title: Combined human papillomavirus DNA and human papillomavirus-like particle serologic assay to identify women at risk for high-grade cervical intraepithelial neoplasia.
abstract: The objective of this study was to assess the utility of a second generation human papillomavirus (HPV) virus-like particle (VLP)-based ELISA as an adjunct to HPV DNA testing to identify women at risk for high-grade cervical intraepithelial neoplasia (CIN). Participants provided blood, cervical samples and interviewer-obtained questionnaire information. HPV VLPs for types 16, 18, 33, 45 and 52 were produced using a baculovirus expression system. These highly purified VLPs were used in a polymer-based ELISA test. Cases with biopsy-confirmed CIN (CIN I, n = 237; CIN II, n = 56; CIN III, n = 48) and controls (n = 351) with normal Pap smears were tested for HPV DNA by PCR and serologic response to multiple oncogenic HPV VLPs. 258/341 (76%) of cases and 230/351 (65.5%) of control patients had any type of HPV VLP antibody (OR = 1.63, 95% CI 1.16-2.30). More cases were seropositive than controls for each individual HPV type (p < 0.001 for HPV types 16, 18, 33 and 45; p = 0.06 for HPV 52). Reactivity to an increasing number of different HPV type-specific VLPs are associated with high-grade CIN independent of HPV DNA status. HPV VLP assays may be useful as an adjunct to HPV DNA testing in a subset of patients that needs to be defined by further studies.
authors.affiliation: Albert Einstein College of Medicine, Bronx, NY 10461, USA. meinstei@montefiore.org
authors.forename: Mark H
authors.initials: MH
authors.lastname: Einstein
authors.forename: Yevgeniy Y
authors.initials: YY
authors.lastname: Studentsov
authors.forename: Gloria Y F
authors.initials: GY
authors.lastname: Ho
authors.forename: Melissa
authors.initials: M
authors.lastname: Fazzari
authors.forename: Morgan
authors.initials: M
authors.lastname: Marks
authors.forename: Anna S
authors.initials: AS
authors.lastname: Kadish
authors.forename: Gary L
authors.initials: GL
authors.lastname: Goldberg
authors.forename: Carolyn D
authors.initials: CD
authors.lastname: Runowicz
authors.forename: Robert D
authors.initials: RD
authors.lastname: Burk
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D000956:Antigens, Viral / Q000276:immunology; D016022:Case-Control Studies; D004279:DNA, Viral / Q000235:genetics*; D004268:DNA-Binding Proteins; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D009856:Oncogene Proteins, Viral / Q000276:immunology; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics* / Q000276:immunology*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology*; D018570:Risk Assessment; D014157:Transcription Factors; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology*; D014626:Vaginal Smears; D019562:Viral Load; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology*
chemical_list: D000914:Antibodies, Viral; D000956:Antigens, Viral; D004279:DNA, Viral; D004268:DNA-Binding Proteins; D009856:Oncogene Proteins, Viral; D014157:Transcription Factors; C484332:ZNF395 protein, human