Evaluation Of TruScreen In Cervical Cancer Screening Based On Grass-root Population

Objective To explore the effect of TruScreen(TS)in cervical cancer screening in grass-roots areas of China,as well as provide references and data to judge whether TS is a suitable screening method for grass-roots areas of China.Meanwhile,exploring the effect of different screening strategies so that provide scientific evidence and choose ideal method for cervical cancer screening in ChinaMethods The cross-sectional study was conducted to explore the effect of cervical cancer screening in the counties of the National Cervical Cancer Screening Program in 8 provinces/municipalities/Autonomous Region belonging to eastern,central and western regions.TS test,Human Papillomavirus(HPV)test and Liquid-based cytology(LBC)test were conducted simultaneously on 9972 women complying with research standard.The women with positive results of either test were referred to colposcopy,and biopsies were implemented if the results of colposcopy were abnormal.In addition,this study simulated HPV-based cervical cancer screening programs that was HPV test conducted firstly,then triaged with TS test and LBC test.This study also simulated three contest strategies,including TS contest with HPV,TS contest with LBC and HPV contest with LBC.The screening effects of each test,triage and contest strategies were analyzed by comparing their sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV)and the areas under the receiver operating characteristic(ROC)curve(AUC)for detection of CIN2+.Results The average age of the participants was 45.16±5.40 years old.Among the pathological results,689 cases were reported as normal and inflammation,164 had CIN1,29 had CIN2,42 had CIN3,2 had AIS and 4 had cancer.For single screening method,the sensitivity of TS was 40.3%,which was smaller than HPV(94.8%)and there was statistically significant difference between TS and HPV.The sensitivity of LBC was 57.1%,and there was no statistically significant difference between TS and LBC(P<0.017).The specificity of TS was 88.0%,which was smaller than HPV(93.1%)and LBC(97.4%),and there were statistically significant differences between TS and other two screening methods(P<0.017),but for the age group of 51?54,there was no statistically significant difference in specificity between TS and HPV.The AUC of TS was 0.641,which was smaller than HPV and LBC(0.940 and 0.773,respectively),and there were statistically significant differences between TS and other two screening methods(P<0.017),but for central and western regions,there were no statistically significant differences in AUC between TS and LBC,and for age groups of 46?and 51-54,there were also no statistically significant differences in AUC between TS and LBC.For HPV positive women,the sensitivity and specificity of TS triage was 33.3%and 82.4%,there were no statistically significant differences between TS and LBC triage(the sensitivity and specificity were 53.8%and 86.2%,respectively).The AUC of TS was 0.579,which was smaller than that of LBC triage(0.700).and there was statistically significant difference between TS and LBC triage(P<0.05).In the contest strategies,the sensitivity of TS contest with HPV was the highest(100.0%),which was higher than that of TS contest with LBC(71.4%)and there was statistically significant difference between them,but there was no statistically significant difference in sensitivity between TS contest with HPV and HPV contest with LBC(96.1%).The specificity of TS contest with HPV was 82.3%,which was smaller than that of TS contest with LBC(86.1%)and HPV contest with LBC(91.4%),and there were statistically significant differences in specificity among three contest strategies(P<0.05).However,for eastern region and the age group of 35?,there were no statistically significant differences in specificity between TS contest with HPV and TS contest with LBC,and for the age group of 51?54,there was no statistically significant difference in specificity between TS contest with LBC and HPV contest with LBC.The AUC of TS contest with LBC was 0.788,which was smaller than that of TS contest with HPV(0.911)and HPV contest with LBC(0.938),and there were statistically significant differences in AUC among three contest strategies(P<0.05),but there was no statistically significant difference in AUC between TS contest with HPV and HPV contest with LBC.On the contrary,for eastern region and the age groups of 35? and 41?,there were statistically significant differences in AUC between TS contest with HPV and HPV contest with LBCConclusion For single screening method,if local regions don't have sufficient medical resources and fail to meet the requirements of the laboratory and personnel for HPV test,then TS test can be regarded as a new cervical cancer screening method taken into consideration For HPV positive women,there were no statistically significant differences between TS triage and LBC triage in sensitivity,specificity,positive predict value and negative predict value.TS triage may be suitable in areas with limited or no cytology infrastructure and expertise,or where it is difficult to follow up colposcopy For the contest strategies,the screen effect of TS contest with HPV was consistent with that of HPV contest with LBC,if the medical resource of local region was sufficient,taking account of there was no need to cytologists and the result was relatively object for TS test,TS contest with HPV can be an alternative screening strategy.