[Application of isothermal HPV DNA amplification test in cervical cancer screening]

Objective: To evaluate the feasibility and effectiveness of isothermal human papillomavirus (HPV) DNA amplification test as a primary screening test in the early detection of cervical cancer. Methods: From June to August 2016, 2, 774 women aged 30-64 years old from Inner Mongolia were recruited for cervical cancer screening. HPV DNA was detected by Isomega and cobas4800. INNO-LiPA HPV Genotyping Extra was served as a reference method for the cases whose results were inconsistent by using these two methods. Histological diagnosis was considered as a gold standard to estimate the effectiveness and accuracy of Isomega and cobas4800 for detecting CIN2 or greater. Results: The concordance of Isomega and cobas4800 was 94.84% (Kappa=0.82) for high risk HPV (HR-HPV), 99.68% (Kappa=0.95) for HPV16, 99.78% (Kappa=0.91) for HPV18 and 94.34% (Kappa=0.76) for other HR-HPV types. The concordances of Isomega and the reference were 99.71% (Kappa=0.96), 99.86% (Kappa=0.94) and 96.76% (Kappa=0.87) for HPV16, 18 and other HR-HPV, respectively, while the concordances of cobas4800 and the reference were 99.82% (Kappa=0.97), 99.86% (Kappa=0.94) and 97.51% (Kappa=0.90), respectively. The sensitivity and specificity of Isomega for detecting CIN2+ (including CIN2, CIN3 and squamous cell carcinoma) were 87.76% and 82.94%, respectively, while those of cobas4800 were 89.80% and 85.06%, respectively. Conclusions: The concordances of Isomega and cobas4800 is confident. These two methods can accurately detect the HPV16 and 18 genotyping, and have good sensitivity and specificity for clinical diagnosis and population screening of cervical cancer.