Daponte A, Pournaras S, Mademtzis I, Hadjichristodoulou C, Kostopoulou E, Maniatis A N, Messinis I E
Department of Obstetrics and Gynaecology, University Hospital of Larissa, Larissa, Greece.
Gynecol Oncol. 2006 Nov;103(2):463-6. doi: 10.1016/j.ygyno.2006.03.021. Epub 2006 Apr 19.
A clinical prospective evaluation study was conducted to evaluate PCR detection of high-risk human papillomavirus (HPV) type 16 in self-sampled vaginal compared with clinician-collected cervical specimens.
Paired vaginal and cervical specimens were collected from 137 consecutive women referred for colposcopy because of abnormal cervical cytology. In-house and a commercial PCR method for HPV type 16 were used. Self-sampled vaginal HPV 16 detection was compared to histology and physician-collected cervical specimens.
Of the 137 patients, 98 had proven abnormal histology and were included in the analysis. Overall, using the cervix HPV detection as reference method, the self-sampled vaginal sample showed sensitivity 91.8%, specificity 96.1% and agreement kappa (kappa) 0.881. Using the histology as reference, all 11 cervical cancer cases were HPV-16-positive in both cervical and vaginal samples, and in 43 high-grade lesions, detection sensitivity in cervix was 72.1% (kappa 0.588) and vagina 67.4% (kappa 0.516). HPV 16 detection did not differ (P=0.27) between clinician-collected cervical and self-sampled vaginal specimens.
The self-collected vaginal sample is highly concordant with the physician-collected cervical sample in HPV 16 detection.
开展一项临床前瞻性评估研究，以评估与临床医生采集的宫颈标本相比，自采阴道标本中高危型人乳头瘤病毒16型（HPV-16）的PCR检测情况。
连续收集137例因宫颈细胞学异常而转诊接受阴道镜检查的女性的配对阴道和宫颈标本。采用内部研发的及一种商用的HPV-16 PCR检测方法。将自采阴道标本HPV-16检测结果与组织学检查结果及临床医生采集的宫颈标本检测结果进行比较。
137例患者中，98例经证实存在组织学异常并纳入分析。总体而言，以宫颈HPV检测作为参考方法，自采阴道标本显示敏感性为91.8%，特异性为96.1%，一致性kappa值为0.881。以组织学检查作为参考，11例宫颈癌病例的宫颈和阴道标本HPV-16均呈阳性，在43例高级别病变中，宫颈检测敏感性为72.1%（kappa值为0.588），阴道检测敏感性为67.4%（kappa值为0.516）。临床医生采集的宫颈标本与自采阴道标本的HPV-16检测结果无差异（P=0.27）。
在HPV-16检测中，自采阴道标本与临床医生采集的宫颈标本高度一致。
