title: Clinical Performance of APTIMA Human Papillomavirus (HPV) 16 18/45 mRNA Genotyping Testing for the Detection of Cervical Intraepithelial Neoplasia 3 (CIN3) or Cancer in a Select Group of Chinese Women.
abstract: HPV type was evaluated in a select group of Chinese women that were positive with hybrid capture, and correlations were performed between the pathology found, the type of virus and a semiquantitation from the hybrid capture results. Totally 394 referred high-risk-HPV-positive women evaluated by Hybrid Capture 2 (HC-2) assay were enrolled. Before colposcopy, cervical specimens were collected from all participants and suspended into PreservCytcollection medium (Hologic Inc., Marlborough, MA), and tested with the APTIMA HPV16 18/45 mRNA assay. Colposcopy and diagnostic biopsies were done on all participants. Viral load was assessed by HC2 assay. Totally 55 women were diagnosed as CIN 3 plus cancer (≥CIN3), and the prevalence of HPV16/18/45 was 65.5 % (95 % confidence interval [CI], 52.9-78.0 %) among these ≥CIN3 women. Compared with the group with positive HC2 but negative HPV16/18/45, the odds ratio (OR) to identify ≥CIN3 was 6.3 (95 % CI, 3.2-12.3) for HPV16 and 3.2 (95 % CI, 1.4-7.2) for HPV18/45. When using ≥CIN3 as an endpoint, the sensitivity and specificity was 65.5 % (95 % CI, 52.9-78.0 %) and 72.0 % (95 % CI, 67.2-76.8 %). In the case of HPV16/18/45 negative, no high HPV load had a statistically significant increased risk for the prevalence of ≥CIN3. HPV16, 18 and 45 infection is a major cause for ≥CIN3 in Chinese women. Women with positive HPV16/18/45 should be referred to colposcopy immediately. HPV load was not suitable for the further triaged of the HPV16/18/45 negative cases.
authors.affiliation: Department of Obstetrics and Gynecology, Peking University Third Hospital, Number 49 Huayuanbei Road Haidian District, Beijing, 100191, China.
authors.forename: Yan-Li
authors.initials: YL
authors.lastname: Guo
authors.affiliation: Department of Obstetrics and Gynecology, Peking University Third Hospital, Number 49 Huayuanbei Road Haidian District, Beijing, 100191, China.
authors.forename: Ke
authors.initials: K
authors.lastname: You
authors.affiliation: Department of Obstetrics and Gynecology, Peking University Third Hospital, Number 49 Huayuanbei Road Haidian District, Beijing, 100191, China. gengli57@163.com.
authors.forename: Li
authors.initials: L
authors.lastname: Geng
authors.affiliation: Department of Obstetrics and Gynecology, Peking University Third Hospital, Number 49 Huayuanbei Road Haidian District, Beijing, 100191, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Qiao
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D001681:Biological Assay / Q000379:methods; D001706:Biopsy / Q000379:methods; D003127:Colposcopy / Q000379:methods; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000821:virology*; D012333:RNA, Messenger / Q000235:genetics*; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000821:virology*; D014626:Vaginal Smears / Q000379:methods; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000821:virology*
chemical_list: D004279:DNA, Viral; D012333:RNA, Messenger
keywords: Cervical cancer; HPV mRNA genotyping; Human papillomavirus; Screening