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BIBTEX RIS

Use of Cytology, E6/E7 mRNA, and p16 INK4a –Ki-67 to Define the Management of Human Papillomavirus (HPV)–Positive Women in Cervical Cancer Screening

2015; Oxford University Press; Volume: 145; Issue: 1 Linguagem: Inglês

10.1093/ajcp/aqv019

ISSN

1943-7722

Autores

Daniela Gustinucci, Paolo Giorgi Rossi, Elena Cesarini, Massimo Broccolini, Simonetta Bulletti, Angela Carlani, Valentina D’Angelo, Maria Rosaria D’Amico, Eugenio Di Dato, Paola Galeazzi, Morena Malaspina, Nadia Martinelli, Nicoletta Spita, Beatrice Tintori, Maria Donata Giaimo, Basilio Passamonti,

Tópico(s)

Molecular Biology Techniques and Applications

Resumo

We measured the accuracy of p16(INK4a)-Ki67 (CINtec PLUS, Roche, Mannheim, Germany), and E6/E7mRNA (types 16/18/31/33/45 NucliSENS easyQ, bioMérieux, Boxtel, The Netherlands) as triage test, alone and combined with cytology.Six thousand two hundred and seventy two women were recruited in a population-based screening using HPV DNA as primary test; 396 were positive and were tested for cytology and biomarkers. All tests were performed on the same sample. Cytology-positive women were referred to colposcopy; cytology-negative women were referred to one-year HPV re-testing. The endpoint was CIN2+ at baseline or follow up.Sensitivity was 77.6% (95% confidence interval (CI) 65.3-86.7) and 53.2% (95%CI: 40.3-65.4) for cytology at atypical squamous cells of undetermined significance (ASC-US) and high-grade threshold, and 87.6% (95%CI:75.7-93.6), and 80.8% (95%CI: 67.6-89.8) for p16INK4a-Ki67, and E6/E7mRNA, respectively. Colposcopy referral was 36% (95%CI: 31.2-40.9) and 11.2% (95%CI: 7.8-14.1) for cytology at ASC-US and high-grade threshold, respectively, and 36.0% (95%CI: 29.9-29.6), and 47.5% (95%CI: 32.5-42.4) for p16(INK4a)-Ki67, and E6/E7mRNA, respectively. Strategies referring high-grade cytology or biomarker positive women to colposcopy reached sensitivity close to 100%, with modest increase in colposcopy referral.The high sensitivity of combined strategies probably allows longer intervals in HPV-positive, triage-negative women.

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