Laval University, Quebec City, Canada.
J Low Genit Tract Dis. 1999 Oct;3(4):231-8. doi: 10.1046/j.1526-0976.1999.34003.x.
The objective of this study was to detect human papillomavirus (HPV) in women with a newly diagnosed atypical squamous cells of undetermined significance (ASCUS) using the hybrid capture (HC) test and the polymerase chain reaction (PCR). We sought to evaluate the accuracy of both tests in identifying women with a concomitant cervical intraepithelial neoplasia (CIN).
We studied 360 women who had a diagnosis of ASCUS and were referred to the colposcopy clinic. Subjects were between 18 and 50 years, had newly diagnosed ASCUS, had no history of cervical biopsies or treatment, and were not pregnant. A cell sample for HPV testing and colposcopically directed biopsies of lesions were obtained. HPV was detected using the Digene HC and PCR systems (Digene, Silver Spring, MD).
Biopsies showed concomitant CIN in 80 patients (22.2%). Of these, 19 had CIN2 or CIN3. HPV-DNA was detected in 76 of the 360 women (21.1%) using HC and in 166 of 348 women (47.7%) using PCR. The concordance between HC and PCR for detecting HPV was 65%. The sensitivity, specificity, and positive and negative predictive values of HC for detecting CIN were 48%, 86%, 50%, and 85%, respectively. The sensitivity, specificity, and positive and negative predictive values of PCR for detecting CIN were 67%, 58%, 31%, and 86%, respectively. Focusing on CIN2 and CIN3 alone, these values were 79%, 82%, 20%, and 99% for HC, respectively, and 89%, 55%, 10%, and 99% for PCR, respectively.
The specificity of HC was higher than the specificity of PCR. For this reason, the HC might be more useful than PCR as a secondary triage method for detecting CIN in women who have incident ASCUS and need colposcopy.
本研究旨在使用杂交捕获（HC）试验和聚合酶链反应（PCR）检测新诊断的非典型意义不明确的鳞状细胞（ASCUS）女性中的人乳头瘤病毒（HPV）。我们旨在评估这两种检测方法在识别同时患有宫颈上皮内瘤变（CIN）的女性中的准确性。
我们研究了 360 名新诊断为 ASCUS 并转至阴道镜检查门诊的女性。研究对象年龄在 18 至 50 岁之间，有新诊断的 ASCUS，无宫颈活检或治疗史，且未怀孕。采集用于 HPV 检测的细胞样本和阴道镜指导下的病变活检。使用 Digene HC 和 PCR 系统（Digene，Silver Spring，MD）检测 HPV。
活检显示 80 例患者（22.2%）同时患有 CIN。其中，19 例有 CIN2 或 CIN3。使用 HC 在 360 名女性中的 76 名（21.1%）和在 348 名女性中的 166 名（47.7%）中检测到 HPV-DNA。HC 和 PCR 检测 HPV 的一致性为 65%。HC 检测 CIN 的敏感性、特异性、阳性预测值和阴性预测值分别为 48%、86%、50%和 85%。PCR 检测 CIN 的敏感性、特异性、阳性预测值和阴性预测值分别为 67%、58%、31%和 86%。仅关注 CIN2 和 CIN3，HC 的这些值分别为 79%、82%、20%和 99%，PCR 的这些值分别为 89%、55%、10%和 99%。
HC 的特异性高于 PCR。因此，HC 可能比 PCR 更有用，作为新诊断为 ASCUS 且需要阴道镜检查的女性中检测 CIN 的二级分流方法。
