Clinical investigation of taking Cervista high-risk human Papilloma virus DNA test and cytological test in the same sample

Abstract

Objective To explore the feasibility of taking Cervista high-risk human Papilloma virus DNA (Cervista HR HPVDNA) test and Thinprep cytologic test in the same sample, and to assess the availability and significance of Cervista HR HPVDNA in detecting HPV infection in people, also to study the correlation of Cervista A9 group with high grade cervical dysplasia and the value of HPV16/18 in diagnosing cervical dysplasia. Methods Totally 148 cases diagnosed in gynecology clinic during March to April, aging 20 to 65, cytological test ≥ASCUS (atypical squamous cells undetermined significance) were involved in the investigation group, and 153 cases with normal cytological test at the same time were involved in the control group. Cytological test and Cervista high-risk human Papilloma virus DNA test were implemented at the same time on two groups, cases with one of the test method tested abnormal were further biopsied under the colposcope if necessary. Results Cervista HR HPVDNA infection rate was 83.78% in the investigation group and 18.30% in the control group with statistic difference (P 0.05). We further founded that A9 group take the large proportion of Cervista HR HPVDNA infection, and co-infection by 2 or 3 genotypes tested in part grades and A9 group related with Pathology≥CINⅡ(P<0.05). The sensitivity, specificity, positive-predictive value and negative-predictive value of Cervista HR HPVDNA for detecting all cases of CINⅡ were 90.9%, 18.1%, 22.7%, and 88.2%, respectively. A portion (30.6%) of the Cervista HR HPVDNA positive cases showed HPV16/18 positive, while none showed in the Cervista HR HPVDNA negative cases. HPV16/18 infection rate in normal, CINⅠ, CINⅡ, CINⅢ, and Cervical carcinoma were 13.33%, 37.50%, 50.00%, 75%, and 100% with significant difference(Fisher exact Test P<0.05). Conclusions Cervista HR HPVDNA test was feasible as an Cervical carcinoma screening method. The method of combining Cervista HR HPVDNA test with cytological test in the same sample deserves promotion as its easy operating and definite effect. Key words: Biopsy; Uterine cervical neoplasms/DI; Papillomaviridae/ME