title: HPV genotyping for triage of women with abnormal cervical cancer screening results: a multicenter prospective study.
abstract: BACKGROUND
  In cervical cancer screening programs, women with abnormal cytology are referred for colposcopy for histological evaluation. We examined whether a human papillomavirus (HPV) genotyping assay could be used to identify women who do not need immediate colposcopy and biopsy because of low risk of cervical intraepithelial neoplasia grade 3 or worse (CIN3+).
  
  
  METHODS
  We prospectively evaluated test performance for 2 carcinogenic HPV genotypes (HPV16/18), for 8 types (HPV16/18/31/33/35/45/52/58), and for 13 types (HPV16/18/31/33/35/45/51/52/56/58/59/68) for prediction of histological CIN3+ results among 427 screen-positive women referred for colposcopy. The study subjects consisted of 214 women with low-grade squamous intraepithelial lesion (LSIL), 184 with high-grade squamous intraepithelial lesion (HSIL), and 29 with atypical squamous cells, cannot exclude HSIL (ASC-H).
  
  
  RESULTS
  Among women with LSIL cytology, HPV16/18 positivity was 29.4 % and increased to 58.9 % for 8 types and to 74.8 % for 13 types (P < 0.001). The risk of CIN3+ biopsy results was still 7.9 % for women testing negative for HPV16/18, but decreased to 0.0 % for those testing negative for at least eight types of HPV (HPV16/18/31/33/35/45/52/58). Although HPV genotyping results enabled additional risk stratification among women with HSIL/ASC-H cytology, the risk of histological CIN3+ diagnosis among women testing negative for eight types or more was still sufficiently high (>35 %) to warrant immediate colposcopy referral.
  
  
  CONCLUSIONS
  Of women with LSIL cytology, those testing negative for at least eight of the highest-risk types of HPV (HPV16/18/31/33/35/45/52/58) may not need immediate colposcopy and biopsy. This would reduce the number of colposcopy referrals by approximately 40 %. However, the HPV genotyping assay is not likely to alter the clinical management of women with HSIL/ASC-H.
authors: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan.|Department of Pathology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan.
authors: Yuko
authors: Y
authors: Nakamura
authors: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan. matsumok@mui.biglobe.ne.jp.
authors: Koji
authors: K
authors: Matsumoto
authors: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan.
authors: Toyomi
authors: T
authors: Satoh
authors: Department of Gynecology, Tsukuba Medical Center Hospital, Tsukuba, 305-8558, Japan.
authors: Ken
authors: K
authors: Nishide
authors: Department of Gynecology, Tsukuba Medical Center Hospital, Tsukuba, 305-8558, Japan.
authors: Akiko
authors: A
authors: Nozue
authors: Department of Obstetrics and Gynecology, Tsuchiura Kyodo General Hospital, Tsuchiura, 300-0053, Japan.
authors: Koji
authors: K
authors: Shimabukuro
authors: Department of Obstetrics and Gynecology, Tsuchiura Kyodo General Hospital, Tsuchiura, 300-0053, Japan.
authors: Seiichi
authors: S
authors: Endo
authors: Department of Gynecology, Ibaraki Prefectural Central Hospital, Kasama, 309-1793, Japan.
authors: Kimihiro
authors: K
authors: Nagai
authors: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan.|Department of Gynecology, Ibaraki Prefectural Central Hospital, Kasama, 309-1793, Japan.
authors: Akinori
authors: A
authors: Oki
authors: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan.
authors: Hiroyuki
authors: H
authors: Ochi
authors: Department of Pathology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan.
authors: Yukio
authors: Y
authors: Morishita
authors: Department of Pathology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan.
authors: Masayuki
authors: M
authors: Noguchi
authors: Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, 305-8575, Japan.
authors: Hiroyuki
authors: H
authors: Yoshikawa
mesh_terms: D000328:Adult; D065309:Atypical Squamous Cells of the Cervix / Q000473:pathology*; D003127:Colposcopy; D003581:Cytodiagnosis; D055088:Early Detection of Cancer; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics*; D011446:Prospective Studies; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000473:pathology* / Q000821:virology; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000821:virology; D014626:Vaginal Smears
keywords: Cervical cancer; Cervical intraepithelial neoplasia; Colposcopy; Genotyping; Human papillomavirus; Low-grade squamous intraepithelial lesion
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