Comparing Study Of TruScreen Cervical Cancer Screening System And Cervical Cytological Test In The Screening Of Cervical Cancer

Objective:To study the clinical value of TruScreen Cervical Cancer Screening system(TS) compared with cervical cytological test in the screening of cervical Cancer.Methods :392 patients were screened by TS,Papsmear test (Pap),Thinprep-liquid-based cytological test (TCT),Human papilloma virus (HPV) based on the colposcopy and the pathology result as a golden standard. Cervical Cytological test take The Bethesda System(TBS) classify standard .To compare the sensitivity,specificity,Youden's index(γ) and the area of under Receiver operator characteristic curve(ROC) of each method and their combination(Parallel test and Series test ) methods.Results :1) Of the 392 patients, the positive result cases of TS,Pap,TCT and HPV were 33.4%(131/392),9.9%(39/392),14.5%(57/392) and 22.7%(89/392);The positive result cases of pathology results was 23%(90/392), 71 had Cervical intraepithelial neoplasia(CIN) I,18 had CINII,1 had CINIII.2) The sensitivity of TS,Pap,TCT and HPV were 32.2%,42.2%,74.4% and 47.8%, the specificity were 96.7%,93.7%,78.8% and 84.8%. The sensitivity of TCT parallel with HPV,TCT parallel with TS,Pap parallel with TS and HPV parallel with TS were 65.6%,87.8%,82.2% and 86.7%, the specificity were 81.1%,74.5%,75.8% and 67.2%. The sensitivity of TCT Series with HPV,TS Series with TCT,TS Series with Pap and TS Series with HPV were 24.4%,28.9%,24.4% and 35.6%, the specificity were 97.4%,98.0%,99.7% and 96.4%.3) Contrasting the areas of under ROC , there were significant differences between TS and Pap,TS and TCT (P<0.05), there were no significant differences between TCT and Pap,TCT and TS (P>0.05). Among the Parallel tests, there were significant differences between the Parallel tests with TS and that without TS (P<0.05), there were no significant differences between the Parallel tests with TS and TS alone (P>0.05), there were no significant differences between these Parallel tests(P>0.05).Among the Series tests, there were significant differences between the Series tests with TS and TS alone (P<0.05), there were no significant differences between these Series tests(P>0.05).4) The sensitivity and the specificity of TS in the patients who had unsatisfactory Pap were 66.7%and 87.5%, whose Pap implied ASCUS were 85.7% and 90.0%, whose TCT implied ASCUS were 70.0% and 70.0%.Conclusions:1) As a new instant detecting method for cervical lesion, TS demonstrates a definite sensitivity and specificity and has the value of recommending to the clinic for the early screening of cervical carcinoma.2) In this study, TS has the same diagnosis effect as TCT ,and better than conventional Pap and HPV. Contrasting diagnosis effect,the Parallel tests with TS is better than that without TS, but similar with TS alone and have no statistical differences.3) TS can clarify unsatisfactory cytology results and cytological test imply ASCUS results. For the cases whose cervical cytological test implied ASCUS, TS has potential to be used as a confirmatory detective method in clinical practice.