Objective: 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.
Methods: 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.
Results: 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.
Conclusions: 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.