Preliminary Evaluation On The Performance Of New Screening Technology In Cervical Cancer Screening

Objectives: To evaluate the performance of a new screening technology-microfluidic automatic nucleic acid detection technique(Genplex HPV)in cervical cancer screening,and to compare it with the traditional cervical cancer screening methods including liquidbased cytology(LBC)and care HPV test.Furthermore,other objective of this research was to analyze the changes of human papillomavirus(HPV)type distribution between baseline(2015)and follow-up(2017)visit to provide evidence for cervical cancer prevention and management.Methods: The study design was population-based screening cohort from the national "cervical and breast cancers" screening project sites —Xiangyuan and Yangcheng county of Shanxi Province.Cervical samples from a cohort of women aged 35-64 years recruited from 2015 to 2017,were analyzed using Bohui automatic nucleic acid detection test(Genplex HPV).The analytical and clinical performance of Genplex HPV test was evaluated and compared with LBC and care HPV test.Moreover,the changes in HPV type distribution over time and the risk factors of HPV infection were also analyzed.Results: 1.A total of 2142 women were included in this study,with an average age of(48.26±7.11)years old.According to the pathological analysis,normal results were identified in 2,040(95.2%)women,CIN1 lesions were identified in 50(2.3%)women,and CIN2+ lesions in 52(2.4%)women.2.The consistency rate of Genplex HPV with care HPV test was 90.6%,the Kappa value was 0.66,while the consistency rate with LBC test was 79.3%,and the Kappa value was lower only at 0.17.For CIN2+ detection,Genplex HPV is more sensitive and less specific than care HPV and cytology.The overall screening effect of Genplex HPV was similar to the effect of care HPV and cytology,and there was no statistical difference in AUC(P > 0.05).3.Compared with the HPV type distribution at baseline,HPV66 infection rate after threeyears follow-up increased in the population(0.6% vs 1.3%,P=0.03),HPV52 infection rate decreased,but the difference was not statistically significant(3.2% vs 2.7%,P=0.32).The infection rate of other HPV types was relatively stable.Among women with normal results histologically confirmed,the changes of the HPV infection rate were similar to those of the general population.Among women with CIN1 results,HPV42 infection rate decreased(16.0% vs 12.8%,P < 0.01),while HPV33,52 and 58 infection rate increased,but the difference was not statistically significant(P > 0.05).Among the women with CIN2+ results,there was no significant change in all HPV types(P>0.05).4.Among women with positive HR-HPV at baseline,234(55.6%)had a persistent infection during follow-up,most of them persistently infected by HPV 31,while HPV 73 and HPV 83 were completely cleared during follow-up.From all women with a negative result for HR-HPV at baseline,188(11.1%)developed new HPV infections during the follow-up.The most common HPV genotypes for new infections were HPV16(1.5%)?HPV58(1.4%)? HPV66(1.2%)? HPV68(1.2%)? HPV51(1.1%)and HPV52(1.1%).Multivariate analysis showed that the education level is correlated to HR-HPV persistent infection and HR-HPV new infection.Conclusion: 1.As a new automatic HPV detection method,our study suggests that the clinical performance of Genplex HPV test for cervical cancer screening is similar to that of care HPV,and more effective than that of LBC.2.During the three-years follow-up,the HPV infection rate changed slightly.Most women were likely to continue to be infected with HPV,especially HPV 31;only a small number of women experienced a new HPV infection.3.HR-HPV persistent infection and HR-HPV new infection were both related to the education level of women.The characteristics of the distribution of HPV infection types should be taken into account when formulating comprehensive prevention strategies for cervical cancer in China.