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

 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 E6/E7 mRNA-based methods for triage of Iranian women with abnormal cytological results regarding the histopathological cut-off.

In this cross-sectional study, 360 non-pregnant women (≥ 21 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 E6/E7 mRNA-based methods for detection of HR-HPV. Regarding the CIN-2+ histopathological cut-off, the diagnostic value of each molecular-based assay was calculated.

Among the study participants, 260 cases had ASC-US, and 100 had LSIL. The overall positivity rate for DNA- and mRNA-based methods was 74.4% (268/360) and 64.2% (231/360), respectively. Fifty-nine (16.4%) individuals showed CIN-2+. The DNA-based test showed higher sensitivity (100%) than the mRNA-based method (93.2%), while the mRNA-based method revealed greater clinical specificity (41.5%) compared to the DNA-based test (30.6%).

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-2+.