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Combined human papillomavirus DNA and human papillomavirus‐like particle serologic assay to identify women at risk for high‐grade cervical intraepithelial neoplasia

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. © 2006 Wiley‐Liss, Inc.