHPV brush and a clinician-collected (CC) cervical sample was obtained using a similar brush. Paired specimens were tested for HPV DNA (14 high-risk types) by careHPV assay (Qiagen) and by HPV genotyping (Anyplex II, Seegene).
RESULTS
Overall, 194 women of mean age 44.1 years (SD ± 11.3) were enrolled and 191 paired SC and CC results were analysed. The overall HPV detection concordance was 94.2% (95%CI: 89.9-97.1), Kappa value of 0.88 (p < 0.0001), showing excellent agreement. This agreement was similar between HIV positive (93.8%) and negative (94.7%) women. Sensitivity and specificity of SC compared to CC were 92.6% (95%CI: 85.3-97.0) and 95.9% (95%CI: 89.8-98.8) respectively. The highest sensitivity was among HIV positive women (95.7%, 95%CI: 88.0-99.1) and highest specificity among HIV negative women (98.6%, 95%CI: 92.4-100). Overall, 76.3% women found SC very easy/easy to obtain, 57.7% preferred SC to CC and 61.9% felt SC would increase their likelihood to access cervical cancer screening.
CONCLUSIONS
The feasibility, acceptability and performance of SC using careHPV support the use of this alternative form of HPV screening among Ghanaian women. This could be a potential new affordable strategy to improve uptake of the national cervical cancer screening program.
背景
检测生殖道人乳头瘤病毒（HPV）DNA被推荐为现代宫颈癌筛查的一项重要策略。面临的挑战包括服务可及性、对临床医生采集宫颈样本的依赖以及患者对医疗服务提供者性别的偏好。本研究的目的是确定加纳女性自行采集的阴道样本用于HPV检测的可接受性、可行性及性能。
方法
在加纳海岸角教学医院就诊于艾滋病和门诊的女性系统性（1:5）样本中开展了一项频率匹配的对照研究。指导参与者使用careHPV刷自行采集阴道样本，并使用类似刷子获取临床医生采集的宫颈样本。通过careHPV检测法（Qiagen）和HPV基因分型（Anyplex II，Seegene）对配对样本检测HPV DNA（14种高危型别）。
结果
总体而言，纳入了194名平均年龄44.1岁（标准差±11.3）的女性，分析了191对自行采集样本和临床医生采集样本的结果。HPV总体检测一致性为94.2%（95%置信区间：89.9 - 97.1），Kappa值为0.88（p < 0.0001），显示出极好的一致性。HIV阳性女性（93.8%）和阴性女性（94.7%）之间的一致性相似。与临床医生采集样本相比，自行采集样本的敏感性和特异性分别为92.6%（95%置信区间：85.3 - 97.0）和95.9%（95%置信区间：89.8 - 98.8）。HIV阳性女性中的敏感性最高（95.7%，95%置信区间：88.0 - 99.1），HIV阴性女性中的特异性最高（98.6%，95%置信区间：92.4 - 100）。总体而言，76.3%的女性认为自行采集样本非常容易/容易获取，57.7%的女性更喜欢自行采集样本而非临床医生采集样本，61.9%的女性认为自行采集样本会增加她们接受宫颈癌筛查的可能性。
结论
使用careHPV自行采集样本的可行性、可接受性及性能支持在加纳女性中采用这种HPV筛查替代形式。这可能是提高国家宫颈癌筛查项目参与率的一种潜在的新的经济适用策略。
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