Assessment of Cervical Cancer Molecular-Based Screening Tools; HPV-DNA Detection versus E6/E7 mRNA Testing; First Report of a Prospective Cohort Study among Iranian Women

BACKGROUND: Human papillomavirus (HPV) has been found as the most considerable causes of cervical cancer. Recently, several molecular methods have been introduced to increase the accuracy of the screening programs and decrease the mortality rate. Among these methods, mRNA-based methods have more advantages as they assess the expression level of HPV E6 and E7 oncogenic mRNAs. This study aimed to evaluate the results of HPV RNA- and DNA-based methods among Iranian women population with normal cytology results. METHODS: Overall, 4640 women were enrolled referred to the Gynecology Oncology Ward of Vali-e-Asr Hospital, private and academic clinics, Tehran, Iran from Jan 2016 to Apr 2018. To assess the HPV-DNA infection INNO-LiPA® HPV Genotyping Extra-II kit was used. For HPV-RNA assessment, Aptima HPV Assay and in house HPV-RNA genotyping methods were applied. RESULTS: The positivity rates of HPV infection according to DNA- and RNA-based methods were 18.0% and 11.2%, respectively (P<0.001). The positive predictive value, negative predictive value, specificity and sensitivity of DNA-based method in contrast with RNA-based method were 59.2% (56.6–61.6), 99.4% (99.0–99.6), 91.7% (90.8–92.6) and 95.2% (93.0–96.9) respectively. CONCLUSION: At the present study for prognosis of cervical cancer, RNA-based method seemed to be more specific in contrast to DNA-based method. Patient follow up and further studies will be conducted in order to clarify the clinical sensitivity and specificity of the two methods.