Evaluation of p16/Ki-67 dual staining in the detection of cervical precancer and cancer in China |
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| Institution: | 1. Division of Cancer Epidemiology and Genetics, US National Cancer Institute, Rockville, MD, United States;2. Department of Oncology, McGill University, Montréal, Québec, Canada;3. Department of Obstetrics & Gynecology, Dalhousie University, Halifax, Nova Scotia, Canada;4. Society of Obstetricians and Gynaecologists of Canada, Ottawa, Ontario, Canada;5. Département de microbiologie et infectiologie, Centre Hospitalier de l''Université de Montréal, Montréal, Québec, Canada;6. Department of Pathology and Laboratory Medicine, University of Calgary, Calgary, Alberta, Canada;7. Departments of Pathology, Obstetrics & Gynecology, McGill University, Montréal, Québec, Canada;8. Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada;9. Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, Ontario, Canada;10. Departments of Oncology, Obstetrics & Gynecology, McGill University, Montréal, Québec, Canada;11. Département d''obstétrique-gynécologie et Médecine Sociale et Préventive, Université de Montréal, Montréal, Québec, Canada;12. Department of Pathology and Laboratory Medicine, Western University, London, Ontario, Canada;13. Department of Obstetrics & Gynecology, University of Toronto, Toronto, Ontario, Canada;14. Departments of Family Practice, Obstetrics & Gynecology, University of British Columbia, Vancouver, British Columbia, Canada;15. Division of Community Health and Humanities, Faculty of Medicine, Memorial University, St. John''s, Newfoundland and Labrador, Canada;1. BD Diagnostics - Women''s Health and Cancer, Durham, NC, USA;2. Solstas Lab Partners, Greensboro, NC, USA |
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| Abstract: | Background This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining in the detection of cervical intraepithelial neoplasia grade 2 or 3 or worse (CIN2+/CIN3+) in Chinese women.Methods Cervical exfoliated cells were collected from 537 eligible women and were used for liquid-based cytology (LBC), p16/Ki-67 dual staining, and human papillomavirus (HPV) DNA testing. All women received colposcopy with biopsies taken at abnormal sites. Histopathological diagnoses were used as the gold standard.Results p16/Ki-67 staining had a positivity rate of 43.58% overall; the rate increased significantly with histological severity (p <0.001). The sensitivities of p16/ki-67 for detecting CIN2+ and CIN3+ were 88.10% and 91.30%, respectively. Compared with high-risk HPV (HR-HPV), sensitivity of p16/Ki-67 was lower for detecting CIN2+ (88.10% versus 95.71%), but similar for detecting CIN3+ (91.30% versus 96.27%). Specificities of p16/Ki-67 were 85.02% for detecting CIN2+ and 76.86% for detecting CIN3+, values similar to those for LBC (84.71% for CIN2+, 80.05% for CIN3+) but higher than those for HR-HPV (62.77% for CIN2+, 71.25% for CIN3+). All the tests performed better in women>30 years. With respect to the performance of triage for women with ASC-US, sensitivities of p16/Ki-67 were 86.36% for detecting CIN2+ and 83.33% for detecting CIN3+, values similar to those of HR-HPV. However, specificities of p16/Ki-67 were both higher than those of HR-HPV (85.96% versus 67.54% for CIN2+, 79.84% versus 62.90% for CIN3+).Conclusion P16/Ki-67 dual staining could probably provide an optional method for China’s national cervical cancer screening, and could also be considered as an efficient method of triage for managing women with ASC-US. |
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| Keywords: | Cervical cancer P16/Ki-67 dual staining Precancer Clinical performance China |
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