Department of Gynaecology and Obstetrics, Hannover Medical School, Hannover, Germany.
Acta Obstet Gynecol Scand. 2013 Feb;92(2):160-4. doi: 10.1111/aogs.12032. Epub 2012 Dec 5.
To evaluate enzyme-linked immunosorbent assay (ELISA) for cyclin-dependent kinase inhibitor 2A protein (p16(INK4a) ) on self-collected cervicovaginal lavage samples as an additional triage test to identify women with high-grade cervical intraepithelial neoplasia (CIN).
Retrospective feasibility, sensitivity and specificity study.
University Medical School, Germany.
One hundred and fifty-two patients from the colposcopy clinic were included.
All women used a cervico-vaginal lavage device (Delphi Screener) for self-sampling and had gynecological examinations with Pap smears, cervical smears in ThinPrep PreservCyt solution and Cervatec medium for human papillomavirus (HPV) testing (Qiagen Hybrid Capture 2) and colposcopic examinations with biopsies if abnormalities were detected (72 women; 51%). All cytological samples were examined by p16(INK4a) ELISA.
Sensitivity and specificity of p16(INK4a) ELISA for high-grade CIN.
Complete data were available for 140 women. Among these, 62 women (46%) presented with an atypical Pap smear and 65 (46.4%) were high-risk HPV positive in the reference smear sample. Seventeen women (12%) had CIN 3+. Twenty-seven (19%) physician-collected samples were p16(INK4a) ELISA positive. In contrast, p16(INK4a) ELISA turned out to be positive in only one (1%) vaginal lavage sample.
Our study shows that self-sampling with cervicovaginal lavage followed by p16(INK4a) ELISA is not suitable for the detection of high-grade CIN.
评估细胞周期蛋白依赖性激酶抑制剂 2A 蛋白（p16INK4a）酶联免疫吸附试验（ELISA）在自我采集的宫颈阴道灌洗液样本中的应用，作为一种额外的分流试验，以识别患有高级别宫颈上皮内瘤变（CIN）的女性。
回顾性可行性、敏感性和特异性研究。
德国某大学医学院。
共纳入 152 名来自阴道镜门诊的患者。
所有女性均使用宫颈阴道灌洗装置（Delphi Screener）进行自我采样，并进行妇科检查，包括巴氏涂片、宫颈涂片在 ThinPrep PreservCyt 溶液和 Cervatec 液中进行人乳头瘤病毒（HPV）检测（Qiagen Hybrid Capture 2）以及阴道镜检查和活检，如果发现异常（72 名女性；51%）。所有细胞学样本均采用 p16INK4a ELISA 进行检测。
p16INK4a ELISA 检测高级别 CIN 的敏感性和特异性。
140 名女性的完整数据可用。其中，62 名女性（46%）巴氏涂片异常，65 名女性（46.4%）高危型 HPV 在参考涂片样本中阳性。17 名女性（12%）患有 CIN3+。27 名（19%）医生采集的样本 p16INK4a ELISA 阳性。相比之下，仅 1 名（1%）阴道灌洗液样本 p16INK4a ELISA 阳性。
我们的研究表明，宫颈阴道灌洗后进行自我采样，再结合 p16INK4a ELISA 检测，不适合用于检测高级别 CIN。
