Department of Obstetrics and Gynecology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
J Gynecol Oncol. 2012 Jan;23(1):5-10. doi: 10.3802/jgo.2012.23.1.5. Epub 2012 Jan 9.
To validate the efficacy of Seeplex HPV4A ACE for the detection of high-risk (HR) human papillomavirus (HPV) and HPV 16 and/or HPV 18 genotypes as compared to the PCR method and the Cervista HPV assays in cervical swab samples.
Besides liquid-based cytology, additional 97 cervical swab samples were collected for HPV genotyping by HPV4A ACE, Cervista HPV assays, and PCR method. To check the statistical differences, we also conducted the paired proportion test, Cohen's κ statistic, and a receiver operating characteristic curve.
Seeplex HPV4A ACE and the Cervista HPV HR showed substantial agreement with PCR for detection of HR HPVs (88.3%, κ=0.767 and 81.7%, κ=0.636, respectively). Seeplex HPV4A ACE also showed substantial agreement with the Cervista HPV 16/18 test (89.5%, κ=0.628). Additionally, the sensitivity and specificity of Seeplex HPV4A ACE and Cervista HPV HR were 91.4% vs. 84.5% and 73.4%, vs. 72.7%, respectively, when those higher than low-grade squamous intraepithelial lesions were regarded as abnormalities. HPV genotyping for HPV 16/18 detected cervical intraepithelial neoplasias (CINs) better than HR HPV tests (66.7% vs. 24.6% by HPV4A ACE, 52.6% vs. 25.9% by Cervista HPV assays in CIN II or more, relatively).
Seeplex HPV4A ACE is an effective method as the PCR and the Cervista HPV assays for the detection of HR HPVs and for genotyping of HPV 16 and 18.
与 PCR 方法和 Cervista HPV 检测相比，验证 Seeplex HPV4A ACE 检测高危型（HR）人乳头瘤病毒（HPV）和 HPV16 和/或 HPV18 基因型的疗效，用于宫颈拭子样本。
除了液基细胞学检查外，还收集了另外 97 例宫颈拭子样本，用于 HPV4A ACE、Cervista HPV 检测和 PCR 方法进行 HPV 基因分型。为了检查统计学差异，我们还进行了配对比例检验、Cohen's κ 统计和受试者工作特征曲线。
Seeplex HPV4A ACE 和 Cervista HPV HR 与 PCR 检测 HR HPV 具有实质性一致性（88.3%，κ=0.767 和 81.7%，κ=0.636）。Seeplex HPV4A ACE 与 Cervista HPV 16/18 检测也具有实质性一致性（89.5%，κ=0.628）。此外，当将高于低级别鳞状上皮内病变视为异常时，Seeplex HPV4A ACE 和 Cervista HPV HR 的灵敏度和特异性分别为 91.4%和 84.5%和 73.4%和 72.7%。HPV16/18 基因分型检测 CIN 优于 HR HPV 检测（HPV4A ACE 为 66.7%，Cervista HPV 检测为 52.6%，CIN II 或更高级别为 24.6%和 25.9%）。
Seeplex HPV4A ACE 是一种有效的方法，与 PCR 和 Cervista HPV 检测一样，可用于检测 HR HPV 并对 HPV16 和 18 进行基因分型。
