title: Usefulness of hybrid capture HPV DNA assay as a diagnostic tool for human papillomavirus infection.
abstract: The purpose of this study was to determine the usefulness of the hybrid capture HPV DNA assay, a new nonradioactive solution hybridization assay, as a diagnostic tool for human papillomavirus infection. In a total of 234 women, samples for the hybrid capture assay and polymerase chain reaction (PCR) assay were obtained by wiping a swab across the cervix and external os (either a Dacron swab or a cotton swab was used). The papanicolaou smear test (Pap smear) was carried out on all 234 women. Tissue samples for biopsy were obtained by colposcopy from 118 of the women. Fisher exact test was used for statistical analyses. Using the hybrid capture assay, HPV DNA of high- and intermediate-oncogenic-risk type was detected in 23 (13.9%) of 166 samples from women with Pap smear Class I or II, and 48 (70.6%) of 68 with Pap smear Class III, IV or V (p < 0.0001). The HPV DNA type was detected in 18 (29.0%) of 62 samples from those with no evidence of cervical intraepithelial neoplasia and 44 (78.6%) of 56 with cervical intraepithelial neoplasia or squamous cell carcinoma (p < 0.0001). Correlation of the test results between the hybrid capture test and PCR was determined by using the 217 samples in which both test results were available (PCR test results were not obtainable in 17 samples. When PCR is set as a gold standard, the hybrid capture test has high sensitivity (74.6%) and specificity (92.7%). These findings suggest that the hybrid capture HPV DNA assay is a useful method for diagnosing HPV infection in the clinic.
authors.affiliation: Department of Obstetrics and Gynecology, Juntendo University, Chiba, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Kubota
authors.forename: K
authors.initials: K
authors.lastname: Ishi
authors.forename: M
authors.initials: M
authors.lastname: Suzuki
authors.forename: S
authors.initials: S
authors.lastname: Utsuno
authors.forename: J
authors.initials: J
authors.lastname: Igari
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009693:Nucleic Acid Hybridization / Q000379:methods*; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis*; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D014412:Tumor Virus Infections / Q000175:diagnosis*; D014626:Vaginal Smears
chemical_list: D004279:DNA, Viral