Human papillomavirus (HPV) E6/E7 mRNA detection in cervical exfoliated cells: a potential triage for HPV-positive women

Abstract

Cytology triage has been generally recommended for human papillomavirus (HPV)-positive women, but is highly dependent on well-trained cytologists. The present study was designed to explore whether HPV E6/E7 mRNA detection in cervical exfoliated cells can be a potential triage for HPV-positive women from a clinic-based population. Both the primary HPV testing and Papanicolaou (Pap) test were performed on all eligible HPV-positive women. HPV E6/E7 mRNA was detected by QuantiVirus HPV E6/E7 mRNA assay in cervical exfoliated cells. All HPV-positive women underwent colposcopy and further biopsy if indicated. The data were assessed by Pearson's Chi-squared test and the receiver operating characteristic curve. A total of 404 eligible HPV-positive women were enrolled. Positive rate of E6/E7 mRNA in high-grade squamous intraepithelial lesion (HSIL) cases was higher than that in low-grade squamous intraepithelial lesion (LSIL) or normal cases. There was no statistical difference found between mRNA and cytological testing with sensitivity (89.52% vs. 86.67%, P=0.671), specificity (48.96% vs. 48.96%, P=1.000), positive predictive value (39.00% vs. 38.24%, P=1.000), and negative predictive value (92.76% vs. 90.97%, P=0.678) for detecting ≥HSIL. HPV E6/E7 mRNA detection in cervical exfoliated cells shows the same performance as Pap triage for HSIL identification for HPV-positive women. Detection of HPV E6/E7 mRNA may be used as a new triage option for HPV-positive women.

Performance of p16/Ki67 immunostaining, HPV E6/E7 mRNA testing, and HPV DNA assay to detect high-grade cervical dysplasia in women with ASCUS

“…The figure found that when the optimal cut-off value of HPV E6/E7 mRNA testing is selected at 882.53 copies/ml, the specificity of HPV E6/E7 mRNA testing is improved. Tong-Yu Liu’s and Ye-li Yao’s finding also supported this result [23, 35]. However, the diagnostic performance of HPV E6/E7 mRNA testing was still lower than p16/Ki67 immunocytochemistry.…”

Prognostic and diagnostic validity of p16/Ki-67, HPV E6/E7 mRNA, and HPV DNA in women with ASCUS: a follow-up study

“…Thus, a ROC curve was used to further demonstrate the diagnostic performance of HPV E6/E7 mRNA testing, and the optimal cut-off value of mRNA testing is selected at 2097.09 copies/ml. Tong-Yu Liu’s and Ye-li Yao’s finding also supported that when an optimal cut-off value of mRNA testing was found out, the diagnosis accuracy will be improved [20, 29]. As the ROC shows, the AUC of p16/Ki-67 immunocytochemistry is the largest (AUC = 0.799, 95%CI: 0.649–0.908), followed by HPV E6/E7 mRNA testing and HPV DNA assay.…”

Sensitivity and specificity of hr hPV E6/E7 mrna test in detecting cervical squamous intraepithelial lesion and cervical cancer

“…Moreover, the sensitivity and specificity of the abovementioned test was estimated at 89.52% and 48.96% respectively in the diagnosis of high-grade squamous intraepithelial lesion of uterine cervix. Additionally, the percentage of positive HR HPV E6/E7 mRNA test results was significantly higher in the histopathological HSIL diagnoses than LSIL [17].…”