Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Int J Med Sci. 2013;10(2):119-23. doi: 10.7150/ijms.5460. Epub 2012 Dec 30.
It is well-known that persistent cervical infections with high-risk human papillomavirus (HPV) are related to the development of high-grade cervical intraepithelial neoplasia and invasive cervical cancer and that infection with HPV 16 and HPV 18 accounts for approximately 70% of all cases of invasive cervical cancer.
We performed 3 HPV molecular tests-the Cobas 4800 HPV test, the Seeplex HPV4A ACE, and the hybrid capture 2 (HC2) test-in 146 cervical swab samples to compare between these three tests.
There was a concordance rate of 82.8% between the results of the Cobas 4800 HPV and the HC2 test and a concordance rate of 84.9% between the results of the Seeplex HPV4A ACE and the HC2 test. Between the Cobas 4800 HPV test and the Seeplex HPV4A ACE, there was a concordance rate of 89.6% in the detection of high-risk HPV between the results and a concordance rate of 98.7% in the detection of HPV 16 or 18. When an abnormal Pap test was defined as ≥ low grade squamous intraepithelial lesion (LSIL), the sensitivity of the Cobas 4800 HPV test, the Seeplex HPV4A ACE and the HC2 test were 71.1%, 80.0%, and 88.9%, respectively, while their specificities were 76.4%, 74.5%, and 67.9%, respectively.
The results of this study suggest that the Cobas 4800 HPV test and the Seeplex HPV4A ACE may be as effective as the HC2 test in detecting HR HPV and that the concordance between the results of the Cobas 4800 HPV test and the Seeplex HDV4A ACE may be higher in the detection of HPV 16 and HPV18 than concerning high-risk HPV.
众所周知，持续性的高危型人乳头瘤病毒（HPV）宫颈感染与高级别宫颈上皮内瘤变和浸润性宫颈癌的发展有关，HPV16 和 HPV18 感染约占所有浸润性宫颈癌病例的 70%。
我们对 146 例宫颈拭子样本进行了 3 种 HPV 分子检测——Cobas 4800 HPV 检测、Seeplex HPV4A ACE 和杂交捕获 2（HC2）检测，以比较这三种检测方法。
Cobas 4800 HPV 检测和 HC2 检测的结果一致性为 82.8%，Seeplex HPV4A ACE 和 HC2 检测的结果一致性为 84.9%。Cobas 4800 HPV 检测和 Seeplex HPV4A ACE 检测的结果在高危型 HPV 检测中一致性为 89.6%，在 HPV16 或 18 检测中一致性为 98.7%。当异常 Pap 检测定义为≥低度鳞状上皮内病变（LSIL）时，Cobas 4800 HPV 检测、Seeplex HPV4A ACE 和 HC2 检测的灵敏度分别为 71.1%、80.0%和 88.9%，特异性分别为 76.4%、74.5%和 67.9%。
本研究结果表明，Cobas 4800 HPV 检测和 Seeplex HPV4A ACE 与 HC2 检测在检测 HR HPV 方面可能同样有效，Cobas 4800 HPV 检测与 Seeplex HPV4A ACE 检测结果的一致性在检测 HPV16 和 HPV18 方面可能高于高危型 HPV。
