The value of HPV E6/E7 mRNA quantitative analysis in distinguishing high-grade cervical squamous intraepithelial lesions from low-grade cervical squamous intraepithelial lesions.

A quantitative assay for HPV E6/E7 mRNA may be a valuable tool for cervical cancer screening. The purpose of this study is to compare the expression levels of HPV E6/E7 mRNA in high-grade cervical squamous intraepithelial lesion (HSIL) and low-grade squamous intraepithelial lesions (LSIL) and to determine a new method that can be used to distinguish cervical squamous intraepithelial lesions. Routine cytology, HR-HPV E6/E7 mRNA, histology, and p16 immunohistochemistry were performed in tissues from 142 patients with cervical squamous intraepithelial lesions. Significant differences were observed between the E6/E7 mRNA copy number values between the LSIL and HSIL cases (Mann-Whitney U-test, P < 0.001). The optimal cut-off value (≥9,222.00 copies/mL) was determined using the receiver operating characteristic curve to predict diagnostic performance. Out of the 161 samples tested in this study, four cases were classified cytologically as HSIL but had normal histology. The E6/E7 copy numbers in these cases were all higher than 9,222 copies/mL. Therefore, a quantitative assay for HPV E6/E7 mRNA may be a valuable tool that can be used to distinguish HSIL and LSIL, especially for those with HSIL, for which samples are not obtained by biopsy, or when HSIL is difficult to distinguish by morphology and p16 immunohistochemistry.