An Evaluation Of Isothermal DNA Amplification Technology For HPV Assay In Cervical Cancer Screening

Objective To evaluate the feasibility and utility of isothermal amplification HPV DNA test(Isomega)in HPV DNA detection and cervical cancer screening,and provide evidence for finding a more effective and suitable cervical cancer screening medthod for China.Methods From June to August in 2016,2,774 Inner Mongolia women aged from 30 to 64 years old with sexual activities history were recruited for cervical cancer screening.Liquid-based cytology was applied for cytological diagnosis.The agreement between HC2,Isomega and cobas 4800 was assessed.INNO-LiPA HPV Genotyping Extra was used as a reference method to evaluate the res?Lts of 3 HPV tests.Histological diagnosis was considered as a gold standard to estimate the effectiveness and accuracy of HC2,cobas 4800 and Isomega for cervical cancer screening.Results:1.The concordance rate for Isomega and HC2 was 92.7%(Kappa=0.74),and the concordance rate for Isomega and cobas 4800 was 94.8%(Kappa=0.82),while the concordance rate of HPV16 and 18 were 99.7%(Kappa=0.95),99,8%(Kappa=0.91)respectively.2.On the basis of INNO-LiPA genotyping detection,the concordance rate for HC2 and INNO-LiPA was 92.3%(Kappa=0.72).The concordance rate for cobas 4800 and INNO-LiPA was 93.6%(Kappa=0.78),and HPV16 and 18 were 99.1%and 99.5%respectively.The total concordance rate for Isomega and INNO-LiPA was 92.1%(Kappa=0.74),and HPV16 and 18 were 99.0%and 99.4%respectively.3.The sensitivity and specificity of CIN2+ and CIN3+ were measured by HC2,cobas 4800 and Isomega respectively.The sensitivity and specificity for CIN2+ were 100.0%and 86.5%for HC2,89.8%and 85.1%for cobas 4800 and 87.8%and 82.9%for Isomega respectively;the sensitivity and specificity for CIN3+ were 100.0%and 85.7%for HC2,90.9%and 84.0%for cobas 4800 and 90.9%and 82.3%for Isomega respectively.Conclusions Isomega HPV test can detect HPV16 and 18 and other high-risk HPV accurately,and yield fairly good sensitivity and specificity for cervical cancer screening with the featuers of simplicity,high effciency and low cost.So it can be used as a primary screening method for cervical cancer screening.