Tao Ping-ping, Bian Mei-lu, Ou Hua, Chen Qing-yun, Li Min, Liu Jun
Department of Obstetrics and Gynecology, China-Japan Friendship Hospital, Beijing 100029, China.
Zhonghua Fu Chan Ke Za Zhi. 2006 Jan;41(1):43-7.
To evaluate the clinical efficacy of flow-through hybridization and gene chip (HybriMax) on female low genital human papillomavirus (HPV) detection and to identify the most common HPV genotypes.
Five hundred and ninety-one of 7520 women who received cervical cancer screening in China-Japan Friendship Hospital during Jun 2004 to May 2005 were selected for 21 genotypes HPV detecting by HybriMax, including 138 women with normal cytological diagnosis and 453 women with abnormal cytological diagnosis. The abnormal patients were classified into groups according to their histological diagnosis as chronic cervicitis, cervical intraepithelial neoplasia (CIN) I, II, III, cervical cancer and condyloma acuminata. Among them 413 women were tested with HC-II for 13 types of high-risk HPV, and 101 paraffin-embedded specimens from these 453 patients were detected for HPV16, 18 with in situ hybridization (ISH). The accordance of the results was compared. The infection rates of each HPV type for each group were calculated.
The total accordant rate of HybriMax and HC-II on 13 types of high-risk HPV detecting was 92.5% (382/413) and was 100.0% in group of cancer. The accordance was good, and the Kappa index (KI) was as below: overall 0.814, in normal group 0.750, in chronic cervicitis 0.781, in CIN I 0.755, in CIN II 0.619, in CIN III 0.548, in condyloma acuminata 0.800. The accordant rate of HybriMax and ISH was 89.1% (90/101), and KI was 0.766. The 10 most common genotypes were (in descending sequences): in normal group 16, 68, 18, 52, 58, 11, 53, 31, 39, 33; in abnormal group 16, 52, 58, 18, 33, 31, 81, 53, 68, 66, in cervical cancer 16, 18, 52, 58, 33, 66, 68, 31, 51, 53.
HybriMax has good accordance to HC-II and ISH for HPV detection. It provides useful information on viral genotype and is more suitable for clinical use. The 6 most common genotypes in abnormal cytological group are 16, 18, 52, 58, 33, 31.
评估导流杂交基因芯片技术（HybriMax）检测女性下生殖道人乳头瘤病毒（HPV）的临床效果，并确定最常见的HPV基因型。
选取2004年6月至2005年5月间在中国-日本友好医院接受宫颈癌筛查的7520名女性中的591名，采用HybriMax技术检测21种基因型的HPV，其中包括138名细胞学诊断正常的女性和453名细胞学诊断异常的女性。将异常患者根据组织学诊断分为慢性宫颈炎、宫颈上皮内瘤变（CIN）I、II、III级、宫颈癌和尖锐湿疣组。其中413名女性采用杂交捕获二代（HC-II）技术检测13种高危型HPV，对这453名患者中的101份石蜡包埋标本采用原位杂交（ISH）技术检测HPV16、18。比较结果的一致性。计算每组中各HPV型别的感染率。
HybriMax与HC-II检测13种高危型HPV的总符合率为92.5%（382/413），在癌症组中符合率为100.0%。一致性良好，Kappa指数（KI）如下：总体为0.814，正常组为0.750，慢性宫颈炎组为0.781，CIN I级为0.755，CIN II级为0.619，CIN III级为0.548，尖锐湿疣组为0.800。HybriMax与ISH的符合率为89.1%（90/101），KI为0.766。10种最常见的基因型（按降序排列）为：正常组为16、68、18、52、58、11、53、31、39、33；异常组为16、52、58、18、33、31、81、53、68、66；宫颈癌组为16、18、52、58、33、66、68、31、51、53。
HybriMax在HPV检测方面与HC-II和ISH具有良好的一致性。它提供了有关病毒基因型的有用信息，更适合临床应用。细胞学异常组中6种最常见的基因型为16、18、52、58、33、31。
