Diagnostic validity of human papillomavirus E6/E7 mRNA test in cervical cytological samples

摘要

Human papillomavirus (HPV) DNA tests tend to show high sensitivity, but poor specificity in detecting high-grade cervical lesions. This study aimed to explore the clinical performance of QuantiVirus (R) HPV E6/E7 mRNA in identifying >= Grade 2 cervical intraepithelial neoplasia. Thin-prep liquid based cytology test (LBC) samples were collected from October 2009 to October 2011 from women who underwent outpatient hospital-based gynecological screening. LBC samples were processed for E6/E7 mRNA detection and HPV DNA detection. Of 335 patients, 135 (40.3%) were HPV E6/E7 mRNA positive for high-risk HPV subtypes. The positivity rate of HPV E6/E7 mRNA increased with the severity of cytological and histological evaluation. An optimal cut-off value of >= 567 copies/ml was determined using receiver operating characteristic (ROC) curve, and positive predictive value and negative predictive value of cut-off value (>= 567 copies/ml) were higher than those of E6/E7 mRNA positivity only, but not significant. QuantiVirus HPV E6/E7 mRNA testing may be a valuable tool in triage for identifying >= Grade 2 cervical intraepithelial neoplasia. A high specificity and a low positivity rate of E6/E7 mRNA testing as a triage test in HPV DNA-positive women can be translated into a low referral for colposcopy. Studies composed of large population-based samples of women and with rigorous disease ascertainment, are needed to establish the optimal cut-off point based on ROC curve analysis