Study Of Comparing Cervista With Genotyping Detection Of The High-risk Human Papilloma Virus DNA

Objectives1.To evaluate the effectiveness and clinical signiifcance of High-risk HumanPapilloma virus DNA (Cervista HR HPV DNA) Detection Kit.2.To evaluate the effectiveness and clinical signiifcance of gene chips technologyfor the detection of HPV infection.3.To compare the consistency of Cervista HR HPV DNA test and gene chiptechnology.Methods328gynecological outpatients with abnormal cytology results (>AS-CUS) inFuzhou General Hospital of Nanjing Military Command of Chinese PLA from Jan.2012to Dec.2012were Collected, and randomly selected200cases with normalcytology as the control group. Detect the infection of HR-HPV with Cervista HR HPVDNA test and HPV DNA gene chip technology. Patients with abnormal cytologyresults wre proformed colposcopy and biopsy, pathological examination results aredivided into chronic inflammation, CIN I，CIN II，CIN III and cervical cancer.Investigate the validity of the Cervista test, and compare the consistency of Cervistatest and HPV genotyping test.Results1.The HPV positive rates in women with normal cytologic results were15.00%(30/200) and12.00%(24/200) for the Cervista and genotyping tests, respectively.2.The overall positive rate in women with AS-CUS or worse cytologic results was59.15%(194/328) for the Cervista test. HR-HPV positive rates in inflammation,CIN I，CIN II，CIN III and cervical cancer were49.59%(122/246)，82.50%(33/40)，92.31%(24/26)，93.33%(14/15) and100%(1/1), respectively. Thesensitivity, specificity, positive predictive value and negative predictive value of Cervista for CINII or worse were92.86%，45.80%，20.10%and97.76%. Thesensitivity of A5/A6，A7and A9group for CIN II or worse were66.67%，76.92%and88.88%，the specificity were86.75%，85.06%and53.91%.3.The total positive rate in women with AS-CUS or worse cytologic results was61.89%(203/328) for genotyping test. HR-HPV positive rates in inflammation,CIN I，CIN II，CIN III and cervical cancer were52.03%(128/246)，87.5%(35/40)，96.15%(25/26)，93.33%(14/15) and100%(1/1). The sensitivity,specificity, positive predictive value and negative predictive value of Cervista forCIN II or worse were95.24%，43.01%，19.70%and98.40%.4.There were no statistical differences between Cervista and genotyping tests inwomen with AS-CUS or worse cytologic results (尸>0.05). The consistency ofthe two detection methods is good. The total coincidence rate was94.21%inAS-CUS cytology results.Conclusions1.HR-HPV is an important pathogenic factor of the high-grade CIN and cervicalcancer. The infection rate of HPV is higher, and the cervical lesion may be moresevere. The severity of cervical lesions is positively related with detecion rate ofHPV DNA.2.The date from Cervista and genotyping tests was consistent. Cervista test hashighly sensitivity and specificity for CIN II or worse.It could be used as a reliablescreening tool in a clinical test.