Assessment of the Diagnostic Value of High-Risk HPV Molecular-based Methods for Triage of Iranian Women with Abnormal Cytological Findings of ASC-US and LSIL

Background & Objective:  Recent advances in molecular testing for human papillomavirus (HPV) has increased the accuracy of cervical screening programs. This study intended to estimate the diagnostic value of high-risk (HR) HPV DNA- and E۶/E۷ mRNA-based methods for triage of Iranian women with abnormal cytological results regarding the histopathological cut-off. Materials & Methods: In this cross-sectional study, ۳۶۰ non-pregnant women (≥ ۲۱ years) who had faced abnormal cytological findings (ASC-US and LSIL) were enrolled and referred for further diagnostic tests. The INNO-LiPA® HPV Genotyping Extra-II and Aptima HPV assay kits were used in DNA- and E۶/E۷ mRNA-based methods for detection of HR-HPV. Regarding the CIN-۲+ histopathological cut-off, the diagnostic value of each molecular-based assay was calculated. Results: Among the study participants, ۲۶۰ cases had ASC-US, and ۱۰۰ had LSIL. The overall positivity rate for DNA- and mRNA-based methods was ۷۴.۴% (۲۶۸/۳۶۰) and ۶۴.۲% (۲۳۱/۳۶۰), respectively. Fifty-nine (۱۶.۴%) individuals showed CIN-۲+. The DNA-based test showed higher sensitivity (۱۰۰%) than the mRNA-based method (۹۳.۲%), while the mRNA-based method revealed greater clinical specificity (۴۱.۵%) compared to the DNA-based test (۳۰.۶%). Conclusion: Our results revealed appropriate clinical sensitivity of the molecular-based methods for triage of Iranian women with abnormal cytological results; however, the mRNA-based method showed greater specificity for detection of CIN-۲+.

Keywords:

ASC-US , Cervical Intraepithelial Neoplasia (CIN) , Human Papillomavirus (HPV) , LSIL , Molecular-based methods