Wang Shao-Ming, Hu Shang-Ying, Chen Feng, Chen Wen, Zhao Fang-Hui, Zhang Yu-Qing, Ma Xin-Ming, Qiao You-Lin
National Cancer Center and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China E-mail :
Asian Pac J Cancer Prev. 2014;15(17):7085-9. doi: 10.7314/apjcp.2014.15.17.7085.
To make the clinical evaluation of a solid-state human papillomavirus (HPV) sampling medium in combination with an economical HPV testing method (careHPV™) for cervical cancer screening.
396 women aged 25-65 years were enrolled for cervical cancer screening, and four samples were collected. Two samples were collected by woman themselves, among which one was stored in DCM preservative solution (called "liquid sample") and the other was applied on the Whatman Indicating FTA Elute® card (FTA card). Another two samples were collected by physician and stored in DCM preservative solution and FTA card, respectively. All the samples were detected by careHPV™ test. All the women were administered a colposcopy examination, and biopsies were taken for pathological confirmation if necessary.
FTA card demonstrated a comparable sensitivity of detecting high grade Cervical Intraepithelial Neoplasia (CIN) with the liquid sample carrier for self and physician-sampling, but showed a higher specificity than that of liquid sample carrier for self-sampling (FTA vs Liquid: 79.0% vs 71.6%, p=0.02). Generally, the FTA card had a comparable accuracy with that of Liquid-based medium by different sampling operators, with an area under the curve of 0.807 for physician and FTA, 0.781 for physician and Liquid, 0.728 for self and FTA, and 0.733 for self and Liquid (p>0.05).
FTA card is a promising sample carrier for cervical cancer screening. With appropriate education programmes and further optimization of the experimental workflow, FTA card based self-collection in combination with centralized careHPV™ testing can help expand the coverage of cervical cancer screening in low-resource areas.
对一种固态人乳头瘤病毒（HPV）采样介质结合一种经济的HPV检测方法（careHPV™）用于宫颈癌筛查进行临床评估。
招募396名年龄在25至65岁的女性进行宫颈癌筛查，并采集四份样本。两份样本由女性自行采集，其中一份保存在DCM保存液中（称为“液体样本”），另一份应用于Whatman指示FTA Elute®卡（FTA卡）上。另外两份样本由医生采集，分别保存在DCM保存液和FTA卡中。所有样本均通过careHPV™检测。所有女性均接受阴道镜检查，必要时进行活检以进行病理确诊。
FTA卡显示，在自我采样和医生采样中，检测高级别宫颈上皮内瘤变（CIN）的敏感性与液体样本载体相当，但在自我采样中显示出比液体样本载体更高的特异性（FTA与液体：79.0%对71.6%，p = 0.02）。总体而言，不同采样操作人员使用FTA卡的准确性与液基介质相当，医生与FTA的曲线下面积为0.807，医生与液体为0.781，自我与FTA为0.728，自我与液体为0.733（p>0.05）。
FTA卡是一种有前景的宫颈癌筛查样本载体。通过适当的教育计划和进一步优化实验工作流程，基于FTA卡的自我采样结合集中式careHPV™检测有助于扩大资源匮乏地区宫颈癌筛查的覆盖范围。
