Synchronous HPV genotyping and quantification assay to predict the outcome of high risk HPV infection: report of 2 784 cases

Abstract

Objective To explore the law of natural outcome of high-risk human papillomavirus (HR-HPV) infection and determine the optimal cutoff for prediction of the infection natural outcome based on the synchronous HPV genotyping and quantification. Methods A total of 2 784 women who underwent primary cervical screening with single type HPV infection for the first time by the synchronous HPV genotyping and quantification assay were enrolled and followed up for 2 years in this study. The correlation between standardized quantification and HR-HPV infection natural outcome was analyzed. Receiver operating characteristic (ROC) curve was plotted to determine the optimal cutoffs of individual HR-HPV standardized quantification in prediction of persistent infection. Results Among all the subjects, the natural clearance rate of HR-HPV infection was 73.71%, the persistent infection rate was 20.26% and the progression rate was 6.03%. Statistical differences were observed in the 13 HR-HPVs standardized quantifications among the natural clearance group, persistent infection group, and progression group (H=673.943, P < 0.001). The best threshold of the synchronous HPV genotyping and quantification assay to predict the outcome of HR-HPV infection was established according to ROC curve, and the optimal cutoffs of the log10-transformed quantification for HPV16, 18, 33, 52, 58, 59 and 68 in prediction of persistent infection were 3.00 copies per 10 000 cells, those for HPV31, 39, 51 and 56 were 4.00 copies per 10 000 cells. The optimal cutoff of the log10-transformed quantification for 13 HR-HPVs in prediction persistent infection was 3.00 copies per 10 000 cells, and the sensitivity was 88.66% and the specificity was 59.36% (P < 0.001). Conclusion HR-HPV standardized quantification can be used as a biological maker to predict the outcome of HR-HPV infection in the genital tract of female.

Keywords

• human papillomavirus
• standardized quantification
• outcome