Human Papillomavirus genotype testing combined with cytology as a ‘test of cure’ post treatment: The importance of a persistent viral infection |
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Authors: | Joanne Jones Azka Saleem Nima Rai TS Shylasree Suzanne Ashman Kate Gregory Ned Powell Amanda Tristram Alison Fiander Samantha Hibbitts |
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Institution: | aDepartment of Obstetrics & Gynaecology, School of Medicine, Cardiff University, Heath Park, Cardiff CF14 4XN, United Kingdom;bRoyal Victoria Infirmary, Queen Victoria Road, Newcastle upon Tyne NE1 4LP, United Kingdom;cUniversity Hospital Llandough, Penlan Road, Llandough CF64 2XX, United Kingdom;dCervical Screening Wales, 18 Cathedral Rd, Cardiff CF11 9LH, United Kingdom |
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Abstract: | BackgroundHuman Papillomavirus (HPV) testing has been evaluated as a test of cure in patients following treatment of high-grade cervical intraepithelial neoplasia (CIN2+). Studies show that women who are HPV and cytology negative post treatment can be safely returned to routine recall. The management strategy for HPV positive women requires confirmation.ObjectiveTo evaluate the clinical utility of the PapilloCheck® genotyping assay for predicting disease recurrence in a test of cure setting.Study designNinety-eight women (19–52 years) treated for CIN2+ by large loop excision of the transformation zone (LLETZ) were evaluated with samples taken before and 6 months after treatment for HPV testing. Cytology and histology were available from recruitment until 24 months post treatment.ResultsRecurrent disease was evident in 4% of patients with 2 cases low-grade and 2 cases of high-grade disease. In women with no disease recurrence, 40% (95% CI 30.42–51.05%) were high risk (HR) HPV negative post LLETZ. Both cases with high-grade disease had persistent HPV16 infection. Genotyping before and after treatment revealed 83% (95% CI 75.74–88.78%) of total viral infections were cleared and 17% (95% CI 11.22–24.26) viral infections persisted. Post treatment, combined cytology and HPV test results predicted CIN2+ with 100% sensitivity, 91.7% specificity, 100% NPV and 20% PPV and measuring viral persistence marginally increased specificity and PPV.ConclusionPost treatment, cytology combined with a single HR HPV test has high sensitivity and specificity for predicting disease recurrence. HPV genotyping before and after LLETZ identifies persistent viral infections and could help refine patient management. |
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Keywords: | Abbreviations: HPV Human Papillomavirus CIN2+ high-grade cervical intraepithelial neoplasia LLETZ large loop excision of the transformation zone CI confidence interval HR high risk NPV negative predictive value PPV positive predictive value CSW Cervical Screening Wales LBC liquid based cytology QC quality control |
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