Comparing triage algorithms using HPV DNA genotyping,HPV E7 mRNA detection and cytology in high-risk HPV DNA-positive women |
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| Affiliation: | 1. Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA;2. Division of Biostatistics and Epidemiology, Cincinnati Children''s Hospital Medical Center, Cincinnati, OH, USA;3. Department of Obstetrics and Gynecology, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA;4. Biosciences Division, Center for Cancer & Metabolism, SRI International, USA;5. Department of Nutrition Sciences, School of Nutrition, University of Alabama at Birmingham, Birmingham, AL, USA;1. Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO, USA;2. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;3. Department of Pathology and Obstetrics, University of California, San Francisco, CA, USA;4. Department of Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA;5. Maimonides Medical Center, Brooklyn, NY, USA;6. Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA;7. Division of Infectious Diseases and Travel Medicine, Department of Medicine, Georgetown University, Washington, DC, USA;8. University of Southern California, Los Angeles, CA, USA;9. Department of Preventive Medicine and Center for Healthcare Studies, Northwestern University, Chicago, IL, USA;10. Department of Veterans Affairs Center of Innovation for Complex Chronic Healthcare, Edward Hines J. VA Hospital, Hines, IL, USA;1. Department of Cytopathology, The Third Affiliated Hospital of Zhengzhou University, No. 7 Front Kangfu Street, Er''qi District, Zhengzhou 450052, China;2. The Cancer Hospital Affiliated to Zhengzhou University, No. 127 Dongming Street, Jinshui District, Zhengzhou 450008, China;3. The Second Affiliated Hospital of Zhengzhou University, No. 2 Jingba Street, Guancheng Hui District, Zhengzhou 450014, China |
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| Abstract: | BackgroundHigh-risk human papillomavirus (hrHPV) DNA positive women require triage testing to identify those with high-grade cervical intraepithelial neoplasia or cancer (≥CIN2).ObjectiveComparing three triage algorithms (1) E7 mRNA testing following HPV16/18/31/33/45/52/58 genotyping (E7 mRNA test), (2) HPV16/18 DNA genotyping and (3) cytology, for ≥CIN2 detection in hrHPV DNA-positive women.Study designhrHPV DNA-positive women aged 18–63 years visiting gynecology outpatient clinics were included in a prospective observational cohort study. From these women a cervical scrape and colposcopy-directed biopsies were obtained. Cervical scrapes were evaluated by cytology, HPV DNA genotyping by bead-based multiplex genotyping of GP5+6+-PCR-products, and presence of HPV16/18/31/33/45/52/58 E7 mRNA using nucleic acid sequence-based amplification (NASBA) in DNA positive women for respective HPV types. Sensitivities and specificities for ≥CIN2 were compared between E7 mRNA test and HPV16/18 DNA genotyping in the total group (n = 348), and E7 mRNA test and cytology in a subgroup of women referred for non-cervix-related gynecological complaints (n = 133).ResultsSensitivity for ≥CIN2 of the E7 mRNA test was slightly higher than that of HPV16/18 DNA genotyping (66.9% versus 60.9%; ratio 1.10, 95% CI: 1.0002–1.21), at similar specificity (54.8% versus 52.3%; ratio 1.05, 95% CI: 0.93–1.18). Neither sensitivity nor specificity of the E7 mRNA test differed significantly from that of cytology (sensitivity: 68.8% versus 75.0%; ratio 0.92, 95% CI: 0.72–1.17; specificity: 59.4% versus 65.3%; ratio 0.91, 95% CI: 0.75–1.10).ConclusionFor detection of ≥CIN2 in hrHPV DNA-positive women, an algorithm including E7 mRNA testing following HPV16/18/31/33/45/52/58 DNA genotyping performs similar to HPV16/18 DNA genotyping or cytology. |
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| Keywords: | Human papillomavirus Triage E7 mRNA Genotyping Cytology Cervical cancer |
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