A novel method for colposcopic shunting in HPV-positive women: Quantitative detection of HPV E7 oncoprotein

The objective of the study was to evaluate the clinical application potential of quantitatively detecting human papillomavirus (HPV) E7 oncoprotein in HPV-positive women, with the goal of detecting potential high-grade cervical squamous intraepithelial lesions (HSIL) and cervical cancer improving the accuracy of colposcopic shunting in these patients.HPV-positive women (N = 611) were selected for quantitatively detecting HPV E7 protein levels by magnetic particle-based chemiluminescence immunoassay before colposcopy. Receiver operating characteristic (ROC) curve analysis was performed (n = 400) to determine diagnostic detection thresholds for HPV E7 oncoprotein. ThinPrep cytology test (TCT) and Aptima HPV E6/E7 mRNA analysis were also performed (n = 211). The diagnostic performance of these three diagnostic methods in detecting HSIL and cervical cancer was compared with the gold standard of pathological diagnosis. The area under the ROC curve was 0.724. The diagnostic detection threshold of HPV E7 oncoprotein was ≥10.88 ng/mL. The sensitivity (SEN), specificity (SPE), positive predictive value (PPV), negative predictive value (NPV), and Youden index of HPV E7 oncoprotein for the identification of HSIL and cervical cancer were 78.7 %, 77.9 %, 72.2 %, 83.3 %, and 56.6 %, respectively, which were higher than those of TCT and HPV E6/E7 mRNA.The results indicate that quantitative detection of HPV E7 oncoprotein can effectively shunt HPV-positive women and reduce unnecessary colposcopy and biopsy. It can detect potential HSIL and cervical cancer in a timely manner and prevent high-risk patients from missing diagnosis.