Cervical cancer is one of the most common cancers among women. The development of cervical cancer is associated with persistent high risk human papillomavirus (HPV) infection. So HPV detection is of great value for cervical cancer screening and prevention.A novel HPV DNA detection assay using gold magnetic nanoparticles(GMNs)-based lateral flow immunoassay (LFIA) strips combined with GP5+/6+ PCR was developed. The clinical performance of the assay was tested on 110 cervical scraping samples and the results were compared to what were attained from PCR reverse dot blot assay.The results showed that the overall agreement of the two assays was 85.5%(94/110), the agreement for negative samples was 94.2% (65/69), the positive samples agreement was 70.7% (29/41), the kappa value is 0.676. PCR- lateral flow immunoassay (LFIA) strips for HPV DNA detection has high specificity, and the sensitivity need to be improved even the agreement for positive sample detection reach the level as reported in elsewhere. Collectively, we conclude that the GMNs-based PCR-LFIA strips test is a rapid, simple, economical HPV detection test that can be a promising clinical tool for cervical cancer screening and individual HPV detection in the near future. |